Actimmune Generic Name & Formulations
Legal Class
Rx
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
Legal Class
Rx
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