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Vaccinia immune globulin (intravenous) (United States: Availability limited to health department/CDC expanded access protocol): Drug information

Vaccinia immune globulin (intravenous) (United States: Availability limited to health department/CDC expanded access protocol): Drug information
(For additional information see "Vaccinia immune globulin (intravenous) (United States: Availability limited to health department/CDC expanded access protocol): Patient drug information" and see "Vaccinia immune globulin (intravenous) (United States: Availability limited to health department/CDC expanded access protocol): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Interactions with glucose monitoring systems:

Blood glucose measurement in patients receiving Vaccinia Immune Globulin Intravenous (Human) (VIGIV) must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. Glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose-dye-oxidoreductase method (monitor and test strips) must not be used for blood glucose testing in patients receiving VIGIV, since maltose in IGIV products has been shown to give falsely high blood glucose levels in these testing systems. This could result in the inappropriate administration of insulin, resulting in life-threatening hypoglycemia. Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.

Carefully review the product information of the blood glucose testing system, including that of the test strips, to determine if the system is appropriate for use with maltose-containing parenteral products.

Brand Names: US
  • CNJ-016
Pharmacologic Category
  • Blood Product Derivative;
  • Immune Globulin
Dosing: Adult
Nonvariola orthopoxvirus infection

Nonvariola orthopoxvirus infection (eg, mpox [monkeypox]) (off-label use): Note: Reserve for patients with or at risk for severe mpox (monkeypox) who are also severely immunocompromised. Use as part of an appropriate combination regimen (Ref).

IV: 6,000 to 9,000 units/kg as a single dose; doses on the upper end of range may confer the most benefit. May repeat dose, depending on duration of illness and severity of immunocompromise (Ref).

Vaccinia conditions

Vaccinia conditions: IV: 6,000 units/kg as soon as symptoms appear; may repeat dose based on severity of symptoms and response to treatment (specific data are lacking); 9,000 units/kg may be considered if patient does not respond to initial dose. Single doses up to 24,000 unit/kg were tolerated in healthy volunteers. Note: Maximum dose for patients with risk factors for thrombosis: 12,000 units/kg/day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use caution. In patients with preexisting renal impairment, at risk of renal dysfunction or volume overload, do not exceed recommended infusion rate; follow infusion schedule closely, and ensure adequate hydration; consider discontinuing if renal function deteriorates.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Vaccinia immune globulin (intravenous) (United States: Availability limited to health department/CDC expanded access protocol): Pediatric drug information")

Vaccinia conditions

Vaccinia conditions:

Adolescents ≥16 years:

Initial dosing: IV: 6,000 units/kg/dose as soon as symptoms appear.

Repeat dosing: IV: May repeat dose (6,000 units/kg/dose) based on severity of symptoms and response to treatment despite lack of specific clinical data; a higher dose (eg, 9,000 units/kg/dose) may be considered depending on clinical response. A specific time frame in which to administer repeat dose is not provided in manufacturer's labeling. Clinical efficacy for maximum doses is lacking; single doses up to 24,000 units/kg were tolerated in healthy adult volunteers. In patients with risk factors for thrombosis, do not exceed 12,000 units/kg/day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use caution. In patients with preexisting renal impairment or who are at risk of renal dysfunction or volume overload, do not exceed recommended infusion rate; follow infusion schedule closely and ensure adequate hydration; consider discontinuing if renal function deteriorates.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined. Actual frequency varies by dose and rate of infusion.

Cardiovascular: Peripheral edema

Central nervous system: Dizziness, fatigue, feeling hot, headache, pain, paresthesia, rigors, sensation of cold

Dermatologic: Diaphoresis, erythema, pallor

Gastrointestinal: Decreased appetite, nausea, vomiting

Local: Injection site reaction

Neuromuscular & skeletal: Back pain, muscle spasm, tremor, weakness

Miscellaneous: Fever

<1%, postmarketing, and/or case reports: Abdominal pain, acute intravascular hemolysis, acute renal failure, altered blood pressure, anaphylaxis, apnea, acute respiratory distress, arthralgia, aseptic meningitis, bronchospasm, bullous rash, chills, circulatory shock, coma, cyanosis, diarrhea, dyspnea, epidermolysis, erythema multiforme, flushing, hemolysis, hepatic insufficiency, hypersensitivity reaction, hypoxemia, hypotension, leukopenia, loss of consciousness, malaise, myalgia, pancytopenia, positive direct Coombs test, proximal tubular nephropathy, pulmonary edema, renal disease (osmotic nephropathy), renal insufficiency, seizure, Stevens-Johnson syndrome, syncope, tachycardia, thrombocytopenia, thromboembolism, transfusion-related acute lung injury (TRALI), urticaria, wheezing

Contraindications

Isolated vaccinia keratitis; history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of VIGIV or other human immune globulin preparations; IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; discontinue therapy and institute immediate treatment (including epinephrine 1 mg/mL). Contains trace amounts of IgA; use caution in IgA-deficient patients; contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity.

• Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with intravenous immune globulin administration and usually begins within several hours to 2 days following treatment; may occur more frequently with high total doses (2 g/kg). Discontinuation of treatment has resulted in remission of AMS within several days without sequelae.

• Hemolysis: Intravenous immune globulin has been associated with antiglobulin hemolysis; monitor for signs of hemolytic anemia. Risk factors for hemolysis include high doses given either as a single administration or divided over several days, underlying associated inflammatory conditions (eg, elevated C-reactive protein or erythrocyte sedimentation rate), and non-O blood group.

• Infusion reactions: Adverse reactions may be related to rate of infusion. Closely follow the recommended infusion rates.

• Pulmonary edema: Noncardiogenic pulmonary edema has been reported with intravenous immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1 to 6 hours after infusion. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies in both the product and patient's serum.

• Renal effects: Renal dysfunction, acute renal failure, osmotic nephropathy, proximal tubular nephropathy, and fatalities may occur; usually occurs in patients receiving total doses containing ≥400 mg/kg of sucrose (VIGIV does not contain sucrose).

• Thrombotic events: Thrombotic events have been reported with administration of intravenous immune globulin; use with caution in patients with a history of cardiovascular risk factors or arterial or venous thrombosis, advanced age, estrogen use, indwelling central venous catheters, impaired cardiac output, hypercoagulable disorders, prolonged periods of immobilization, and/or known or suspected hyperviscosity. For patients at risk for of thrombosis, administer at the minimum dose (do not exceed maximum dose), minimum concentration available, and minimum infusion rate practicable, ensure adequate hydration before administration.

Disease-related concerns:

• Hypovolemia: Patients should not be volume depleted prior to therapy.

• Postvaccinial encephalitis: Not effective for use in postvaccinial encephalitis.

• Renal impairment: Use with caution in patients with preexisting renal insufficiency and in patients at risk of developing renal insufficiency (eg, diabetes mellitus, patients >65 years, volume depletion, paraproteinemia, sepsis, patients receiving known nephrotoxic drugs); administer at the minimum rate of infusion (do not exceed the recommended infusion rate). Ensure patients are not volume depleted prior to VIGIV infusion. If renal function deteriorates, consider discontinuing therapy.

• Vaccinia keratitis: Exercise caution when using VIGIV in the treatment of patients with complications due to vaccinia vaccination that include concomitant vaccinia keratitis, because a single study in rabbits demonstrated increased corneal scarring upon intramuscular vaccinia immune globulin administration in vaccinia keratitis.

Special populations:

• Older adult: Use with caution in the elderly; may be at increased risk for renal dysfunction/failure and thromboembolic events.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

• Maltose: Product may contain maltose. Falsely elevated blood glucose readings may result in unnecessary insulin use and life-threatening hypoglycemia; cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings. Glucose specific monitoring systems and test strips are recommended.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

• Variable volume: Each vial is filled to contain ≥50,000 units, but the actual fill volume is variable per lot (eg, ~8 to 12 mL contained within a 20 mL vial); the vial size does not correspond to the amount of vaccinia immune globulin contained within the vial. It is only necessary to determine the exact fill volume of an individual vial if a partial vial is required to deliver the dose.

Other warnings/precautions:

• Appropriate use: Vaccinia immune globulin is currently not recommended for use in persons with contraindications to smallpox vaccine; inadvertent exposure to smallpox vaccine in high-risk populations should be reported to the CDC so that standardized treatment may be provided. VIGIV is not considered to be effective in the treatment of postvaccinial encephalitis.

Dosage Forms Considerations

Vaccinia immune globulin is supplied in a 20 mL single-dose vial containing ≥50,000 units per vial of neutralizing vaccinia immune globulin antibodies. 20 mL refers to the vial size, not the fill volume; the extractable volume of each VIGIV vial varies per lot and ranges from about 8 to 12 mL. The exact volume or concentration (units/mL) is NOT indicated on the vial label itself.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free; solvent-detergent treated]:

CNJ-016: ≥50,000 units [contains maltose 10% and polysorbate 80 0.03%]

Generic Equivalent Available: US

No

Prescribing and Access Restrictions

Vaccinia immune globulin is not available for general public use. All supplies are currently owned by the federal government for inclusion in the Strategic National Stockpile. The CDC Smallpox Adverse Events Clinical Consultation team will coordinate shipment. The State Health Department should be contacted first concerning severe or unexpected adverse events from smallpox vaccination.

Administration: Adult

IV: For IV infusion only. May be administered undiluted or diluted. If dedicated line is not available, flush with NS prior to administration of VIGIV. Do not exceed recommended rates of infusion.

Patients ≥50 kg: Infuse at ≤2 mL/minute.

Patients <50 kg: Infuse at ≤0.04 mL/kg/minute. Maximum rate of infusion: 2 mL/minute.

In patients who develop minor adverse reactions (eg, flushing) and in patients with risk factors for thrombosis/thromboembolism, consider an initial 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, then increase to the goal infusion rate for the remainder of the infusion (Ref).

Administration: Pediatric

IV: May be administered undiluted or diluted. Administer through a dedicated IV line at the weight-based rate as follows. If a dedicated line is not available, the preexisting catheter must be flushed with NS prior to administration of vaccinia immune globulin.

Weight <50 kg: Infuse at 0.04 mL/kg/minute not to exceed 2 mL/minute.

Weight ≥50 kg: Infuse at ≤2 mL/minute.

In patients who develop minor adverse reactions (eg, flushing), decrease infusion rate. In patients with risk factors for thrombosis/thromboembolism, consider a lower initial 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, then increase to the goal infusion rate for the remainder of the infusion (Ref).

Use: Labeled Indications

Vaccinia conditions: Treatment and/or modification of the following conditions:

- 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.

- Eczema vaccinatum

- Progressive vaccinia

- Severe generalized vaccinia

- Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions

The Advisory Committee on Immunization Practices (ACIP) recommends the following (CDC 2009; CDC [Rotz 2001]; CDC [Wharton 2003]):

Use is recommended for:

- Inadvertent inoculation (considering severity, toxicity of affected person, and pain)

- Eczema vaccinatum

- Generalized vaccinia (severe form or if underlying illness is present)

- Progressive vaccinia

Use may be considered for:

- Severe ocular complications except isolated keratitis

Use is not recommended for:

- Inadvertent inoculation that is not severe

- Mild or limited generalized vaccinia

- Nonspecific rashes, erythema multiforme, or Stevens-Johnson syndrome

- Postvaccinial encephalitis or encephalomyelitis

Use: Off-Label: Adult

Nonvariola orthopoxvirus infection (eg, mpox [monkeypox])

Medication Safety Issues

For use in monkeypox, see current version of CDC's IND protocol as recommendations are rapidly changing: https://www.cdc.gov/poxvirus/monkeypox/clinicians/treatment.html.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification

Pregnancy Considerations

Animal reproduction studies have not been conducted.

IV vaccinia immune globulin (VIGIV) is made from purified human plasma. Human IgG crosses the placenta (Clements 2020).

In general, VIGIV may be administered to pregnant patients when otherwise indicated, considering the risks and benefits of the individual patient (CDC 2003; CDC 2022b).

Breastfeeding Considerations

Caution is recommended if administered to a lactating patient (CDC 2003; CDC 2022b).

Monitoring Parameters

Renal function (including BUN, serum creatinine) and urine output (before initial infusion and at clinically appropriate intervals). Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies. During infusion, monitor patient for signs of infusion-related reactions, including (but not limited to) flushing, fever, chills, respiratory distress, BP or heart rate changes; transfusion-related lung injury (typically 1 to 6 hours after infusion), and signs/symptoms of hemolysis (prior to infusion and ~36 to 96 hours postinfusion); signs and symptoms of thrombosis.

Mechanism of Action

Antibodies obtained from pooled human plasma of individuals immunized with the smallpox vaccine provide passive immunity

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 6.6 L

Half-life elimination: 30 days (range: 13 to 67 days)

Time to peak, plasma: 1.8 to 2.6 hours

  1. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. Centers for Disease Control and Prevention (CDC). Expanded Access IND Protocol: Use of Vaccinia Immune Globulin Intravenous (VIGIV, CNJ-016) for Treatment of Human Orthopoxvirus Infection in Adults and Children. BB-IND No. 10788. CDC IRB No. 3744. Version 8.0. https://www.cdc.gov/poxvirus/monkeypox/pdf/VIGIV-IND-Protocol.pdf. Updated October 13, 2022a. Accessed November 4, 2022.
  3. Centers for Disease Control and Prevention (CDC). Clinical considerations for monkeypox in people who are pregnant or breastfeeding. https://www.cdc.gov/poxvirus/monkeypox/clinicians/pregnancy.html. Updated July 18, 2022b. Accessed July 28, 2022.
  4. Centers for Disease Control and Prevention (CDC). Medical Management of Smallpox (Vaccinia) Vaccine Adverse Reactions: Vaccinia Immune Globulin and Cidofovir. Updated September 28, 2009. https://www.azdhs.gov/documents/preparedness/emergency-preparedness/zebra-manual/zm-s6-mm-vaccinia.pdf.
  5. Centers for Disease Control and Prevention (CDC). Smallpox Vaccine Adverse Events Monitoring and Response System for the first stage of the smallpox vaccination program. MMWR Morb Mortal Wkly Rep. 2003;52(5):88-89, 99. [PubMed 12588007]
  6. Centers for Disease Control and Prevention (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. [PubMed 6423951]
  7. Clements T, Rice TF, Vamvakas G, et al. Update on transplacental transfer of IgG subclasses: impact of maternal and fetal factors. Front Immunol. 2020;11:1920. doi:10.3389/fimmu.2020.01920 [PubMed 33013843]
  8. CNJ-016 (Vaccinia immune globulin intravenous [human]) [prescribing information]. Winnipeg, Manitoba, Canada: Cangene Corporation; November 2018.
  9. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  10. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  11. Rao AK, Schrodt CA, Minhaj FS, et al. Interim clinical treatment considerations for severe manifestations of Mpox - United States, February 2023. MMWR Morb Mortal Wkly Rep. 2023;72(9):232-243. doi:10.15585/mmwr.mm7209a4 [PubMed 36862595]
  12. Rotz LD, Dotson DA, Damon IK, Becher JA; Advisory Committee on Immunization Practices. Vaccinia (smallpox) vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP), 2001. MMWR. 2001;50(RR10):1-25. [PubMed 15580803]
  13. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8960):1312-1313. [PubMed 7746084]
  14. Wharton M, Strikas RA, Harpaz R, et al; Advisory Committee on Immunization Practices; Healthcare Infection Control Practices Advisory Committee. Recommendations for using smallpox vaccine in a pre-event vaccination program. Supplementation recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR. 2003;52(RR-7):1-16. [PubMed 12710832]
Topic 10332 Version 115.0

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