Primary immune deficiency:

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 for renal dysfunction/failure or thrombosis: give at the minimum infusion rate practicable. Dose adjustments: see full labeling.

Contraindications:

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

Boxed Warning:

Thrombosis. Renal dysfunction. Acute renal failure.

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 (Cat.C). Nursing mothers.

Pharmacologic Class:

Immune globulin.

Interactions:

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

Adverse Reactions:

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

Generic Availability:

NO

How Supplied:

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