Indications for BIVIGAM:
Primary humoral immunodeficiency (eg, common variable immunodeficiency, X-linked or congenital agammaglobulinemia, Wiskott-Aldrich syndrome, severe combined immunodeficiencies).
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 of renal dysfunction/failure or thrombosis: give at the minimum practicable infusion rate. Dose adjustments: see full labeling.
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reaction to human immune globulin.
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 of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, obese, hypovolemia, sepsis, paraproteinemia: increased risk of 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, 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. Have epinephrine inj available. Elderly. Pregnancy (Cat.C). Nursing mothers.
May interfere with response to live viral vaccines. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May cause false positive direct or indirect Coombs' test.
Headache, fatigue, infusion site reaction, nausea, sinusitis, BP increased, diarrhea, dizziness, lethargy; renal dysfunction (may be fatal), hyperproteinemia, increased serum viscosity, hyponatremia, hemolytic anemia, TRALI, thrombosis; rare: aseptic meningitis syndrome (esp. with high dose 2g/kg or rapid infusion).
Single-use vial (5g/50mL, 10g/100mL)—1