Select therapeutic use:

Bleeding disorders:

Indications for: OCTAGAM 10%

Chronic immune thrombocytopenic purpura (ITP).

Adult Dosage:

Individualize. Total dose of 2g/kg, divided into equal doses given on 2 consecutive days by IV infusion at a rate of 1mg/kg/min, if tolerated may increase 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 Dosage:

Not established.

OCTAGAM 10% Contraindications:

IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.

Boxed Warning:

Thrombosis. Renal dysfunction and acute renal failure.

OCTAGAM 10% 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 prior to initiation. Assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Corn allergy. Hyperproteinemia, increased serum viscosity and hyponatremia may occur. Risk of aseptic meningitis syndrome esp. in those with a history of migraine, high doses (2g/kg), and/or rapid infusion. Monitor for 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 adverse reactions; 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. Nursing mothers.

OCTAGAM 10% Classification:

Immune globulin.

OCTAGAM 10% 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. May lead to a positive direct or indirect antiglobulin (Coombs) test due to passive transmission of antibodies to erythrocyte antigens.

Adverse Reactions:

ITP: headache, fever, increased heart rate; also with DM: nausea, vomiting, increased BP, chills, musculoskeletal pain, dyspnea, infusion site reactions; thrombosis, renal dysfunction (may be fatal); rare: hemolytic anemia, aseptic meningitis syndrome, TRALI.

Generic Drug Availability:

NO

How Supplied:

Single-use bottle—1

Miscellaneous immune disorders:

Indications for: OCTAGAM 10%

Dermatomyositis (DM).

Adult Dosage:

Individualize. Total dose of 2g/kg, divided into equal doses given on 2–5 consecutive days every 4 weeks by IV infusion at a rate of 1mg/kg/min, if tolerated may increase up to max 4mg/kg/min (increased risk of thromboembolic events if >4mg/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 Dosage:

Not established.

OCTAGAM 10% Contraindications:

IgA deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.

Boxed Warning:

Thrombosis. Renal dysfunction and acute renal failure.

OCTAGAM 10% 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 prior to initiation. Assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Discontinue if hypersensitivity reactions occur; have epinephrine available. Corn allergy. Hyperproteinemia, increased serum viscosity and hyponatremia may occur. Risk of aseptic meningitis syndrome esp. in those with a history of migraine, high doses (2g/kg), and/or rapid infusion. Monitor for 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 adverse reactions; 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. Nursing mothers.

OCTAGAM 10% Classification:

Immune globulin.

OCTAGAM 10% 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. May lead to a positive direct or indirect antiglobulin (Coombs) test due to passive transmission of antibodies to erythrocyte antigens.

Adverse Reactions:

ITP: headache, fever, increased heart rate; also with DM: nausea, vomiting, increased BP, chills, musculoskeletal pain, dyspnea, infusion site reactions; thrombosis, renal dysfunction (may be fatal); rare: hemolytic anemia, aseptic meningitis syndrome, TRALI.

Generic Drug Availability:

NO

How Supplied:

Single-use bottle—1