Dosage &
Administration

Treating your patients with
ARCALYST® (rilonacept)

Dosing instructions

Adult patients aged 18 years and older:

  • Treatment should be initiated with a loading dose of 320 mg delivered as two 2-mL subcutaneous injections of 160 mg each given on the same day at 2 different sites
  • Dosing should be continued with a once-weekly injection of 160 mg administered as a single 2-mL subcutaneous injection
  • ARCALYST® (rilonacept) should not be administered more often than once weekly
  • Dosage modification is not required based on advanced age or gender

Pediatric patients aged 12 to 17 years:

  • Treatment should be initiated with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as 1 or 2 subcutaneous injections with a maximum single-injection volume of 2 mL
  • Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg, administered as a single subcutaneous injection, up to 2 mL
  • If the initial dose is given as 2 injections, they should be given on the same day at 2 different sites
  • ARCALYST should not be administered more often than once weekly

Overdosage: In case of overdose, it is recommended that patients be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Patient Information

Review what your patients should know about treatment with ARCALYST.

See The Details

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.