Arcalyst (rilonacept) is an interleukin-1 blocker indicated for subcutaneous use for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years of age and older. Arcalyst was FDA approved on February 27, 2008 and is manufactured by Regeneron Pharmaceuticals, Inc.

From 11/01/1997 to 08/27/2012, there have been 16 reports of a serious adverse event where ARCALYST was identified as the primary suspect drug causing that event. During that time period, the top three adverse events reported in cases where ARCALYST was identified as the primary suspect drug were: Pulmonary Valve Incompetence, Hypertension and Gingival Hyperplasia.

07/31/2012 - FDA Rejects Regeneron?s Arcalyst for Gout
05/04/2012 - FDA Questions whether Benefit of Arcalyst for Prevention of Gout Flares Outweighs Risk

IL-1 Trap, Rilonacept

Average Age: 31 Years
Gender: 18% M, 82% F
Average Duration of Treatment: 96 Days

Arcalyst
Rilonacept
Rilonacept 1.2ml (220mg Vial) Given 2.2mg/kg Niams-no1-ar-7-0015
Rilonacept 220 Mg
Rilonacept 220 Mg Regeneron Pharmaceuticals
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Regeneron Pharmaceuticals, Inc. (7)