ContenidosdeElseviersobremedicamentos

TRANSFORME LA FORMA DE USAR LA INFORMACIÓN SOBRE MEDICAMENTOS

¡Conozca más acerca de la información sobre medicamentos de Elsevier hoy mismo! Obtenga los datos sobre medicamentos y el apoyo para la toma de decisiones que necesita, incluidas TRUE Daily Updates™, información actualizada todos los días, incluidos fines de semana y festivos.

Feb.06.2024

Immune Globulin IV, IVIG, IGIV

Indications/Dosage

Labeled

  • agammaglobulinemia
  • bacterial infection prophylaxis
  • chronic inflammatory demyelinating polyneuropathy (CIDP)
  • dermatomyositis
  • hypogammaglobulinemia
  • immune thrombocytopenic purpura (ITP)
  • Kawasaki disease
  • measles prophylaxis
  • multifocal motor neuropathy

General dosing information

  • Immune globulin products are not pharmaceutically equivalent but are considered to have comparable efficacy. For patients receiving chronic immune globulin therapy, consider product changes carefully; begin with conservative infusion times and increase monitoring if products are substituted.[53366]
  • In general, immune globulin should be dosed based on actual body weight in patients weighing up to 100 kg with a body mass index (BMI) less than 30 kg/m2. Some experts recommend using adjusted body weight for dosing immune globulin if the patient exceeds these parameters or is greater than 20% over their ideal body weight.[53364][53365]

Off-Label

  • acute disseminated encephalomyelitis
  • encephalitis
  • Guillain-Barre syndrome
  • hyperbilirubinemia
  • multisystem inflammatory syndrome in children (MIS-C)
  • myasthenia gravis
  • myocarditis
  • pemphigus
  • pericarditis
  • polymyositis
  • post-transfusion purpura
  • respiratory syncytial virus (RSV) infection
  • sepsis
  • Stevens-Johnson syndrome
  • tetanus
  • thrombocytopenia
  • toxic epidermal necrolysis
  • varicella (chickenpox) infection prophylaxis
† Off-label indication

For the treatment of primary immunodeficiency (e.g., agammaglobulinemia or hypogammaglobulinemia)

Intravenous dosage (Alyglo)

Adults

300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response.[70019]

Adolescent 17 years

300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response.[70019]

Intravenous dosage (Asceniv)

Adults

300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration. The target trough is at least 600 mg/dL. The dose may be proportionally adjusted starting with the second infusion using the patient's trough concentration and initial dose.[64039]

Children and Adolescents 12 to 17 years

300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration. The target trough is at least 600 mg/dL. The dose may be proportionally adjusted starting with the second infusion using the patient's trough concentration and initial dose.[64039]

Intravenous dosage (Bivigam or Gammaplex)

Adults

300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[42658] [42661]

Children and Adolescents 2 to 17 years

300 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[42658] [42661]

Intravenous dosage (Carimune NF)

Adults

400 to 800 mg/kg/dose IV every 3 to 4 weeks. The first infusion of Carimune NF in previously untreated agammaglobulinemic or hypogammaglobulinemic patients must be given as a 3% solution; if tolerated, subsequent infusions may be administered at a higher concentration.[42654]

Infants, Children, and Adolescents

400 to 800 mg/kg/dose IV every 3 to 4 weeks. The first infusion of Carimune NF in previously untreated agammaglobulinemic or hypogammaglobulinemic patients must be given as a 3% solution; if tolerated, subsequent infusions may be administered at a higher concentration.[42654]

Intravenous dosage (Flebogamma 5%, Gammagard Liquid, Gammagard S/D, Gammaked, Gamunex-C, Panzyga)

Adults

300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[41552] [42655] [42955] [46250] [51240] [63463]

Children and Adolescents 2 to 17 years

300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[41552] [42655] [42955] [46250] [51240] [63463]

Intravenous dosage (Flebogamma 10%)

Adults

300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response.[41553]

Intravenous dosage (Octagam 5%)

Adults

300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[30276]

Children and Adolescents 6 to 17 years

300 to 600 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[30276]

Intravenous dosage (Privigen)

Adults

200 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[42659]

Children and Adolescents 3 to 17 years

200 to 800 mg/kg/dose IV every 3 to 4 weeks. Adjust dose and frequency based on clinical response and desired IgG trough concentration.[42659]

Subcutaneous dosage (Gammagard Liquid 10%)

Adults

Subcutaneous doses are based on the previously established intravenous IVIG dose. Initially, convert the dose by multiplying the current IVIG dose in grams by 1.37, then divide by the number of weeks between IV doses (e.g., if IVIG is administered every 3 weeks, divide by 3). Start the initial subcutaneous dose approximately 1 week after the last IV infusion and administer weekly. Obtain an IgG trough concentration prior to converting from IV to subcutaneous treatment to guide dosage adjustments. Adjust dose and frequency based primarily on clinical response; desired IgG trough concentration should also be considered. Calculate the difference between the patient's target IgG trough concentration and the actual IgG trough concentration during subcutaneous administration. Use the table provided in the product-specific package insert to adjust the dose based on this difference and the patient's body weight.[42655]

Children and Adolescents 2 to 17 years

Subcutaneous doses are based on the previously established intravenous IVIG dose. Initially, convert the dose by multiplying the current IVIG dose in grams by 1.37, then divide by the number of weeks between IV doses (e.g., if IVIG is administered every 3 weeks, divide by 3). Start the initial subcutaneous dose approximately 1 week after the last IV infusion and administer weekly. Obtain an IgG trough concentration prior to converting from IV to subcutaneous treatment to guide dosage adjustments. Adjust dose and frequency based primarily on clinical response; desired IgG trough concentration should also be considered. Calculate the difference between the patient's target IgG trough concentration and the actual IgG trough concentration during subcutaneous administration. Use the table provided in the product-specific package insert to adjust the dose based on this difference and the patient's body weight.[42655]

Subcutaneous dosage (Gammaked or Gamunex-C)

Adults

Subcutaneous doses are based on the previously established intravenous IVIG dose. Initially, convert the dose by multiplying the current IVIG dose in grams by 1.37, then divide by the number of weeks between IV doses (e.g., if IVIG is administered every 3 weeks, divide by 3). To convert the calculated initial subcutaneous dose in grams to mL, multiply by 10. Start the initial subcutaneous dose 1 week after the last IV infusion and administer weekly. Obtain an IgG trough concentration prior to converting from IV to subcutaneous treatment to guide dosage adjustments. Adjust dose and frequency based primarily on clinical response; desired IgG trough concentration should also be considered. An IgG trough concentration may be measured as early as 5 weeks after switching from IV to subcutaneous administration. Calculate the difference between the patient's target IgG trough concentration and the actual IgG trough concentration during subcutaneous administration. The projected target trough level is the last IVIG trough level plus 340 mg/dL. Use the table provided in the product-specific package insert to adjust the dose based on this difference and the patient's body weight. To determine whether further dosage adjustments are necessary, monitor IgG trough concentration every 2 to 3 months.[51240] [54820]

Children and Adolescents 2 to 17 years

Subcutaneous doses are based on the previously established intravenous IVIG dose. Initially, convert the dose by multiplying the current IVIG dose in grams by 1.37, then divide by the number of weeks between IV doses (e.g., if IVIG is administered every 3 weeks, divide by 3). To convert the calculated initial subcutaneous dose in grams to mL, multiply by 10. Start the initial subcutaneous dose 1 week after the last IV infusion and administer weekly. Obtain an IgG trough concentration prior to converting from IV to subcutaneous treatment to guide dosage adjustments. Adjust dose and frequency based primarily on clinical response; desired IgG trough concentration should also be considered. An IgG trough concentration may be measured as early as 5 weeks after switching from IV to subcutaneous administration. Calculate the difference between the patient's target IgG trough concentration and the actual IgG trough concentration during subcutaneous administration. The projected target trough level is the last IVIG trough level plus 340 mg/dL. Use the table provided in the product-specific package insert to adjust the dose based on this difference and the patient's body weight. To determine whether further dosage adjustments are necessary, monitor IgG trough concentration every 2 to 3 months.[51240] [54820]

For the treatment of immune thrombocytopenic purpura (ITP)

NOTE: Carefully consider the relative risks and benefits before prescribing the higher dose regimen (e.g., 1 g/kg) in patients at increased risk of thrombosis, hemolysis, acute kidney injury, or volume overload.

Intravenous dosage (general neonatal dosing)

Neonates

1 g/kg/dose IV once daily for 2 consecutive days. Alternatively, 400 mg/kg/dose IV once daily for 5 consecutive days may be administered. Monitor closely until there is a sustained rise in the platelet count into the normal range. It is important to note that the platelet count in all neonates falls during the first 4 to 7 days of life.[53269] [53270] [53271]

Intravenous dosage (Carimune NF)

Adults

400 mg/kg/dose IV once daily given for 2 to 5 consecutive days. If the platelet count falls less than 30,000/microliter or the patient manifests clinically significant bleeding after induction therapy, 400 mg/kg/dose IV may be given as a single infusion. If an adequate response does not result, the dose can be increased to 800 mg/kg/dose to 1 g/kg/dose IV given as a single infusion.[42654]

Infants, Children, and Adolescents

800 mg/kg/dose to 1 g/kg/dose IV once daily for 2 consecutive days; if platelet count is adequate (30,000 to 50,000/microliter) 24 hours after the initial dose, therapy may be discontinued. Alternatively, 400 mg/kg/dose IV once daily for 2 to 5 consecutive days may be administered. If the platelet count falls below 30,000/microliter or there is clinically significant bleeding after induction therapy, give 400 mg/kg/dose IV as a single infusion. If adequate response does not result, the dose can be increased to 800 mg/kg/dose to 1 g/kg/dose IV administered as a single infusion. May administer intermittently as needed to maintain adequate platelet count.[42654] [46250] [53266] [53267] [53268] [53448] [53449]

Intravenous dosage (Flebogamma 10%)

Adults

1 g/kg/dose IV once daily for 2 consecutive days.[41553]

Children and Adolescents 2 years and older

1 g/kg/dose IV once daily for 2 consecutive days.[41553]

Intravenous dosage (Gammagard S/D)

Adults

1 g/kg IV as a single dose. If the patient's response is inadequate, 1 g/kg/dose IV may be administered on alternate days for up to 3 doses.[42955]

Intravenous dosage (Gammaked)

Adults

400 mg/kg/dose IV given on 5 consecutive days. Alternatively, 1 g/kg/dose IV once daily for 2 consecutive days. If after the administration of the first dose, an adequate increase in the platelet count is observed at 24 hours, the second dose may be withheld.[46250]

Infants, Children, and Adolescents

800 mg/kg/dose to 1 g/kg/dose IV once daily for 2 consecutive days; if platelet count is adequate (30,000 to 50,000/microliter) 24 hours after the initial dose, therapy may be discontinued. Alternatively, 400 mg/kg/dose IV once daily for 2 to 5 consecutive days may be administered. If the platelet count falls below 30,000/microliter or there is clinically significant bleeding after induction therapy, give 400 mg/kg/dose IV as a single infusion. If adequate response does not result, the dose can be increased to 800 mg/kg/dose to 1 g/kg/dose IV administered as a single infusion. May administer intermittently as needed to maintain adequate platelet count.[42654] [46250] [53266] [53267] [53268] [53448] [53449]

Intravenous dosage (Gamunex-C)

Adults

400 mg/kg/dose IV once daily for 5 consecutive days. Alternatively, 1 g/kg/dose IV once daily for 2 consecutive days may be administered; if platelet count is adequate 24 hours after the initial 1 g/kg dose, therapy may be discontinued.[51240]

Infants, Children, and Adolescents

400 mg/kg/dose IV once daily for 5 consecutive days. Alternatively, 1 g/kg/dose IV once daily for 2 consecutive days may be administered; if platelet count is adequate 24 hours after the initial 1 g/kg dose, therapy may be discontinued.[51240] [53266] [53267] [53268]

Intravenous dosage (Gammaplex 5%)

Adults

1 g/kg/day IV given on 2 consecutive days (total of 2 g/kg). Adequate data on the platelet response after 400 mg/kg/day for 5 consecutive days are not available for Gammaplex.[42661]

Intravenous dosage (Gammaplex 10%)

Adults

1 g/kg/day IV given on 2 consecutive days (total of 2 g/kg). Adequate data on the platelet response after 400 mg/kg/day for 5 consecutive days are not available for Gammaplex.[61745]

Intravenous dosage (Octagam 10%)

Adults

1 g/kg/dose IV once daily for 2 consecutive days.[57655]

Intravenous dosage (Privigen)

Adults

1 g/kg/day IV for 2 consecutive days (total of 2 g/kg).[42659]

Adolescents 15 years and older

1 g/kg/day IV for 2 consecutive days (total of 2 g/kg).[42659]

Intravenous dosage (Panzyga)

Adults

1 g/kg/day IV for 2 consecutive days (total of 2 g/kg).[63463]

For bacterial infection prophylaxis in immunocompromised patients

for the prevention of bacterial infections in patients with hypogammaglobulinemia and/or recurrent bacterial infections associated with B-cell Chronic Lymphocytic Leukemia (CLL)

Intravenous dosage (Gammagard S/D)

Adults, Adolescents, and Children

400 mg/kg/dose IV given every 3 to 4 weeks.[42955]

for the prevention of serious bacterial infections in hematopoietic cell transplantation (HCT) recipients with severe hypogammaglobulinemia (immunoglobulin G less than 400 mg/dL)†

Intravenous dosage

Infants and Children (first 100 days post-HCT)

400 mg/kg/dose IV once monthly. Monitor IgG trough concentration every 2 weeks during IVIG therapy, and adjust dose and frequency to maintain a IgG concentration greater than 400 mg/dL. In general, the half-life of IVIG among HCT patients is much shorter than that of healthy patients; larger doses may be required.[51812]

Infants and Children (beyond 100 days post-HCT)

500 mg/kg/dose IV every 3 to 4 weeks.[51812]

Adults and Adolescents (first 100 days post-HCT)

500 mg/kg/dose IV once weekly. Monitor IgG trough concentration every 2 weeks during IVIG therapy; adjust dose and frequency to maintain a IgG concentration greater than 400 mg/dL. In general, the half-life of IVIG among HCT patients is much shorter than that of healthy patients; larger doses may be required.[51812]

Adults and Adolescents (beyond 100 days post-HCT)

500 mg/kg/dose IV every 3 to 4 weeks.[51812]

for the prevention of serious bacterial infections in HIV-infected patients who have hypogammaglobulinemia (immunoglobulin G less than 400 mg/dL)†

Intravenous dosage

Infants and Children

400 mg/kg/dose IV every 2 to 4 weeks.[34361]

For measles prophylaxis in patients with immunoglobulin deficiency who have been exposed to measles or are at risk of measles exposure

Intravenous dosage (Alyglo)

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[70019]

Adolescents 17 years

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[70019]

Intravenous dosage (Flebogamma 5%, Gammagard Liquid, Gammagard S/D, Gammaplex, or Panzyga)

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[41552] [42661] [42955] [55005] [63463]

Children and Adolescents 2 to 17 years

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[41552] [42661] [42955] [55005] [63463]

Intravenous dosage (Flebogamma 10%)

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[41553] [55005]

Intravenous dosage (Gammaked and Gamunex-C)

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 400 mg/kg/dose IV every 3 to 4 weeks, administer at least 400 mg/kg IV as single dose immediately prior to expected exposure.[46250] [51240] [55005]

Children and Adolescents 2 to 17 years

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 400 mg/kg/dose IV every 3 to 4 weeks, administer at least 400 mg/kg IV as single dose immediately prior to expected exposure.[46250] [51240] [55005]

Intravenous dosage (Privigen)

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[42659] [55005]

Children and Adolescents 3 to 17 years

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[42659] [55005] [61745]

Intravenous dosage (Octagam 5%)

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[30276] [55005]

Children and Adolescents 6 to 17 years

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks. If a patient is at risk of future measles exposure and receives less than 530 mg/kg/dose IV every 3 to 4 weeks, increase the dose to at least 530 mg/kg/dose (to provide a serum concentration of 240 milli-International Units/mL of measles antibodies for at least 22 days after infusion).[30276] [55005]

Intravenous dosage (Asceniv, Bivigam, Carimmune NF, or Octagam 10%)†

Adults

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks.[30276] [55005]

Infants, Children, and Adolescents

400 mg/kg IV as a single dose as soon as possible and within 6 days of exposure. This dose should provide a serum concentration more than 240 milli-International Units/mL of measles antibodies for at least 2 weeks.[30276] [55005]

For the treatment of Kawasaki disease

Intravenous dosage (Gammagard S/D)

Infants, Children, and Adolescents

1,000 mg/kg/dose IV as a single dose or 400 mg/kg/dose IV once daily for 4 consecutive days beginning within 7 days of fever onset. Administer concurrently with moderate- to high-dose aspirin.[42955]

Intravenous dosage (all products† except Gammagard S/D)

Infants, Children, and Adolescents

2,000 mg/kg/dose IV as a single dose within 10 days of illness onset but as soon as possible after diagnosis. Administer concurrently with moderate- to high-dose aspirin. Treat children presenting after day 10 of illness if they have unexplained persistent fever or coronary artery abnormalities with ongoing systemic inflammation (e.g., elevated ESR and CRP). Consider a second dose if persistent or recrudescent fever at least 36 hours after completion of the initial IVIG infusion.[61950]

For the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability and impairment

NOTE: Some patients may not require continued maintenance therapy beyond 6 months to maintain therapeutic response. Maintenance therapy beyond 6 months has not been studied.[42655] [51240] [54820] [63463] [42659]

Intravenous dosage (General dosing, all products)

Adults

2 g/kg IV loading dose in divided doses over 2 to 5 consecutive days, followed by maintenance dose of 1 g/kg/dose IV every 3 weeks. A maintenance dose range of 0.4 to 1 g/kg/dose IV every 2 to 6 weeks may be considered.[53272] [70243] [70246]

Children† and Adolescents†

2 g/kg IV loading dose in divided doses over 2 to 5 consecutive days, followed by maintenance dose of 1 g/kg/dose IV every 3 weeks. A maintenance dose range of 0.4 to 1 g/kg/dose IV every 2 to 6 weeks may be considered.[53339] [53340] [53341] [53272] [70243] [70246]

Intravenous dosage (Gamunex-C or Gammaked)

Adults

2 g/kg IV loading dose in divided doses over 2 to 4 consecutive days, followed by maintenance dose of 1 g/kg/dose IV administered as a single infusion or as 2 infusions of 500 mg/kg/dose given on 2 consecutive days every 3 weeks.[51240] [54820]

Intravenous dosage (Gammagard Liquid)

Adults

2 g/kg IV loading dose in divided doses over 2 to 5 consecutive days, followed by maintenance dose of 1 g/kg/dose IV administered as a single infusion or in divided doses over 1 to 4 consecutive days every 3 weeks.[42655]

Intravenous dosage (Panzyga)

Adults

2 g/kg IV loading dose in divided doses over 2 consecutive days, followed by maintenance dose of 1 to 2 g/kg/dose IV in divided doses over 2 consecutive days every 3 weeks.[63463]

Intravenous dosage (Privigen)

Adults

2 g/kg IV loading dose in divided doses over 2 to 5 consecutive days, followed by maintenance dose of 1 g/kg/dose IV administered as a single infusion or as 2 infusions of 500 mg/kg/dose given on 2 consecutive days every 3 weeks.[42659]

For the treatment of HIV-associated thrombocytopenia†

Intravenous dosage

Adults

1 g/kg IV daily for 2 days when there is active bleeding or platelet counts are less than 10 x 109/L was recommended by a panel of 14 clinical and practice guideline experts.[42611] This recommendation was based on data from 4 published randomized controlled trials.[42663] [42665] [42666] [42667] These trials were of mixed quality with only 2 requiring patients to have thrombocytopenia (less than 50 x 109/L) at baseline.[42663] [42667] Additionally, the dosing regimens evaluated in these trials were not standardized, and the trials included a small number of patients (range, 12 to 30 patients). Despite these limitations, the panel deemed the results to be favorable toward IVIG use.

For the treatment of dermatomyositis and polymyositis†

Intravenous dosage (Octagam 10%)

Adults

2 g/kg IV divided in equal doses over 2 to 5 consecutive days every 4 weeks.[57655] [68308] [68309] [68311] [68322] [70295]

Children and Adolescents

2 g/kg (Max: 70 g) IV divided in equal doses over 1 to 5 consecutive days every 2 weeks for initial therapy and then every 4 to 6 weeks.[53272] [53273] [53276] [68313] [68314] [68137] [68318] [70295]

Intravenous dosage (excluding Octagam 10%)†

Adults

2 g/kg IV divided in equal doses over 2 to 5 consecutive days every 4 weeks.[68308] [68309] [68311] [68322] [70295]

Children and Adolescents

2 g/kg (Max: 70 g) IV divided in equal doses over 1 to 5 consecutive days every 2 weeks for initial therapy and then every 4 to 6 weeks.[53272] [53273] [53276] [68313] [68314] [68137] [68318] [70295]

For the treatment of Guillain-Barre syndrome†

Intravenous dosage

Adults

1 g/kg/dose IV once daily for 2 days or 400 mg/kg/dose IV once daily for 5 days within 2 weeks of symptom onset for persons with symptoms of grade 3 severity or higher or symptoms less than grade 3 severity that are progressing and for persons who initially responded to IVIG and are experiencing a relapse of symptoms.[24601] [53272] [64898] [64899]

Children and Adolescents

1 g/kg/dose IV once daily for 2 days or 400 mg/kg/dose IV once daily for 5 days within 2 weeks of symptom onset for persons with symptoms of grade 3 severity or higher or symptoms less than grade 3 severity that are progressing and for persons who initially responded to IVIG and are experiencing a relapse of symptoms.[24601] [53272] [53346]

For the treatment of myasthenia gravis†

in adult patients

Intravenous dosage

Adults

1 g/kg IV once daily for 1 to 2 days.[63192] [63193] [63194] Guidelines suggest IVIG in patients with life-threatening symptoms, in patients with significant bulbar dysfunction in preparation for surgery, when a rapid response to treatment is needed, when other treatments are ineffective, and prior to beginning corticosteroids if deemed necessary to prevent or minimize exacerbations. May consider IVIG as maintenance therapy for patients with refractory disease or those in whom immunosuppressive agents are relatively contraindicated.[61823]

in pediatric patients

Intravenous dosage

Infants, Children, and Adolescents

2 g/kg IV as a total dose divided over 1 to 5 days. Improvement is typically seen within 1 week. Duration of clinical effect is 4 to 6 weeks. If additional therapy is required, adjust dose based on response; use minimum effective dose. In comparison to plasmapheresis, IVIG may provide equal efficacy and better tolerability in pediatric patients.[53272] [53287] [53289] [53290]

Neonates

2 g/kg IV as a total dose divided over 1 to 5 days.[53272] 400 mg/kg/dose IV once daily for 5 days was used successfully in a 35 week preterm neonate with transient neonatal myasthenia gravis already receiving neostigmine. The neonate was weaned from the ventilator after the third dose of IVIG.[53286] In comparison to plasmapheresis, IVIG may provide equal efficacy and better tolerability in pediatric patients.[53287]

For the treatment of neonatal hyperbilirubinemia† due to hemolytic disease of the newborn (e.g., isoimmune hemolytic disease, Rh incompatibility)

Intravenous dosage

Premature Neonates 32 weeks and older and Neonates

0.5 to 1 g/kg/dose IV over 2 hours; may repeat dose in 12 hours if necessary. Therapy is most effective when initiated promptly after diagnosis.[34425] [53293] [53294] [68260] [68261]

For the treatment of post-transfusion purpura†

Intravenous dosage

Adults

A review written by the University Hospital Consortium lists IVIG as an acceptable, first-line agent in the treatment of post-transfusion purpura.[24601] The effects of IVIG were studied in 11 patients with post-transfusion purpura. In the same report, the results of the treatment of an additional 8 patients described in the literature were also summarized. One patient failed therapy due to under dosing and 1 other patient died of CHF. Out of the 17 remaining patients, 16 were determined to have good or excellent results. Five different IVIG preparations were used in the study with no obvious differences in efficacy. The total dose of IVIG per course ranged from 52 to 180 g.[24602] (NOTE: For many clinical conditions, a total dose of 2 g/kg IV divided evenly over 2 to 5 days represents the typical dose.)

For the treatment of refractory pemphigus vulgaris†

Intravenous dosage

Adults

Multiple regimens have been studied. In a small study, 11 patients were treated with 2 induction cycles of rituximab (375 mg/m2 IV weekly) for 3 weeks and intravenous immune globulin, IVIG 2 g/kg IV in the fourth week followed by once monthly infusions of rituximab (375 mg/m2) and IVIG 2 g/kg for 4 consecutive months. If the patient was clinically free of disease following this regimen, 7 additional infusions of IVIG were given. All patients experienced improvement between the third and sixth infusions of rituximab with complete clearance between the seventh and ninth infusions. Nine of the 11 patients had a sustained remission lasting for 22 to 37 months of observation (duration of follow-up after the discontinuation of rituximab therapy was 15 to 37 months). These patients were able to discontinue all conventional immunosuppressive therapy and remained free of pemphigus lesions during the remission period.[32859] In a placebo-controlled study, receipt of a single-course of IVIG by a drip infusion led to symptom improvement among patients whose symptoms did not respond to at least 20 mg/day of prednisolone equivalent. Specifically, 85 days after IVIG 400 mg/kg/day for 5 consecutive days, no additional treatment was needed for 85% of patients. In contrast, 71% of patients who got 200 mg/kg/day for 5 consecutive days and 27% of placebo recipients did not need additional treatment. Additional treatment was given when symptoms were unchanged for 2 weeks or when symptoms were aggravated.[41196] In another study, repeated IVIG receipt led to a sustained remission in all 21 patients with severe cutaneous and mucosal disease who had not responded to the prolonged use of oral prednisone and multiple immunosuppressive agents. Patients received IVIG 2 g/kg every 4 weeks until all lesions healed. The interval between doses was gradually increased to 6, 8, 10, 12, 14, and 16 weeks. IVIG was stopped once the patient remained disease-free with a 16-week interval between doses; the mean total number of IVIG cycles given per patient was 18 (range, 14 to 34), and the mean therapy duration was 27.1 months (range, 23 to 34 months). The remission continued in all 21 patients after IVIG cessation; the mean time interval between the last IVIG treatment and the last office visit was 20.4 months. Once IVIG treatment began, the doses of oral prednisone and immunosuppressive agents were reduced until both were discontinued.[41197]

For the maintenance treatment of multifocal motor neuropathy to improve muscle strength and disability

Intravenous dosage (Gammagard Liquid 10%)

Adults

0.5 to 2.4 g/kg/month IV based on clinical response; initial infusion rate is 0.8 mg/kg/minute (Max: 9 mg/kg/minute).[42655]

For the adjuvant treatment of neonatal sepsis†

Intravenous dosage

Neonates

Efficacy data are limited and variable; dosage regimens vary. 500 to 1,000 mg/kg/dose IV once daily for 1 to 6 days beginning as soon as sepsis is diagnosed is a commonly used dosage range.[53352] [53354] A meta-analyses of 3 prospective, randomized studies reported septic neonates receiving IVIG (n = 55) had a decreased death rate; analyses concluded IVIG administration in addition to conventional therapy increased the survival of early-onset of neonatal sepsis nearly 6-fold.[53352] However, the results from the large International Neonatal Immunotherapy Study (n = 3,493) concluded that IVIG 500 mg/kg/dose IV every 48 hours for 2 doses did not affect the outcomes of suspected or proven neonatal sepsis.[53353] Pediatric guidelines recommend against the routine use of IVIG in patients with septic shock; however, select patients (e.g., those with toxic shock syndrome, necrotizing fasciitis, primary humoral immunodeficiencies, or low immunoglobulin concentrations) may benefit from such treatment.[64985]

For the treatment of acute myocarditis†

Intravenous dosage

Infants, Children, and Adolescents

2 g/kg IV as a single dose. Efficacy data is limited and variable. Data from a cohort study of 46 pediatric patients suggested those treated with IVIG (n = 21) had improved left ventricular function recovery and survival at 1 year.[53298] Systemic reviews and multi-institutional analyses have failed to prove efficacy or survival benefit.[53300] [53301] [53302] [53303] [66775]

Neonates

2 g/kg IV as a single dose. Efficacy data is limited and variable. Data from a cohort study of 46 pediatric patients suggested those treated with IVIG (n = 21) had improved left ventricular function recovery and survival at 1 year.[53298] Systemic reviews and multi-institutional analyses have failed to prove efficacy or survival benefit.[53300] [53301] [53302] [53303] [66775]

For postexposure varicella (chickenpox) infection prophylaxis† in at-risk populations

NOTE: Use only if varicella-zoster immune globulin is unavailable.[66745]

Intravenous dosage

Adults

400 mg/kg/dose IV as a single dose administered as soon as possible (preferably within 96 hours), but up to 10 days after exposure in those without evidence of immunity.[34362] [51900] [66745] [68723]

Infants, Children, and Adolescents

400 mg/kg/dose IV as a single dose administered as soon as possible (preferably within 96 hours), but up to 10 days after exposure in those without evidence of immunity.[34361] [66745]

For the treatment of immune-mediated encephalitis†, including acute disseminated encephalomyelitis† (ADEM)

Intravenous dosage

Adults

1 g/kg/dose IV once daily for 2 days or 400 mg/kg/dose IV once daily for 5 days.[53272] [64893] [67800] [67918] [67919] [67920] [67921]

Infants, Children, and Adolescents

1 g/kg/dose IV once daily for 2 days or 400 mg/kg/dose IV once daily for 5 days.[53272] [67801] [67917]

For the treatment of Stevens-Johnson syndrome† (SJS) and/or toxic epidermal necrolysis† (TEN)

Intravenous dosage

Adults

2 to 3 g/kg IV divided over 1 to 4 days. Total doses ranging from 0.8 to 7.4 g/kg have been reported.[68070] [68088] [68089] [68090]

Infants, Children, and Adolescents

2 g/kg IV divided over 1 to 4 days. Total doses ranging from 1.5 to 5.8 g/kg have been reported.[53359] [53360] [53361] [53362] [53363] [68093]

For the treatment of tetanus†

Intravenous dosage

Adults

200 to 400 mg/kg IV once if tetanus immune globulin is not available.[64478]

Infants, Children, and Adolescents

200 to 400 mg/kg IV once if tetanus immune globulin is not available.[64478] [66745]

For the management of multisystem inflammatory syndrome in children (MIS-C) post SARS-CoV-2 exposure†

Intravenous dosage

Infants, Children, and Adolescents

2 g/kg (based on ideal body weight; Max: 100 g/dose) IV as a single dose in combination with low-to-moderate methylprednisolone or equivalent glucocorticoid. The dose may be divided in patients with cardiac dysfunction or fluid overload (1 g/kg IV every 24 hours for 2 doses).[65314] [65707] [65720] [66644] The National Institutes of Health (NIH) treatment guidelines recommend against the routine use of IVIG monotherapy for the treatment of MIS-C, unless glucocorticoid use is contraindicated.[65314]

For the treatment of recurrent pericarditis†

Intravenous dosage

Adults

400 to 500 mg/kg/dose IV once daily for 5 days or 1 g/kg/dose IV once daily for 2 days, then repeat dose every 4 weeks for several months.[60439] [67418] [67419]

Children and Adolescents

400 to 500 mg/kg/dose IV once daily for 5 days or 1 g/kg/dose IV once daily for 2 days, then repeat dose every 4 weeks for several months.[60439] [67418] [67419]

For the treatment of respiratory syncytial virus (RSV) infection† in high-risk immunocompromised patients (i.e., hematologic malignancies, HSCT recipients, solid organ transplant patients)

NOTE: Guidelines recommend treatment with aerosolized or systemic ribavirin and IVIG for patients with RSV upper respiratory tract infection disease (URTID) undergoing allogeneic HSCT or recipients of allogeneic HSCT with lower respiratory tract infection disease (LRTID) or risk factors for progression to RSV LRTID and death.[68208] [68226] For solid organ transplant patients, the addition of IVIG and corticosteroids to ribavirin can be considered for lung transplant recipients with URTID or LRTID.[68241]

Intravenous dosage

Adults

500 mg/kg/dose IV in combination with aerosolized or systemic ribavirin. Dosing frequency has ranged from one-time to every 48 hours for 5 to 7 doses in clinical studies.[68203] [68202] [68211] [68212] [68223] [68224] [68225] [68240]

Infants, Children, and Adolescents

400 to 500 mg/kg/dose IV in combination with aerosolized or systemic ribavirin. Dosing frequency has ranged from one-time to every 48 hours for 5 to 7 doses in clinical studies.[68203] [68219] [68220] [68221] [68222]

Therapeutic Drug Monitoring

Maximum Dosage Limits

    Patients with Hepatic Impairment Dosing

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing

    To minimize the risk for further acute renal function deterioration or renal failure, use the minimum recommended IVIG dose administered at the minimum concentration available and the minimum practicable intravenous rate. Recommended infusion rates may vary by product. Avoid sucrose-containing IVIG products if possible. If renal deterioration occurs despite adequate volume status, it is recommended to discontinue the IVIG.[42655][42658][64039][70019]

    † Off-label indication
    Revision Date: 02/06/2024, 05:45:13 PM

    References

    24601 - Ratko TA, Burnett DA, The University Hospital Consortium Expert Panel for the Off-Label Use of Polyvalent Intravenously Administered Immunoglobulin Preparations, et al. Recommendations for off-label use of intravenously administered immunoglobulin preparations. JAMA 1995;273:1865-70.24602 - Mueller-Eckhardt C, Kiefel V. High-dose IgG for post-transfusion purpura-revisited. Blut 1988;57:163-7.30276 - Octagam (immune globulin 5% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.32859 - Ahmed AR, Spigelman Z, Cavacini LA et al. Treatment of pemphigus vulgaris with rituximab and intravenous immune globulin. N Engl J Med 2006;355:1772-9.34361 - Panel on Opportunistic Infections in Children with and Exposed to HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV: Department of Health and Human Services. Accessed Oct 10, 2023. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-oi/guidelines-pediatric-oi.pdf.34362 - Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the National Institutes of Health, the Centers for Disease Control and Prevention, the HIV Medicine Association, and the Infectious Diseases Society of America. Accessed Oct 10, 2023. Available at https://clinicalinfo.hiv.gov/en/guidelines/34425 - Gottstein R, Cooke R. Systematic review of intravenous immunoglobulin in haemolytic disease of the newborn. Arch Dis Child Fetal Neonatal Ed 2003;88:F6-10.41196 - Amagai M, Ikeda S, Shimizu H, et al. A randomized, double-blind trial of intravenous immunoglobulin for pemphigus. J Am Acad Dermatol 2009;60:595-602.41197 - Ahmed AR. Intravenous immunoglobulin therapy in the treatment of patients with pemphigus vulgaris unresponsive to conventional immunosuppressive treatment. J Am Acad Dermatol 2001;45:679-90.41552 - Flebogamma 5% DIF (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.41553 - Flebogamma DIF 10% (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.42611 - Anderson D, Ali K, Blanchette V, et al. Guidelines on the use of intravenous immune globulin for hematologic conditions. Transfus Med Rev. 2007;21(2 Suppl 1):S9-56.42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42655 - Gammagard Liquid (immune globulin injection [human], 10% Solution) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2024 Jan.42658 - Bivigam 10% (immune globulin intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.42661 - Gammaplex (immune globulin 5% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep.42663 - Jahnke L, Applebaum S, Sherman LA, et al. An evaluation of intravenous immunoglobulin in the treatment of human immunodeficiency virus-associated thrombocytopenia. Transfusion 1994;34:759-764.42665 - De Simone C, Tzantzoglou S, Santini G, et al. Clinical and immunologic effects of combination therapy with intravenous immunoglobulins and AZT in HIV-infected patients. Immunopharmacology and Immunotoxicology 1991;13(3):447-458.42666 - Schrappe-Bacher M, Rasokat H, Bauer P, et al. High-dose intravenous immunoglobulins in HIV-1-infected adults with AIDS-related complex and Walter-Reed 5. Vox Sang 1990;59(suppl 1):3-14.42667 - Perrella O. Idiopathic thrombocytopenic purpura in HIV infection: therapeutic possibilities of intravenous immunoglobulins. J Chemother 1990;2(6):390-393.42955 - Gammagard S/D (immune globulin injection, human) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.46250 - Gammaked (immune globulin 10% intravenous, human) package insert. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2012 Jun.51240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.51812 - Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: A global perspective. Biol Blood Marrow Transplant 2009;15:1143-1238.51900 - Smith CK. Varicella in the fetus and newborn. Semin fetal neonatal med 2009; 14(4): 209-217.53266 - Imbach P, Wagner HP, Berchtold W. Intravenous immunoglobulin versus oral corticosteroids in acute immune thrombocytopenic purpura in childhood. Lancet 1985;2:464-468.53267 - Blanchette VS, Luke B, Andrew M. A prospective, randomized trial of high-dose intravenous immune globulin G therapy, oral prednisone therapy, and no therapy in childhood acute immune thrombocytopenic purpura. J Pediatr 1993;123:989-995.53268 - Bussel JB, Goldman A, Imbach P. Treatment of acute idiopathic thrombocytopenia of childhood with intravenous infusions of gammaglobulin. J Pediatr 1985;106:886-890.53269 - Ballin A, Andrew M, Ling E. High-dose intravenous gammaglobulin therapy for neonatal autoimmune thrombocytopenia. J Pediatr 1988;112:789-792.53270 - Chakravorty S, Roberts I. How I manage neonatal thrombocytopenia. Br J Haematol 2011;156:155-162.53271 - Gill KK, Kelton JG. Management of idiopathic thrombocytopenic purpura in pregnancy. Semin Hematol 2000;37:275-289.53272 - Feasby T, Banwell B, Benstead T. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev 2007;21:S57-S107.53273 - Palit A, Inamadar AC. Current treatment strategies: collagen vascular diseases in children. Indian J Dermatol 2012;57:449-458.53276 - Batthish M, Feldman BM. Juvenile dermatomyositis. Curr Rheumatol Rep 2011;12:216-224.53286 - Bassan H, Muhlbaur B, Tomer A. High-dose intravenous immunoglobulin in transient neonatal myasthenia gravis. Pediatr Neurol 1998;18:181-183.53287 - Anlar B. Juvenile myasthenia. Paediatr Drugs 2000;2:161-169.53289 - Selcen D, Dabrowski ER, Michon AM. High-dose intravenous immunoglobulin therapy in juvenile myasthenia gravis. Pediatr Neurol 2000;22:40-43.53290 - Herrmann DN, Carney PR, Wald JJ. Juvenile myasthenia gravis: treatment with immune globulin and thymectomy. Pediatr Neurol 1998:18:63-66.53293 - Tanyer G, Siklar Z, Dallar Y. Multiple dose IVIG treatment in neonatal immune hemolytic jaundice. J Trop Pediatr 2001;47:50-53.53294 - Girish G, Chawla D, Agarwal R. Efficacy of two dose regimes of intravenous immunoglobulin in Rh hemoyltic disease of newborn a randomized controlled trial. Indian Pediatr 2008;45:653-659.53298 - Drucker NA, Colan SD, Lewis AB. Gamma-globulin treatment of acute myocarditis in the pediatric population. Circulation 1994;89:252-257.53300 - Klugman D, Berger JT, Sable CA. Pediatric patients hospitalized with myocarditis: a multi-institutional analysis. Pediatr Cardiol 2010;31:222-228.53301 - Robinson J, Hartling L, Vandermeer B. Intravenous immunoglobulin for presumed viral myocarditis in children and adults (review). : Cochrane Database Syst Rev 2005;25:CD004370.53302 - English RB, Janosky JE, Ettedgui JA. Outcomes for children with acute myocarditis. Cardiol Young 2004;14:488-493.53303 - Hia CP, Yip WC, Tai BC. Immunosuppressive therapy in acute myocarditis: an 18 year systematic review. Arch Dis Child 2004;89:580-584.53339 - Rossignol E, DAnjou G, Lapointe N. Evolution and treatment of childhood chronic inflammatory polyneuropathy. Pediatr Neurol 2007;36:88-94.53340 - Vedanarayanan VV, Kandt RS, Lewis DV. Chronic inflammatory polyradiculoneuropathy of childhood: treatment with high-dose intravenous immunoglobin. Neurology 1991;41:828-830.53341 - Ryan MM, Grattan-Smith PJ, Procopis PG. Childhood chronic inflammatory demyelinating polyneuropathy: clinical course and long-term outcome. Neuromuscul Disord 2000;10:398-406.53346 - Korinthenberg R, Schessl J, Kirschner J. Intravenously administered immunoglobulin in the treatment of childhood Guillain-Barre syndrome: a randomized trial. Pediatrics 2005;116:9-14.53352 - Jenson HB, Pollock BH. Meta-analyses of the effectiveness of intravenous immune globulin for prevention and treatment of neonatal sepsis. Pediatrics 1997;99:1-11.53353 - INIS Collaborative Group, Brocklehurst P, Farrell B. Treatment of neonatal sepsis with intravenous immune globulin. N Engl J Med 2011;365:1201-1211.53354 - Ohlsson A, Lacy J. Intravenous immunoglobulin for suspected or subsequently proven infection in neonates (review). Cochrane Database Syst Rev 2010;17:CD001239.53359 - Viard I, Wehrli P, Bullani R. Inhibition of toxic epidermal necrolysis by blockade of CD95 with human intravenous immunoglobulin. Science 1998;282:490-493.53360 - Tristani-Firouzi P, Peterson MJ, Saffle JR. Treatment of toxic epidermal necrolysis with intravenous immunoglobulin in children. J Am Acad Dermatol 2002;47:548-552.53361 - Morici MV, Galen WK, Shetty AK. Intravenous immunoglobulin therapy for children with stevens-johnson syndrome. J Rheumatol 2000;27:2494-2497.53362 - Koh MJ, Tay Y. Stevens-Johnson syndrome and toxic epidermal necrolysis in Asian children. J Am Acad Dermatol 2010;62:54-60.53363 - Metry DW, Jung P, Levy ML. Use of intravenous immunoglobulin in children with Stevens-Johnson syndrome and toxic epidermal necrolysis: seven cases and review of the literature. Pediatrics 2003;112:1430-1436.53364 - Wimperis J, Lunn M, Jones A. Clinical guidelines for the use of immunoglobulin use: Second edition update, March 2012. Retrieved February 27, 2013. Available on the World Wide Web at https://www.gov.uk/government/publications/clinical-guidelines-for-immunoglobulin-use-second-edition-update53365 - Siegel J. Immunoglobulins and obesity. Pharmacy Practice News 2010;37. Retrieved February 27, 2013. Available on the World Wide Web at: https://www.pharmacypracticenews.com/Opinion/Article/01-10/Immunoglobulins-and-Obesity/1454653366 - Siegel J. Immune globulins: Therapeutic, Pharmaceutical, Cost, and Administration Considerations. Pharmacy Practice News. May 2023. Retrieved January 31, 2024. Available on the World Wide Web at: https://www.pharmacypracticenews.com/Monographs-and-Whitepapers/Article/05-23/Immune-Globulins-Therapeutic-Pharmaceutical-Cost-and-Administration-Considerations/7024353448 - Neunert C, Lim W, Crowther M. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 2011;117:4190-4207.53449 - British Committee for Standards in Haematology: General Haematology Task Force. Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy. Br J Haematol 2003;120:574-596.54820 - Gammaked (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics LLC; 2018 Jun.55005 - Centers for Disease Control and Prevention. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013 summary recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2013;62(4):1-34.57655 - Octagam (immune globulin 10% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.60439 - Imazio M, Gaita F, LeWinter M. Evaluation and Treatment of Pericarditis: A Systematic Review. JAMA. 2015;314:1498-1506. Review. Erratum in: JAMA. 2015;314:1978.61745 - Gammaplex (immune globulin 10% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep..61823 - Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology 2016;87:1-7.61950 - McCrindle BW, Rowley AH, Newburger JW, et al. Diagnosis, treatment, and long-term management of Kawasaki disease: A scientific statement for health professionals from the American Heart Association. Circulation 2017;135:e927-e999.63192 - Gajdos P, Tranchant C, Clair B, et al. Treatment of myasthenia gravis exacerbation with intravenous immunoglobulin. Arch Neurol 2005;62:1689-1693.63193 - Zinman L, Eduardo N, Bril V. IV immunoglobulin in patients with myasthenia gravis. A randomized controlled trial. Neurology 2007;68:837-841.63194 - Barth D, Nabavi Nouri M, Ng E, et al. Comparison of IVIg and PLEX in patients with myasthenia gravis. Neurol 2011;76:2017-2023.63463 - Panzyga (immune globulin 10% intravenous, human) package insert. Lingolsheim, France: Octapharma SAS; 2021 Jan.64039 - Asceniv (immune globulin 10% intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.64478 - Centers for Disease Control and Prevention (CDC). Tetanus Clinical Information. Retrieved April 5, 2023. Available on the World Wide Web at https://www.cdc.gov/tetanus/clinicians.html.64893 - Basic-Kes V, Kes P, Zavoreo I, et al. Guidelines for the use of intravenous immunoglobulin in the treatment of neurologic diseases. Acta Clin Croat 2012;51:673-83.64898 - Hughes RAC, Swan A, van Doorn PA. Intravenous immunoglobulin for Guillain-Barre syndrome. Cochrane Database Sys Rev 2014;9:CD002063.64899 - Ortiz-Salas P, Velez-Van-Meerbeke A, Galvis-Gomez CA, et al. Human immunoglobulin versus plasmapheresis in Guillain-Barre syndrome and myasthenia gravis: a meta-analysis. J Clin Neuromuscul Dis 2016;18:1-11.64985 - Weiss SL, Peters MJ, Alhazzani W, et al. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med 2020;21:e52-e106.65314 - COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Accessed March 1, 2024. Available at https://www.covid19treatmentguidelines.nih.gov/65707 - Henderson LA, Canna SW, Friedman KG, et al. American college of rheumatology clinical guidance for multisystem inflammatory syndrome in children associated with SARS-CoV-2 and hyperinflammation in pediatric COVID-19: Version 3. Arthritis Rheumatol 2022;74:e1-e20.65720 - American Academy of Pediatrics (AAP). Multisystem inflammatory syndrome in children (MIS-C) interim guidance. Accessed Feb 28, 2022. Available on the World Wide Web at: https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/multisystem-inflammatory-syndrome-in-children-mis-c-interim-guidance/66644 - Harwood R, Allin B, Jones C, et al. A national consensus management pathway for paediatric inflammatory multisystem syndrome temporally associated with COVID-19 (PIMS-TS): results of a national Delphi process. Lancet 2021;5:133-4166745 - American Academy of Pediatrics. Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. Elk Grove Village, IL: American Academy of Pediatrics; 2021.66775 - Law YM, Lal AK, Chen S, et al. Diagnosis and management of myocarditis in children: a scientific statement from the American Heart Association. Circulation 2021; Epub ahead of print. doi: 10.1161/CIR.0000000000001001.67418 - Adler Y, Charron P, Imazio M, et al. 2015 ESC Guidelines on the diagnosis and management of pericardial diseases. Eur Heart J. 2015;36:2921-2964.67419 - Adler Y, Charron P, Imazio M, et al. 2015 ESC Guidelines on the diagnosis and management of pericardial diseases - Web Addenda. Eur Heart J. 2015; doi:10.1093/eurheart/ehv31867800 - Solomon T, Michael BD, Smith PE, et al. Management of suspected viral encephalitis in adults--Association of British Neurologists and British Infection Association National Guidelines. J Infect 2012;64:347-73.67801 - Kneen R, Michael BD, Menson E, et al. Management of suspected viral encephalitis in children - Association of British Neurologists and British Paediatric Allergy, Immunology and Infection Group national guidelines. J Infect 2012;64:449-77.67917 - Nosadini M, Thomas T, Eyre M, et al. International consensus recommendations for the treatment of pediatric NMDAR antibody encephalitis. Neurol Neuroimmunol Neuroinflamm 2021;8:1-15.67918 - Abboud H, Probasco JC, Irani S, et al. Autoimmune encephalitis: proposed best practice recommendations for diagnosis and acute management. J Neurol Neurosurg Psychiatry 2021;92:757-68.67919 - Shin YW, Lee ST, Park KI, et al. Treatment strategies for autoimmune encephalitis. Ther Adv Neurol Disord 2018;11:175628561772234.67920 - Venkatesan A, Geocadin RG. Diagnosis and management of acute encephalitis: a practical approach. Neurol Clin Pract 2014;4:206-15.67921 - Venkatesan A, Michael BD, Probasco JC, et al. Acute encephalitis in immunocompetent adults. Lancet 2019;393:702-16.68070 - Gupta LK, Martin AM, Agarwal N, et al. Guidelines for the management of Stevens-Johnson syndrome/toxic epidermal necrolysis: an Indian perspective. Indian J Dermatol Venereol Leprol 2016;82: 603-25.68088 - Creamer D, Walsh SA, Dziewulski P, et al. UK guidelines for the management of Stevens-Johnson syndrome/toxic epidermal necrolysis in adults 2016. J Plast Reconstr Aesthet Surg 2016;69:736-41.68089 - Kumar R, Das A, Das S. Management of Stevens-Johnson syndrome-toxic epidermal necrolysis: looking beyond guidelines. Indian J Dermatol 2018;63:117-24.68090 - Patel TK, Patel PB, Thakkar S. Comparison of effectiveness of interventions in reducing mortality in patients of toxic epidermal necrolysis: A network meta-analysis. Indian J Dermatol Venereol Leprol 2021;87:628-44.68093 - Williams V, Reddy M, Bansal A, et al. Intensive care needs and long-term outcome of pediatric toxic epidermal necrolysis - a 10-year experience. Int J Dermatol 2021;60:44-52.68137 - Mulsant BH, Foglia JP, Sweet RA, Rosen J, Lo KH, Pollock BG. The effects of perphenazine on the concentration of nortriptyline and its hydroxymetabolites in older patients. J Clin Psychopharmacol. 1997 Aug;17(4):318-21.68202 - Ghosh S, Champlin RE, Englund J, et al. Respiratory syncytial virus upper respiratory tract illnesses in adult blood and marrow transplant recipients: combination therapy with aerosolized ribavirin and intravenous immunoglobulin. Bone Marrow Transplant 2000;25:751-755.68203 - Shah DP, Ghantoki S, Shah JN, et al. Impact of aerosolized ribavirin on mortality in 280 allogeneic haematopoietic stem cell transplant recipients with respiratory syncytial virus infections. J Antimicrob Chemother 2013;68:1872-1880.68208 - Hirsch HH, Martino R, Ward KN, et al. Fourth European Conference on Infections in Leukaemia (ECIL-4): Guidelines for Diagnosis and Treatment of Human Respiratory Syncytial Virus, Parainfluenza Virus, Metapneumovirus, Rhinovirus, and Coronavirus. Clin Infect Dis 2013;56:258-266.68211 - Trang TP, Whalen M, Hilts-Horeczko A, et al. Comparative effectiveness of aerosolized versus oral ribavirin for the treatment of respiratory syncytial virus infections: A single-center retrospective cohort study and review of the literature. Transpl Infect Dis 2018;20:e12844.68212 - Marcelin JR, Wilson JW, Razonable RR. Oral ribavirin therapy for respiratory syncytial virus infections in moderately to severely immunocompromised patients. Transpl Infect Dis 2014;16:242-250.68219 - Anak S, Atay D, Unuvar A, et al. Respiratory syncytial virus infection outbreak among pediatric patients with oncologic diseases and/or BMT. Pediatr Pulmonol 2010;45:307-311.68220 - Keck M, Mindru C, Kalil AC, et al. Respiratory syncytial virus lower respiratory tract infection in a pediatric liver transplant recipient treated with oral ribavirin. Pediatr Transplant 2012;16:e348-e351.68221 - Danziger-Isakov LA, Arslan D, Sweet S, et al. RSV prevention and treatment in pediatric lung transplant patients: A survey of current practices among the International Pediatric Lung Transplant Collaborative. Pediatr Transplant 2012;16:638-644.68222 - Molinos-Quintana A, Perez-de Soto C, Gomez-Rosa M, et al. Intravenous ribavirin for respiratory syncytial viral infections in pediatric hematopoietic SCT recipients. Bone Marrow Transplant 2013;48:265-268.68223 - Spahr Y, Tschudin-Sutter S, Baettig V, et al. Community-acquired respiratory paramyxovirus infection after allogeneic hematopoietic cell transplantation: A single-center experience. Open Forum Infect Dis 2018;5:ofy077.68224 - Beaird OE, Freifeld A, Ison MG, et al. Current practices for treatment of respiratory syncytial virus and other non-influenza respiratory viruses in high-risk patient populations: a survey of institutions in the Midwestern Respiratory Virus Collaborative. Transpl Infect Dis 2016;18:210-215.68225 - Liu V, Dhillon GS, Weill D. A multi-drug regimen for respiratory syncytial virus and parainfluenza virus infections in adult lung and heart-lung transplant recipients. Transpl Infect Dis 2010;12:38-44.68226 - Dignan FL, Clark A, Aitken C, et al. BCSH/BSBMT/UK clinical virology network guideline: diagnosis and management of common respiratory viral infections in patients undergoing treatment for haematological malignancies or stem cell transplantation. Br J Haematol 2016;173:380-393.68240 - Khanna N, Widmer AF, Decker M, et al. Respiratory syncytial virus infection in patients with hematological diseases: single-center study and review of the literature. Clin Infect Dis 2008;46:402-412.68241 - Manuel O, Estabrook M, American Society of Transplantation Infectious Diseases Community of Practice. RNA respiratory viral infections in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clinical Transplantation 2019;33:e13511.68260 - Kemper AR, Newman TB, Slaughter JL, et al. Clinical Practice Guideline Revision: Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation. Pediatrics. 2022 Sep 1;150:e2022058859.68261 - Lieberman L, Lopriore E, Baker JM, et al; International Collaboration for Transfusion Medicine Guidelines (ICTMG). International guidelines regarding the role of IVIG in the management of Rh- and ABO-mediated haemolytic disease of the newborn. Br J Haematol. 2022 Jul;198:183-195.68308 - Kohsaka H, Mimori T, Kanda T, et al. Treatment consensus for management of polymyositis and dermatomyositis among rheumatologists, neurologists and dermatologists. Mod Rheumatol 2019;29:1-19.68309 - Malik A, Hayat G, Kalia JS, et al. Idiopathic inflammatory myopathies: clinical approach and management. Front Neurol 2016;7:1-19.68311 - de Souza FHC, de Araujo DB, Vilela VS, et al. Guidelines of the Brazilian Society of Rheumatology for the treatment of systemic autoimmune myopathies. Adv Rheumatol 2019;59:1-12.68313 - Bader-Meunier B, Gitiaux C, Belot A, et al. French expert opinion for the management of juvenile drmatomyositis. Arch Pediatr 2019;26:120-5.68314 - Enders FB, Bader-Meunier B, Baildam E, et al. Consensus-based recommendations for the management of juvenile dermatomyositis. Ann Rheum Dis 2017;76:329-40.68318 - Huber AM, Robinson AB, Reed AM, et al. Consensus treatments for moderate juvenile dermatomyositis: beyond the first two months. Results of the second Childhood Arthritis and Rheumatology Research Alliance consensus conference. Arthritis Care Res (Hoboken) 2012;64:546-53.68322 - Hunter K, Lyon MG. Evaluation and management of polymyositis. Indian J Dermatol 2012; 57:371-4.68723 - Pergam SA, Limaye AP. Varicella zoster virus in solid organ transplantation: guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant 2019;33:e13622.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.70243 - Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision. J Peripher Nerv Syst. 2021;26:242-268.70246 - Fargeot G, Gitiaux C, Magy L, et al. French recommendations for the management of adult & pediatric chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). Rev Neurol (Paris) 2022;178:953-968.70295 - Oldroyd AGS, Lilleker JB, Amin T, et al. British Society for Rheumatology guideline on management of paediatric, adolescent and adult patients with idiopathic inflammatory myopathy. Rheumatology (Oxford) 2022;61:1760-8.

    How Supplied

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 0.5g Powder for Injection (00944-2620) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune 1g Powder for Injection (44206-0505) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune NF 1g Powder for Injection (44206-0415) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Panglobulin NF 1g Powder for Injection (52769-0415) (American National Red Cross) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 1g Powder for Injection (44206-0120) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 1g Powder for Injection (00078-0120) (Novartis Pharmaceuticals Corporation) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 2.5g Powder for Injection (00944-2620) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune 3g Powder for Injection (44206-0506) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune NF 3g Powder for Injection (44206-0416) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Panglobulin NF 3g Powder for Injection (52769-0416) (American National Red Cross) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 3g Powder for Injection (44206-0122) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 3g Powder for Injection (00078-0122) (Novartis Pharmaceuticals Corporation) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 5g Powder for Injection (00944-2620) (Baxalta Inc, a Shire Company) (off market)Gammagard S/D 5g Powder for Injection package photo

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 5g Powder for Injection (00944-2655) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 5g Powder for Injection (00944-2656) (Baxalta Inc, a Shire Company) null

    Immune Globulin Lyophilisate for solution for injection

    Gammar-P IV 5g Powder for Injection (00053-7486) (CSL Behring) (off market)Gammar-P IV 5g Powder for Injection package photo

    Immune Globulin Lyophilisate for solution for injection

    Gammar-P IV 5g Powder for Injection (00053-7486) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Iveegam 5g Powder for Injection (54129-0233) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Iveegam EN 5g Powder for Injection (64193-0250) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Polygam S/D 5% Powder for Injection (00944-0471) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune 6g Powder for Injection (44206-0507) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune NF 6g Powder for Injection (44206-0417) (CSL Behring) nullCarimune NF 6g Powder for Injection package photo

    Immune Globulin Lyophilisate for solution for injection

    Panglobulin 6g Powder for Injection (52769-0268) (American National Red Cross) (off market)Panglobulin 6g Powder for Injection package photo

    Immune Globulin Lyophilisate for solution for injection

    Panglobulin NF 6g Powder for Injection (52769-0417) (American National Red Cross) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 6g Powder for Injection (44206-0124) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 6g Powder for Injection (00078-0124) (Novartis Pharmaceuticals Corporation) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 10g Powder for Injection (00944-2620) (Baxalta Inc, a Shire Company) (off market)Gammagard S/D 10g Powder for Injection package photo

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 10g Powder for Injection (00944-2655) (Baxalta Inc, a Shire Company) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Gammagard S/D 10g Powder for Injection (00944-2658) (Baxalta Inc, a Shire Company) null

    Immune Globulin Lyophilisate for solution for injection

    Gammar-P IV 10g Powder for Injection (00053-7486) (CSL Behring) (off market)Gammar-P IV 10g Powder for Injection package photo

    Immune Globulin Lyophilisate for solution for injection

    Carimune 12g Powder for Injection (44206-0508) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Carimune NF 12g Powder for Injection (44206-0418) (CSL Behring) null

    Immune Globulin Lyophilisate for solution for injection

    Panglobulin 12g Powder for Injection (52769-0269) (American National Red Cross) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Panglobulin NF 12g Powder for Injection (52769-0418) (American National Red Cross) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 12g Powder for Injection (44206-0226) (CSL Behring) (off market)

    Immune Globulin Lyophilisate for solution for injection

    Sandoglobulin 12g Powder for Injection (00078-0244) (Novartis Pharmaceuticals Corporation) (off market)

    Immune Globulin Solution for injection

    Flebogamma 5% 0.5g Solution for Injection (61953-0003) (Grifols USA, LLC) (off market)

    Immune Globulin Solution for injection

    Flebogamma 5% 10g Solution for Injection (61953-0003) (Grifols USA, LLC) (off market)

    Immune Globulin Solution for injection

    Flebogamma 5% 2.5g Solution for Injection (61953-0003) (Grifols USA, LLC) (off market)

    Immune Globulin Solution for injection

    Flebogamma 5% 5g Solution for Injection (61953-0003) (Grifols USA, LLC) (off market)

    Immune Globulin Solution for injection

    Flebogamma DIF 5% 0.5g Solution for Injection (61953-0004) (Grifols USA, LLC) (off market)

    Immune Globulin Solution for injection

    Flebogamma DIF 5% 10g Solution for Injection (61953-0004) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Flebogamma DIF 5% 2.5g Solution for Injection (61953-0004) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Flebogamma DIF 5% 20g Solution for Injection (61953-0004) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Flebogamma DIF 5% 5g Solution for Injection (61953-0004) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Gamimune N 5% Solution for Injection (00026-0646) (Bayer Pharmaceuticals Corporation) (off market)

    Immune Globulin Solution for injection

    Gammaplex 2.5g/50ml Solution for Injection (64208-8234) (Bio Products Laboratory) (off market)

    Immune Globulin Solution for injection

    Gammaplex 5% 10g Solution for Injection (64208-8234) (Bio Products Laboratory) null

    Immune Globulin Solution for injection

    Gammaplex 5% 20g Solution for Injection (64208-8234) (Bio Products Laboratory) null

    Immune Globulin Solution for injection

    Gammaplex 5% 5g Solution for Injection (64208-8234) (Bio Products Laboratory) null

    Immune Globulin Solution for injection

    Octagam 5% 10g Solution for Injection (68982-0840) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 5% 10g Solution for Injection (00069-8476) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    Octagam 5% 1g Solution for Injection (68982-0840) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 5% 1g Solution for Injection (00069-8400) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    Octagam 5% 2.5g Solution for Injection (68982-0840) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 5% 2.5g Solution for Injection (00069-8425) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    Octagam 5% 25g Solution for Injection (68982-0840) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 5% 5g Solution for Injection (68982-0840) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 5% 5g Solution for Injection (00069-8451) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    Octagam 5% Solution for Injection (67467-0843) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    Octagam 5% Solution for Injection (67467-0843) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    Venoglobulin S 5% Solution for Injection (49669-1612) (Alpha Therapeutic Corp) (off market)

    Immune Globulin Solution for injection

    Venoglobulin S 5% Solution for Injection (49669-1613) (Alpha Therapeutic Corp) (off market)

    Immune Globulin Solution for injection

    Venoglobulin S 5% Solution for Injection (49669-1614) (Alpha Therapeutic Corp) (off market)

    Immune Globulin Solution for injection

    Vigam 5% Solution for Injection (64208-1948) (Bio Products Laboratory) (off market)

    Immune Globulin Solution for injection

    ASCENIV Liquid 5g 10% Solution for Injection (69800-0250) (ADMA Biologics) nullASCENIV Liquid 5g 10% Solution for Injection package photo

    Immune Globulin Solution for injection

    BIVIGAM 10% 10g Liquid (69800-6503) (ADMA Biologics) nullBIVIGAM 10% 10g Liquid package photo

    Immune Globulin Solution for injection

    BIVIGAM 10% 10g Liquid (59730-6503) (Biotest Pharmaceuticals Corporation) (off market)

    Immune Globulin Solution for injection

    BIVIGAM 10% 5g Liquid (69800-6502) (ADMA Biologics) nullBIVIGAM 10% 5g Liquid package photo

    Immune Globulin Solution for injection

    BIVIGAM 10% 5g Liquid (59730-6502) (Biotest Pharmaceuticals Corporation) null

    Immune Globulin Solution for injection

    Flebogamma DIF 10% 10g Solution for Injection (61953-0005) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Flebogamma DIF 10% 20g Solution for Injection (61953-0005) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Flebogamma DIF 10% 5g Solution for Injection (61953-0005) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Gamimune N 10% Solution for Injection (00026-0649) (Bayer Pharmaceuticals Corporation) (off market)

    Immune Globulin Solution for injection

    Gamimune N 10% Solution for Injection (00026-0648) (Bayer Pharmaceuticals Corporation) (off market)

    Immune Globulin Solution for injection

    Gammagard Liquid 10g 10% Solution for Injection (00944-2700) (Baxalta Inc, a Shire Company) null

    Immune Globulin Solution for injection

    Gammagard Liquid 1g 10% Solution for Injection (00944-2700) (Baxalta Inc, a Shire Company) null

    Immune Globulin Solution for injection

    Gammagard Liquid 2.5g 10% Solution for Injection (00944-2700) (Baxalta Inc, a Shire Company) null

    Immune Globulin Solution for injection

    Gammagard Liquid 20g 10% Solution for Injection (00944-2700) (Baxalta Inc, a Shire Company) null

    Immune Globulin Solution for injection

    Gammagard Liquid 30g 10% Solution for Injection (00944-2700) (Baxalta Inc, a Shire Company) null

    Immune Globulin Solution for injection

    Gammagard Liquid 5g 10% Solution for Injection (00944-2700) (Baxalta Inc, a Shire Company) null

    Immune Globulin Solution for injection

    Gammaked 10% 10g Solution for Injection (76125-0900) (Kedrion Biopharma Inc) null

    Immune Globulin Solution for injection

    Gammaked 10% 1g Solution for Injection (76125-0900) (Kedrion Biopharma Inc) null

    Immune Globulin Solution for injection

    Gammaked 10% 2.5g Solution for Injection (76125-0900) (Kedrion Biopharma Inc) (off market)

    Immune Globulin Solution for injection

    Gammaked 10% 20g Solution for Injection (76125-0900) (Kedrion Biopharma Inc) nullGammaked 10% 20g Solution for Injection package photo

    Immune Globulin Solution for injection

    Gammaked 10% 5g Solution for Injection (76125-0900) (Kedrion Biopharma Inc) null

    Immune Globulin Solution for injection

    Gammaplex 10% 10g Solution for Injection (64208-8235) (Bio Products Laboratory) null

    Immune Globulin Solution for injection

    Gammaplex 10% 20g Solution for Injection (64208-8235) (Bio Products Laboratory) null

    Immune Globulin Solution for injection

    Gammaplex 10% 5g Solution for Injection (64208-8235) (Bio Products Laboratory) null

    Immune Globulin Solution for injection

    Gamunex 10% Solution for Injection (00026-0645) (Bayer Pharmaceuticals Corporation) (off market)

    Immune Globulin Solution for injection

    Gamunex 10% Solution for Injection (13533-0645) (Grifols USA, LLC) (off market)

    Immune Globulin Solution for injection

    Gamunex-C 10% 10g Solution for Injection (13533-0800) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Gamunex-C 10% 1gm Solution for Injection (13533-0800) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Gamunex-C 10% 2.5g Solution for Injection (13533-0800) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Gamunex-C 10% 20g Solution for Injection (13533-0800) (Grifols USA, LLC) nullGamunex-C 10% 20g Solution for Injection package photo

    Immune Globulin Solution for injection

    Gamunex-C 10% 40g Solution for Injection (13533-0800) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Gamunex-C 10% 5g Solution for Injection (13533-0800) (Grifols USA, LLC) null

    Immune Globulin Solution for injection

    Octagam 10% 10g Solution for Injection (68982-0850) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 10% 10g Solution for Injection (00069-6111) (Pfizer Injectables) nullOctagam 10% 10g Solution for Injection package photo

    Immune Globulin Solution for injection

    Octagam 10% 20g Solution for Injection (68982-0850) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 10% 20g Solution for Injection (00069-6237) (Pfizer Injectables) nullOctagam 10% 20g Solution for Injection package photo

    Immune Globulin Solution for injection

    Octagam 10% 2g Solution for Injection (68982-0850) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 10% 2g Solution for Injection (00069-6002) (Pfizer Injectables) nullOctagam 10% 2g Solution for Injection package photo

    Immune Globulin Solution for injection

    Octagam 10% 30g Solution for Injection (68982-0850) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 10% 30g Solution for Injection (00069-6339) (Pfizer Injectables) nullOctagam 10% 30g Solution for Injection package photo

    Immune Globulin Solution for injection

    Octagam 10% 5g Solution for Injection (68982-0850) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    Octagam 10% 5g Solution for Injection (00069-6550) (Pfizer Injectables) nullOctagam 10% 5g Solution for Injection package photo

    Immune Globulin Solution for injection

    panzyga 10% 10g Solution for Injection (68982-0820) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    panzyga 10% 1g Solution for Injection (68982-0820) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    panzyga 10% 2.5g Solution for Injection (68982-0820) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    panzyga 10% 20g Solution for Injection (68982-0820) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    panzyga 10% 30g Solution for Injection (68982-0820) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    panzyga 10% 5g Solution for Injection (68982-0820) (Octapharma USA Inc.) (off market)

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 10g Solution for Injection (68982-0822) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 10g Solution for Injection (00069-1312) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 1g Solution for Injection (68982-0822) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 1g Solution for Injection (00069-1011) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 2.5g Solution for Injection (68982-0822) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 2.5g Solution for Injection (00069-1109) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 20g Solution for Injection (68982-0822) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 20g Solution for Injection (00069-1415) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 30g Solution for Injection (68982-0822) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 30g Solution for Injection (00069-1558) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 5g Solution for Injection (68982-0822) (Octapharma USA Inc.) null

    Immune Globulin Solution for injection

    panzyga Immune Globulin Intravenous (Human) - ifas 10% 5g Solution for Injection (00069-1224) (Pfizer Injectables) null

    Immune Globulin Solution for injection

    Privigen 10% 10g Solution for Injection (44206-0437) (CSL Behring) null

    Immune Globulin Solution for injection

    Privigen 10% 20g Solution for Injection (44206-0438) (CSL Behring) null

    Immune Globulin Solution for injection

    Privigen 10% 40g Solution for Injection (44206-0439) (CSL Behring) null

    Immune Globulin Solution for injection

    Privigen 10% 5g Solution for Injection (44206-0436) (CSL Behring) null

    Immune Globulin Solution for injection

    Venoglobulin S 10% Solution for Injection (49669-1623) (Alpha Therapeutic Corp) (off market)

    Immune Globulin Solution for injection

    Venoglobulin S 10% Solution for Injection (49669-1622) (Alpha Therapeutic Corp) (off market)

    Immune Globulin Solution for injection

    Venoglobulin S 20% Solution for Injection (49669-1624) (Alpha Therapeutic Corp) (off market)

    Description/Classification

    Description

    Immune globulin IV (IVIG) is an intravenous solution composed primarily of human immunoglobulin G (IgG), with trace amounts of IgA and IgM.[42659][66745][70019] IVIG is derived from the pooled human plasma of thousands of donors, ensuring a diversified collection of antibodies with variable antigen-binding regions.[53218] All samples undergo human immunodeficiency virus (HIV), hepatitis B, and hepatitis C testing.[42659][70019] Although the amount of each IgG subclass is similar to that of human plasma in all IVIG formulations, titers among specific antigens, preparation methods, viral inactivation steps, stabilizing agents, osmolality, and IgA content differ among products. Thus, IVIG products have comparable efficacy but are not pharmaceutically equivalent. IVIG is used for a variety of conditions; its primary indication is as replacement therapy for patients with primary immunodeficiency. It is also used to treat idiopathic thrombocytopenic purpura (ITP), chronic inflammatory demyelinating polyneuropathy (CIDP), Guillain-Barre syndrome, and Kawasaki disease in pediatric patients.[34425][53366][53272][61950][66745] The majority of adverse reactions associated with IVIG are infusion-related; however, serious reactions including acute renal failure, hemolytic anemia, aseptic meningitis syndrome, and thrombotic events have been reported.[53441][66745] Conservative product-specific infusion rates and careful monitoring is essential with IVIG use.[53366]

    Classifications

    • Antineoplastic and Immunomodulating Agents
      • Immunomodulating Agents
        • Immunoglobulins
          • Immunoglobulins, Normal Human
    Revision Date: 01/31/2024, 01:25:37 PM

    References

    34425 - Gottstein R, Cooke R. Systematic review of intravenous immunoglobulin in haemolytic disease of the newborn. Arch Dis Child Fetal Neonatal Ed 2003;88:F6-10.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.53218 - Fernandez-Cruz E, Alecsandru D. Mechanisms of action of immune globulin. Clin Exp Immunol. 2009;157:1–2.53272 - Feasby T, Banwell B, Benstead T. Guidelines on the use of intravenous immune globulin for neurologic conditions. Transfus Med Rev 2007;21:S57-S107.53366 - Siegel J. Immune globulins: Therapeutic, Pharmaceutical, Cost, and Administration Considerations. Pharmacy Practice News. May 2023. Retrieved January 31, 2024. Available on the World Wide Web at: https://www.pharmacypracticenews.com/Monographs-and-Whitepapers/Article/05-23/Immune-Globulins-Therapeutic-Pharmaceutical-Cost-and-Administration-Considerations/7024353441 - Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev 2003;17:241-251.61950 - McCrindle BW, Rowley AH, Newburger JW, et al. Diagnosis, treatment, and long-term management of Kawasaki disease: A scientific statement for health professionals from the American Heart Association. Circulation 2017;135:e927-e999.66745 - American Academy of Pediatrics. Red Book: 2021-2024 Report of the Committee on Infectious Diseases. 32nd ed. Elk Grove Village, IL: American Academy of Pediatrics; 2021.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.

    Administration Information

    General Administration Information

    For storage information, see the specific product information within the How Supplied section.

    Route-Specific Administration

    Injectable Administration

    • Titers against specific antigens vary between manufacturers. Due to this variance, some clinicians feel strongly that IVIG products are not equivalent.
    • Prior to administration, ensure that the patient is adequately hydrated. Assess the patient for any risk factors for thrombosis. For patients at risk of thrombosis receiving IVIG, administer at the minimum concentration available and the slowest rate of infusion practicable. Monitor all patients carefully for signs and symptoms of thrombosis; thrombosis can occur even in the absence of risk factors.
    • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.[42655][42658][42659][42955] 

    Intravenous Administration

    • Administer by a separate infusion line. Do not mix with other medications, fluids, or blood products. Do not mix different IVIG products.
    • Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur; headache, nausea, vomiting, flushing, pulse rate, and blood pressure changes may be related to the rate of infusion. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
    • Begin infusions at a low rate and gradually increase if patients are receiving IVIG for the first time, if there has been a prolonged interval between doses, or a different brand is used. Adverse reactions are more likely to occur in these situations.
    • Ensure patients with pre-existing renal insufficiency are not volume depleted.[42655][42658][42659][42955]

     

    Alyglo

    • Alyglo is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter. Do not use any solution that has been frozen, heated, or shaken.
    • Allow refrigerated product to come to room temperature before use and maintain at room temperature during administration.
    • No reconstitution is necessary.
    • Do not dilute
    • If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags. Discard any unused product; each vial is single-use only. Infuse within 24 hours after pooling.
    • Infuse using a separate infusion line. Do not mix with other IVIG products or other intravenous medications or fluids.
    • For the first infusion, the recommended initial infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute). If tolerated, double the infusion rate every 30 minutes up to 8 mg/kg/minute (0.08 mL/kg/minute). The initial rate for the second infusion may be started at 2 mg/kg/minute (0.02 mL/kg/minute). If tolerated, double the infusion rate every 15 minutes up to 8 mg/kg/minute (0.08 mL/kg/minute).
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[70019]

    Asceniv

    • Asceniv is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter. Do not use any solution that has been frozen, heated, or shaken.
    • Allow refrigerated product to come to room temperature before use and maintain at room temperature during administration.
    • Do not mix with other IVIG products or other intravenous medications or fluids.
    • No reconstitution is necessary.
    • Do not dilute.
    • If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags.
    • The recommended initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute) for 15 minutes; if tolerated, increase gradually every 15 minutes to a maximum rate of 8 mg/kg/minute (0.08 mL/kg/minute).
      • For patients at risk of developing renal dysfunction or thromboembolic events, use the minimum practicable infusion rate. Consider discontinuation if renal function deteriorates.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[64039]

     

    Bivigam 10%

    • Bivigam is a clear or slightly opalescent, colorless to pale yellow solution; do not use if the solution is cloudy or turbid or contains particulate matter.
    • Allow product to come to room temperature before use and maintain at room temperature during administration; do not use any solution that has been frozen, heated, or shaken.
    • Do not mix with other IVIG products or other intravenous medications or fluids.
    • If large doses are to be administered, several vials may be pooled using aseptic technique into sterile infusion bags. Discard any unused product; each vial is single-use only.
    • Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute) for 10 minutes. If no adverse reactions occur, the rate may be gradually increased every 20 minutes by 0.8 mg/kg/minute to a maximum of 6 mg/kg/minute.
      • For patients judged to be at risk for renal dysfunction or thrombotic events, administer at the minimum infusion rate practicable, and consider discontinuation if renal function deteriorates.
    • Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42658]

     

    Carimune NF

    • Reconstitute with sterile water for injection, 5% Dextrose Injection, or 0.9% Sodium Chloride Injection according to the manufacturer's directions.
    • To aid in dissolution, vigorously swirl the vial; avoid shaking and foaming. Dissolution may take up to 20 minutes.
    • The solution should be clear. Do not use if particulate matter is present.
    • Solutions are stable for 24 hours under refrigeration if reconstituted in a sterile laminar flow hood. Bring to room temperature prior to administration. Otherwise, use promptly and discard unused portions. Do not freeze.
    • The final concentration of the immunoglobulin solution to be administered is dependent on indication.
      • Primary Immunodeficiency: In previously untreated patients, a 3% Immunoglobulin solution must be used for the initial IV infusion. If the initial infusion is well tolerated, higher concentrations may be used for subsequent infusions.
      • Idiopathic Thrombocytopenic Purpura: A 6% immunoglobulin solution is recommended.
    • Initial IV infusion rate is 0.5 mg/kg/minute for 30 minutes. If tolerated, the rate may be increased to 1 mg/kg/minute for the next 30 minutes. The infusion may then be gradually increased in a stepwise manner to a maximum of 2 mg/kg/minute for patients at risk of renal dysfunction or thromboembolic events and a maximum of 3 mg/kg/minute for all other patients. The mL/kg/minute infusion rate depends on the solution concentration.
      • For patients at risk of acute renal failure, use the minimum practicable concentration and infusion rate.
    • If side effects occur, stop or slow the infusion until symptoms subside.
    • Filtering is not required, but if used, a pore size of 15 microns or larger will be less likely to slow infusion, especially with higher solution concentrations; 0.2 micron antibacterial filters may be used.
    • Administer by a separate infusion line. Do not mix with other medications or fluids.[42654]

     

    Flebogamma DIF 5% or 10%

    • No reconstitution necessary. Throw away unused product, as it does not contain preservatives. Do not use if turbid, contains particles, or was previously frozen.
    • Do not dilute with IV fluids. Compatibility with drugs or solutions has not been established; do not mix with other IVIG products.
    • If large doses are to be administered, several vials may be pooled using aseptic technique into an empty, sterile solution container. Discard any unused product; each vial is single-use only.
    • Infuse immunoglobulin solutions through a dedicated IV line.[41552][41553]
    • Flebogamma DIF 5% and 10% can be administered sequentially into a primary intravenous line containing 0.9% Sodium Chloride Injection or flushed with 0.9% Sodium Chloride Injection without causing precipitation or turbidity.[48515]
    • Infusion rate dependent on immunoglobulin solution concentration.
      • For the 5% Immunoglobulin solution, initial IV infusion rate is 0.5 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, the rate may be gradually increased to a maximum of 5 mg/kg/minute (0.1 mL/kg/minute).
        • Dose titration to a maximum rate of less than 3 mg/kg/minute (0.06 mL/kg/minute) is recommended for patients at least 65 years of age or who are judged to be at risk of renal dysfunction. Infuse at the minimum infusion rate practicable for patients judged to be at risk for developing renal dysfunction or thromboembolic events.
        • If side effects occur, rate may be reduced, or infusion interrupted until symptoms subside; resume at a rate that is comfortable for the patient.[41552]
      • For the 10% immunoglobulin solution, initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, the rate may be gradually increased to 4 mg/kg/minute (0.04 mL/kg/minute). If tolerated, the rate may be further increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
        • Slower than recommended infusion rates may be utilized for the first 2 to 3 infusions. If no adverse reactions occur, the infusion rate may be gradually increased for subsequent infusions up to the maximum rate.
        • Dose titration to a maximum rate of less than 4 mg/kg/minute (0.04 mL/kg/minute) is recommended for patients over 65 years of age or who are judged to be at risk of renal dysfunction. Infuse at the minimum infusion rate practicable in patients over 65 years of age, at risk of renal dysfunction, or at risk of thrombotic events; consider product discontinuation if renal function deteriorates.
        • Patients who experience adverse reactions, either reduce the infusion rate in subsequent infusions or switch to the 5% immunoglobulin solution.[41553]
    • Record lot numbers of the drug vials administered.
    • Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[41552][41553]

     

    Gammagard Liquid 10%

    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear or slightly opalescent, colorless to pale yellow. Do not shake.
    • No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
    • Prior to use, allow solution to reach ambient room temperature. Do not heat the product; the vials may take up to 60 minutes to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
    • Use of an in-line filter is optional. Infuse through a dedicated line.
    • Monitor vital signs throughout the infusion. Adverse reactions such as headaches, flushing, and changes in pulse rate and blood pressure may be related to the infusion rate; slow or stop the infusion if they occur. If symptoms subside promptly, infusion may be resumed at a lower rate that does not cause symptom recurrence.
    • Initial and maximum infusion rates:
      • Primary immunodeficiency: Initial IV infusion rate is 0.8 mg/kg/minute (0.5 mL/kg/hour) for 30 minutes. If no adverse reactions occur, rate may be gradually increased every 30 minutes to a maximum of 8 mg/kg/minute (5 mL/kg/minute).
      • Multifocal motor neuropathy/chronic inflammatory demyelinating polyneuropathy: Initial IV infusion rate is 0.8 mg/kg/minute (0.5 mL/kg/hour) and titrate, if tolerated, to a maximum of 9 mg/kg/minute (5.4 mL/kg/hour) as the maintenance infusion rate.
      • For patients more than 65 years or who are at risk of renal dysfunction or thrombotic complications, dose titration to a maximum rate of less than 3.3 mg/kg/minute (less than 2 mL/kg/hour). Consider discontinuation if renal function deteriorates.
    • Record the name and lot number of the product administered.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42655]

     

    Gammagard S/D

    • NOTE: Manufacturer's directions for reconstitution must be read thoroughly before attempting to reconstitute this product.
    • Both the diluent and the lyophilized powder should be at room temperature before reconstitution. The solution should be clear to slightly opalescent and colorless to pale yellow. Do not use solution if there are particles or discoloration.
    • If prepared outside a sterile laminar air flow hood, begin administration within 2 hours of reconstitution.
    • If prepared in a sterile laminar air flow hood and stored in the original glass container or pooled into ViaFlex bags under constant refrigeration (2 to 8 degrees C [36 to 46 degrees F]), begin administration within 24 hours of reconstitution.
    • Using the supplied administration set, administer by a separate infusion line. Use the antecubital vein, if possible, especially for the 10% solution. Do not mix with other medications or fluids; do not mix with other IVIG products.
    • If refrigerated, allow solution to reach room temperature prior to administration.
    • Initial IV infusion rate for the 5% solution should begin at 0.0083 mL/kg/minute. If the patient does not experience any discomfort, the infusion rate may be gradually increased to a maximum of approximately 0.067 mL/kg/minute.
      • If the highest rate for the 5% solution is tolerated, the 10% solution may be used with an initial rate of 0.0083 mL/kg/minute. If the patient does not experience any discomfort, the infusion rate may be gradually increased to a maximum rate of 0.133 mL/kg/minute.
      • For patients at risk of renal dysfunction or thrombotic complications, infuse solution at the minimum practicable rate and gradually titrate up to a maximum rate of less than 0.067 mL/kg/minute for the 5% solution or less than 0.033 mL/kg/minute for the 10% solution.[42955]

     

    Gammaked

    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
      No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
    • Allow solution to reach ambient room temperature prior to administration.
    • Only 18 gauge needles should be used to penetrate the stopper for dispensing the product from the 10 mL vials; 16 gauge needles should only be used with the 25 mL vial sizes and larger. Do not insert the needle or dispensing pin more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    • Promptly administer solution after piercing the cap. If large doses are to be administered, several vials may be pooled into sterile infusion bags using aseptic technique. Begin infusion within 8 hours after pooling.
    • The infusion line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
    • Infuse using a separate infusion line. Do not mix with other IV medications, fluids, or other IVIG products.
    • Avoid coadministration of Gammaked and heparin through a single lumen delivery device due to Gammaked and heparin incompatibility. Following Gammaked infusion, flush the IV line, delivery device, and/or heparin lock (Hep-Lock) with either 5% Dextrose Injection or 0.9% Sodium chloride Injection; do not flush with heparin.
    • Initial (first 30 minutes) and maximum infusion rates:
      • Idiopathic thrombocytopenic purpura (ITP) or primary immunodeficiency: Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
      • Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 2 mg/kg/minute (0.02 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
      • For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum infusion rate practicable. Discontinue the infusion if renal function deteriorates.
    • If side effects occur, rate may be reduced, or infusion interrupted until symptoms subside; resume at a rate that is comfortable for the patient.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[54820]

     

    Gammaplex 5% or 10%

    • The solution should be clear or slightly opalescent and colorless. Do not use if solution is cloudy, discolored, or contains particulate matter. Do not shake or use if it has been frozen.
    • Gammaplex should be at room temperature (up to 25 degrees C [77 degrees F]) at the time of administration. After piercing the cap, promptly administer; there are no preservatives, and it is for single use only. Dispose of partially used or unused product. If large doses are to be administered, several vials may be pooled using aseptic technique.
    • Infuse using an infusion set and a separate infusion line. Do not mix with other IV medications (including 0.9% Sodium Chloride Injection) or other IVIG products. An infusion pump may be used to control the rate of administration.
    • Initial and maximum infusion rates:
      • For 5% product, initial IV infusion rate is 0.05 mg/kg/minute (0.01 mL/kg/minute) for 15 minutes. If well tolerated, the rate may be gradually increased every 15 minutes to a maximum of 4 mg/kg/minute (0.08 mL/kg/minute).
      • For 10% product, initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute) for 15 minutes. If well tolerated, the rate may be gradually increased every 15 minutes to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
      • For patients judged to be at risk for renal dysfunction, thrombotic events, or volume overload, administer at the minimum infusion rate practicable, and discontinue if renal function deteriorates.
    • Monitor vital signs throughout the infusion. If side effects occur, slow or stop the infusion. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient. The observation time of patients after administration may vary. If the patient has not received an IgG product, is switched from an alternative IVIG product, or has had a long interval since the previous infusion, prolong the observation time for adverse reactions after Gammaplex infusion.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42661][61745]

     

    Gamunex-C

    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
    • No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection; do NOT use 0.9% Sodium Chloride Injection. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
    • Allow solution to reach ambient room temperature prior to administration.
    • Only 18 gauge needles should be used to penetrate the stopper for dispensing the product from the 10 mL vials; 16 gauge needles should only be used with the 25 mL vial sizes and larger. Do not insert the needle or dispensing pin more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    • Promptly administer solution after piercing the cap. If large doses are to be administered, several vials may be pooled into sterile infusion bags using aseptic technique. Begin infusion within 8 hours after pooling.
    • The infusion line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
    • Infuse using a separate infusion line. Do not mix with other IV medications, fluids, or other IVIG products.
    • Avoid coadministration of Gamunex-C and heparin through a single lumen delivery device due to Gamunex-C and heparin incompatibility. Following Gamunex-C infusion, flush the IV line, delivery device, and/or heparin lock (Hep-Lock) with either 5% Dextrose Injection or 0.9% Sodium chloride Injection; do not flush with heparin.
    • Initial (first 30 minutes) and maximum infusion rates:
      • Idiopathic thrombocytopenic purpura (ITP) or primary immunodeficiency: Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
      • Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 2 mg/kg/minute (0.02 mL/kg/minute). If well-tolerated, the rate may be gradually increased to a maximum of 8 mg/kg/minute (0.08 mL/kg/minute).
      • For patients at risk for developing renal dysfunction or thromboembolic events, use the minimum infusion rate practicable. Discontinue the infusion if renal function deteriorates.
    • If side effects occur, rate may be reduced, or infusion interrupted until symptoms subside; resume at a rate that is comfortable for the patient.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[51240]

     

    Octagam 5% or 10%

    • Do not use if solution has discoloration, cloudiness, or particulate matter. Do not shake. Do not freeze or use solutions that have been frozen.
    • No reconstitution necessary; Octagam should not be diluted.
    • Use no larger than a 16 gauge needle. Do not insert the needle more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    • Bottles may be pooled under aseptic conditions into sterile infusion bags and administered within 8 hours after pooling.
    • Allow refrigerated product to come to ambient room temperature before administration.
    • If an in-line filter is used, the pore size should be 0.2 to 200 microns. Infuse through a dedicated line. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.[30276][57655]
    • Initial and maximum infusion rates:
      • For the 5% product, the initial IV infusion rate is 0.5 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, rate may be increased to 1 mg/kg/minute (0.02 mL/kg/minute) for the next 30 minutes. If tolerated, infusion may be further increased to 2 mg/kg/minute (0.04 mL/kg/minute) for the next 30 minutes.
        • Do not exceed a maximum of 3.33 mg/kg/minute (0.07 mL/kg/minute).
        • For geriatric patients and patients at risk for renal dysfunction or thrombosis, infuse at the minimum infusion rate practicable.[30276]
      • For the 10% product, the initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If no adverse reactions occur, rate may be increased to 2 mg/kg/minute (0.02 mL/kg/minute) for the next 30 minutes. If tolerated, infusion may be further increased to 4 mg/kg/minute (0.04 mL/kg/minute) for the next 30 minutes. If tolerated, the infusion may be further increased to 8 mg/kg/minute (0.08 mL/kg/minute) for the next 30 minutes in patients with chronic immune thrombocytopenic purpura.
        • Do not exceed a maximum of 4 mg/kg/minute (0.04 mL/kg/minute) in patients with dermatomyositis or 12 mg/kg/minute (0.12 mL/kg/minute) in patients with chronic immune thrombocytopenic purpura.
        • For geriatric patients and patients at risk for renal dysfunction or thrombosis, infuse at the minimum infusion rate practicable, not to exceed 3.3 mg/kg/minute (0.03 mL/kg/minute).[57655]
    • The IV infusion line may be flushed before and after administration of Octagam 5% or 10% with either 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
    • Monitor vital signs throughout the infusion. Slow or stop infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate. Discontinue if renal function deteriorates.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[30276][57655]

     

    Panzyga

    • No reconstitution necessary. Do not use if cloudy, turbid, contains particles, or was previously frozen. Do not freeze.
    • Use no larger than a 16 gauge needle. Do not insert the needle more than once. Penetrate the stopper perpendicular to the plane of the stopper within the ring.
    • Bottles may be pooled under aseptic conditions into sterile infusion bags and administered within 8 hours after pooling.
    • Allow refrigerated product to come to room temperature before administration.
    • If an in-line filter is used, the pore size should be 0.2 to 200 microns. Infuse through a dedicated line. Compatibility with other drugs or solutions has not been established; do not mix with other IVIG products.
    • Initial and maximum infusion rates:
      • Primary immunodeficiency: Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If infusion is well tolerated, gradually increase every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 14 mg/kg/minute (0.14 mL/kg/minute).
      • Chronic immune thrombocytopenia (ITP): Initial IV infusion rate for chronic ITP is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If infusion is well tolerated, gradually increase every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 8 mg/kg/minute (0.08 mL/kg/minute).
      • Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 1 mg/kg/minute (0.01 mL/kg/minute) for 30 minutes. If infusion is well tolerated, gradually increase every 15 to 30 minutes, as tolerated, to the maximum infusion rate of 12 mg/kg/minute (0.12 mL/kg/minute).
      • For patients who are at risk of renal dysfunction or thromboembolic complications, titrate, as tolerated, to a maximum rate of less than 3.3 mg/kg/minute (0.033 mL/kg/minute). Consider discontinuation if renal function deteriorates.
    • Monitor vital signs during the infusion. If side effects occur, slow or stop the infusion until the symptoms subside. Restart the infusion at a lower rate that is comfortable for the patient.
    • After administration, line may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[63463]

     

    Privigen

    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
    • No reconstitution necessary. If dilution is desired, use 5% Dextrose Injection. Do not mix with other drugs or IVIG products.
    • If large doses are to be administered, several vials may be pooled using aseptic technique and administered within 8 hours of pooling. Promptly use contents of each single-use vial; no preservatives are present.
    • Administer via a separate IV infusion line, which may be flushed with 5% Dextrose Injection or 0.9% Sodium Chloride Injection. An infusion pump may be used to control the administration rate.
    • Initial and maximum infusion rates:
      • Primary immunodeficiency: Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute). If infusion is well tolerated, gradually increase, as tolerated, to the maximum infusion rate of 8 mg/kg/minute (0.08 mL/kg/minute).
      • Chronic immune thrombocytopenia (ITP): Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute). If infusion is well tolerated, gradually increase, as tolerated, to the maximum infusion rate of 4 mg/kg/minute (0.04 mL/kg/minute).
      • Chronic inflammatory demyelinating polyneuropathy (CIDP): Initial IV infusion rate is 0.5 mg/kg/minute (0.005 mL/kg/minute). If infusion is well tolerated, gradually increase, as tolerated, to the maximum infusion rate of 8 mg/kg/minute (0.08 mL/kg/minute).
      • For patients who are at risk of renal dysfunction, thromboembolic complications or volume overload, administer a minimum dose and infuse at the minimum infusion rate practicable. Discontinue therapy if renal function deteriorates.
      • For patients at risk of developing systemic reactions with rapid infusions (greater than 4 mg/kg/minute [0.04 mL/kg/minute]) of Privigen, begin the initial infusion at a slow rate (e.g., 0.5 mg/kg/minute [0.005 mL/kg/minute]) and gradually increase rate as tolerated. Systemic reactions may mimic symptoms of an inflammatory response or infection. Patients at risk of developing a systemic reaction include those that have not previously received Privigen or another immune globulin G (IgG) product or have not received it within the previous 8 weeks and those switching from another IgG product to Privigen.
    • Monitor vital signs during the infusion. If side effects occur, slow or stop the infusion until the symptoms subside. Restart the infusion at a lower rate that is comfortable for the patient.
    • Storage: Vials are for single use only; use promptly and discard any unused portion immediately.[42659]

    Subcutaneous Administration

    Gammagard Liquid 10%

    • Gammagard Liquid may be given by subcutaneous infusion using a subcutaneous infusion pump.
    • Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear or slightly opalescent, colorless to pale yellow. Do not shake.
    • If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach ambient room temperature. Do not heat the product; the vials may take up to 60 minutes to reach room temperature.
    • Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. If using a vented spike, it is not necessary to inject air into the vial. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
    • Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing. Prime administration tubing to ensure no air is left in tubing or needles.
    • Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
    • Injection sites include the abdomen, thighs, upper arms, and/or lower back. Avoid bony areas, visible blood vessels, scars, and areas of inflammation, irritation, or infection. Rotate the injection site with each weekly administration. New infusion sites should be at least 2 inches from a previous site.
    • Select the number of infusion sites based on the volume of the total dose.
      • Patients weighing 40 kg and greater: do not exceed a volume of 30 mL per site. Determine the number of required infusion sites by dividing the total weekly dose (mL) by 30. Do not exceed a total of 8 simultaneous infusion sites.
      • Patients weighing less than 40 kg: do not exceed a volume of 20 mL per site. Do not exceed a total of 8 simultaneous infusion sites.
    • Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of a multi-needle administration set. Injection sites should be at least 2 inches apart.
    • Firmly pinch at least 1 inch of skin between two fingers and insert the needle at a 90-degree angle subcutaneously using rapid motion. Tape the needle into place. Repeat the steps for each injection site.
    • Before starting infusion, ensure correct needle placement. Attach a sterile syringe to the end of the infusion tubing, and pull the plunger back gently. If you see blood in the tubing, take the needle out of the injection site, and throw away the tubing and needle. Try a different site with new infusion tubing and a new needle.
    • Secure needle(s) placement by placing a sterile, clear bandage over the needle.
    • Initial and maintenance infusion rates:
      • Patients weighing 40 kg and greater: Initial subcutaneous infusion rate is 20 mL/hour/site. If tolerated, the infusion rate may be increased to a maximum of 30 mL/hour/site. If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites. For example, if the rate is 30 mL/hour/site, then 30 mL multiplied by 4 sites would be 120 mL/hour. Do NOT exceed a total of 8 infusion sites or maximum infusion rate of 240 mL/hour.
      • Patients weighing less than 40 kg: Initial subcutaneous infusion rate is 15 mL/hour/site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/site. If multiple sites are used, the rate set on the pump should be the rate per site multiplied by the number of sites. For example, if the rate is 20 mL/hour/site, then 20 mL multiplied by 4 sites would be 80 mL/hour. Do NOT exceed a total of 8 infusion sites or maximum infusion rate of 160 mL/hour.
    • To start the subcutaneous infusion, follow the pump manufacturer's instructions.
    • After infusion completion, remove clear bandage and needle(s). If needed, gently press a small piece of gauze over the injection site and cover with a protective dressing.
    • Instruct patients to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
    • Storage: Protect vials from light by storing in their original boxes. Unopened Gammagard vials may be stored under refrigeration at 2 to 8 degrees C (36 to 46 degrees F) for up to 36 months or at a room temperature up to 25 degrees C (77 degrees F) for up to 24 months. Both the vial and carton labels contain the refrigerator and room temperature expiration dates. Once a vial has been stored at room temperature, do not refrigerate again. Do not freeze.[42655]

     

    Gammaked

    • Gammaked may be administered subcutaneously for the treatment of primary immunodeficiency.
    • Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
    • If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach room temperature (20 to 25 degrees C [68 to 77 degrees F]). Do not heat the product; the vials may take up to 60 minutes to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
    • Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
    • Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing and, if needed, Y-site connection tubing. Prime administration tubing to ensure no air is left in tubing or needles.
    • Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
    • Injection sites include the abdomen, thighs, upper arms, lower back, and/or lateral hip. If using multiple simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing. Injection sites should be at least two inches apart.
    • Select the number of infusion sites based on the volume of the total dose.
      • Adult patients: Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
      • Adolescents and children: Do not exceed a total of 6 simultaneous infusion sites.
    • Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of Y-site connection tubing.
    • Firmly pinch the skin between two fingers and insert the needle into the subcutaneous tissue.
    • Ensure correct needle placement by attaching a sterile syringe to the end of the infusion tubing and gently pulling the plunger back. If you see blood in the tubing, remove and discard the needle and administration tubing. Try a different site with new infusion tubing and a new needle. If blood is not observed, secure needle(s) placement by placing a sterile gauze or transparent dressing over the needle. Repeat steps for each infusion site.
    • If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.
    • Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
    • Initial and maintenance infusion rates:
      • Adult patients: Initial, maintenance, and maximum subcutaneous infusion rate is 20 mL/hour/infusion site. Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
      • Adolescents and children weighing 25 kg and greater: Initial subcutaneous infusion rate is 15 mL/hour/infusion site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
      • Adolescents and children weighing less than 25 kg: Initial, maintenance, and maximum subcutaneous infusion rate is 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
    • To start the subcutaneous infusion, follow the pump manufacturer's instructions.
    • After infusion completion, turn off pump, gently remove inserted needles, and discard used equipment in an appropriate waste container.
    • Instruct patients to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
    • Storage: Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). If needed, unopened Gammagard vials may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 6 months anytime during the 36-month shelf life; the vials must be used during this time or discarded. Do not freeze or shake.[54820]

     

    Gamunex-C

    • Gamunex-C may be administered by subcutaneous infusion for the treatment of primary immunodeficiency.
    • Only an individual trained in subcutaneous drug delivery should administer the subcutaneous infusion.
    • Do not use if solution has discoloration, cloudiness, or particulate matter; appearance can vary from clear to opalescent, colorless to pale yellow. Do not shake. Do not freeze or use solutions that have been frozen.
    • If stored under refrigeration, remove vial(s) from the refrigerator and allow solution to reach room temperature (20 to 25 degrees C [68 to 77 degrees F]). Do not heat the product; the vials may take up to 60 minutes to reach room temperature. Promptly use contents of each single-use vial; no preservatives are present. Discard any partially used vials.
    • Using aseptic technique, inject an amount of air equivalent to the amount of product to be withdrawn. Multiple vials may be required to achieve the desired dose. After piercing the cap, promptly administer solution from each single-use vial; no preservatives are present. Discard any partially used vials.
    • Follow pump manufacturer's instructions for filling the pump reservoir, preparing the pump, and filling the administration tubing and, if needed, Y-site connection tubing. Prime administration tubing to ensure no air is left in tubing or needles.
    • Cleanse the injection site with an alcohol wipe or other appropriate antiseptic.
    • Injection sites include the abdomen, thighs, upper arms, lower back, and/or lateral hip. If using multiple simultaneous injection sites, use Y-site connection tubing and secure to the administration tubing.
    • Injection sites should be at least two inches apart.
    • Select the number of infusion sites based on the volume of the total dose.
      • Adult patients: Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
      • Adolescents and children: Do not exceed a total of 6 simultaneous infusion sites.
    • Simultaneous subcutaneous infusion at multiple sites may be facilitated with use of Y-site connection tubing.
    • Firmly pinch the skin between two fingers and insert the needle into the subcutaneous tissue.
    • Ensure correct needle placement by attaching a sterile syringe to the end of the infusion tubing and gently pulling the plunger back. If you see blood in the tubing, remove and discard the needle and administration tubing. Try a different site with new infusion tubing and a new needle. If blood is not observed, secure needle(s) placement by placing a sterile gauze or transparent dressing over the needle. Repeat steps for each infusion site.
    • If using multiple, simultaneous infusion sites, use Y-site connection tubing and secure to the administration tubing.
    • Follow the manufacturer's instructions for filling the pump reservoir, preparing the pump, and for filling the administration tubing.
    • Initial and maintenance infusion rates:
      • Adult patients: Initial, maintenance, and maximum subcutaneous infusion rate is 20 mL/hour/infusion site. Do not exceed a total of 8 simultaneous infusion sites; most patients will require only 4 infusion sites.
      • Adolescents and children weighing 25 kg and greater: Initial subcutaneous infusion rate is 15 mL/hour/infusion site. If tolerated, the infusion rate may be increased to a maximum of 20 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
      • Adolescents and children weighing less than 25 kg: Initial, maintenance, and maximum subcutaneous infusion rate is 10 mL/hour/infusion site. Do not exceed a total of 6 simultaneous infusion sites.
    • To start the subcutaneous infusion, follow the pump manufacturer's instructions.
    • After infusion completion, turn off pump, gently remove inserted needles, and discard used equipment in an appropriate waste container.
    • Instruct patients to keep a treatment diary or log book to track information about each infusion, such as time, date, dose, vial lot number (s), and any reactions. The peel-off label from the vial, which includes the product lot number and expiration date, should be placed in the treatment diary or log book.
    • Storage: Store unopened vials under refrigeration at 2 to 8 degrees C (36 to 46 degrees F). If needed, unopened Gammagard vials may be stored at room temperature up to 25 degrees C (77 degrees F) for up to 6 months anytime during the 36-month shelf life; the vials must be used during this time or discarded. Do not freeze or shake.[51240]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database

    Immune globulin (intravenous)

    pH Range
    Range: pH 4 to 7.2 See Product pH under Other Information.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
    Sodium Content
    Carimune NF- Sodium content depends on the diluent used. Gamimune N- Trace amounts of sodium only. Gammagard S/D- Contains sodium chloride 0.85%. Gammar P IV- Contains sodium chloride 0.5%. Gamunex- Contains only trace amounts of sodium. Iveegam EN- Contains sodium 3 mg/mL. Panglobulin- Sodium content depends on the diluent used. Polygam S/D- Contains sodium chloride 0.85%. Privigen- Trace amounts of sodium. Venoglobulin S- 5% is less than 0.0013 mEq/mL; 10% is less than 0.001 mEq/mL.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
    Osmolality/Osmolarity
    Carimune NF- Depends on the diluent and concentration. See Below. Cuvitru 20% - 280 to 292 mOsm/kg. Flebogamma 5%- 240 to 380 mOsm/L. Gamimune N- 10% is 274 mOsm/kg. Gammagard S/D- 5% is 636 mOsm/L; 10% is 1250 mOsm/L. Gammar P IV- 5% is 309 mOsm/L; 10% is 600 mOsm/L. Gamunex- 10% is 258 mOsm/kg. Iveegam EN- Over 240 mOsm/L. Octagam- 5% is 310 to 380 mOsm/kg. Panglobulin- Depends on the diluent and concentration. See Below. Polygam S/D- 5% is 636 mOsm/L; 10% is 1250 mOsm/L. Privigen- 10% is 320 mOsm/kg. Venoglobulin S- 5% is 300 mOsm/L; 10% is 330 mOsm/L. The osmolality of Carimune NF and Panglobulin depends on the diluent used in reconstitution and the resulting concentration. When reconstituted with the following diluents to a protein concentration ranging from 30 to 120 mg/mL (3 to 12%) the osmolalities are: Dextrose 5%- 444 (at 3%) to 1020 mOsm/kg (at 12%). Sodium chloride 0.9%- 498 (at 3%) to 1074 mOsm/kg (at 12%). Sterile water for injection- 192 (at 3%) to 768 mOsm/kg (at 12%).
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
    Stability
    Immune globulin injections in intact containers stored as directed by the manufacturer is stable until the labeled expiration date. Parti et al. reported that reconstituted Gammagard S/D and Polygam immune globulins at concentrations of 5 and 10% were stable in the original glass vials and in polyvinyl chloride (PVC) plastic bags for 48 hours under refrigeration and for 12 hours at room temperature. The products remained visibly clear and protein content and antibody activity measurements all indicated the products remained stable and active throughout the study periods. Bing et al. reported that Gammagard SD repackaged in ethylene vinyl acetate (EVA) bags and polypropylene (IntraVia) bags was stable for 3 days at room temperature and 14 days under refrigeration. Wu and Lee reported that immune globulin 10% (Gammagard Liquid, Baxter) in intact containers within the labeled expiration date was stable when subjected to 12 months of room temperature storage at 25 degree C and 60% relative humidity after (1) refrigerated storage at 5 degree C for 15 months, and (2) 40 degree C and 75% relative humidity for 2 weeks followed by refrigerated storage at 5 degree C for 28 weeks. Infusion Solutions: The manufacturers of the various immune globulin products indicate the following compatibility characteristics with diluents and infusion solutions: Carimune NF- Reconstitute with dextrose 5%, sodium chloride 0.9%, and sterile water for injection. Flebogamma- Dilution with infusion solutions is not recommended. Gamimune N- Dextrose 5% should be used for dilution. Incompatible in sodium chloride 0.9%. Gammagard S/D- Use only the accompanying sterile water for injection for reconstitution. Use no other solutions. Gammar P- Use only sterile water for injection for reconstitution. Gammar P may be administered before or after dextrose 5% and also sodium chloride 0.9%. Gamunex- Dextrose 5% should be used for dilution. Incompatible in sodium chloride 0.9%. Iveegam EN- Reconstitute with the accompanying sterile water for injection. May be diluted with dextrose 5% or sodium chloride 0.9%. Panglobulin- Reconstitute with dextrose 5%, sodium chloride 0.9%, or sterile water for injection. Privigen- May be diluted with dextrose 5%. Venoglobulin S- Do not mix infusion solutions with Venoglobulin S. It may be administered before or after or flushed with dextrose 5% or sodium chloride 0.9%.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesBing CM, Chamallas SN, Filibeck DJ, et al. Extended stability for Parenteral Drugs, 4th ed., Bethesda, MD: American Society of Health-System Pharmacists. 2009;
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
    ReferencesParti R, Mankarious S. Stability assessment of lyophilized intravenous immunoglobulin after reconstitution in glass containers and poly(vinyl chloride) bags. Biotechnol Appl Biochem. 1997; 23
    ReferencesWu Y, Lee H. Extension of room temperature storage conditions from 9 months to 12 months for intravenous immune globulin, 10%. ASHP Midyear Clinical Meeting. 2009;
    Freezing
    Immune globulin liquid products should be protected from freezing. If inadvertently frozen, they should be discarded.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
    Filtration
    Manufacturers' recommendations: Carimune NF- No filter required. Flebogamma- Filters with a porosity of 15 to 20 microns may be used, but 0.2-micron filters may slow the infusion rate. Gamimune N- No filter required. Gammagard S/D- Use of a filter is required. Gammar P IV- No filter required. Gamunex- No filter required. Iveegam EN- Use of a 15-micron filter is required. Panglobulin- No filter required. Polygam S/D- Use of a filter is required. Privigen- No filter required. Venoglobulin S- No filter required. Study 1: Huang et al. evaluated the impact of extractable and leachable materials from three kinds of sterilizing filters (polyvinylidene fluoride, polyethersulfone, and mixed cellulose ester) on the stability of a model monoclonal antibody formulation of IgG2. The extractable and leachable materials from the filters were found to be generally destabilizing.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesHuang M, Horwitz TS, Zweiben C, et al. Impact of extractables/leachables from filters on stability of protein formulations. J Pharm Sci. 2011; 100
    Sorption Leaching
    Parti et al., and Bing et al. reported that immune globulin in glass containers, polyvinyl chloride (PVC) bags, ethylene vinyl acetate (EVA) bags, and polypropylene (IntraVia) bags exhibited no loss of activity due to sorption. Parti et al. also evaluated the leaching of diethylhexyl phthalate (DEHP) plasticizer from PVC bags by immune globulin stored in PVC containers for 48 hours under refrigeration and 12 hours at room temperature. Only small amounts of DEHP were leached ranging from undetectable qualities up to a maximum of 86 nanograms/mL.
    ReferencesBing CM, Chamallas SN, Filibeck DJ, et al. Extended stability for Parenteral Drugs, 4th ed., Bethesda, MD: American Society of Health-System Pharmacists. 2009;
    ReferencesParti R, Mankarious S. Stability assessment of lyophilized intravenous immunoglobulin after reconstitution in glass containers and poly(vinyl chloride) bags. Biotechnol Appl Biochem. 1997; 23
    Other Information
    Other Drugs: All of the manufacturers of immune globulin recommend not admixing other drugs with any of the immune globulin products. Other Immune Globulins: Mixing differing brands of immune globulin may result in aggregate formation. Product pH: Various immune globulin products have pH ranges as noted below. Carimune NF, Panglobulin - pH 6.4 to 6.8; Cuvitru - pH 4.6 to 5.1; Flebogamma - pH 5 to 6; Gamimune N and Gamunex - pH 4 to 4.5; Gammagard S/D, Gammar-P IV, Iveegam EN, Polygam S/D - pH 6.4 to 7.2; Octagam - pH 5.1 to 6; Privigen - pH 4.6 to 5; and Venoglobulin S - pH 5.2 to 5.8.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesHazlet TK, Tankersley DL. Possible incompatibilities with immune globulin for i.v. use. Am J Hosp Pharm. 1993; 50
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
      Revision Date: 01/30/2024, 09:39:21 AMCopyright 2004-2024 by Lawrence A. Trissel. All Rights Reserved.

      References

      30276 - Octagam (immune globulin 5% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.41552 - Flebogamma 5% DIF (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.41553 - Flebogamma DIF 10% (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42655 - Gammagard Liquid (immune globulin injection [human], 10% Solution) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2024 Jan.42658 - Bivigam 10% (immune globulin intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.42661 - Gammaplex (immune globulin 5% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep.42955 - Gammagard S/D (immune globulin injection, human) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.48515 - Personal communication, Grifols, January 201251240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.54820 - Gammaked (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics LLC; 2018 Jun.57655 - Octagam (immune globulin 10% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.61745 - Gammaplex (immune globulin 10% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep..63463 - Panzyga (immune globulin 10% intravenous, human) package insert. Lingolsheim, France: Octapharma SAS; 2021 Jan.64039 - Asceniv (immune globulin 10% intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.

      Adverse Reactions

      Mild

      • abdominal pain
      • agitation
      • alopecia
      • anorexia
      • anxiety
      • arthralgia
      • asthenia
      • back pain
      • chills
      • cough
      • dental pain
      • diaphoresis
      • diarrhea
      • dizziness
      • drowsiness
      • dyspepsia
      • ecchymosis
      • epistaxis
      • fatigue
      • fever
      • flushing
      • gastroesophageal reflux
      • headache
      • hyperhidrosis
      • hypoesthesia
      • infection
      • influenza
      • injection site reaction
      • insomnia
      • lethargy
      • maculopapular rash
      • malaise
      • muscle cramps
      • musculoskeletal pain
      • myalgia
      • nasal congestion
      • nausea
      • ocular discharge
      • ocular irritation
      • ocular pain
      • otalgia
      • pallor
      • paresthesias
      • petechiae
      • pharyngitis
      • pruritus
      • purpura
      • rash
      • rhinitis
      • rhinorrhea
      • sinusitis
      • throat irritation
      • tremor
      • urticaria
      • vomiting
      • weakness
      • xerosis

      Moderate

      • anemia
      • angina
      • atopic dermatitis
      • bleeding
      • bullous rash
      • candidiasis
      • chest pain (unspecified)
      • confusion
      • conjunctivitis
      • cystitis
      • depression
      • dysarthria
      • dyspnea
      • dysuria
      • edema
      • elevated hepatic enzymes
      • encephalopathy
      • erythema
      • hematuria
      • hemolysis
      • hepatitis
      • hot flashes
      • hyperbilirubinemia
      • hypertension
      • hypoglycemia
      • hyponatremia
      • hypotension
      • hypoxia
      • infusion-related reactions
      • jaundice
      • leukopenia
      • lymphadenopathy
      • migraine
      • myasthenia
      • neutropenia
      • palpitations
      • paresis
      • phlebitis
      • photophobia
      • sinus tachycardia
      • synovitis
      • thrombocytopenia
      • wheezing

      Severe

      • acute respiratory distress syndrome (ARDS)
      • anaphylactic shock
      • anaphylactoid reactions
      • angioedema
      • anuria
      • apnea
      • aseptic meningitis
      • azotemia
      • bradycardia
      • bronchospasm
      • cardiac arrest
      • coma
      • cyanosis
      • disseminated intravascular coagulation (DIC)
      • enterocolitis
      • erythema multiforme
      • hemolytic anemia
      • myocardial infarction
      • oliguria
      • osmotic nephrosis
      • pancytopenia
      • pulmonary edema
      • pulmonary embolism
      • renal failure (unspecified)
      • renal tubular necrosis
      • retinal thrombosis
      • seizures
      • Stevens-Johnson syndrome
      • stroke
      • thromboembolism
      • thrombosis
      • visual impairment

      Transfusion-related acute lung injury (TRALI) is a life-threatening and potentially fatal complication of blood product administration; it has rarely been reported after IVIG administration. TRALI is characterized by severe respiratory distress, hypoxemia (hypoxia), fever, normal left ventricular function, and severe non-cardiogenic pulmonary edema. Symptoms typically begin 1 to 2 hours after administration and manifest fully within 1 to 6 hours. The clinical presentation may be subtle or significant. Radiographs show bilateral pulmonary infiltrates without evidence of cardiac compromise or fluid overload. Respiratory support may be necessary. Diuretics are not effective in TRALI as the cause involves microvascular injury, rather than fluid overload. The etiology of TRALI may be attributable to the presence of anti-HLA antibodies and/or anti-granulocyte antibodies in the plasma of multiparous females or donors who have received previous transfusions who serve as donors for the plasma-derived product. Recipients of IVIG should be monitored for pulmonary adverse events. If TRALI is suspected, both the product and the patient need to be tested for the presence of anti-neutrophil and anti-HLA antibodies.[26918] [51240] [53383] [53384] [53385] [70019]

      Immune globulin is derived from human plasma. Based on effective donor screening and product manufacturing processes, IVIG carries an extremely remote risk of transmission of viral infection or disease. A theoretical risk for transmission of Creutzfeldt-Jakob disease also is considered to be extremely remote. Before prescribing IVIG, discuss the risks and benefits of its use with the patient. Infectious events reported during IVIG therapy include bronchitis (6% to 30%), upper respiratory tract infection (6% to 33%), fungal infection (7% to 9%), viral infection (6%), otitis media (7%), urinary tract infection (7% to 11%), vaginal candidiasis (9%), and flu-like syndrome (5% to 6%).[30276] [41552] [41553] [42654] [42655] [42659] [42661] [42955] [46250] [63463] [70019]

      Respiratory adverse events, including cough/increased cough (6% to 54%), dyspnea (5% to 11%; 8% of pediatric patients), epistaxis (5% to 23%), pharyngitis (10% to 41%), nasopharyngitis (22%), rhinitis (5% to 51%), asthma (15% to 29%), pharyngolaryngeal pain (6%), nasal congestion (6% to 52%), sinusitis (2% to 50%), sore throat, rhinorrhea (7% to 17%), sinus congestion, post-nasal drip, sinus pain, respiratory tract congestion (7%), upper respiratory tract infection (8% to 22%), bronchitis (5% to 20%), oropharyngeal pain, cyanosis, throat irritation (6% to 7%), acute otitis media (8% of pediatric patients), tonsillar disorder (8% of pediatric patients), painful respiration, hypoxemia, apnea, hyperventilation, throat tightness, acute respiratory distress syndrome (ARDS), and influenza-like illness (7%), have been reported with the use of immune globulin. Influenza (less than 1%) has also been reported with subcutaneous use in pediatric patients. Wheezing (3% to 14%), dyspnea, and bronchospasm (14% to 29%) may be associated with immune globulin infusion; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these reactions.[30276] [41552] [41553] [42654] [42655] [42659] [42661] [42955] [46250] [51240] [57655] [63463] [64039] [70019]

      Nausea (5% to 67%), vomiting (6% to 42%), and diarrhea (5% to 28%) are commonly reported adverse effects associated with immune globulin. Necrotizing enterocolitis (NEC) has been associated with high-dose immune globulin used for isoimmune hemolytic disease in preterm and term neonates. Other gastrointestinal adverse effects reported include abdominal pain or cramps (15% or less), dyspepsia (6% to 9%), stomach discomfort (6%), gastroenteritis (9% to 22%), gastroesophageal reflux (7%), and toothache (dental pain). Of note, vomiting was reported more frequently in pediatric patients vs. adult patients during clinical trials of immune globulin for primary immunodeficiency. Nausea, vomiting, abdominal pain/cramping, and loss of appetite (anorexia) may be associated with immune globulin infusion; slowing or stopping the infusion as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms.[30276] [41552] [41553] [42654] [42655] [42658] [42659] [42661] [42955] [46250] [51240] [53417] [57655] [64039] [70019]

      Renal dysfunction, including oliguria, anuria, acute renal failure (unspecified), osmotic nephrosis (osmotic nephropathy), acute renal tubular necrosis, proximal tubular nephropathy, and death have been reported in patients receiving IVIG. Increases in BUN (azotemia) and serum creatinine have been observed as soon as 1 to 2 days after infusion of IVIG. Progression to oliguria and anuria requiring dialysis has been observed; although, some patients have spontaneously recovered following cessation of treatment. Renal histopathologic examination suggested an osmotic injury to the proximal renal tubules (acute renal tubular necrosis, proximal tubular nephropathy, vacuolar degeneration, and osmotic nephrosis). Renal dysfunction is more common with the use of IVIG products containing sucrose as a stabilizer. Use IVIG with caution in patients at risk for developing renal dysfunction, including those with any pre-existing degree of renal insufficiency or renal disease, sepsis, paraproteinemia, diabetes mellitus, hypovolemia, dehydration, obesity, age more than 65 years, or concomitant use of nephrotoxic agents. Especially in such patients, use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate. Ensure patients are not volume depleted prior to IVIG administration. Monitor renal function, including BUN, serum creatinine, and urine output at baseline and appropriate intervals thereafter. If renal function deteriorates, consider IVIG therapy discontinuation. Dysuria, cystitis, or urinary tract infection was reported in 5% of patients who received Gammaplex. There are postmarketing reports of renal pain with IVIG therapy.[30276] [39573] [41552] [41553] [46250] [42654] [42655] [42659] [42661] [42955] [51240] [57655] [70019]

      Nervous system or psychiatric adverse events have been reported during the use of immune globulin. Headache (8% to 92%), dizziness (4% to 13%), and anxiety may be associated with the immune globulin infusion; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms. Other adverse events reported with immune globulin use include insomnia (6% to 9%), agitation, migraine (6% to 7%), restlessness, tremor, hypoesthesia, paresthesias, coma, encephalopathy, loss of consciousness, confusion, nervousness, depression (6%), dysarthria (speech disorder), lethargy, and seizures.[30276] [41552] [41553] [46250] [42654] [42655] [42658] [42659] [42661] [42955] [46250] [51240] [57655] [61745] [70019]

      Aseptic meningitis syndrome (AMS) may rarely occur after IVIG therapy. Signs and symptoms appear within several hours to 2 days and include severe head pain, nuchal rigidity, drowsiness, pyrexia, photophobia, painful eye movements, and emesis. AMS may be more frequent after high-dose (more than 1,000 to 2,000 mg/kg/dose) or rapid-infusion IVIG treatment. Patients with a history of migraine may be at higher risk for this complication of IVIG. Patients presenting with signs and symptoms should undergo a thorough neurological evaluation, including cerebrospinal fluid (CSF) studies; the CSF is often positive for pleocytosis and elevated protein levels, with negative culture results. Discontinuation of IVIG treatment may result in remission of AMS within several days without sequelae.[23788] [30276] [41552] [41553] [46250] [42654] [42655] [42659] [42661] [42955] [57655] [70019]

      Thrombotic events, such as thromboembolism, myocardial infarction, cerebrovascular accident (stroke), transient ischemic attack, thrombophlebitis, deep vein thrombosis, vena cava thrombosis, arterial thrombosis, retinal thrombosis, and pulmonary embolism, have been reported with IVIG. Signs and symptoms of thrombosis include numbness or weakness (paresis) on one side of the body, pain, swelling, discoloration, and/or warmth of the arms or legs, unexplained shortness of breath, and unexplained tachycardia. Additional adverse events associated with thrombosis include chest pain (unspecified) (5% to 15%), pallor, decreased heart rate, vascular collapse, myocardial infarction, and cardiac arrest. Thrombosis may occur regardless of the route of administration and in the absence of known risk factors; however, patients at highest risk for thrombotic events include age more than 65 years, those with multiple cardiovascular risk factors, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, diabetes mellitus, obesity, thrombophilic disorders, a history of vascular disease, a history of atherosclerosis, a history of a previous thromboembolic event, use of estrogens, indwelling catheters, and/or known or suspected hyperviscosity. Ensure that patients are not volume depleted prior to the initiation of IVIG. For patients judged to be at risk for developing thrombotic events, use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate. Monitor all patients receiving IVIG during and after each infusion and encourage patients to report any signs and symptoms of thrombosis.[42655] [42658] [64039] [70019]

      Ecchymosis (9% to 40%), purpura (40%), bleeding/hemorrhage (29%), petechiae (21%), and thrombocytopenia (15%) have been reported during clinical trials of IVIG for the treatment of immune thrombocytopenic purpura (ITP). Other hematologic adverse effects reported with IVIG use include anemia (6% to 11%), decreased hematocrit (5%), decreased hemoglobin, leukopenia (7%), neutropenia, pancytopenia, autoimmune pure red cell aplasia exacerbation, hemoglobinuria, hematuria, chromaturia, and lymphadenopathy (7%).[30276] [41552] [41553] [42654] [42655] [42659] [42955] [46250] [51240] [57655] [70019]

      Antibodies present in IVIG may act as hemolysins and induce immunoglobulin adherence to red blood cells, causing a positive direct antiglobulin test (DAT, Coombs' test), and rarely, hemolysis. Acute hemolysis consistent with intravascular hemolysis, severe hemolysis-related renal dysfunction/failure, and disseminated intravascular coagulation (DIC) have been reported with IVIG therapy. Hemolysis was reported in 7% of immune globulin-treated patients with chronic inflammatory demyelinating polyneuropathy (CIDP) during a clinical trial. In addition, delayed hemolytic anemia can develop after IVIG therapy due to enhanced red blood cell sequestration; cases have generally been reversible. Hemolytic events not associated with a positive DAT have also been observed in clinical trials. Risk factors related to the development of hemolysis include high doses (2,000 mg/kg or more) as a single infusion or divided over several days, and non-O blood type. An underlying inflammatory state reflected by elevated C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) may also contribute to the risk of hemolysis, however the role is uncertain. Monitor patients receiving immune globulin for hemolysis and hemolytic anemia. In high risk patients, consider appropriate lab testing, including hemoglobin and hematocrit prior to therapy and for 36 to 96 hours after infusion. If signs and symptoms of hemolysis are present after the infusion, perform confirmatory lab testing. If a transfusion is indicated, perform adequate cross-matching to avoid exacerbating ongoing hemolysis.[30276] [41552] [41553] [42654] [42655] [42659] [42955] [46250] [51240] [57655] [70019]

      Anaphylactoid reactions, including angioedema, facial edema, and anaphylactic shock, have been reported with IVIG use. Patients who are IgA deficient and have known antibodies to IgA may be at greater risk for developing severe hypersensitivity reactions. Epinephrine should be immediately available during IVIG infusions. If a hypersensitivity reaction occurs, immediately discontinue the infusion.[30276] [46250] [42654] [42655] [42659] [42661] [42955] [51240] [57655] [70019]

      An injection site reaction (5% to 15%), characterized by erythema, pain, irritation/burning, pruritus, edema, and swelling, has occurred with immune globulin. Phlebitis, including thrombophlebitis, has also been reported. Local reactions tend to be more common after hand vein infusions with higher concentrations of immune globulin solution (i.e., 10% vs. 5%); incidence may be reduced by administering immune globulin via the antecubital vein. Local reactions may also be common with subcutaneous infusion, particularly during the first week of infusion. Local reactions were reported in nearly 60% of subcutaneous infusions, and 75% of adult and adolescent patients during clinical trials; incidence rates were similar in pediatric trials (60% of infusions, 100% of patients). The incidence of local reactions may decrease with time in patients receiving chronic infusions. If local reactions occur, application of a warm compress to the infusion site may alleviate symptoms.[30276] [41552] [41553] [42654] [42655] [42659] [42661] [42955] [46250] [51240] [57655] [70019]

      Dermatologic adverse reactions, such as urticaria or hives, pruritis, and rash, have been reported in approximately 5% to 12% of patients receiving IVIG infusion; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms. Stevens-Johnson syndrome, epidermolysis, bullous dermatitis/bullous rash, allergic dermatitis (6%), contact thermal burn or abrasion (7%), eczema or atopic dermatitis, dry skin or xerosis (5% to 9%), maculopapular rash, alopecia, skin exfoliation, and erythema multiforme have also been associated with the use of IVIG.[30276] [41552] [41553] [42654] [42655] [42658] [42659] [42661] [42955] [46250] [51240] [57655] [64039] [70019]

      Hyperproteinemia, increased serum viscosity, hyponatremia, and fluid overload may occur in patients receiving IVIG therapy. The hyponatremia is likely to be a pseudohyponatremia as demonstrated by a decreased calculated serum osmolality or elevated osmolar gap. Distinguishing between true hyponatremia and pseudohyponatremia is important since treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, further increased serum viscosity, and a disposition to thromboembolic events.[30276] [42654] [42655] [42659] [42955] [46250] [51240] [57655] [70019]

      Musculoskeletal pain (5% to 25%), arthralgia (9% or less), back pain (4% to 17%), neck pain (6%), extremity pain (5%), fibromyalgia, myalgia (5% to 6%), muscle cramps or spasms (7%), muscle strain, and muscular weakness or myasthenia have been reported with immune globulin use. Accidental injury (13%) has also been reported. Musculoskeletal adverse events such as arthralgia, myalgia, back pain/backache, muscle cramps, and flu-like symptoms may be associated with IVIG infusion reaction; slowing or stopping the infusion, as well as premedication with acetaminophen and antihistamines may help alleviate these symptoms. Synovitis/tenosynovitis, joint swelling/effusion (6% to 11%), bursitis, chondromalacia patellae, epicondylitis, joint sprain, and trigger finger have been reported during clinical trials of IVIG.[30276] [41552] [41553] [42654] [42655] [42658] [42659] [42661] [42955] [46250] [51240] [57655] [64039] [70019]

      Otalgia (earache/pain 18%) has been reported in patients receiving IVIG. Ocular adverse events reported with IVIG include conjunctivitis (9% to 13%), ocular discharge (7%), ocular irritation (7%), ocular pain, and visual impairment/disturbance.[30276] [41552] [41553] [42654] [42655] [42659] [42661] [42955] [46250] [51240] [57655]

      Elevated hepatic enzymes and hepatic dysfunction have been reported with the use of IVIG. Elevations in AST (7% to 13%), ALT (7% to 18%), alkaline phosphatase (13%), and lactate dehydrogenase (5%) have occurred. Elevations in AST and ALT are generally mild (less than 3 times the upper limit of normal), transient, and not associated with symptoms of liver disease. Hyperbilirubinemia (5%) and increases in unconjugated bilirubin (9% to 11%), conjugated bilirubin (9%), and total bilirubin (7%) were all noted during clinical trials. Jaundice, hepatic dysfunction, and non-infectious hepatitis have been reported postmarketing.[30276] [41552] [41553] [42654] [42658] [42659] [42955] [46250] [51240] [57655] [64039] [70019]

      Infusion-related reactions may occur during immune globulin administration. Symptoms include flushing (6%), chest tightness, headache, chills (5% to 33%), rigors (7% to 37%), fever or increased body temperature (33% or less), diaphoresis, hyperhidrosis (6%), hot flush/hot flashes, dyspnea, wheezing (14%), bronchospasm, dizziness (6%), asthenia (5% to 15%), fatigue (18% or less), malaise (5%), gastrointestinal complaints (nausea, vomiting, upper abdominal pain and/or cramping, loss of appetite), hypotension (2% to 25%), diastolic hypotension (21% in pediatric patients), muscle symptoms (e.g., cramps, backache, arthralgia, myalgia), general flu-like symptoms, anxiety, palpitations, bradycardia (16%), sinus tachycardia (2% to 25%), dizziness, edema, and transient skin reactions. Hypertension occurred in 4% to 14% of patients during clinical trials. Four patients experienced reversible increases in systolic blood pressure to 180 mmHg or more during or within 1 to 4 hours after infusion. Of the 3 patients who had a history of hypertension, a patient with history of untreated hypertension also experienced a reversible increase in diastolic blood pressure from 84 mmHg to 135 mm Hg at 1 hour after the end of the infusion. All cases of hypertension resolved within 1 to 6 hours with observation or changes to oral antihypertensive therapy. Other general adverse events include accidental injury (13% to 16%), angina pectoris, chest discomfort (7% to 9%), extremity pain (11%), and falls (7%). Hyperhidrosis and hot flush/hot flashes have been noted in postmarketing reports. Compared to adult patients, fever was reported more frequently in pediatric patients during clinical trials of IVIG for idiopathic thrombocytopenic purpura (ITP) and primary immunodeficiency. Patients who have never received immune globulin, have been switched from a certain immune globulin product to another, or have had an interruption in immune globulin therapy more than 8 weeks may be at a higher risk for the development of an inflammatory reaction, especially with rapid infusion rates. Symptoms typically begin 30 to 60 minutes after initiation of the infusion and appear to be related to the infusion rate rather than the dose. Slowing or stopping the infusion usually allows these symptoms to resolve. Pretreatment with oral antihistamines and analgesics may help to alleviate these symptoms.[30276] [39573] [41552] [41553] [46250] [42654] [42655] [42658] [42659] [42661] [42955] [51240] [57655] [70019]

      Life-threatening hypoglycemia can occur with the use of Octagam 5% and 10%. Some glucose monitoring systems interpret the maltose in Octagam as glucose. Inaccurate glucose readings can result in inappropriate administration of insulin. Furthermore, falsely elevated glucose readings could mask true cases of hypoglycemia. Monitor glucose in diabetic patients with a glucose-specific method only. Ensure blood glucose testing systems, including test strips, are appropriate to use with maltose-containing products.[30276] [57655]

      Revision Date: 01/30/2024, 04:00:03 PM

      References

      23788 - Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994;121:259-62.26918 - Rizk A, Gorson K, Kenny L, et al. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001;41:264-268.30276 - Octagam (immune globulin 5% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.39573 - Gamunex (immune globulin intravenous human) package insert. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2010 Oct.41552 - Flebogamma 5% DIF (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.41553 - Flebogamma DIF 10% (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42655 - Gammagard Liquid (immune globulin injection [human], 10% Solution) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2024 Jan.42658 - Bivigam 10% (immune globulin intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.42661 - Gammaplex (immune globulin 5% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep.42955 - Gammagard S/D (immune globulin injection, human) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.46250 - Gammaked (immune globulin 10% intravenous, human) package insert. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2012 Jun.51240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.53383 - US Food and Drug Administration (FDA). Transfusion Related Acute Lung Injury (TRALI). October 19, 2001. Retrieved March 1, 2013. Available on the World Wide Wide at http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/BloodSafety/ucm095556.htm53384 - Gupta S, Som T, Iyer L. Transfusion related acute lung injury in a neonate. Indian J Pediatr 2012;79:1363-1365.53385 - Gupta V, Gupta P, Yadav TP. Transfusion related acute lung injury with intravenous immunoglobulin. Indian Pediatr 2011;48:807-808.53417 - Figueras-Aloy J, Rodriguez-Miquelez JM, Iriondo-Sanz M. Intravenous immunoglobulin and necrotizing enterocolitis in newborns with hemolytic disease. Pediatrics 2010;125:139-144.53441 - Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Transfus Med Rev 2003;17:241-251.57655 - Octagam (immune globulin 10% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.61745 - Gammaplex (immune globulin 10% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep..63463 - Panzyga (immune globulin 10% intravenous, human) package insert. Lingolsheim, France: Octapharma SAS; 2021 Jan.64039 - Asceniv (immune globulin 10% intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • corn hypersensitivity
      • hereditary fructose intolerance
      • hyperprolinemia
      • IgA deficiency
      • albumin hypersensitivity
      • aseptic meningitis
      • breast-feeding
      • cardiac disease
      • coronary artery disease
      • dehydration
      • diabetes mellitus
      • geriatric
      • heart failure
      • hemolysis
      • hypertension
      • hypertriglyceridemia
      • hypervolemia
      • hyponatremia
      • hypovolemia
      • infants
      • laboratory test interference
      • migraine
      • neonates
      • obesity
      • pregnancy
      • renal disease
      • renal failure
      • renal impairment
      • sepsis
      • subcutaneous administration
      • thromboembolism
      • vaccination
      • viral infection

      Consider the patient's fluid status when considering the IVIG dose and product to be used. Administration of IVIG can significantly contribute to the daily fluid balance; high dose regimens (e.g., 1,000 mg/kg/day or more, for example) may put patients at increased risk for volume overload (hypervolemia).[42659] [46250] [51240] Monitor patients for signs and symptoms such as acute edema (peripheral or pulmonary) and dyspnea during infusions.

      IVIG should be used cautiously in patients with a history of human immunoglobulin hypersensitivity. Carimune NF, Gammagard Liquid, Gammar-P I.V., Privigen, Bivigam, Gammaplex, Flebogamma 10%, Flebogamma 5%, Octagam 10%, Octagam 5%, and Gamunex-C are contraindicated in patients who with a history of anaphylactic or severe systemic reaction to immune globulin.[30276] [39573] [41553] [41552] [42654] [42655] [42658] [42659] [42661] [57655] IVIG products contain albumin and thus should be used with caution in patients with albumin hypersensitivity; some products contraindicate use. Octagam 5% is contraindicated for use by patients with an acute corn hypersensitivity, as the 5% liquid contains maltose (100 mg/mL).[30276] Octagam 10% also contains maltose (90 mg/mL); hypersensitivity reactions may occur in patients with corn allergy.[57655] Privigen is contraindicated for use by patients with hyperprolinemia because it contains the stabilizer L-proline.[42659] Gammaplex and Flebogamma 10% are contraindicated in patients with hereditary fructose intolerance as these products contain 50 mg of sorbitol per mL as an excipient; also, do not use in neonates and infants for whom sucrose or fructose tolerance has not been established.[42661]

      IVIG is contraindicated for use in patients with IgA deficiency who have antibodies against IgA and a history of hypersensitivity to human immunoglobulin treatment. Patients with IgA deficiency and known anti-IgA antibodies have a higher risk of developing potentially severe hypersensitivity and/or anaphylactic reactions (including anaphylaxis and shock) with administration of IVIG.[42655] [42658] [64039] [70019]

      Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with IVIG treatment. Signs and symptoms usually appear within several hours to 2 days and include severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting. AMS may occur more frequently after high-dose (e.g., more than 1,000 to 2,000 mg/kg/dose) and/or rapid-infusion IVIG treatment. In addition, patients with a history of migraine may be more susceptible to the development of aseptic meningitis syndrome due to IVIG.[23788] Patients presenting with signs and symptoms should undergo a thorough neurological evaluation, including CSF studies, to rule out other causes of meningitis. The diagnosis of aseptic meningitis is one of exclusion. Cerebrospinal fluid studies are frequently positive with pleocytosis up to several thousand cells per cubic mm, predominantly from the granulocytic series, and elevated protein concentrations up to several hundred mg/dL. Discontinuation of IVIG treatment has resulted in remission of aseptic meningitis syndrome within several days without sequelae.[30276] [41552] [42661] [42654] [42655] [42658] [42659] [42955] [46250] [51240] [57655] [70019]

      IVIG is a derivative of human blood. As with other products derived from or purified with human blood components, the remote possibility of contamination with bacterial or viral infection, including hepatitis, or Creutzfeldt-Jakob disease (CJD) exists in patients receiving IVIG. Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating and/or reducing viruses has reduced the risk of transmission of infectious agents; however, none of the processes are completely effective. Some viruses, such as parvovirus B19, are particularly difficult to remove or inactivate. Parvovirus B19 most seriously affects pregnant women and immune compromised individuals and symptoms include fever, drowsiness, chills, and rhinitis followed in about 2 weeks with rash and joint pain. There is also the possibility that unknown infectious agents are present in the pooled product. Discuss the risks and benefits of IVIG therapy with the patient prior to administration. Patients and caregivers should be encouraged to notify their health care provider if they develop infectious symptoms. All infections thought to have been transmitted by IVIG should be reported to the manufacturer.[30276] [39573] [41553] [41552] [42654] [42655] [42658] [42659] [42661] [57655] [70019]

      Thromboembolism is known to be associated with IVIG therapy, regardless of the route of administration. Thrombosis can occur in patients without any known risk factors; however, patients most at risk include geriatric patients, those with multiple cardiovascular risk factors (e.g., known cardiac disease), impaired cardiac output (heart failure), prolonged immobilization, obesity, diabetes mellitus, use of estrogens, indwelling central venous catheters, acquired or inherited coagulation disorders, and patients with a history of a thrombotic event, vascular disease, atherosclerosis (coronary artery disease), and/or known or suspected hyperviscosity. Assessment of blood viscosity may be warranted for patients at risk for hyperviscosity such as those with cryoglobulins, fasting chylomicronemia, hypertriglyceridemia, or monoclonal gammopathies. Due to an increased risk of thromboembolic events, patients with dermatomyositis should be closely monitored and the infusion rate should not exceed 0.04 mL/kg/minute. Rapid infusion rates and high doses of IVIG may increase the risk in patients who are already at risk for thrombotic events. For patients at risk of developing thrombosis, use the minimum recommended dose of IVIG administered at the minimum practicable rate. Hyperproteinemia, increased serum viscosity, and hyponatremia may also occur in patients receiving IVIG therapy. Distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap. Treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity, and a possible predisposition to thrombotic events. Ensure patients are not volume depleted prior to the initiation of IVIG and monitor for signs and symptoms of thrombosis during and after each infusion. Encourage patients to report any pain, swelling, discoloration, and/or warmth of the arms or legs, unexplained shortness of breath, chest pain/discomfort, unexplained tachycardia, and numbness or weakness on 1 side of the body. Elevation of systolic blood pressure to 180 mm Hg or more and/or diastolic blood pressure to more than 120 mm Hg has been observed during and shortly after infusion, especially in patients with a history or hypertension. Monitor blood pressure before, during, and after infusion.[30276] [41552] [42661] [42654] [42655] [42658] [42659] [42955] [46250] [51240] [57655] [70019]

      Renal impairment, acute renal failure, osmotic nephrosis, and death may occur with the administration of IVIG products in predisposed patients. Renal dysfunction and failure are more common with the use of IVIG products containing sucrose as a stabilizer; Carimune NF contains sucrose.[42654] Use IVIG with caution in patients at risk for developing renal dysfunction, including those with any pre-existing degree of renal insufficiency or renal disease, sepsis, paraproteinemia, diabetes mellitus, hypovolemia, dehydration, or obesity, elderly patients (more than 65 years of age), or concomitant use of nephrotoxic agents. Use the minimum recommended dose of IVIG administered at the minimum concentration available and the minimum practicable rate in patients at risk for developing renal dysfunction. Ensure patients are not volume depleted prior to IVIG administration. Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output at baseline and appropriate intervals thereafter. If renal function deteriorates, consider IVIG therapy discontinuation.[42655] [42658] [64039] [70019]

      Certain cautions are to be used with patients receiving IVIG who must undergo vaccination. Inactivated vaccines can be administered any time before, after, or simultaneously with IVIG; if administered simultaneously, different administration sites should be used. In addition, the live vaccines Ty21a typhoid, yellow fever, live-attenuated influenza, zoster, and rotavirus vaccines may be administered at any time during IVIG therapy. Because of the passive transfer of antibodies, IVIG, like other antibody-containing blood products, can inhibit the immune response to measles, mumps, and rubella vaccines for 3 months or more. IVIG products also contain antibodies to varicella, however their effect on immune response to this virus is unknown. If simultaneous administration of measles-containing vaccine or varicella vaccine is unavoidable, administer the products at different sites, and revaccinate or test for seroconversion after the recommended interval. The duration of interference of IVIG with the immune response to the measles and possibly varicella vaccine is dose related; patients receiving standard-dose therapy must delay 8 months, while those receiving high-dose therapy must delay 10 to 11 months. The immunizing physician should be informed of recent IVIG therapy so appropriate measures can be taken. It is important to note that various antibodies acquired through passive transfer may confound the results of serological testing.[30276] [41552] [42661] [42654] [42655] [42658] [42659] [42955] [43236] [46250] [51240] [57655]

      IVIG products may contain blood group antibodies that act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin test (DAT, Coombs' test), and rarely, hemolysis. Delayed hemolytic anemia can develop after immune globulin therapy due to enhanced RBC sequestration. Acute hemolysis (consistent with intravascular hemolysis), severe hemolysis-related renal dysfunction, and disseminated intravascular coagulation (DIC) have occurred. Risk factors related to the development of hemolysis include high doses (2,000 mg/kg or more) as a single infusion or divided over several days and non-O blood type. An underlying inflammatory state reflected by elevated C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR) may also contribute to the risk of hemolysis, however the role is uncertain. Monitor patients receiving IVIG for hemolysis and hemolytic anemia. In higher risk patients, consider appropriate lab testing, including hemoglobin and hematocrit prior to therapy, 36 to 96 hours after infusion, and 7 to 10 days post infusion. If signs and symptoms of hemolysis are present after the infusion, perform confirmatory lab testing. If a transfusion is indicated, perform adequate cross-matching to avoid exacerbating ongoing hemolysis.[30276] [41552] [42661] [42654] [42655] [42658] [42659] [42955] [46250] [51240] [57655] [70019]

      Studies with immune globulin IV (IVIG) during pregnancy have not been conducted in humans or animals, and the ability of IVIG to cause fetal harm or affect reproduction capacity is unknown.[42658] [51240] [70019] Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.[42658] [70019] In cases of maternal idiopathic thrombocytopenic purpura where IVIG was administered to the mother before delivery, the platelet response and clinical effect were similar in the mother and neonate.[42654] According to the Advisory Committee on Immunization Practices (ACIP), fetal adverse events have not occurred after administration of immune globulin preparations to pregnant women. Administer during pregnancy only if clearly needed.[43236]

      Use of immune globulin IV (IVIG) has not been evaluated in women who are breast-feeding and excretion of IVIG into breast milk is unknown.[51240] [70019] However, endogenous immune globulin is a normal component in breast milk.[60441] Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk.[48199] There is emerging consensus that IVIG may be the preferred treatment for postpartum mothers with multiple sclerosis who are breastfeeding, although 1 retrospective study failed to find a decrease in relapse rate among mothers who received IgG postpartum.[60441] In a retrospective study of patients with relapsing remitting multiple sclerosis, 73% of neonates were breast-fed for periods of 3 to 12 weeks with no adverse effects. Patients received IVIG through 12 weeks postpartum with regimens of 400 mg/kg/day for 5 days after delivery with additional booster doses at 6 and 12 week postpartum (n = 41) or 0.4 mg/kg/day for 5 days during weeks 6 to 8 of gestation with booster doses every 6 weeks until 12 weeks postpartum.[60442]

      Subcutaneous administration of immune globulin should not be used in patients with immune thrombocytopenic purpura (ITP) because of the risk of hematoma.[51240]

      Immune globulin administration may result in laboratory test interference. After infusion of immunoglobulins, the transitory rise of the various passively transferred antibodies in the blood may yield false positive serological testing results, with the potential for misleading interpretation. Passive transmission of antibodies to erythrocyte antigens (e.g., A, B, D) may cause a positive direct or indirect antiglobulin (Coombs') test.[30276] [70019] Measurement of blood glucose must be done with a glucose-specific method if a patient takes a parenteral product that contains maltose, such as Octagam IVIG. Blood glucose testing systems based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase methods falsely interpret the maltose contained in Octagam as glucose. Falsely elevated glucose readings during Octagam therapy have led to life-threatening hypoglycemia because of inappropriate administration of insulin. Falsely elevated glucose readings could also mask true cases of hypoglycemia. Read the product information of the blood glucose testing system including the information about the test strips to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system.[30276] [57655]

      Revision Date: 12/21/2023, 10:44:47 AM

      References

      23788 - Sekul EA, Cupler EJ, Dalakas MC. Aseptic meningitis associated with high-dose intravenous immunoglobulin therapy: frequency and risk factors. Ann Intern Med 1994;121:259-62.30276 - Octagam (immune globulin 5% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.39573 - Gamunex (immune globulin intravenous human) package insert. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2010 Oct.41552 - Flebogamma 5% DIF (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.41553 - Flebogamma DIF 10% (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42655 - Gammagard Liquid (immune globulin injection [human], 10% Solution) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2024 Jan.42658 - Bivigam 10% (immune globulin intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.42661 - Gammaplex (immune globulin 5% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep.42955 - Gammagard S/D (immune globulin injection, human) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.46250 - Gammaked (immune globulin 10% intravenous, human) package insert. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2012 Jun.48199 - Palmeira P, Costa-Carvalho BT, Arslanian C, et al. Transfer of antibodies across the placenta and in breast milk from mothers on intravenous immunoglobulin. Pediatr Allergy Immunol. 2009;20:528-535.51240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.57655 - Octagam (immune globulin 10% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.60441 - National Institute of Health (NIH). Immune Globulin monograph. LactMed: a Toxnet Database. Revised Nov 2016. Available at National Institute of Health (NIH). Accessed November 15, 2016.60442 - Archiron A, Kishner I, Dolev M, et al. Effect of intravenous immunoglobulin treatment on pregnancy and postpartum-related relapses in multiple sclerosis. J Neurol 2004;251:1133-1137.64039 - Asceniv (immune globulin 10% intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.

      Mechanism of Action

      Immunoglobulins are antibodies synthesized by B lymphocytes. IVIG is derived from the pooled human plasma of thousands of donors. Most preparations consist of intact immunoglobulin (Ig)G molecules with trace amounts of IgA, IgM, soluble CD4, CD8, human leukocyte antigen (HLA), and cytokines. The pooled, heterogenous IgG present in IVIG provides a plethora of antibodies capable of opsonization and neutralization of many toxins and microbes as well as complement activation. Although the amount of each IgG subclass in the parenteral products is similar to that of human plasma, the titers against specific antigens vary from manufacturer to manufacturer. The Fc fragment of the IgG molecule allows the molecule to interact with and signal through Fc- gamma receptors on B cells and other cells of the phagocytic system. The Fc fragment also interacts with the Fc-binding plasma proteins, which is essential for complement activation and microorganism clearance. The passive immunity imparted by IVIG is capable of attenuating or preventing infectious diseases or deleterious reactions from toxins, mycoplasma, parasites, bacteria, and viruses.[53218]

       

      In immunomodulatory and anti-inflammatory disease states, it is believed the Fc fragment of IgG and the Fc-gamma receptors on target cells (e.g., macrophages, B cells, natural killer cells, plasma cells, eosinophils, neutrophils, platelets) interact to up-regulate or down-regulate inflammatory and immune responses. In autoimmune cytopenias and inflammatory neurologic disorders, blockade of Fc-gamma receptors on macrophages blocks the clearance of opsonized target cells and suppresses antibody-dependent cell-mediated cytotoxicity, respectively. Immunoglobulins may also modulate inflammatory response by preventing complement-mediated tissue damage and regulating the induction of anti-inflammatory cytokines and cytokine antagonists (e.g., interleukin 1-beta, interleukin-1 receptor antagonist, tumor necrosis factor alpha). Immunomodulatory response may be facilitated by the immunoregulatory effects of anti-idiotypic antibodies on B cells and autoantibodies, regulation of helper T cell production, and apoptosis of immune system gene expression.[53218]

       

      In ITP treatment, IVIG produces an immediate rise in platelet count, usually lasting only a few weeks, although platelet stabilization for up to 1 year after administration has been reported.[23982]

      Revision Date: 12/14/2023, 12:24:49 PM

      References

      23982 - Fehr J, Hofmann V, Kappeler U. Transient reversal of thrombocytopenia in idiopathic thrombocytopenic purpura by high-dose intravenous gamma globulin. N Engl J Med 1982;306:1254-8.53218 - Fernandez-Cruz E, Alecsandru D. Mechanisms of action of immune globulin. Clin Exp Immunol. 2009;157:1–2.

      Pharmacokinetics

      Immune globulin is administered intravenously; some products (e.g., Gammagard Liquid, Gamunex-C) can also be given as subcutaneous infusion.[42655] Data concerning distribution are scant, but immune globulin appears to distribute equally throughout intravascular and extravascular spaces. It crosses the placenta (in increasing amounts after 30 weeks of gestation) and may be excreted into breast milk. Mean volume of distribution at steady state is 0.05 to 0.08 L/kg. The exact fate of IVIG is not well-defined, but plasma clearance is slow, ranging from 1.3 to 2.5 mL/kg/day; the serum half-life of immune globulin (IgG) is approximately 18 to 25 days. Great interpatient variability exists for the half-life of IgG. Fever, infection, or high IgG concentrations appear to coincide with a shortened half-life whereas immunodeficiency appears to be associated with a longer half-life of IgG (18 to 40 days).[30276][42654][42655][42658][42659][42955][70019]

      Route-Specific Pharmacokinetics

      Intravenous Route

      Peak serum concentrations occur immediately after IV infusion and are dose-related. After infusion, immune globulin follows a biphasic decay curve. The initial phase is characterized by an immediate peak in serum IgG and is followed by rapid decay due to equilibration between the plasma and extravascular fluid compartments; a rapid initial drop in serum IgG is expected. After approximately 6 days, equilibrium is reached and IgG is distributed equally between the intravascular and extravascular space. The second phase is characterized by a slower and constant rate of decay.[30276][42654][42655] In a pharmacokinetic study of 61 adult patients with humoral immunodeficiency receiving intravenous (IV) Gammagard Liquid (median dose: 455 mg/kg/dose every 4 weeks), the mean peak and trough IgG concentration for IV Gammagard Liquid was 2,240 +/- 536 mg/dL and 1,050 +/- 260 mg/dL, respectively. The AUC was 9,958 +/- 2,274 mg x days/dL.[42655]

      Subcutaneous Route

      Some immune globulin products (e.g., Gammagard Liquid, Gamunex-C) have been administered as subcutaneous infusions. The subcutaneous dose required to provide an exposure non-inferior to the exposure from intravenous (IV) administration was 137% of the IV dose.[42655][54339][51240] Specifically, the mean adjusted subcutaneous dose was 141% (100.5% to 160%) for patients younger than 12 years and 137.3% (125.7 to 150.8%) of the IV dose for patients at least 12 years of age. After subcutaneous administration, the peak IgG concentration occurred 2.9 (1.2 to 3.2) days later, and the mean peak concentration was 1,393 +/- 289 mg/dL. The mean trough concentration was 1,202 +/- 282 mg/dL. As compared with IV administration, the mean peak concentration was lower after subcutaneous administration, and the mean trough concentration was higher.[42655] Therefore, subcutaneous infusion doses are adjusted to 1.37 times the IV dosage on average for these products.[42655][51240]

      Special Populations

      Pediatrics

      Neonates

      Volume of distribution in neonates has been reported with variance, ranging from 0.04 to 0.25 L/kg. The IVIG half-life is comparable to normal adult parameters with a reported range of 18 to 29 days.[53227][53228][53229] In a study of 15 neonates (gestational age 32 to 41 weeks; birth weight more than 1,500 grams), IVIG infusions of 500 mg/kg resulted in a mean peak IgG concentration of 2,171 mg/dL, 15 minutes after infusion; this dosage resulted in a significant increase in IgG concentrations greater than 8 days after the infusion. IVIG infusions of 1,000 mg/kg resulted in mean peak IgG concentrations of 2,734 mg/dL and resulted in significant increases in IgG concentrations more than 11 days after the infusion. A biphasic decay curve resulted in an initial rapid decay within 24 hours after infusion followed by a slower decay over the next 6 weeks. Plasma clearance was 3 mL/kg/day. Gestational age, birth weight, dose, and pretreatment serum IgG concentrations had minimal effect on pharmacokinetic parameters.[53228]

       

      Children and Adolescents

      The pharmacokinetics of intravenous and subcutaneous immune globulin are similar in children, adolescents, and adults.[42658][51240] Both intravenous and subcutaneous infusions of immune globulin appear to be effective in children and with similar trough IgG concentrations achieved as in adults.[42658][54339] No pediatric specific dose requirements are necessary to achieve the desired serum IgG levels. Dosage, as in adults, must be individualized and adjusted over time to achieve the desired trough levels and clinical responses.

      Revision Date: 12/20/2023, 01:55:56 PM

      References

      30276 - Octagam (immune globulin 5% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42655 - Gammagard Liquid (immune globulin injection [human], 10% Solution) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2024 Jan.42658 - Bivigam 10% (immune globulin intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.42955 - Gammagard S/D (immune globulin injection, human) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.51240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.53227 - Kinney J, Mundorf L, Gleason C. Efficacy and pharmacokinetics of intravenous immune globulin administration to high-risk neonates. Am J Dis Child 1991;145:1233-1238.53228 - Weisman LE, Fischer GW, Marinelli P. Pharmacokinetics of intravenous immunoglobulin in neonates. Vox Sang 1989;57"243-248.53229 - Noya FJ, Rench MA, Courtney JT. Pharmacokinetics of intravenous immunoglobulin in very low birth weight neonates. Pediatr Infect Dis J 1989;8:759-763.54339 - Wasserman RL, Melamed I, Kobrynski L, et al. Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol. 2011;31:323-331.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.

      Pregnancy/Breast-feeding

      pregnancy

      Studies with immune globulin IV (IVIG) during pregnancy have not been conducted in humans or animals, and the ability of IVIG to cause fetal harm or affect reproduction capacity is unknown.[42658] [51240] [70019] Immunoglobulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation.[42658] [70019] In cases of maternal idiopathic thrombocytopenic purpura where IVIG was administered to the mother before delivery, the platelet response and clinical effect were similar in the mother and neonate.[42654] According to the Advisory Committee on Immunization Practices (ACIP), fetal adverse events have not occurred after administration of immune globulin preparations to pregnant women. Administer during pregnancy only if clearly needed.[43236]

      breast-feeding

      Use of immune globulin IV (IVIG) has not been evaluated in women who are breast-feeding and excretion of IVIG into breast milk is unknown.[51240] [70019] However, endogenous immune globulin is a normal component in breast milk.[60441] Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk.[48199] There is emerging consensus that IVIG may be the preferred treatment for postpartum mothers with multiple sclerosis who are breastfeeding, although 1 retrospective study failed to find a decrease in relapse rate among mothers who received IgG postpartum.[60441] In a retrospective study of patients with relapsing remitting multiple sclerosis, 73% of neonates were breast-fed for periods of 3 to 12 weeks with no adverse effects. Patients received IVIG through 12 weeks postpartum with regimens of 400 mg/kg/day for 5 days after delivery with additional booster doses at 6 and 12 week postpartum (n = 41) or 0.4 mg/kg/day for 5 days during weeks 6 to 8 of gestation with booster doses every 6 weeks until 12 weeks postpartum.[60442]

      Revision Date: 12/19/2023, 11:17:57 AM

      References

      42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42658 - Bivigam 10% (immune globulin intravenous, human) package insert. Boca Raton, FL: ADMA Biologics; 2024 Mar.43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.48199 - Palmeira P, Costa-Carvalho BT, Arslanian C, et al. Transfer of antibodies across the placenta and in breast milk from mothers on intravenous immunoglobulin. Pediatr Allergy Immunol. 2009;20:528-535.51240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.60441 - National Institute of Health (NIH). Immune Globulin monograph. LactMed: a Toxnet Database. Revised Nov 2016. Available at National Institute of Health (NIH). Accessed November 15, 2016.60442 - Archiron A, Kishner I, Dolev M, et al. Effect of intravenous immunoglobulin treatment on pregnancy and postpartum-related relapses in multiple sclerosis. J Neurol 2004;251:1133-1137.70019 - Alyglo (immune globulin 10% intravenous, human) package insert. Teaneck, NJ: GC Biopharma USA, Inc.; 2023 Dec.

      Interactions

      Level 2 (Major)

      • Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
      • Measles/Mumps/Rubella Vaccines, MMR
      • Pozelimab
      • Ravulizumab
      • Rotavirus Vaccine
      • Varicella-Zoster Virus Vaccine, Live

      Level 3 (Moderate)

      • Acetaminophen; Aspirin
      • Acetaminophen; Aspirin, ASA; Caffeine
      • Acetaminophen; Aspirin; Diphenhydramine
      • Acetaminophen; Ibuprofen
      • Acyclovir
      • Adefovir
      • Amikacin
      • Aminoglycosides
      • Amlodipine; Celecoxib
      • Amphotericin B
      • Amphotericin B lipid complex (ABLC)
      • Amphotericin B liposomal (LAmB)
      • Aspirin, ASA
      • Aspirin, ASA; Butalbital; Caffeine
      • Aspirin, ASA; Caffeine
      • Aspirin, ASA; Caffeine; Orphenadrine
      • Aspirin, ASA; Carisoprodol; Codeine
      • Aspirin, ASA; Citric Acid; Sodium Bicarbonate
      • Aspirin, ASA; Dipyridamole
      • Aspirin, ASA; Omeprazole
      • Aspirin, ASA; Oxycodone
      • Bacitracin
      • Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
      • Bismuth Subsalicylate
      • Bismuth Subsalicylate; Metronidazole; Tetracycline
      • Bupivacaine; Meloxicam
      • Butalbital; Aspirin; Caffeine; Codeine
      • Capreomycin
      • Celecoxib
      • Celecoxib; Tramadol
      • Chlorpheniramine; Ibuprofen; Pseudoephedrine
      • Choline Salicylate; Magnesium Salicylate
      • Cidofovir
      • Cisplatin
      • Colistimethate, Colistin, Polymyxin E
      • Colistin
      • Cyclosporine
      • Diclofenac
      • Diclofenac; Misoprostol
      • Diflunisal
      • Diphenhydramine; Ibuprofen
      • Diphenhydramine; Naproxen
      • Efgartigimod Alfa
      • Efgartigimod Alfa; Hyaluronidase
      • Etodolac
      • Fenoprofen
      • Flurbiprofen
      • Foscarnet
      • Ganciclovir
      • Gentamicin
      • Hydrocodone; Ibuprofen
      • Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
      • Ibuprofen
      • Ibuprofen; Famotidine
      • Ibuprofen; Oxycodone
      • Ibuprofen; Pseudoephedrine
      • Indomethacin
      • Ketoprofen
      • Ketorolac
      • Magnesium Salicylate
      • Meclofenamate Sodium
      • Mefenamic Acid
      • Meloxicam
      • Nabumetone
      • Naproxen
      • Naproxen; Esomeprazole
      • Naproxen; Pseudoephedrine
      • Nonsteroidal antiinflammatory drugs
      • Oxaprozin
      • Pamidronate
      • Paromomycin
      • Pentamidine
      • Piroxicam
      • Plazomicin
      • Polymyxin B
      • Salsalate
      • Streptomycin
      • Streptozocin
      • Sulindac
      • Sumatriptan; Naproxen
      • Tacrolimus
      • Tobramycin
      • Tolmetin
      • Valacyclovir
      • Valganciclovir
      • Vancomycin
      • Zoledronic Acid
      Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Acetaminophen; Aspirin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Acetaminophen; Aspirin; Diphenhydramine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Acetaminophen; Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Acyclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like acyclovir. Administer IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. Periodic monitoring of renal function tests and urine output is particularly important in patients judged to have a potential risk for developing acute renal failure. [28977] [48345] Adefovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like adefovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5516] Amikacin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Aminoglycosides: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Amlodipine; Celecoxib: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Amphotericin B lipid complex (ABLC): (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like amphotericin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [25654] [28333] Amphotericin B liposomal (LAmB): (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like amphotericin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [25654] [28333] Amphotericin B: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like amphotericin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [25654] [28333] Aspirin, ASA: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Butalbital; Caffeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Caffeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Caffeine; Orphenadrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Carisoprodol; Codeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Dipyridamole: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Omeprazole: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Aspirin, ASA; Oxycodone: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Bacitracin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like bacitracin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [31047] Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Bismuth Subsalicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Bupivacaine; Meloxicam: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Butalbital; Aspirin; Caffeine; Codeine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Capreomycin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like capreomycin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [7872] Celecoxib: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Celecoxib; Tramadol: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Choline Salicylate; Magnesium Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Cidofovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like cidofovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5118] Cisplatin: (Moderate) Closely monitor renal function if concomitant use with cisplatin and immune globulin products (IVIG) are necessary. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Cisplatin can cause nephrotoxicity, which may be exacerbated with the use of additional nephrotoxins. IVIG has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. [28393] [30276] [39573] [41552] [41553] [42654] [42655] [42659] [42661] [42955] [46250] [51240] [57655] Colistimethate, Colistin, Polymyxin E: (Moderate) Use caution with concomitant Immune Globulin (IG) products and colistimethate sodium. IG products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [30276] [33636] [39573] [41552] [51240] Colistin: (Moderate) Use caution with concomitant Immune Globulin (IG) products and colistimethate sodium. IG products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [30276] [33636] [39573] [41552] [51240] Cyclosporine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like cyclosporine. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5134] Diclofenac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Diclofenac; Misoprostol: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Diflunisal: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Diphenhydramine; Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Diphenhydramine; Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Efgartigimod Alfa: (Moderate) Monitor for reduced efficacy of immune globulin during coadministration with efgartigimod. Concomitant use of efgartigimod with medications that bind to the human neonatal Fc receptor (FcRn), such as immune globulin, may reduce immune globulin exposure and efficacy. Consider efgartigimod discontinuation and the use of alternative therapies if long-term therapy with immune globulin is needed. [67194] Efgartigimod Alfa; Hyaluronidase: (Moderate) Monitor for reduced efficacy of immune globulin during coadministration with efgartigimod. Concomitant use of efgartigimod with medications that bind to the human neonatal Fc receptor (FcRn), such as immune globulin, may reduce immune globulin exposure and efficacy. Consider efgartigimod discontinuation and the use of alternative therapies if long-term therapy with immune globulin is needed. [67194] Etodolac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Fenoprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Flurbiprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Foscarnet: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like foscarnet. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5106] Ganciclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like ganciclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5173] Gentamicin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Hydrocodone; Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Ibuprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Ibuprofen; Famotidine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Ibuprofen; Oxycodone: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Ibuprofen; Pseudoephedrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Indomethacin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Ketoprofen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Ketorolac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Magnesium Salicylate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. There should be an interval of at least 5 months following administration of immune globulin, including varicella-zoster immune globulin, VZIG, before varicella vaccination. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. [28336] [32232] (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of blood, plasma, and/or immunoglobulins because antibodies in these products can neutralize the vaccine. [497] [8097] Measles/Mumps/Rubella Vaccines, MMR: (Major) Rubella virus vaccine or Measles/mumps/rubella vaccines, MMR should not be given for at least 3 months following administration of blood, plasma, and/or immunoglobulins because antibodies in these products can neutralize the vaccine. [497] [8097] Meclofenamate Sodium: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Mefenamic Acid: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Meloxicam: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Nabumetone: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Naproxen; Esomeprazole: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Naproxen; Pseudoephedrine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Nonsteroidal antiinflammatory drugs: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Oxaprozin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Pamidronate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like pamidronate. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [7799] Paromomycin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Pentamidine: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like pentamidine. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5612] Piroxicam: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Plazomicin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Polymyxin B: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like polymyxin B. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5177] Pozelimab: (Major) Avoid concomitant use of pozelimab and intravenous immune globulin (IVIG). If use is necessary, monitor for reduced clinical efficacy of pozelimab. Concomitant use may decrease serum pozelimab concentrations. [69372] Ravulizumab: (Major) Administer a supplemental dose of ravulizumab and monitor for reduced efficacy of ravulizumab during concurrent use with immune globulin. Consult the manufacturer's recommendations for the supplemental dosage. Concomitant use of immune gloublin with ravulizumab may reduce ravulizumab exposure and efficacy. [63845] Rotavirus Vaccine: (Major) Efficacy of live attenuated virus vaccines such as Rotavirus may be impaired by immune globulin administration; revaccination may be necessary. As the passive transfer of antibodies may impair the efficacy of live attenuated virus vaccines, defer vaccination with live virus vaccines until approximately 3 months after immune globulin administration. Inform the immunizing physician of recent therapy with immune globulin so that appropriate measures can be taken. [31875] [43236] [53241] [61170] [61745] Salsalate: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Streptomycin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Streptozocin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like streptozocin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6757] Sulindac: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Sumatriptan; Naproxen: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Tacrolimus: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like tacrolimus. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5342] Tobramycin: (Moderate) Immune globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like aminoglycosides. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Closely monitor renal function. [29874] [30007] [34037] [34041] Tolmetin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like nonsteroidal anti-inflammatory drugs (NSAIDs) and salicylates. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [6859] [7020] [7823] Valacyclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like valacyclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [29970] [59311] Valganciclovir: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like valganciclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5193] Vancomycin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like vancomycin. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5198] Varicella-Zoster Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. There should be an interval of at least 5 months following administration of immune globulin, including varicella-zoster immune globulin, VZIG, before varicella vaccination. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. [28336] [32232] Zoledronic Acid: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like zoledronic acid. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [58724]
      Revision Date: 11/08/2023, 01:29:00 AM

      References

      497 - Centers for Disease Control and Prevention (CDC). Measles, mumps, and rubella - vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1998;47(no. RR-8):1-57.5106 - Foscavir (foscarnet) package insert. Lake Forest, IL: Hospira, Inc.; 2020 Oct.5118 - Cidofovir injection solution package insert. Morgantown, WV: Mylan Institutional LLC; 2021 Apr.5134 - Neoral (cyclosporine) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2023 Sept.5173 - Cytovene (ganciclovir) injection package insert. South San Francisco, CA: Genetech USA, Inc.; 2010 Feb.5177 - Polymyxin B package insert. Big Flats, NY: X-Gen Pharmaceuticals, Inc.; 2015 Dec.5193 - Valcyte (valganciclovir hydrochloride) package insert. South San Francisco, CA: Genentech USA, Inc.; 2021 Dec.5198 - Vancocin HCl capsules (vancomycin hydrochloride) package insert. Baudette, MN: Ani Pharmaceuticals, Inc.; 2021 Dec.5342 - Prograf (tacrolimus) capsules, injection, and granules for oral suspension package insert. Northbrook, IL: Astellas Pharma US, Inc.; 2023 Aug.5516 - Hepsera (adefovir dipivoxil) package insert. Foster City, CA: Gilead Sciences, Inc.; 2018 Dec.5612 - Pentamidine isethionate injection package insert. East Brunswick, NJ: Avet Pharmaceuticals Inc.; 2021 Jan.6757 - Zanosar® (streptozocin sterile powder) package insert. Kalamazoo, MI: Pharmacia & Upjohn Company; 2003 Feb.6859 - Insel PA. Analgesic-antipyretic and antiinflammatory agents and drugs employed in the treatment of gout. In: Hardman JG, Limbird LE, Molinoff PB, et al., eds. Goodman and Gilman's the pharmacological basis of therapeutics, 9th edn. New York: McGraw Hill, 1996;617-657.7020 - Perez Gutthann S, Garcia Rodriguez LA, Raiford DS, et al. Nonsteroidal anti-inflammatory drugs [NSAIDs] and the risk of hospitalization for acute renal failure. Arch Intern Med 1996;156(21):2433-9.7799 - Pamidronate disodium injection package insert. Lake Forest, IL: Hospira, Inc.; 2021 Apr.7823 - Doans extra strength (magnesium salicylate tetrahydrate) package insert. Sommerville, NJ: Ducere Pharma; 2016 Jun.7872 - Capastat® (capreomycin sulfate for injection) package insert. Indianapolis, IN: Eli Lilly; 2003 Dec.8097 - Hershberger RE, Starling RC, Eisen HJ, et al. Daclizumab to prevent rejection after cardiac transplantation. N Engl J Med 2005;352:2705-13.25654 - White MH, Bowden RA, Sandler ES, et al. Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia. Clin Infect Dis 1998;27:296-302.28333 - Amphocin (amphotericin B) package insert. Kalamazoo, MI: Pharmacia Corporation; 2003 Sep.28336 - Varivax (varicella virus vaccine frozen) package insert. Rahway, NJ: Merck Sharp & Dohme LLC; 2023 Aug.28393 - Platinol (cisplatin) for injection package insert. Paramus, NJ: WG Critical Care, LLC; 2022 March.28977 - Zovirax (acyclovir capsule, tablet, suspension) package insert. Newtown, PA: Prestium Pharma, Inc.; Oct 2014.29874 - Amikacin sulfate injection package insert. East Brunswick, NJ: Avet Pharmaceuticals Inc.; 2022 Oct.29970 - Valtrex (valacyclovir) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2022 Nov.30007 - Streptomycin for Injection USP package insert. Northport, NY: X-Gen Pharmaceuticals, Inc.; 2012 May.30276 - Octagam (immune globulin 5% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.31047 - Bacitracin for Injection package insert. New York, NY: Pfizer, Inc.; 2018 Apr31875 - RotaTeq Vaccine (Rotavirus vaccine, live, oral, pentavalent) package insert. Merck and Co Inc: Whitehouse Station, NJ; 2020 Aug.32232 - Zostavax (zoster vaccine live, Oka/Merck) package insert. Whitehouse Station, NJ: Merck & Co, Inc.; 2019 Jan.33636 - Coly-Mycin M Parenteral (colistimethate sodium) package insert. Chestnut Ridge, NY: Par Pharmaceutical Companies, Inc.; 2015 Jul.34037 - Tobramycin 1.2 g bulk vials for injection package insert. Lake Zurich, IL: Fresenius Kabi USA, LLC; 2023 Feb.34041 - Gentamicin (gentamicin sulfate premix solution) package insert. Lake Forest, IL: Hospira, Inc.; 2022 Oct.39573 - Gamunex (immune globulin intravenous human) package insert. Research Triangle Park, NC: Talecris Biotherapeutics, Inc.; 2010 Oct.41552 - Flebogamma 5% DIF (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.41553 - Flebogamma DIF 10% (immune globulin intravenous, human) package insert. Barcelona, Spain: Instituto Grifols; 2019 Sep.42654 - Carimune NF (immune globulin injection, human) package insert. Kankakee, IL: CSL Behring LLC; 2018 May.42655 - Gammagard Liquid (immune globulin injection [human], 10% Solution) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2024 Jan.42659 - Privigen (immune globulin 10% intravenous, human) package insert. Kankakee, IL: CSL Behring LLC; 2022 Mar.42661 - Gammaplex (immune globulin 5% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep.42955 - Gammagard S/D (immune globulin injection, human) package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.43236 - National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2011;60(2):1-64.46250 - Gammaked (immune globulin 10% intravenous, human) package insert. Research Triangle Park, NC: Grifols Therapeutics Inc.; 2012 Jun.48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.51240 - Gamunex-C (immune globulin 10% injection, human) package insert. Research Triangle Park, NC: Grifols Therapeutics, LLC.; 2020 Jan.53241 - Gamimune N (immune globulin 5% injection, human) package insert. Research Triangle Park, NC: Talecris Biotherapeutics, Inc. 2005 Oct.57655 - Octagam (immune globulin 10% intravenous, human) package insert. Paramus, NJ: Octapharma USA, Inc.; 2022 Mar.58724 - Zoledronic acid injection package insert. Columbus, OH: BluePoint Laboratories; 2020 Jun.59311 - Anthrasil (anthrax immune globulin intravenous) package insert. Winnipeg, MB: Emergent BioSolutions Canada, Inc.; 2018 May.61170 - Cuvitru (immune globulin subcutaneous human) 20% package insert. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.; 2023 Mar.61745 - Gammaplex (immune globulin 10% injection, human) package insert. Elstree, UK: Bio Products Laboratory Limited; 2019 Sep..63845 - Ultomiris (ravulizumab-cwvs) injection package insert. Boston, MA; Alexion Pharmaceuticals, Inc. 2024 Feb.67194 - Vyvgart (efgartigimod alfa-facb) package insert. Boston, MA: Argenx US, Inc.; 2023 Dec.69372 - Veopoz (pozelimab-bbfg) injection package insert. Tarrytown, NY: Regeneron Pharmaceuticals, Inc.; 2023 Aug.

      Monitoring Parameters

      • serum creatinine/BUN
      • serum IgG concentrations

      US Drug Names

      • ASCENIV
      • BIVIGAM
      • Carimune
      • Carimune NF
      • Flebogamma
      • Flebogamma DIF
      • Gamimune N
      • Gammagard
      • Gammagard S/D
      • Gammaked
      • Gammaplex
      • Gammar-P IV
      • Gamunex
      • Gamunex-C
      • Iveegam
      • Iveegam EN
      • Octagam
      • Panglobulin
      • Panglobulin NF
      • panzyga
      • Polygam S/D
      • Privigen
      • Sandoglobulin
      • Venoglobulin-S
      • Vigam
      ;