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New Drug Approved for Rheumatoid Arthritis
The U.S. Food and Drug Administration approved Actemra (tocilizumab) on Friday to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis. 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.
Website Address:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197108.htm
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Please note that all Travel Nursing Opportunities listed on this New York Travel Nurses web site are subject to change. Please contact a Recruiter at New York Travel Nurses today at (888) 894-2900 to find out about the most current Travel Nursing opportunities that are available. RNs need the appropriate experience for all Travel Nursing Jobs that are offered on this site. The New York Travel Nursing Assignments listed within this site are all a minimum of thirteen weeks in duration. Once you agree to accept one of these New York Travel Nursing Assignments, your particular Assignment length of time and the hours will be guaranteed as part of a written Employment Agreement. This guarantee will make you comfortable that you are receiving exactly what you agreed to upfront. You cannot be cancelled during this thirteen week Travel Nursing Assignment due to a low patient census. This will enable you to budget your finances efficiently without worry. Once you complete one of these New York Travel Nurse Assignments you can elect to continue your travel adventure at another Hospital, or continue at the same Hospital if the staffing need continues. You may also decide to accept a permanent position with the Hospital if that is your desire. The choice is entirely yours. When you work as a Travel Nurse at one of the New York Travel Nurse Assignments listed within this site, you will receive a premium salary and top notch health, life and disability insurance. Health Insurance for these New York Travel Nurse Assignments is 100% company paid. Employee Life/AD&D Benefits associated with these New York Travel Nurse Assignments are $25,000. Dental, Vision and Prescription Benefits are included as part of the benefits package associated with each of these New York Travel Nurse Assignments. For all of the New York Travel Nurse Assignments listed within this site, there are no Networks (use legitimate caregiver of choice), and there is no Medical Underwriting. There is a comprehensive 401(k) Plan for all New York Travel Nurse Assignments that includes 100% Company Matching, Immediate Vesting and Immediate Eligibility. As an New York Travelling Registered Nurse for the Assignments listed here, YOU decide your what housing best suits you. You have the choice of free private housing or a monthly housing stipend to cover housing expenses that you incur during your New York Travel Nursing assignment. All New York Travelling Registered Nurses receive a generous bonus for any RN who is referred that accepts one of the New York Travel Nurse Assignments listed on this site.
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