Actemra Indications and Important Safety Information
ACTEMRA® (tocilizumab) 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 more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
ACTEMRA 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 is contraindicated in patients with known hypersensitivity to ACTEMRA. Hypersensitivity reactions, including anaphylaxis and death, have occurred.
- If anaphylaxis or other hypersensitivity reaction occurs, stop administration of ACTEMRA immediately and discontinue ACTEMRA permanently.
Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations.
Other potential risks of ACTEMRA include demyelinating disorders and malignancies.
Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests.
Common adverse reactions in RA studies included upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, and injection-site reactions (SC only).
Common adverse reactions in SJIA studies included upper respiratory tract infections, headache, nasopharyngitis, and diarrhea.
In general, the types of adverse drug reactions in patients with PJIA were consistent with those seen in RA and SJIA patients.
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.
ACTEMRA® and its logo are trademarks of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
The Access Solutions logo is a registered trademark of Genentech, Inc.