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BIVIGAM
Primary immune deficiency
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Drug Name:

BIVIGAM Rx

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

Company:
Biotest Pharmaceuticals Corp.

Therapeutic Use:

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.

Contraindications:

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

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 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.

Interactions:

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.

Pharmacological Class:

Immune globulin.

Adverse Reactions:

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).

How Supplied:

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

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