Actimmune Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

Cardiovascular Disorders

Acute and transient "flu-like" symptoms such as fever and chills induced by ACTIMMUNE  at doses of 250 mcg/m2/day (greater than 10 times the weekly recommended dose) or higher may exacerbate pre-existing cardiac conditions. ACTIMMUNE  should be used with caution in patients with pre-existing cardiac conditions, including ischemia, congestive heart failure or arrhythmia.

Neurologic Disorders

Decreased mental status, gait disturbance and dizziness have been observed, particularly in patients receiving ACTIMMUNE  doses greater than 250 mcg/m2/day (greater than 10 times the weekly recommended dose). Most of these abnormalities were mild and reversible within a few days upon dose reduction or discontinuation of therapy. Caution should be exercised when administering ACTIMMUNE  to patients with seizure disorders or compromised central nervous system function.

Bone Marrow Toxicity

Reversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during ACTIMMUNE  therapy. Caution should be exercised when administering ACTIMMUNE  to patients with myelosuppression.

Hepatic Toxicity

Elevations of AST and/or ALT (up to 25-fold) have been observed during ACTIMMUNE  therapy. The incidence appeared to be higher in patients less than 1 year of age compared to older children. The transaminase elevations were reversible with reduction in dosage or interruption of ACTIMMUNE  treatment. Patients begun on ACTIMMUNE  before age one year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE  dosage should be modified (see DOSAGE AND ADMINISTRATIONDose Modification).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


ACTIMMUNE  is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease.

ACTIMMUNE  is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.


There is currently no drug history available for this drug.

Other Information

ACTIMMUNE®  (Interferon gamma-1b), a biologic response modifier, is a single-chain polypeptide containing 140 amino acids. Production of ACTIMMUNE  is achieved by fermentation of a genetically engineered Escherichia coli  bacterium containing the DNA which encodes for the human protein. Purification of the product is achieved by conventional column chromatography. ACTIMMUNE  is a highly purified sterile solution consisting of non-covalent dimers of two identical 16,465 dalton monomers; with a specific activity of 20 million International Units (IU)/mg (2x106 IU per 0.5 mL) which is equivalent to 30 million units/mg.

ACTIMMUNE  is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each 0.5 mL of ACTIMMUNE  contains: 100 mcg (2 million IU) of Interferon gamma-1b formulated in 20 mg mannitol, 0.36 mg sodium succinate, 0.05 mg polysorbate 20 and Sterile Water for Injection. Note that the above activity is expressed in International Units (1 million IU/50mcg). This is equivalent to what was previously expressed as units (1.5 million U/50mcg).

Actimmune Manufacturers

  • Intermune, Inc.
    Actimmune (Interferon Gamma-1b) Injection, Solution [Intermune, Inc.]
  • Vidara Therapeutics Inc
    Actimmune (Interferon Gamma-1b) Injection, Solution [Vidara Therapeutics Inc]

Login To Your Free Account