Primary immune deficiency:

Indications for ASCENIV:

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

Adults and Children:

<12yrs: insufficient data. ≥12yrs: Individualize. 300‒800mg/kg by IV infusion every 3‒4 weeks. Initial infusion rate: 0.5mg/kg/min for first 15mins. Maintenance infusion rate: increase gradually every 15mins (if tolerated) up to 8mg/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:

Have epinephrine inj available. 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. Pre-existing renal insufficiency, diabetes, >65yrs, overweight, concomitant nephrotoxic drugs, hypovolemia: 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.

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, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, nausea; hypersensitivity reactions, hyperproteinemia, increased serum viscosity, hyponatremia, hemolytic anemia, TRALI.

Generic Availability:

NO

How Supplied:

Single-use vial (5g/50mL)—1