BIVIGAM Dosage & Rx Info | Uses, Side Effects

Bivigam Generic Name & Formulations

Legal Class

General Description

Immune globulin (human) 10% (100mg/mL); liq for IV infusion; sucrose-, preservative- and latex-free.

Pharmacological Class

Immune globulin.

How Supplied

Single-use vial (5g/50mL, 10g/100mL)—1

Manufacturer

ADMA Biologics, Inc.

Generic Availability

Mechanism of Action

The broad spectrum of neutralizing IgG antibodies against bacterial and viral pathogens and their toxins helps to avoid recurrent serious opportunistic infections. IgG antibodies are opsonins that increase phagocytosis and elimination of pathogens from the circulation. The mechanism of action has not been fully elucidated in primary humoral immunodeficiency.

Bivigam Indications

Indications

Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked or congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).

Bivigam Dosage and Administration

Adults and Children

<2yrs: not established. ≥2yrs: Individualize. 300‒800mg/kg by IV infusion every 3‒4 weeks. Initial infusion rate: 0.5mg/kg/min for first 10mins. Maintenance infusion rate: increase every 20mins (if tolerated) by 0.8mg/kg/min up to 6mg/kg/min. Risk for renal dysfunction/failure or thrombosis: give at the minimum infusion rate practicable. Dose adjustments: see full labeling.

Bivigam Contraindications

Contraindications

IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.

Bivigam Boxed Warnings

Boxed Warning

Thrombosis. Renal dysfunction. Acute renal failure.

Bivigam Warnings/Precautions

Warnings/Precautions

Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk for thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration. Have epinephrine inj available. Pre-existing renal insufficiency, diabetes, >65yrs, overweight, concomitant nephrotoxic drugs, hypovolemia, sepsis, paraproteinemia: increased risk for renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis syndrome (esp. with high dose 2g/kg and/or rapid infusion), hemolysis and delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Elderly. Pregnancy. Nursing mothers.

Bivigam Pharmacokinetics

Elimination

Half-life: 30 days.

Bivigam Interactions

Interactions

May interfere with response to live viral vaccines (eg, measles, mumps, rubella, varicella). May cause false (+) direct or indirect Coombs' test.

Bivigam Adverse Reactions

Adverse Reactions

Headache, fatigue, infusion site reaction, nausea, sinusitis, BP increased, diarrhea, dizziness, lethargy; hypersensitivity reactions, hyperproteinemia, increased serum viscosity, hyponatremia, hemolytic anemia, TRALI.

Bivigam Clinical Trials

See Literature

Bivigam Note

Not Applicable

Bivigam Patient Counseling