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Vaccinia Immune Globulin, VIG Injection
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NOTE: Vaccinia immune globulin intravenous (VIGIV) is not considered effective for the treatment of postvaccinial encephalitis and is contraindicated for use in isolated vaccinia keratitis.[48345]
NOTE: The efficacy of VIGIV as prophylaxis against vaccinial infection has not been studied in a controlled setting. Thus, VIGIV is not recommended for prophylaxis when persons with contraindications to smallpox vaccination are inadvertently exposed to vaccinia and are otherwise well. Such persons should have careful clinical follow-up to ensure prompt diagnosis and treatment of an adverse event, if one occurs. Further, in the absence of circulating smallpox virus, VIGIV is not recommended for concomitant use with smallpox vaccination among persons with contraindications. Careful screening criteria should be used to exclude persons with contraindications from pre-outbreak smallpox vaccination programs.[31173]
6,000 Units/kg via IV infusion at a rate of no more than 2 mL/minute. If patient weighs less than 50 kg, infuse at a rate of no more than 0.04 mL/kg/minute (133.3 Units/kg/minute). Administer as soon as symptoms appear and are deemed to be due to severe vaccinia-related complications. Repeat dosing may be considered based on severity of symptoms and treatment response; higher doses (e.g., 9,000 Units/kg) may be required.[48345]
6,000 Units/kg via IV infusion at a rate of no more than 2 mL/minute. If patient weighs less than 50 kg, infuse at a rate of no more than 0.04 mL/kg/minute (133.3 Units/kg/minute). Administer as soon as symptoms appear and are deemed to be due to severe vaccinia-related complications. Repeat dosing may be considered based on severity of symptoms and treatment response; higher doses (e.g., 9,000 Units/kg) may be required.[48345]
NOTE: The CDC holds an Expanded Access Investigational New Drug Protocol (EA-IND) that allows for vaccinia immune globulin intravenous (VIGIV) to be used to treat orthopoxvirus infections, including monkeypox virus (mpox) infections and vaccinia vaccine complications not covered by its FDA-approved indications. State and territorial health authorities can contact the CDC Emergency Operations Center at 770-488-7100 for information regarding the protocol.[67654] [68110]
NOTE: For mpox infection, VIGIV may be considered for use as treatment for the following: [68110]
NOTE: For orthopoxvirus infections, VIGIV may be considered for use as treatment for the following: [68110]
6,000 to 9,000 units/kg/dose (actual body weight) IV as single dose. Higher doses (e.g., 9,000 units/kg/dose or 24,000 units/kg/dose) may be considered if there is no response to the initial dose (6,000 units/kg/dose or 9,000 units/kg/dose). Repeat dosing may be considered depending on the severity of symptoms and response to treatment; an additional dose 3 to 4 days after the initial dose may help saturate viral antigens and halt viremia and viral replication.[67654] [68110] [70312] For people with HIV or severe immunocompromise and severe disease, consider early intervention with combination therapy at the time of the first medical encounter, in consultation with CDC or an expert in mpox treatment. Additionally, people with HIV not currently taking antiretroviral therapy (ART) should initiate a treatment regimen as soon as possible.[34362] [70312]
6,000 to 9,000 units/kg/dose (actual body weight) IV as single dose. Higher doses (e.g., 9,000 units/kg/dose or 24,000 units/kg/dose) may be considered if there is no response to the initial dose (6,000 units/kg/dose or 9,000 units/kg/dose). Repeat dosing may be considered depending on the severity of symptoms and response to treatment; an additional dose 3 to 4 days after the initial dose may help saturate viral antigens and halt viremia and viral replication.[67654] [67802] [68110] [70312] For people with HIV or severe immunocompromise and severe disease, consider early intervention with combination therapy at the time of the first medical encounter, in consultation with CDC or an expert in mpox treatment. Additionally, people with HIV not currently taking antiretroviral therapy (ART) should initiate a treatment regimen as soon as possible.[34362] [70312]
6,000 to 9,000 units/kg/dose (actual body weight) IV as single dose. Higher doses (e.g., 9,000 units/kg/dose or 24,000 units/kg/dose) may be considered if there is no response to the initial dose (6,000 units/kg/dose or 9,000 units/kg/dose). Repeat dosing may be considered depending on the severity of symptoms and response to treatment; an additional dose 3 to 4 days after the initial dose may help saturate viral antigens and halt viremia and viral replication.[67654] [67802] [68110] [70312] For people with severe immunocompromise and severe disease, consider early intervention with combination therapy at the time of the first medical encounter, in consultation with CDC or an expert in mpox treatment. Additionally, people with HIV not currently taking antiretroviral therapy (ART) should initiate a treatment regimen as soon as possible.[70312]
6,000 to 9,000 units/kg/dose (actual body weight) IV as single dose. Higher doses (e.g., 9,000 units/kg/dose or 24,000 units/kg/dose) may be considered if there is no response to the initial dose (6,000 units/kg/dose or 9,000 units/kg/dose). Repeat dosing may be considered depending on the severity of symptoms and response to treatment; an additional dose 3 to 4 days after the initial dose may help saturate viral antigens and halt viremia and viral replication.[67654] [67802] [68110] [70312] For people with severe immunocompromise and severe disease, consider early intervention with combination therapy at the time of the first medical encounter, in consultation with CDC or an expert in mpox treatment. Additionally, people with HIV not currently taking antiretroviral therapy (ART) should initiate a treatment regimen as soon as possible.[70312]
NOTE: The CDC holds an Expanded Access Investigational New Drug Protocol (EA-IND) that allows for vaccinia immune globulin intravenous (VIGIV) to be used for PEP of orthopoxvirus infections, including monkeypox virus (mpox) infections and vaccinia vaccine complications not covered by its FDA-approved indications. State and territorial health authorities can contact the CDC Emergency Operations Center at 770-488-7100 for information regarding the protocol.[68110]
NOTE: VIGIV may be considered for PEP on an individual case-by-case basis in consultation with CDC for the following: [68110]
6,000 units/kg/dose (actual body weight) IV as a single dose.[68110]
6,000 units/kg/dose (actual body weight) IV as a single dose.[68110]
6,000 units/kg/dose (actual body weight) IV as a single dose.[68110]
6,000 to 9,000 units/kg/dose (actual body weight) IV as a single dose.[34362] [68110]
6,000 to 9,000 units/kg/dose (actual body weight) IV as a single dose.[34362] [68110]
6,000 units/kg/dose (actual body weight) IV as a single dose.[68110]
6,000 units/kg/dose (actual body weight) IV as a single dose.[68110]
9,000 Units/kg/dose IV; 24,000 Units/kg/dose IV have been well tolerated in healthy volunteers.
66 years and older: Safety and efficacy have not been established; however, doses up to 24,000 Units/kg have been authorized for the treatment of orthopoxvirus infections, including monkeypox virus (mpox) infections.[68110]
65 years: 9,000 Units/kg/dose IV; 24,000 Units/kg/dose IV have been well tolerated in healthy volunteers.
16 to 17 years: 9,000 Units/kg/dose IV; 24,000 Units/kg/dose IV have been well tolerated in healthy volunteers.
13 to 15 years: Safety and efficacy have not been established; however, doses up to 24,000 Units/kg have been authorized for the treatment of orthopoxvirus infections, including monkeypox virus (mpox) infections.[68110]
Safety and efficacy have not been established; however, doses up to 24,000 Units/kg have been authorized for the treatment of orthopoxvirus infections, including monkeypox virus (mpox) infections.[68110]
Safety and efficacy have not been established; however, doses up to 24,000 Units/kg have been authorized for the treatment of orthopoxvirus infections, including monkeypox virus (mpox) infections.[68110]
Safety and efficacy have not been established; however, doses up to 24,000 Units/kg have been authorized for the treatment of orthopoxvirus infections, including monkeypox virus (mpox) infections.[68110]
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Use with caution in patients with preexisting renal impairment or patients at risk of developing renal impairment. Do not exceed the recommended infusion rate and follow the infusion schedule closely.
† Off-label indicationVaccinia immune globulin intravenous (VIGIV) is an intravenous sterile solution of purified human immune globulin G (IgG) with trace amounts of IgA (40 mcg/mL or less). The product is derived from pooled human plasma collected from healthy donors who received booster immunizations with the smallpox vaccine, vaccinia vaccine prior to donating. All donors for the product are tested and found negative for HIV, HBV, and HCV. VIGIV is approved by the FDA for the treatment or modification of the following conditions: eczema vaccinatum, progressive vaccinia, severe generalized vaccina, vaccinia infection in certain individuals with skin conditions, and aberrant infections induced by vaccinia virus. It is not considered effective in the treatment of postvaccinial encephalitis and is contraindicated for use in isolated vaccinia keratitis. VIGIV has also been made available through an Expanded Access Investigational New Drug Protocol (EA-IND) for postexposure prophylaxis and treatment of orthopoxvirus infections, including monkeypox virus (mpox) infections and vaccinia vaccine complications not covered by its FDA-approval. For information on the EA-IND, contact the CDC Emergency Operations Center at 770-488-7100. VIGIV must be administered through a dedicated intravenous line. For patients weighing less than 50 kg, the infusion rate must be reduced. Do not administer VIGIV to IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity, or to patients with a history of anaphylaxis or serious systemic reaction to this or other human immune globulin preparations. VIGIV is not commercially available, but can be obtained through the Strategic National Stockpile (SNS) by contacting the State or local health department or the CDC Emergency Operations Center.[48345][67664][68110]
For storage information, see the specific product information within the How Supplied section.
NOTE: Vaccinia immune globulin intravenous (VIGIV) is not commercially available, but can be obtained through the Strategic National Stockpile (SNS). Health care providers in need of clinical consultation or who are requesting release of VIGIV should contact their State or local health department or the CDC Emergency Operations Center at 770-488-7100. If it is determined that treatment with VIGIV is required, the CDC Smallpox Vaccine Adverse Events Clinical Consultation Team will coordinate shipment with the SNS.[67664]
NOTE: Ensure appropriate equipment, oxygen, medication (including epinephrine, diphenhydramine, and corticosteroids), and personnel trained in the management of infusion or hypersensitivity reactions are available.[68110]
Preparation:
Intravenous infusion:
Products made from human blood may contain infectious agents, such as viruses, that can cause disease. Vaccinia immune globulin intravenous (VIGIV) is a derivative of human plasma. As with other products derived from or purified with human blood components, the remote possibility of contamination or infection with bacteria or viruses exists in patients receiving VIGIV. 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 infectious agent transmission. Transmissibility of the Creutzfeldt-Jakob disease (CJD) virus by plasma-derived products is unknown. The manufacturing processes are designed to reduce the risk of transmitting viral infection; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents may be present in this product. VIGIV should be given only if a benefit is expected. All infections thought by a physician to have been possibly transmitted by VIGIV should be reported to the manufacturer. The health care provider should discuss the risks and benefits of this product with the patient or legal guardian of the patient.[48345]
During clinical trials, the safety of vaccinia immune globulin intravenous (VIGIV) was evaluated in 110 patients who received doses of either 6,000 Units per kg, 9,000 Units per kg, or 24,000 Units per kg. Most adverse reactions were mild in intensity, with no serious adverse reactions reported and no instances of treatment discontinuation due to an adverse reaction. The most commonly reported adverse reactions were headache (5% to 59%), nausea (up to 28.2%), rigors (up to 22.6%), dizziness (up to 17.9%), feeling cold (up to 15.4%), and pain (up to 12.8%). Other adverse reactions reported in at least 5% of drug recipients included feeling hot (up to 9.7%), increased sweating or hyperhidrosis (up to 9.7%), pallor (up to 7.7%), vomiting (up to 7.7%), fever (up to 6.5%), asthenia (up to 6.5%), decreased appetite or anorexia (up to 6.5%), muscle spasms and back pain (up to 6.5%), paresthesias (up to 6.5%), fatigue (up to 5.1%), tremor (up to 5.1%), and peripheral edema (up to 5%).[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Acute renal failure, renal dysfunction, osmotic nephrosis, proximal tubular nephropathy, and death have been reported in patients receiving IGIV. Most cases of renal insufficiency associated with IGIV products have occurred in patients receiving total doses containing at least 400 mg/kg of sucrose; VIGIV does not contain sucrose.[48345]
Vaccinia immune globulin intravenous (VIGIV) may contain blood group antibodies that can behave as hemolysins and induce in vivo coating of red blood cells with immune globulin, resulting in a positive direct antiglobulin reaction and hemolysis. Hemolytic anemia due to enhanced red blood cell sequestering may ensue. Monitored for signs and symptoms of hemolysis in patients receiving VIGIV.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) derived product. Noncardiogenic pulmonary edema [Transfusion-related acute lung injury (TRALI)] has been reported in patients administered IGIV. Characteristics of TRALI include severe respiratory distress, pulmonary edema, hypoxia, normal left ventricular function, and fever and usually occurs within 1 to 6 hours after transfusion. Other respiratory adverse events reported during postapproval use of IGIV products include apnea, acute respiratory distress syndrome (ARDS), cyanosis, dyspnea, bronchospasm, and wheezing. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) derived product. Treatment with IGIV has been associated with the development of an aseptic meningitis syndrome (AMS). The syndrome usually begins within several hours to 2 days following IGIV treatment. It is characterized by signs and symptoms including severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements (ocular pain), nausea, and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per mm3 (predominately from granulocytic series) and with elevated protein concentrations up to several hundred mg/dL, but culture results are negative. For drug recipients exhibiting the above symptoms, conduct a thorough neurological examination with CSF studies to rule out other causes of meningitis. Stopping IGIV treatment has resulted in remission within several days without sequelae.[48345]
Mild and transient chest pain (unspecified) has been reported on the same day as treatment with vaccinia immune globulin intravenous (VIGIV). VIGIV is a human immune globulin intravenous (IGIV) product. Cardiovascular adverse events reported during postapproval use of other IGIV products include cardiac arrest and sinus tachycardia. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Hematologic and lymphatic adverse events reported during postapproval use of other IGIV products include anemia, neutropenia, leukopenia, and lymphadenopathy. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Dermatologic adverse events reported during postapproval use of other IGIV products include Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (e.g., bullous dermatitis), urticaria, and other skin reactions. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Gastrointestinal adverse events reported during postapproval use of other IGIV products include abdominal pain, diarrhea, and hepatic dysfunction. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Neurologic adverse events reported during postapproval use of other IGIV products include coma, loss of consciousness, and seizures. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) product. Musculoskeletal and general adverse events reported during postapproval use of other IGIV products include arthralgia, myalgia, malaise, and chest discomfort. Due to the voluntary nature of postmarketing reports, neither a frequency nor a definitive causal relationship can be established.[48345]
Although not observed during clinical trials, severe hypersensitivity reaction such as hypotension, anaphylactic shock, or anaphylactoid reactions are possible with vaccinia immune globulin intravenous (VIGIV). If anaphylaxis or hypotension occurs, discontinue the infusion and give supportive care as needed.[48345]
Vaccinia immune globulin intravenous (VIGIV) is a human immune globulin intravenous (IGIV) derived product. Thrombotic events (e.g., thrombosis, thromboembolism) have been associated with IGIV treatment. Before administering VIGIV to an individual at risk for a thrombotic event, ensure the patient is adequately hydrated and do not exceed a maximum daily dose of 12,000 Units per kg.[48345]
Aseptic meningitis syndrome is associated with human immune globulin intravenous (IGIV) therapy, and may occur more frequently with high total doses (i.e., 2 gram per kg). For vaccinia immune globulin intravenous (VIGIV), at the recommended dosage of 6,000 Units per kg, a patient may be exposed to 0.18 gram per kg. Aseptic meningitis syndrome usually begins within several hours to 2 days after IGIV treatment and is characterized by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting. Cerebrospinal fluid (CSF) studies are frequently positive with pleocytosis up to several thousand cells per mm3 (predominately from granulocytic series) and with elevated protein concentrations up to several hundred mg/dL, but culture results are negative. For drug recipients exhibiting the above symptoms, conduct a thorough neurological examination with CSF studies to rule out other causes of meningitis. Stopping IGIV treatment has resulted in remission within several days without sequelae.[48345]
As with other products derived from or purified with human blood components, the possibility of transmission of viral or bacterial infections exists in patients receiving vaccinia immune globulin intravenous (VIGIV). Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating or reducing viruses has reduced the risk of transmission of infectious agents. Additionally, the manufacturing processes are designed to reduce the risk of transmitting viral infection; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents may be present in this product.[48345]
Use of vaccinia immune globulin intravenous (VIGIV) is contraindicated in IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity. Individuals with IgA deficiency with antibodies against IgA could have a severe hypersensitivity reaction to subsequent administration of blood products that contain IgA; VIGIV contains trace amounts of IgA (up to 40 mcg/mL). Administer VIGIV only in a setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are readily available. In case of hypotension, allergic or anaphylactic reactions, discontinue VIGIV immediately and administer supportive care as needed. In case of shock, observe the current medical standards for shock treatment.[48345]
Vaccinia immune globulin intravenous (VIGIV) may be associated with infusion-related reactions (e.g., back or abdominal pain, nausea, vomiting) that develop within the first 10 minutes of drug administration. Additionally, chills, fever, headache, myalgia, and fatigue may begin at the end of the infusion and continue for several hours.[68110] Ensure that the maximum recommended infusion rate of 2 mL/minute is not exceeded. For patients weighing less than 50 kg, the infusion rate should not exceed 0.04 mL/kg/minute. Slower infusion rates may be needed for patients who develop a minor adverse reaction (e.g., flushing) or who are at risk for blood clots. Patients administered human immune globulin intravenous (IGIV) may also develop noncardiogenic pulmonary edema. Transfusion-related acute lung injury (TRALI) typically occurs within 1 to 6 hours of transfusion and is characterized by severe respiratory distress, pulmonary edema, hypoxia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilatory support. Closely monitor patients vital signs and observe for any symptoms, including pulmonary adverse reactions, throughout the infusion period and immediately after the infusion. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies in both the product and patient serum.[48345]
Vaccinia immune globulin intravenous (VIGIV) is contraindicated for use in isolated vaccinia keratitis. A single study in rabbits showed intramuscular administration of vaccinia immune globulin in vaccinia keratitis increased corneal scarring.[48345] However, patients having other complications due to vaccinia vaccination that include vaccinia keratitis, may still receive treatment with VIGIV in addition to trifluridine and ophthalmologic consultation.[68110]
Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and death may occur with use of immune globulin intravenous (IGIV) products. Vaccinia immune globulin intravenous (VIGIV) should be used cautiously in patients with preexisting renal impairment and those at increased risk for volume overload or acute kidney injury (e.g., renal disease, diabetes, dehydration, volume depletion or hypovolemia, sepsis, paraproteinemia, geriatric patients, or those who are receiving known nephrotoxic drugs). Ensure patients are not volume depleted before initiating the infusion. Administer VIGIV at the minimum infusion rate practicable. Do not exceed the maximum recommended infusion rate and follow the infusion schedule closely. Assess renal function before the initial infusion and at appropriate intervals thereafter. Periodic monitoring of renal function and urine output is especially important in patients determined to be at increased risk of developing acute renal failure. Consider discontinuing VIGIV if renal function deteriorates. Most cases of renal insufficiency associated with IGIV products have occurred in patients receiving total doses containing at least 400 mg/kg of sucrose; VIGIV does not contain sucrose. No prospective data are available in patients with risk factors for renal insufficiency to identify a maximum safe dose, concentration, or rate of infusion for VIGIV.[48345]
No well-controlled studies have been conducted regarding use of vaccinia immune globulin intravenous (VIGIV) during pregnancy, and it is unknown whether the product can cause fetal harm or affect the reproductive capacity. According to the Advisory Committee on Immunization Practices, administration of immune globulin preparations to pregnant women results in no known risk to the fetus. Fetal vaccinia may occur if a pregnant woman receives the smallpox vaccine; the likelihood of fetal vaccinia development is unknown but appears to be rare. No indication exists for the routine prophylactic use of VIGIV to prevent fetal vaccinia. Only use during pregnancy if clearly needed; however, if a pregnant woman develops a condition for which use of VIGIV is required, the product should not be withheld.[31173] [43236] [48345]
Vaccinia immune globulin intravenous (VIGIV) may contain blood group antibodies which act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immune globulin, resulting in a positive antiglobulin reaction and hemolysis. Acute hemolysis, consistent with intravascular hemolysis, has been reported and hemolytic anemia can develop after exposure to human immune globulin intravenous (IGIV) due to enhanced RBC sequestration. Risk factors that may be associated with the development of hemolysis after receipt of IGIV products include high doses given as a single administration or divided over several days and non-O blood group. An underlying inflammatory state (as reflected by elevated C-reactive protein or erythrocyte sedimentation rate) is an individual patient factor hypothesized to increase the risk of hemolysis after administration of IGIV; however, the role is uncertain. Closely monitor VIGIV recipients for clinical signs and symptoms of hemolysis, particularly those with the above listed risk factors. Consider appropriate laboratory testing for higher risk patients, including measuring hemoglobin or hematocrit at baseline and again within approximately 36 to 96 hours post-infusion. If signs or symptoms of hemolysis develop or a significant drop in hemoglobin or hematocrit is observed, perform additional confirmatory laboratory testing. If transfusion is indicated for patients who develop hemolysis with clinically compromising anemia after receiving VIGIV, perform adequate cross-matching to avoid exacerbating ongoing hemolysis.[48345]
Thrombotic events have been associated with human immune globulin intravenous (IGIV) products. Patients at increased risk for thrombotic events include those with a history of arteriosclerosis, multiple cardiovascular risk factors (coronary artery disease), advanced age, impaired cardiac output (heart failure), hypercoagulable disorders, prolonged periods of immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheters, and known or suspected hyperviscosity. When considering treatment options, weight the potential risks and benefits of vaccinia immune globulin intravenous (VIGIV) therapy against those of alternative therapies. In patients where the benefits of VIGIV outweigh the potential risk of a thrombotic or thromboembolic event, administer VIGIV at the minimum concentration available and at the minimum infusion rate practicable. Ensure the patient is adequately hydrated before administration and do not exceed a maximum daily dose of 12,000 Units per kg in patients with thrombotic risk factors. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including patients with cryoglobulins, fasting chylomicronemia, hypertriglyceridemia, or monoclonal gammopathies.[48345]
There are no data on the presence of vaccinia immune globulin intravenous (VIGIV) in human milk, the effects on the breast-fed infant, or the effects on milk production. Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[48345] [48199]
Vaccinia immune globulin intravenous (VIGIV) contains maltose, and use may result in laboratory test interference, specifically falsely elevated glucose readings leading to unrecognized hypoglycemia or inappropriate insulin administration. When administering vaccinia immune globulin to patients with diabetes mellitus, blood glucose should be measured using a glucose-specific method. Do not use blood glucose monitors or strips using glucose dehydrogenase pyrroloquinolinequinone (GDH-PGG) or glucose-dye-oxidoreductase (GDO) because the presence of maltose can interfere with their readings. Carefully review the product information of the blood glucose testing system to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the system to ensure appropriate use. Additionally, antibodies present in VIGIV may interfere with some serological tests. After administration of immune globulins like VIGIV, a transitory increase of passively transferred antibodies in the patient's blood may result in positive results in serological testing (e.g., Coomb's test).[48345]
Vaccinia immune globulin intravenous (VIGIV) may impair the efficacy of live attenuated virus vaccines. Therefore, vaccinations with live virus vaccines should be delayed until 3 months after VIGIV administration. Persons who received VIGIV shortly after a live virus vaccination should be revaccinated 3 months after administration of the immune globulin.[48345]
Vaccinia immune globulin intravenous (VIGIV) contains high titers of anti-vaccinia concentration neutralizing antibodies. VIGIV has demonstrated efficacy in the treatment of smallpox vaccine adverse reactions that are secondary to continued vaccinia virus replication after vaccination.[31173] VIGIV has not been shown effective in postvaccinial encephalitis. VIGIV is primarily comprised of immune globulin G (IgG); IgG is involved in viral neutralization as well as tissue protection and complement activation. Although the exact mechanism of VIG is not known, immune globulins, in general, inhibit the ability of extracellular viruses to infect their target cells. Viral neutralization limits the capacity of viruses to spread from an extracellular focus to an intracellular location.
Revision Date: 12/17/2024, 02:01:00 AMVaccinia immune globulin intravenous (VIGIV) is administered via intravenous infusion. Once in systemic circulation, the drug has a large volume of distribution (6,630 mL), as demonstrated by both non-compartmental and compartmental analysis. Vaccinia immune globulin concentrations remain in circulation for a prolonged period of time, with a mean half-life ranging from 26 to 30 days.[48345]
Affected cytochrome P450 isoenzymes: none
A pharmacokinetic study was conducted in 60 healthy subjects randomized to receive either 6,000 Units per kg or 9,000 Units per kg of vaccinia immune globulin intravenous (VIGIV). After IV administration of 6,000 Units per kg of VIGIV to 31 subjects, the mean peak plasma concentration (Cmax) of 161 Units/mL was achieved at 1.84 hours. The mean Cmax for the 9,000 Units per kg group of 232 Units/mL was reached at 2.61 hours. Mean systemic exposures (AUC) for 6,000 Units per kg and 9,000 Units per kg groups were 58,521 Units x hour/mL and 78,401 Units x hour/mL, respectively.[48345]
No well-controlled studies have been conducted regarding use of vaccinia immune globulin intravenous (VIGIV) during pregnancy, and it is unknown whether the product can cause fetal harm or affect the reproductive capacity. According to the Advisory Committee on Immunization Practices, administration of immune globulin preparations to pregnant women results in no known risk to the fetus. Fetal vaccinia may occur if a pregnant woman receives the smallpox vaccine; the likelihood of fetal vaccinia development is unknown but appears to be rare. No indication exists for the routine prophylactic use of VIGIV to prevent fetal vaccinia. Only use during pregnancy if clearly needed; however, if a pregnant woman develops a condition for which use of VIGIV is required, the product should not be withheld.[31173] [43236] [48345]
There are no data on the presence of vaccinia immune globulin intravenous (VIGIV) in human milk, the effects on the breast-fed infant, or the effects on milk production. Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.[48345] [48199]
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