A treatment for

Cryopyrin-Associated Periodic
Syndromes (CAPS)

About ARCALYST

ARCALYST® (rilonacept) is a targeted inhibitor of IL-1β, the key driver of inflammation in Cryopyrin-Associated Periodic Syndromes (CAPS). It is approved for the treatment of CAPS, including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged ≥12 years. It has not been studied in, and is not indicated for, the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID). ARCALYST is self-administered as a once-weekly subcutaneous (SC) injection.


IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections.

  See Full Prescribing Information

Dosage &
Administration

View the dosing instructions for adult patients and pediatric
patients aged 12 to 17 years.

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Patient
Information

Review what your patients should know about treatment
with ARCALYST.

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Important Safety Information

  • IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections
  • Patients should not receive a live vaccine while taking ARCALYST. It is recommended that prior to initiation of therapy with ARCALYST patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine
  • In the initial development program for ARCALYST, six serious adverse reactions were reported by four patients: Mycobacterium intracellulare infection, gastrointestinal bleeding and colitis, sinusitis and bronchitis, and Streptococcus pneumoniae meningitis
  • The most commonly reported adverse reactions associated with ARCALYST were injection site reaction and upper respiratory tract infection
  • Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted
  • Treatment with immunosuppressants, including ARCALYST, may result in an increase in risk of malignancies
  • Hypersensitivity reactions associated with ARCALYST administration in clinical studies have been rare. If a hypersensitivity reaction occurs, administration of ARCALYST should be discontinued and appropriate therapy initiated

IMPORTANT PRESCRIBING INFORMATION

ARCALYST® (rilonacept), an interleukin-1 blocker, is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children age 12 and over. It has not been studied in patients with Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

Please see the full Prescribing Information for ARCALYST.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The information provided in this site is intended only for healthcare professionals in the United States. The products discussed herein may have different product labeling in different countries.

Copyright © 2018,
Regeneron Pharmaceuticals, Inc. May 2018 US-ARC-13325(1)

Important Safety Information
and Indication

IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections.