Actemra recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated Low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations.
“Physicians and patients need to be aware of the risk of serious adverse effects of Actemra and make informed decisions regarding its benefits and risks in the treatment of individual patients,” said Bob Rappaport, M.D., director of the Division of Analgesics, Anesthetics and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA is requiring the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of Actemra. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra.
In addition, a Risk Evaluation and Mitigation Strategy (REMS) will require the drug sponsor to implement a Communication Plan for physicians informing them how to appropriately monitor their patients for liver and/or gastrointestinal side effects. The REMS will include a Medication Guide to ensure that patients are informed of the benefits and risks of Actemra.
Actemra works by blocking the action of interleukin-6, an immune system protein that is overabundant in people with rheumatoid arthritis.
The effectiveness and safety of Actemra was determined in five clinical trials in adult patients with active rheumatoid arthritis. In all of the trials, patients treated with Actemra experienced greater improvement in their tender or swollen joints than patients treated with a placebo.
The most common adverse reactions in clinical trials were upper respiratory tract infections, headache, inflammation of the nose or nasal passage, high blood pressure and increased liver enzymes. Elevations in the LDL or bad cholesterol were also seen in some patients, some of whom required the addition of lipid lowering agents.
Patients treated with Actemra are at increased risk for developing serious infections. Most patients who developed these infections in clinical trials were also taking other drugs that suppress the immune system such as methotrexate or corticosteroids.
Actemra is marketed by San Francisco-based Genentech Inc., a subsidiary of the Roche Group.
Media Inquiries: Karen Riley, 301-796-4674, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA