Actemra® (tocilizumab)

• Full Prescribing Information
• Healthcare Provider Letters

  2 letters

  Actemra for RA and SJIA - Oct 2012 Actemra for RA and SJIA - June 2011
• Material Safety Data Sheet

Indication

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 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.

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 death, have occurred.

• 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.

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 infections,nasopharyngitis, headache, hypertension, and increased ALT.

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 consistentwith those seen in RA and SJIA patients.

Please see full Prescribing Information including Boxed Warning at www.actemra.com for additional important safety information.