SCROLL FOR IMPORTANT SAFETY INFORMATION AND INDICATIONS
Important Safety Information
ACTIMMUNE® (Interferon gamma-1b)
Approved Uses for ACTIMMUNE®
Chronic Granulomatous Disease (CGD)
ACTIMMUNE® is approved by the US Food and Drug Administration to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease. CGD is a genetic disorder that affects the functioning of some cells of the immune system.
Severe, Malignant Osteopetrosis (SMO)
ACTIMMUNE® is approved by the US Food and Drug Administration to slow the worsening of severe, malignant osteopetrosis. SMO is a genetic disorder that affects normal bone formation.
Important Safety Information (ISI)
The most common side effects with ACTIMMUNE® are “flu-like” symptoms such as fever, headache, chills, myalgia (muscle pain), or fatigue, which may decrease in severity as treatment continues. Bedtime administration of ACTIMMUNE® may minimize some of these symptoms. Acetaminophen may be helpful in preventing fever and headache.
If you are pregnant or plan to become pregnant or plan to nurse, you should consult your physician.
ACTIMMUNE® can cause severe allergic reactions and/or rash. Do not use ACTIMMUNE® if you are allergic to interferon-gamma, E coli-derived products, or any component of the product. (See Full Prescribing Information for a list of components). If you develop a serious reaction to ACTIMMUNE®, discontinue it immediately and contact your doctor or seek medical help.
At high doses, ACTIMMUNE® can cause (flu-like) symptoms, which may worsen some pre-existing heart conditions. Tell your doctor if you have a cardiac condition such as irregular heartbeat, heart failure, or decreased blood flow to your heart.
ACTIMMUNE® may cause reversible changes to your nervous system, including decreased mental status, walking disturbances, and dizziness. Tell your doctor if you have a history of seizures or other neurologic disorders.
Bone marrow function may be suppressed with ACTIMMUNE®, and decreased production of cells important to the body may occur. This effect, which can be severe, is usually reversible when the drug is discontinued or the dose is reduced. Tell your doctor if you have, or have had, reduced bone marrow function. Your doctor will monitor these cells with blood tests at the beginning of therapy and at 3-month intervals thereafter.
Taking ACTIMMUNE® may cause reversible changes to your liver function, particularly in patients less than 1 year old. Your doctor will monitor your liver function with blood tests at the beginning of therapy and at 3-month intervals. If the patient is 1 year or less, monitoring will be done on a monthly basis.
If you are receiving ACTIMMUNE® at home, your doctor will provide to you or your caregiver appropriate instructions on the administration of the drug and disposal of the container, needles, and syringes.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
This information is not intended to replace discussions with your doctor. For additional information about ACTIMMUNE®, please consult the Full Prescribing Information and the Information for the Patient/Caregiver, and talk to your doctor. ACTIMMUNE® is available by prescription only.
Download a copy of the ACTIMMUNE® Full Prescribing Information.