About ACTEMRA
ACTEMRA was approved by the U.S. Food and Drug Administration (FDA) in January 2010 for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
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.
The first biologic to specifically inhibit the IL-6 receptor
IL-6 plays a fundamental role in driving the inflammation associated with RA1
- Interleukin-6 (IL-6) is one of the most abundant cytokines in the rheumatoid synovium2,3
- IL-6, alone or with other cytokines, interacts with various cells such as T cells, B cells, lymphocytes, monocytes and fibroblasts, driving synovial proliferation, inflammation, autoimmunity and destruction of articular structures1,4
- Serum IL-6 levels are highly elevated in patients with RA5,6
- Levels directly associated with disease stage, severity of joint destruction and extra-articular manifestations of RA6–8
ACTEMRA inhibits IL-6 signaling, a key driver of inflammation8–10
ACTEMRA rapidly normalizes CRP and increases Hb
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 tumor necrosis factor (TNF) antagonist therapies.
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.
- 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 include upper respiratory infection, nasopharyngitis, headache, hypertension, and increased ALT.
Please see full Prescribing Information including Boxed Warning for additional important safety information.
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