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Nov.04.2022

Vaccinia Immune Globulin, VIG

Indications/Dosage

Labeled

  • eczema vaccinatum
  • generalized vaccinia
  • vaccinia necrosum (progressive vaccinia)

Off-Label

  • monkeypox virus (mpox) infection
  • monkeypox virus (mpox) prophylaxis
† Off-label indication

For the treatment or modification of eczema vaccinatum; vaccinia necrosum (progressive vaccinia); severe generalized vaccinia; vaccinia infections in individuals who have skin conditions (e.g., burns, impetigo, varicella-zoster, poison ivy, or eczematous skin lesions because of either the activity or extensiveness of such lesions); and for aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard

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]

Intravenous infusion dosage

Adults

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]

Adolescents 16 to 17 years

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]

For the treatment of orthopoxvirus infections, including monkeypox virus infection†

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 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: VIGIV may be used if a patient is ineligible for antiviral treatment (including tecovirimat), after antiviral treatment has been exhausted, or in conjunction with antivirals and/or other therapies for severe manifestations of orthopoxvirus infection based on the treating physician's clinical judgement.[68110]

NOTE: VIGIV may be administered to patients with laboratory confirmed orthopoxvirus infection or suspected infection based on known exposure(s) and/or clinical manifestations of disease. Patients with an initial negative test, but for whom both epidemiologic and clinical evidence suggests orthopoxvirus disease (particularly if clinically worsening or severe disease manifestation), should be re-tested but treated with VIGIV while results are pending.[68110]

NOTE: For orthopoxvirus infection, VIGIV may be considered for persons who: [68110]

  • Have serious illness resulting from exposure to vaccinia virus or related orthopoxviruses (e.g., development of ocular complications or severe generalized skin rash, or other serious illness manifestations that can be associated with a specific orthopoxvirus such as painful head and neck lymph node swelling with airway and/or swallowing compromise, encephalitis, sepsis syndrome that can be associated with monkeypox infection) that is suspected of being the result of continued virus proliferation and may therefore respond to the cross-reactive neutralizing antibodies of VIG.
  • Are at high risk for severe disease including persons with severe immunocompromise (e.g., HIV, AIDS, leukemia, lymphoma), pediatric populations particularly younger than 8 years, pregnant or breast-feeding, people with a condition affecting skin integrity. For detailed information, consult the CDC monkeypox clinical guidance.

NOTE: For replication-competent vaccinia vaccine complications, VIGIV may be considered for persons who: [68110]

  • Have immunosuppressive conditions (e.g., HIV, AIDS, leukemia, hypogammaglobulinemia) or on immunosuppressive therapy identified within the 14-day period following replication-competent vaccinia vaccination before the expected appearance of vaccine-induced neutralizing antibodies. Vaccination sites in an immunosuppressed individual that do not appear to be progressing through normal healing stages after day 14 should be evaluated as possible progressive vaccinia. If progressive vaccinia is suspected, these individuals should receive appropriate VIGIV treatment.
  • Have serious skin-integrity compromising conditions (e.g., extensive burns) that occur within the 10-day period following vaccination before the expected appearance of vaccination-induced neutralizing antibodies.
  • Have high-risk occupational exposures (e.g., eye splash or mucosal membrane exposure or high-dose exposure) to vaccinia virus or related orthopoxvirus that has a high likelihood of resulting in a serious clinical infection such as ocular infection or severe generalized skin rash, or other illness associated with the specific orthopoxvirus to which the laboratory or other worker was exposed.
  • Have serious clinical illness manifestations that are not covered by the FDA-approved indication (e.g., vaccinia keratitis, post-vaccinial encephalitis) following vaccination or exposure to vaccinia virus that is suspected of being the result of continued virus proliferation and would therefore be expected to respond to VIGIV treatment for viral neutralization. For detailed information, consult CDC medical management of vaccinia virus vaccine adverse reactions.
  • Persons who have a positive serum or urine pregnancy test within the 10-day period following replication-competent vaccinia virus vaccination before the expected appearance of vaccination-induced neutralizing antibodies.

Intravenous dosage

Adults

6,000 Units/kg (actual body weight) via IV infusion is the EA-IND authorized dose. A higher initial dose (e.g., 9,000 Units/kg) may be considered for patients with severe disease based on clinical judgement. Administer the dose as soon as symptoms appear and are judged to be due to orthopoxvirus. In the event that the patient does not respond to the initial 6,000 or 9,000 Units/kg dose, higher subsequent doses (e.g., 9,000 Units/kg, 24,000 Units/kg) may be considered. Depending on the severity of the symptoms and response to treatment, repeat dosing may be considered after consultation with the CDC on-call clinical consultation team; however, given the 30-day half-life of VIGIV, redosing within 30 days may be of minimal clinical benefit.[68110]

Neonates, Infants, Children, and Adolescents

6,000 Units/kg (actual body weight) via IV infusion is the EA-IND authorized dose. A higher initial dose (e.g., 9,000 Units/kg) may be considered for patients with severe disease based on clinical judgement. Administer the dose as soon as symptoms appear and are judged to be due to orthopoxvirus. In the event that the patient does not respond to the initial 6,000 or 9,000 Units/kg dose, higher subsequent doses (e.g., 9,000 Units/kg, 24,000 Units/kg) may be considered. Depending on the severity of the symptoms and response to treatment, repeat dosing may be considered after consultation with the CDC on-call clinical consultation team; however, given the 30-day half-life of VIGIV, redosing within 30 days may be of minimal clinical benefit.[68110]

For postexposure prophylaxis (PEP) of orthopoxvirus infection, including monkeypox prophylaxis†

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 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]

  • Individuals with known high-risk exposure to confirmed or probable case of orthopoxvirus infection and clinical conditions that necessitate an alternative or complementary option to PEP vaccination based on clinical judgment (e.g., severe allergic reaction to vaccine or vaccine components, immunocompromising conditions).
  • Prevention of serious complications in individuals with major contraindications to non-emergency vaccination who have been inadvertently vaccinated or inoculated with replication-competent vaccinia vaccine.
  • Use of VIGIV in neonates: VIGIV may be considered as PEP in neonates given the lack of safety and efficacy data for use of Jynneos and tecovirimat as PEP in neonates and the potential concerns of the live attenuated vaccine of Jynneos and a concern for accurately dosing oral tecovirimat in a neonate.

NOTE: Additional considerations for use of VIGIV for orthopoxvirus infections include persons who: [68110]

  • Have serious illness resulting from exposure to vaccinia virus or related orthopoxviruses (e.g., development of ocular complications or severe generalized skin rash, or other serious illness manifestations that can be associated with a specific orthopoxvirus such as painful head and neck lymph node swelling with airway and/or swallowing compromise, encephalitis, sepsis syndrome that can be associated with monkeypox infection) that is suspected of being the result of continued virus proliferation and may therefore respond to the cross-reactive neutralizing antibodies of VIG.
  • Are at high risk for severe disease including persons with severe immunocompromise (e.g., HIV, AIDS, leukemia, lymphoma), pediatric populations particularly those younger than 8 years, pregnant or breast-feeding, people with a condition affecting skin integrity. For detailed information, consult the CDC monkeypox clinical guidance.

NOTE: Addition considerations for use of VIGIV for replication-competent vaccinia vaccine complications include persons who: [68110]

  • Have immunosuppressive conditions (e.g., HIV, AIDS, leukemia, hypogammaglobulinemia) or on immunosuppressive therapy identified within the 14-day period following replication-competent vaccinia vaccination before the expected appearance of vaccine-induced neutralizing antibodies. Vaccination sites in an immunosuppressed individual that do not appear to be progressing through normal healing stages after day 14 should be evaluated as possible progressive vaccinia. If progressive vaccinia is suspected, these individuals should receive appropriate VIGIV treatment.
  • Have serious skin-integrity compromising conditions (e.g., extensive burns) that occur within the 10-day period following vaccination before the expected appearance of vaccination-induced neutralizing antibodies.
  • Have high-risk occupational exposures (e.g., eye splash or mucosal membrane exposure or high-dose exposure) to vaccinia virus or related orthopoxvirus that has a high likelihood of resulting in a serious clinical infection such as ocular infection or severe generalized skin rash, or other illness associated with the specific orthopoxvirus to which the laboratory or other worker was exposed.
  • Have serious clinical illness manifestations that are not covered by the FDA-approved indication (e.g., vaccinia keratitis, post-vaccinial encephalitis) following vaccination or exposure to vaccinia virus that is suspected of being the result of continued virus proliferation and would therefore be expected to respond to VIGIV treatment for viral neutralization. For detailed information, consult CDC medical management of vaccinia virus vaccine adverse reactions.
  • Persons who have a positive serum or urine pregnancy test within the 10-day period following replication-competent vaccinia virus vaccination before the expected appearance of vaccination-induced neutralizing antibodies.

Intravenous dosage

Adults

6,000 Units/kg (actual body weight) via IV infusion is the EA-IND authorized dose.[68110]

Neonates, Infants, Children, and Adolescents

6,000 Units/kg (actual body weight) via IV infusion is the EA-IND authorized dose.[68110]

Therapeutic Drug Monitoring

Maximum Dosage Limits

  • Adults

    9,000 Units/kg/dose IV; 24,000 Units/kg/dose IV have been well tolerated in health volunteers.

  • Geriatric

    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.[68110]

    65 years: 9,000 Units/kg/dose IV; 24,000 Units/kg/dose IV have been well tolerated in health volunteers.

  • Adolescents

    16 to 17 years: 9,000 Units/kg/dose IV; 24,000 Units/kg/dose IV have been well tolerated in health 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.[68110]

  • Children

    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.[68110]

  • Infants

    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.[68110]

  • Neonates

    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.[68110]

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

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 indication
Revision Date: 11/04/2022, 03:35:33 PM

References

31173 - Centers for Disease Control and Prevention (CDC). Smallpox vaccination and adverse reactions: guidance for clinicians. MMWR 2003;52(RR04):1-28.48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.67654 - Centers for Disease Control and Prevention (CDC). Interim Clinical Guidance for the Treatment of Monkeypox. July 28, 2022. Retrieved July 29, 2022. Available on the World Wide Web at https://www.cdc.gov/poxvirus/monkeypox/treatment.html.68110 - Centers for Disease Control and Prevention. Expanded Access IND Protocol: Use of vaccinia immune globulin intravenous (VIGIV, CNJ-016) for treatment of human orthopoxvirus infection in adults and children. Accessed November 3, 2022. Available at on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/pdf/vigiv-ind-protocol_irb-3744_v8_10.13.2022.pdf

How Supplied

Human Vaccinia Virus Immune Globulin Solution for injection

CNJ-016 VIGIV Vaccinia Immune Globulin Intravenous (Human) Solution for Injection (60492-0173) (Emergent BioSolutions Canada Inc.) null

Description/Classification

Description

Vaccinia 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]

Classifications

  • General Anti-infectives Systemic
    • Other Anti-infectives
      • Anti-infective Antitoxins and Immunoglobulins
        • Vaccinia Virus (Smallpox) Antitoxins and Immunoglobulins
Revision Date: 11/30/2022, 01:54:49 PM

References

48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.67664 - Centers for Disease Control and Prevention (CDC). Medical management of adverse reactions to vaccinia virus vaccination. November 2021. Retrieved June 7, 2022. Available on the World Wide Web at https://www.cdc.gov/smallpox/clinicians/vaccine-medical-management6.html.68110 - Centers for Disease Control and Prevention. Expanded Access IND Protocol: Use of vaccinia immune globulin intravenous (VIGIV, CNJ-016) for treatment of human orthopoxvirus infection in adults and children. Accessed November 3, 2022. Available at on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/pdf/vigiv-ind-protocol_irb-3744_v8_10.13.2022.pdf

Administration Information

General Administration Information

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]

Route-Specific Administration

Injectable Administration

  • Vaccinia immune globulin intravenous (VIGIV) is administered by intravenous infusion.
  • Visually inspect parenteral products for particulate matter and discoloration prior to administration. VIGIV is a clear to opalescent solution. Do not use if solution is cloudy, discolored, or contains particulates.[48345]

Intravenous Administration

Preparation:

  • Bring vials to room temperature prior to dosing.
    • If frozen, thaw by placing in the refrigerator at 2 to 8 degrees C (36 to 46 degrees F) until the contents are thawed for approximately 14 hours. Product can be thawed rapidly by placing at room temperature for 1 hour, followed by a water bath at 37 degrees C (98.6 degrees F) until thawed.
    • Do not thaw in a microwave oven.
    • Do not refreeze.
  • DO NOT shake the vial as this may cause foaming.
  • EACH VIAL IS FILLED TO CONTAIN A MINIMUM OF 50,000 UNITS regardless of fill volume (range: 8 to 12 mL); therefore, the concentration (Units/mL) of each vial varies. To obtain the labeled dose, remove the entire contents of the vial. If a partial vial is required for the dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement.[68108][68110]
  • The vials are single use only. Do not reuse or save for future use. The product does not contain preservatives. Discard partially used vials.
  • VIGIV is compatible with 0.9% Sodium Chloride USP; no other drug interactions or compatibilities have been evaluated. If a preexisting catheter must be used, flush the line with 0.9% Sodium Chloride USP before use. VIGIV may be administered either undiluted or diluted no more than 1:2 (volume:volume).
  • Administration of the dose must begin within 4 hours after entering the vial.

 

Intravenous infusion:

  • Administer through a dedicated intravenous line at a rate of no greater than 2 mL/minute. For patients weighing less than 50 kg, infuse at a rate no greater than 0.04 mL/kg/minute (133.3 Units/kg/minute).
  • The rate of infusion may be associated with adverse reactions. Slower infusion rates may be needed for patients who develop minor adverse reactions (e.g., flushing) or for patients with risk factors for thrombosis or thromboembolism.
    • For at risk patients, initiate at an infusion rate of 0.01 to 0.02 mL/kg/minute for the first 30 minutes then increase by 0.01 to 0.02 mL/kg/minute for the next 30 minutes. The remaining infusion may be administered at 2 mL/minute.
  • Ensure the recommended infusion rate is not exceeded in patients with preexisting renal insufficiency, or at increased risk of acute kidney injury, thrombosis, or volume overload.
  • Monitor vital signs before the infusion, every 30 minutes during the infusion, and 1 hour after the infusion. Closely observe patients for any symptoms throughout the infusion period and immediately following the infusion.[48345][68110]

Clinical Pharmaceutics Information

From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
    Revision Date: 11/21/2022, 09:45:11 AM

    References

    48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.67664 - Centers for Disease Control and Prevention (CDC). Medical management of adverse reactions to vaccinia virus vaccination. November 2021. Retrieved June 7, 2022. Available on the World Wide Web at https://www.cdc.gov/smallpox/clinicians/vaccine-medical-management6.html.68108 - Institute for Safe Medication Practices (ISMP). Using VIGIV for monkeypox? The concentration is not as it may seem. Acute Care ISMP Medication Safety Alert 2022;27(22):1-4.68110 - Centers for Disease Control and Prevention. Expanded Access IND Protocol: Use of vaccinia immune globulin intravenous (VIGIV, CNJ-016) for treatment of human orthopoxvirus infection in adults and children. Accessed November 3, 2022. Available at on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/pdf/vigiv-ind-protocol_irb-3744_v8_10.13.2022.pdf

    Adverse Reactions

    Mild

    • abdominal pain
    • anorexia
    • arthralgia
    • asthenia
    • diarrhea
    • drowsiness
    • fatigue
    • fever
    • hyperhidrosis
    • infection
    • malaise
    • myalgia
    • ocular pain
    • pallor
    • paresthesias
    • tremor
    • urticaria

    Moderate

    • anemia
    • chest pain (unspecified)
    • dyspnea
    • hemolysis
    • hypotension
    • hypoxia
    • leukopenia
    • loss of consciousness
    • lymphadenopathy
    • neutropenia
    • peripheral edema
    • photophobia
    • sinus tachycardia
    • wheezing

    Severe

    • acute respiratory distress syndrome (ARDS)
    • anaphylactic shock
    • anaphylactoid reactions
    • apnea
    • aseptic meningitis
    • bronchospasm
    • cardiac arrest
    • coma
    • cyanosis
    • erythema multiforme
    • hemolytic anemia
    • osmotic nephrosis
    • pulmonary edema
    • renal failure
    • seizures
    • Stevens-Johnson syndrome
    • thromboembolism
    • thrombosis

    0

    • back pain
    • dizziness
    • headache
    • nausea
    • vomiting

    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]

    Revision Date: 06/09/2022, 01:28:51 PM

    References

    48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.

    Contraindications/Precautions

    Absolute contraindications are italicized.

    • IgA deficiency
    • keratitis
    • arteriosclerosis
    • aseptic meningitis
    • breast-feeding
    • coronary artery disease
    • dehydration
    • diabetes mellitus
    • geriatric
    • heart failure
    • hemolysis
    • hypertriglyceridemia
    • hypovolemia
    • infusion-related reactions
    • laboratory test interference
    • pregnancy
    • renal disease
    • renal failure
    • renal impairment
    • sepsis
    • thrombosis
    • vaccination
    • viral infection

    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]

    Vaccinia immune globulin intravenous (VIGIV) is contraindicated for use in patients with a history of anaphylaxis or severe systemic reaction to VIGIV or another human immune globulin preparation. Anaphylactic reactions to immunoglobulin products, such as VIGIV, are rare. Anaphylactic reactions appear within seconds to several hours after the infusion, and include symptoms such as flushing, facial swelling, dyspnea, cyanosis, anxiety, nausea, vomiting, malaise, hypotension, loss of consciousness, and death.[68110] Use of VIGIV is also contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity. IgA deficiency patients with antibodies to 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]

    Revision Date: 11/04/2022, 12:40:16 PM

    References

    31173 - Centers for Disease Control and Prevention (CDC). Smallpox vaccination and adverse reactions: guidance for clinicians. MMWR 2003;52(RR04):1-28.43236 - 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;20:528-535.48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.68110 - Centers for Disease Control and Prevention. Expanded Access IND Protocol: Use of vaccinia immune globulin intravenous (VIGIV, CNJ-016) for treatment of human orthopoxvirus infection in adults and children. Accessed November 3, 2022. Available at on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/pdf/vigiv-ind-protocol_irb-3744_v8_10.13.2022.pdf

    Mechanism of Action

    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: 06/06/2022, 05:00:58 PM

    References

    31173 - Centers for Disease Control and Prevention (CDC). Smallpox vaccination and adverse reactions: guidance for clinicians. MMWR 2003;52(RR04):1-28.

    Pharmacokinetics

    Vaccinia 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

    Route-Specific Pharmacokinetics

    Intravenous Route

    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]

    Revision Date: 06/06/2022, 05:03:50 PM

    References

    48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.

    Pregnancy/Breast-feeding

    pregnancy

    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]

    breast-feeding

    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]

    Revision Date: 06/06/2022, 08:43:47 AM

    References

    31173 - Centers for Disease Control and Prevention (CDC). Smallpox vaccination and adverse reactions: guidance for clinicians. MMWR 2003;52(RR04):1-28.43236 - 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;20:528-535.48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.

    Interactions

    Level 2 (Major)

    • Bacillus Calmette-Guerin Vaccine, BCG
    • Intranasal Influenza Vaccine
    • Live Vaccines
    • Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live
    • Measles/Mumps/Rubella Vaccines, MMR
    • Rotavirus Vaccine
    • Rubella Virus Vaccine Live
    • Smallpox and Monkeypox Vaccine, Live, Nonreplicating
    • Smallpox Vaccine, Vaccinia Vaccine
    • Typhoid Vaccine
    • Varicella-Zoster Virus Vaccine, Live
    • Yellow Fever Vaccine, Live
    Bacillus Calmette-Guerin Vaccine, BCG: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Intranasal Influenza Vaccine: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Live Vaccines: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Measles/Mumps/Rubella Vaccines, MMR: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Rotavirus Vaccine: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Rubella Virus Vaccine Live: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Smallpox and Monkeypox Vaccine, Live, Nonreplicating: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Smallpox Vaccine, Vaccinia Vaccine: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Typhoid Vaccine: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Varicella-Zoster Virus Vaccine, Live: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Yellow Fever Vaccine, Live: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345]
    Revision Date: 11/18/2022, 02:26:00 AM

    References

    48345 - CNJ-016 (vaccinia immune globulin intravenous, human) package insert. Winnipeg, Canada: Emergent BioSolutions Canada, Inc.; 2018 Nov.

    Monitoring Parameters

    • hemoglobin/hematocrit
    • serum creatinine/BUN

    US Drug Names

    • CNJ-016
    ;