Actimmune

— THERAPEUTIC CATEGORIES —
  • Bone disorders
  • Miscellaneous immune disorders

Actimmune Generic Name & Formulations

General Description

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

Pharmacological Class

Interferon.

How Supplied

Single-use vial (0.5mL)—1, 12

Manufacturer

Actimmune Indications

Indications

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

Actimmune Dosage and Administration

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.

Actimmune Contraindications

Contraindications

Hypersensitivity to E. coli derived products.

Actimmune Boxed Warnings

Not Applicable

Actimmune Warnings/Precautions

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.

Actimmune Pharmacokinetics

See Literature

Actimmune Interactions

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).

Actimmune Adverse Reactions

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.

Actimmune Clinical Trials

See Literature

Actimmune Note

Not Applicable

Actimmune Patient Counseling

See Literature

Actimmune Generic Name & Formulations

General Description

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

Pharmacological Class

Interferon.

How Supplied

Single-use vial (0.5mL)—1, 12

Manufacturer

Actimmune Indications

Indications

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

Actimmune Dosage and Administration

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.

Actimmune Contraindications

Contraindications

Hypersensitivity to E. coli derived products.

Actimmune Boxed Warnings

Not Applicable

Actimmune Warnings/Precautions

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.

Actimmune Pharmacokinetics

See Literature

Actimmune Interactions

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).

Actimmune Adverse Reactions

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.

Actimmune Clinical Trials

See Literature

Actimmune Note

Not Applicable

Actimmune Patient Counseling

See Literature