Approved February 27, 2008

RILONACEPT
(FDA Category 1S)

ARCALYST(TM) (Regeneron, Inc) is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in Cryopyrin-Associated Periodic Syndromes (CAPS).

DOSING INFORMATION: The recommended loading dose is 320 milligrams (mg) subcutaneously (SubQ) as 2 doses of 160 mg at 2 different sites. Followed by 160 mg SubQ once-weekly. For children aged 12 to 17 years, the recommended loading dose is 4.4 milligrams/kilogram (mg/kg) SubQ (up to a maximum dose of 320 mg) as 1 or 2 injections. If administered as 2 injections, then administer at 2 different sites. Followed by 2.2 mg/kg (up to a maximum dose of 160 mg) SubQ once weekly.

PHARMACOKINETICS: Following weekly subcutaneous doses of 160 milligrams, the average trough levels were about 24 micrograms/milliliter. Steady state was attained in approximately 6 weeks.

CAUTIONS: Serious life-threatening infections and hypersensitivity reactions have been reported. Common adverse events were injection-site reactions and upper respiratory tract infections. Live vaccines should not be administered concurrently with rilonacept.

FDA APPROVED INDICATIONS: Rilonacept is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).