Overview
11 DESCRIPTION VIGIV is a solvent/detergent-treated, filtered sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to vaccinia virus. It is stabilized with 10% maltose and 0.03% polysorbate 80 (pH is between 5.0 and 6.5) and contains no preservative. The product is a clear to opalescent liquid.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action VIGIV provides passive immunity for individuals with complications to vaccinia virus vaccination. The exact mechanism of action is not known. 12.2 Pharmacodynamics Two double-blind pharmacodynamic studies were conducted in which 82 healthy volunteers were randomized to receive vaccinia vaccination with or without VIGIV. In the first study, the efficacy of 9000 Units per kg of VIGIV on the immunologic and local response to Dryvax was evaluated. A total of 32 healthy subjects were randomized to receive single IV infusions of either VIGIV (9000 Units per kg) or Placebo (0.9% Sodium Chloride Injection USP) on Day 0, and either Placebo or VIGIV (9000 Units per kg) concurrently with vaccinia (Dryvax) vaccination on Day 4.
Indications
- 1 INDICATIONS AND USAGE VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following conditions: • 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 • Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated...
Common Doses
- 2 mL
- 0.04 mL
Dosage
2 DOSAGE AND ADMINISTRATION For intravenous use only. • For intravenous use only. • VIGIV is administered at a dose of 6000 Units per kg, as soon as symptoms for complication(s) due to vaccinia vaccination appear ( 2.1 ). • Higher doses (e.g. 9000 Units per kg or 24,000 Units per kg) may be considered in the event that the patient does not respond to the initial dose of 6000 Units per kg ( 2.1 ). • For patients with risk factors for thrombosis, the maximum daily dose of VIGIV should not exceed 12,000 Units per kg ( 2.3 ). 2.
Black Box Warning
WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS Blood glucose measurement in patients receiving 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.
Contraindications
- 4 CONTRAINDICATIONS VIGIV is contraindicated in: • Isolated vaccinia keratitis. • Individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations. • IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity, as it contains trace amounts of IgA (40 mcg/mL). • Isolated vaccinia keratitis ( 4 ) • History of anaphylactic or severe systemic reaction to human globulins ( 4 ) • IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity ( 4...
Side Effects
- 6 ADVERSE REACTIONS The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness. The adverse drug reactions to VIGIV treatment in clinical trials (>10%) include headache, nausea, rigors and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions Canada Inc. at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be...
Interactions
- 7 DRUG INTERACTIONS • Efficacy of live attenuated virus vaccines may be impaired by immune globulin administration; revaccination may be necessary ( 7.1 ) • Antibodies in VIGIV may interfere with some serological tests ( 7.2 ) 7.1 Live, Attenuated Vaccines Immune globulin administration may impair the efficacy of live attenuated vaccines such as measles, rubella, mumps and varicella. Defer vaccination with live virus vaccines until approximately three months after administration of VIGIV.