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Regeneron's Rilonacept Granted European Marketing Authorization for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Date:10/27/2009

The most commonly reported adverse reactions with rilonacept were injection-site reaction and upper respiratory tract infection.

In the United States, rilonacept (ARCALYST®) is indicated 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 and older. ARCALYST was approved by the U.S. Food and Drug Administration in February 2008 and has been available in the United States since March 2008.

IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking rilonacept. Rilonacept should be discontinued if a patient develops a serious infection. Treatment with rilonacept should not be initiated in patients with active or chronic infections. Taking rilonacept with tumor necrosis factor inhibitors is not recommended because this may increase the risk of serious infections. Patients should not receive a live vaccine while taking rilonacept. It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with rilonacept. Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Hypersensitivity reactions associated with rilonacept administration have been rare. Please see the full U.S. Prescribing Information for ARCALYST® (rilonacept), available online at www.regeneron.com/ARCALYST-fpi.pdf. Please see the European Summary of Product Characteristics at www.regeneron.com/RILONACEPT-EU.pdf.

About Regeneron Pharmaceuticals

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions
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SOURCE Regeneron Pharmaceuticals, Inc.
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