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ACTIMMUNE
Bone disorders
Miscellaneous immune disorders
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Drug Name:

ACTIMMUNE Rx

Generic Name and Formulations:
Interferon gamma-1b 100mcg (2 million IU) per 0.5mL; soln for SC inj; preservative-free.

Company:
Horizon Pharma

Therapeutic Use:

Indications for ACTIMMUNE:

To delay time to disease progression in patients with severe, malignant osteopetrosis.

Adults and Children:

<1month: not established. ≥1month: Give by SC inj (into right or left deltoid or anterior thigh) 3 times weekly. BSA ≤0.5m2: 1.5mcg/kg/dose. BSA >0.5m2: 50mcg/m2 (1 million IU/m2). Reduce dose by 50% or interrupt therapy if severe adverse reactions occur.

Contraindications:

Hypersensitivity to E. coli derived products.

Warnings/Precautions:

Pre-exisiting cardiac conditions (eg, ischemia, CHF, arrhythmia). Seizure disorders. Compromised CNS function. Myelosuppression. Advanced hepatic disease. Severe renal insufficiency. Monitor CBCs, differential and platelet counts, urinalysis, renal and liver function tests prior to initiating and at 3 month intervals during treatment. Children <1yr: obtain liver function tests monthly. Latex allergy. Pregnancy. Nursing mothers: not recommended.

Interactions:

Caution with concomitant myelosuppressive agents. Increased toxicity with concomitant neurotoxic, hematotoxic, or cardiotoxic agents. Avoid concomitant other heterologous serum protein or immunological preparations (eg, vaccines).

Pharmacological Class:

Interferon.

Adverse Reactions:

Flu-like symptoms (eg, fever, chills), headache, rash, inj site reactions (erythema, tenderness, pain), fatigue, GI upset, myalgia, arthralgia; CNS effects (eg, decreased mental status, gait disturbance, dizziness), reversible neutropenia, thrombocytopenia (may be severe), elevated AST, ALT (modify dose if severe), hypersensitivity reactions (may be serious; discontinue immediately), renal toxicity, possible antibody formation.

How Supplied:

Single-use vial (0.5mL)—1, 12

Indications for ACTIMMUNE:

To reduce frequency and severity of serious infections associated with chronic granulomatous disease.

Adults and Children:

<1yr: not established. ≥1yr: Give by SC inj (into right or left deltoid or anterior thigh) 3 times weekly. BSA ≤0.5m2: 1.5mcg/kg/dose. BSA >0.5m2: 50mcg/m2 (1 million IU/m2). Reduce dose by 50% or interrupt therapy if severe adverse reactions occur.

Contraindications:

Hypersensitivity to E. coli derived products.

Warnings/Precautions:

Pre-exisiting cardiac conditions (eg, ischemia, CHF, arrhythmia). Seizure disorders. Compromised CNS function. Myelosuppression. Advanced hepatic disease. Severe renal insufficiency. Monitor CBCs, differential and platelet counts, urinalysis, renal and liver function tests prior to initiating and at 3 month intervals during treatment. Children <1yr: obtain liver function tests monthly. Latex allergy. Pregnancy. Nursing mothers: not recommended.

Interactions:

Caution with concomitant myelosuppressive agents. Increased toxicity with concomitant neurotoxic, hematotoxic, or cardiotoxic agents. Avoid concomitant other heterologous serum protein or immunological preparations (eg, vaccines).

Pharmacological Class:

Interferon.

Adverse Reactions:

Flu-like symptoms (eg, fever, chills), headache, rash, inj site reactions (erythema, tenderness, pain), fatigue, GI upset, myalgia, arthralgia; CNS effects (eg, decreased mental status, gait disturbance, dizziness), reversible neutropenia, thrombocytopenia (may be severe), elevated AST, ALT (modify dose if severe), hypersensitivity reactions (may be serious; discontinue immediately), renal toxicity, possible antibody formation.

How Supplied:

Single-use vial (0.5mL)—1, 12

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