Bivigam Generic Name & Formulations
Immune globulin (human) 10% (100mg/mL); liq for IV infusion; sucrose-, preservative- and latex-free.
Single-use vial (5g/50mL, 10g/100mL)—1
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
<6yrs: not established. ≥6yrs: 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.
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.
Bivigam Boxed Warnings
Thrombosis. Renal dysfunction. Acute renal failure.
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 (Cat.C). Nursing mothers.
May interfere with response to live viral vaccines (eg, measles, mumps, rubella, varicella). May cause false (+) direct or indirect Coombs' test.
Bivigam 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
Bivigam Patient Counseling