OCTAGAM Rx

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OCTAGAM

Primary immune deficiency
Only 4 drugs may be compared at once

Generic Name and Formulations:

Immune globulin (human) 1g/20mL, 2.5g/50mL, 5g/100mL, 10g/200mL; liq for IV infusion; sucrose-, preservative- and latex-free.

Company:

Octapharma

Select therapeutic use:

Indications for OCTAGAM:

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

Adults and Children:

Individualize. 300‒600mg/kg by IV infusion every 3‒4 weeks at infusion rate of 0.5mg/kg/min, if tolerated may increase at 30min intervals to 1mg/kg/min, then 2mg/kg/min, then up to max 3.33mg/kg/min. Risk of measles exposure and receives <400mg/kg every 3‒4 weeks, may increase to at least 400mg/kg; if exposed, give as soon as possible. Risk of renal dysfunction/failure or thrombosis: give at the minimum practicable infusion rate; max: <3.3mg/kg/min. See full labeling.

Contraindications:

IgA deficiency with antibodies against IgA. 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. Ensure adequate hydration. Pre-existing renal insufficiency, diabetes, >65yrs, 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. Corn allergy. Discontinue if hypersensitivity reactions occur; have epinephrine available. Monitor for aseptic meningitis, hemolysis and delayed hemolytic anemia; consider measuring baseline hemoglobin or hematocrit and approx. 36–96hrs post-infusion if patients are high risk. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Antibody formation. Risk of transmission of blood-borne diseases. Elderly. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Avoid live viral vaccines for ≥3 months. Concomitant nephrotoxic drugs: increased risk of acute renal failure. Falsely elevated results with some blood glucose tests (eg, GDH-PQQ based or glucose-dye-oxidoreductase methods); use glucose-specific method only.

Pharmacological Class:

Immune globulin.

Adverse Reactions:

Headache, nausea; renal dysfunction (may be fatal), hyperproteinemia, increased serum viscosity, hyponatremia; rare: hemolytic anemia, aseptic meningitis syndrome (esp. with high doses or rapid infusion), TRALI, thrombosis.

How Supplied:

Single-use bottle—1