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Post-Hoc Data Show Daily Activity Participation, Independence and Sleep Quality Improved in Adults with Moderate to Severe Rheumatoid Arthritis After Treatment with ORENCIA(R) (Abatacept)
Date:11/12/2007

t commonly reported acute infusion-related AEs (one to two percent) were dizziness, headache, and hypertension with fewer than one percent of patients discontinuing ORENCIA due to infusion-related events.

About ORENCIA

ORENCIA is indicated in the United States for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.

Dosing and Administration

ORENCIA is administered by a healthcare professional as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with ORENCIA and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion- related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.

Important Safety Information about ORENCIA

Before receiving treatment with ORENCIA individuals should tell their doctor if they are taking a TNF blocker (e.g., Enbrel(R), Humira(R), Remicade(R)) to treat rheumatoid arthritis (RA). ORENCIA should not be taken with these medications because of a higher chance of getting a serious infection. Individuals should also tell their doctor if th
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SOURCE Bristol-Myers Squibb Company
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