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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:
Vidara Therapeutics Inc.



Therapeutic Use:

Indications for ACTIMMUNE:

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

Adults and Children's Dose:

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.

Pharmacological Class:

Interferon.

Contraindications:

Hypersensitivity to E. coli derived products.

Warnings/Precautions:

Pre-exisiting cardiac conditions (eg, ischemia, CHF, arrhythmia). Seizure disorders. Compromised CNS function. Myelosuppression. 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. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Caution with concomitant myelosuppressive agents.

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).

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's Dose:

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.

Pharmacological Class:

Interferon.

Contraindications:

Hypersensitivity to E. coli derived products.

Warnings/Precautions:

Pre-exisiting cardiac conditions (eg, ischemia, CHF, arrhythmia). Seizure disorders. Compromised CNS function. Myelosuppression. 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. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Caution with concomitant myelosuppressive agents.

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).

How Supplied:

Single-use vial (0.5mL)—1, 12

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