Vaccinia Immune Globulin (Intravenous)
Pronunciation
(vax IN ee a i MYUN GLOB yoo lin IN tra VEE nus)
Synonyms
VIGIV
Generic Available
No
Use
Treatment of infectious complications of smallpox (vaccinia virus) vaccination, such as eczema vaccinatum, progressive vaccinia, and severe generalized vaccinia; vaccinia infections in individuals with concurrent skin conditions or accidental virus exposure to eyes (except vaccinia keratitis), mouth, or other areas where viral infection would pose significant risk
Pregnancy Risk Factor
C
Pregnancy Implications
Immune globulins cross the placenta in increased amounts after 30 weeks gestation. There are no adequate and well-controlled studies in pregnant women; use only if benefits outweigh the risks.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to immune globulin or any component of the formulation; isolated vaccinia keratitis; selective IgA deficiency
Warnings/Precautions
Acute renal dysfunction (increased serum creatinine, oliguria, acute renal failure) may rarely occur, usually within 7 days of use (more likely with products stabilized with sucrose); patients should be adequately hydrated prior to therapy. Anaphylactic hypersensitivity reactions may occur, especially in IgA-deficient patients; epinephrine 1:1000 should be readily available. Studies indicate that the currently available product has no discernible risk of transmitting HIV or hepatitis A, B, or C; aseptic meningitis, which may rarely occur, is more likely with higher doses (
2 g/kg). It is unknown whether variant CJD can be transmitted via plasma-derived products. Use with caution in the elderly, patients with renal disease, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and nephrotoxic medications due to risk of renal dysfunction. Immune globulin use may be associated with thrombotic events; use caution in patients with a history of thrombotic events or cardiovascular disease. Intravenous immune globulin has been associated with antiglobulin hemolysis, monitor for signs of hemolytic anemia; monitor for transfusion-related, noncardiogenic pulmonary edema. Not effective for use in postvaccinial encephalitis. Safety and efficacy in pediatric or geriatric populations has not been determined. For intravenous administration only.
Adverse Reactions
>10%: Local: Injection site reaction (12%)
1% to 10%:
Cardiovascular: Flushing (8%)
Central nervous system: Headache (4% to 6%), dizziness (4% to 6%)
Dermatologic: Erythema (4%), urticaria (4% to 8%)
Gastrointestinal: Nausea (3% to 4%), abdominal pain (3% to 4%)
Neuromuscular & skeletal: Back pain (4%), arthralgia (3%)
Postmarketing and/or case reports (as reported with other IVIG products): Apnea, acute respiratory distress syndrome, bronchospasm, bullous dermatitis, coma, Coombs' test positive, cyanosis, dyspnea, epidermolysis, erythema multiforme, hemolysis, hepatic dysfunction, hypoxemia, hypotension, leukopenia, loss of consciousness, lung injury (transfusion-associated), pancytopenia, pulmonary edema, pyrexia, rigors, seizure, Stevens-Johnson syndrome, tremor, thromboembolism, vascular collapse
Overdosage/Toxicology
Symptoms primarily related to volume overload; treatment should be supportive
Drug Interactions
Immune globulin antibodies: May interfere with immune response to live virus vaccines (eg, polio, measles, mumps, and rubella); live virus vaccinations should be deferred until 6 months after administration of VIGIV; if given shortly before receiving VIGIV, revaccination with the live virus may be necessary (consult individual products for guidance)
Stability
Store between 2°C and 8°C (35.6°F to 46.4°F). Use within 6 hours of piercing vial stopper; complete infusion within 12 hours of spiking vial.
Compatibility
Y-site administration: Compatible (in a dilution not to exceed 1:2, v/v) with 0.9% sodium chloride or 2.5% to 20% dextrose solutions with or without sodium chloride
Mechanism of Action
Antibodies obtained from pooled human plasma of individuals immunized with the smallpox vaccine provide passive immunity
Pharmacodynamics/Kinetics
Half-life elimination: 22 days
Dosage
I.V.:
Adults: Total dose: 2 mL/kg (100 mg/kg)
Initial: 1 mL/kg/hour for 30 minutes, then 2 mL/kg/hour for 30 minutes, then 3 mL/kg/hour until complete
Note: Higher doses (200-500 mg/kg) may be considered if patient does not respond to initial recommended dose (sucrose-related renal impairment is worsened at doses 400 mg/kg)
Elderly: Safety and efficacy have not been established
Dosage adjustment in renal impairment: Use caution
Administration
Do not shake; avoid foaming. For intravenous use only. Predilution not recommended; if dedicated line not available, flush prior to administration of VIGIV. Administer through 0.22 micron filtered set; use of infusion pump recommended. Do not exceed recommended rates of infusion.
Monitoring Parameters
During infusion, monitor patient for signs of infusion-related reactions, including (but not limited to) flushing, fever, chills, respiratory distress, blood pressure or heart rate changes
Dietary Considerations
Solution for injection contains sucrose 50 mg/mL, human albumin 10 mg/mL, and sodium 0.02-0.03 mEq/mL.
Nursing Implications
During infusion, monitor for vital sign changes and adverse or allergic reactions.
Dosage Forms
Injection, solution [preservative free; solvent-detergent treated]: 50 mg/mL (50 mL) [contains sucrose 50 mg/mL, human albumin 10 mg/mL, sodium 0.02-0.03 mEq/mL]