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Vaccinia Immune Globulin Intravenous (Human) (VIGIV (vaccinia immune globulin intravenous) ) 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 keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard.
Treatment of complications that include vaccinia keratitis with VIGIV (vaccinia immune globulin intravenous) should be performed with caution since a single study in rabbits has demonstrated increased corneal scarring with intramuscular VIG administration.6 VIGIV (vaccinia immune globulin intravenous) is not considered to be effective in the treatment of postvaccinial encephalitis.
Prospective clinical studies to evaluate the efficacy and safety of any VIG IM/IV product in patients suffering complications of vaccinica vaccination have not been conducted.
DOSAGE AND ADMINISTRATION
For the treatment of severe complications of vaccinia vaccination (see INDICATIONS AND USAGE section), Vaccinia Immune Globulin Intravenous (Human) (VIGIV (vaccinia immune globulin intravenous) ) should be administered at a dose of 6000 U/kg, as soon as symptoms appear and are judged to be due to severe vaccinia-related complication. Consideration may be given to repeat dosing, depending on the severity of the symptoms and response to treatment; however, clinical data on repeat doses are lacking. The administration of higher doses (e.g. 9000 U/kg) may be considered in the event that the patient does not respond to the initial 6000 U/kg dose.
Preparation for Administration
Remove the tab portion of the vial cap and clean the
rubber stopper with 70% alcohol or equivalent. DO NOT SHAKE VIAL; AVOID FOAMING.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
VIGIV (vaccinia immune globulin intravenous) should be administered directly through a dedicated intravenous line with a rate of injection of no greater than 2 mL/min. For subjects weighing less than 50 kg, it is recommended to infuse the product at a rate no greater than 0.04 mL/kg/minute (133.3 U/kg/minute). The maximum assessed rate of infusion of VIGIV has been 4 mL/min (see ADVERSE REACTIONS section). The dosage and the rate of infusion have not been evaluated in pediatric or geriatric patients (see PRECAUTIONS section). It may be prudent to infuse the product more slowly if the patient develops a minor adverse (e.g. flushing) reaction or in patients with risk factors for thrombosis/thromboembolism, and/or renal insufficiency.
Compatibility of VIGIV (vaccinia immune globulin intravenous) was only assessed with 0.9% Sodium Chloride USP and not with other solutions such as dextrose in water. If a pre-existing catheter must be used, the line should be flushed with 0.9% Sodium Chloride USP before use and VIGIV (vaccinia immune globulin intravenous) should not be diluted more than 1:2 (v/v).
Do not reuse or save VIGIV (vaccinia immune globulin intravenous) for future use. This product contains no preservative; therefore partially used vials should be discarded.
VIGIV (vaccinia immune globulin intravenous) is supplied as a 15 mL single dose vial containing ≥ 50,000 U/vial. NDC Number to be determined.
Store at 36 to 46°F (2 to 8°C). Do not use after expiration date.
If product is received frozen, use within 60 days of thawing at 2-8°C. Intravenous infusion should begin within 4 hours after entering the vial.
6. Fulginiti VA, Winograd LA, Jackson M et al.Therapy of experimental vaccinal keratitis: Effect of idoxuridine and VIG. Arch Ophthal 1965; 74:539-544.
Manufactured by: Cangene Corporation. Distributed by: Centers for Disease Control and Prevention. Revised: 26 April 2005.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/5/2009
Additional VIGIV Information
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