Human vaccinia virus immune globulin
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Boxed 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. 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 [see
5.3 Blood Glucose Monitoring ]. WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS See full prescribing information for complete boxed warning. Blood glucose measurement in patients receiving VIGIV (vaccinia immune globulin intravenous, human) must be done with a glucose-specific method (monitor and test strips) to avoid interference by maltose contained in VIGIV. Maltose in IGIV products may give falsely high blood glucose levels in certain types of blood glucose testing systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia.
Cases of true hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated glucose readings.
Human Immunoglobulin G
Dosing in kidney impairment
For patients with pre-existing renal insufficiency, or at increased risk of acute kidney injury, thrombosis, or volume overload, do not exceed the recommended infusion rate and follow the infusion schedule closely.
Preparation and administration
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Preparation
Bring VIGIV vials to room temperature prior to dosing.
If frozen, thaw vial by placing in a refrigerator at 2°C to 8°C (36°F to 46°F) until the contents are thawed for approximately 14 hours. Product can be thawed rapidly by placing at room temperature for one hour followed by a water bath at 37°C (98.6°F ) until thawed.
Do not thaw this product in a microwave oven.
Do not refreeze the vial.
DO NOT SHAKE VIAL. SHAKING VIAL MAY CAUSE FOAMING.
Remove the entire contents of the vial to obtain the labeled dosage of VIGIV. If partial vials are required for the dosage calculation, withdraw the entire contents of the vial to ensure accurate calculation of the dosage requirement.
VIGIV is compatible with 0.9% Sodium Chloride USP. No other drug interactions or compatibilities have been evaluated. If a pre-existing 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 (v/v).
VIGIV vial is for single use only. Do not reuse or save VIGIV for future use.
VIGIV contains no preservatives. Discard partially used vials.
Administration
Inspect the product prior to use and do not use if solution is cloudy, discolored or contains particulates.
Administer VIGIV intravenously through a dedicated intravenous line with the rate of infusion of no greater than 2 mL/min.
For patients weighing less than 50 kg, infuse the product at a rate no greater than 0.04 mL/kg/minute (133.3 Units per kg/minute).
Adverse drug reactions may be related to the rate of infusion. Slower infusion rate may be needed for patients who develop a minor adverse reaction (e.g. flushing) or for patients with risk factors for thrombosis/thromboembolism.
Closely monitor and carefully observe patients and their vital signs for any symptoms throughout the infusion period and immediately following an infusion.
For patients with pre-existing renal insufficiency, or at increased risk of acute kidney injury, thrombosis, or volume overload, do not exceed the recommended infusion rate and follow the infusion schedule closely.
For patients with risk factors for thrombosis, the maximum daily dose of VIGIV should not exceed 12,000 Units per kg [see
Drug interactions
Check human vaccinia virus immune globulin against a medication listLabel text (5 paragraphs)
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. Revaccinate people who received VIGIV shortly after live virus vaccination three months after the administration of the VIGIV.
7.2 Drug/Laboratory Interactions • VIGIV contains maltose, which can be misinterpreted as glucose by certain types of blood glucose testing systems (for example, those based on the GDH-PQQ or glucose-dye-oxidoreductase methods). Due to the potential for falsely elevated glucose readings, only use testing systems that are glucose-specific to test or monitor blood glucose levels in patients receiving VIGIV [see BOXED WARNING and
5.3 Blood Glucose Monitoring ]. • 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. Coombs’ test) [see
5.5 Hemolysis ].
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 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data on the use of VIGIV in pregnant women to inform on drug-associated risk. Animal reproduction studies have not been conducted with VIGIV.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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