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OCTAGAM 10%
Bleeding disorders
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Drug Name:

OCTAGAM 10%

Generic Name and Formulations:
Immune globulin (human) 2g/20mL, 5g/50mL, 10g/100mL, 20g/200mL; liq for IV infusion; contains maltose; sucrose-, preservative-, and latex-free.

Company:
Octapharma

Therapeutic Use:

Indications for OCTAGAM 10%:

Chronic immune thrombocytopenic purpura (ITP).

Adult:

Individualize. Total dose of 2g/kg, divided into 2 doses of 1g/kg (10mL/kg) given on 2 consecutive days by IV infusion at a rate of 1mg/kg/min, if tolerated may increase at 30min intervals to 2mg/kg/min, then 4mg/kg/min, then 8mg/kg/min, then up to max 12mg/kg/min. Risk of renal dysfunction/failure or thrombosis: give at the minimum practicable infusion rate; max: <3.3mg/kg/min. See full labeling.

Children:

Not established.

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, fever, increased heart rate; 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

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