Actemra Indications and Important Safety Information
INDICATIONS
ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
IMPORTANT SAFETY INFORMATION
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections.
If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
ACTEMRA should not be administered to patients with known hypersensitivity to ACTEMRA. Hypersensitivity reactions, including anaphylaxis and dealth have occured.
- If anaphylaxis or other clinically significant hypersensitivity reaction occurs, administration of ACTEMRA should be stopped immediately and ACTEMRA should be permanently discontinued.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations and hypersensitivity reactions.
Other potential risks of ACTEMRA include demyelinating disorders, malignancies and changes to certain lab parameters.
Common adverse reactions in RA studies included upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.
Common adverse reactions in SJIA studies included upper respiratory tract infection, headache, nasopharyngitis and diarrhea.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see full Prescribing Information, including Boxed Warning for additional important safety information.