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... (be used as monotherapy orconcomitantly w...)

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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

be used as monotherapy or concomitantly with MTX in pediatric patients. ORENCIA should not be administered concomitantly with TNF antagonists. ORENCIA is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

For adult patients with RA, ORENCIA, a lyophilized powder for intravenous infusion, should be administered by a healthcare professional as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg. Following the initial administration, ORENCIA should be given at two and four weeks after the first infusion and every four 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. The most frequently reported infusion-related adverse events (one percent to two percent) were dizziness, headache, and hypertension. In clinical studies, premedications were not required. However, appropriate medical support measure of the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.

For pediatric and adolescent patients with JIA who weigh less than 75 kg, ORENCIA(R) (abatacept) should be administered as a 30-minute intravenous infusion at a dose of 10 mg/kg specifically calculated based on the patient's body weight at each administration, not to exceed a maximum dose of 1000 mg. Pediatric patients weighing 75 kg or more should be administered ORENCIA following the adult dosing regimen. Following the initial administration, ORENCIA should be given at two and four weeks after the first infusion and every four weeks thereafter. ORENCIA may be used as monotherapy or concomitantly with MTX.

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1 FDA Website. Approval History: sBLA 125057/
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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...(be used as monotherapy orconcomitantly w...),Health