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U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
Date:4/8/2008

option indicated in pediatric patients ages six and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with MTX. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

Important Safety Information for ORENCIA

Concomitant use with TNF antagonists: Concurrent therapy with ORENCIA and a biologic DMARD is not recommended. In controlled clinical trials, adult patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63 percent) and serious infections (4.4 percent) compared to patients treated with only TNF antagonists (43 percent and 0.8 percent, respectively), without an important enhancement of efficacy.

Hypersensitivity: Less than one percent of adult patients treated with ORENCIA experienced hypersensitivity reactions, including some cases of anaphylaxis or anaphylactoid reactions. Other events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9 percent of patients treated with ORENCIA and generally occurred within 24 hours of infusion. There was one case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5 percent; n =190). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use in the event of a reaction.

Infections: Caution should be exercised in patients with a history of infection or underlying conditions which predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis, and viral hepatitis in accordance with published guidelines, and if positive treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be give
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SOURCE Bristol-Myers Squibb Company
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