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Trade namesArcalyst
Other namesIL-1 Trap
Clinical data
Drug classInterleukin 1 receptor inhibitor[1]
Main usesCryopyrin-associated periodic syndromes; deficiency of interleukin-1 receptor antagonist; recurrent pericarditis[2]
Side effectsPain at the site of injection, respiratory tract infection[2]
Routes of
External links
US NLMRilonacept
License data
Legal status
Chemical and physical data
Molar mass201209.36 g·mol−1
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Rilonacept, sold under the brand name Arcalyst, is a medication used to treat cryopyrin-associated periodic syndromes, including familial cold autoinflammatory syndrome, and Muckle–Wells syndrome; deficiency of interleukin-1 receptor antagonist; and recurrent pericarditis.[2] It is given by injection under the skin.[2]

Common side effects pain at the site of injection and respiratory tract infection.[2] Other side effects may include infections, cancer, and allergic reactions.[2][1] There are concerns that use in pregnancy could harm the baby.[4] It is an interleukin 1 receptor inhibitor.[1]

Rilonacept was approved for medical use in the United States in 2008.[1] While it was approved in Europe in 2009, this approval was withdrawn in 2012.[5] In the United States, four vials of 220 mg cost about 21,000 USD as of 2021.[6]

Medical uses


In adults it is given at an initial dose of 320 mg.[2] Further doses are than given weekly of 160 to 320 mg.[2]


Rilonacept is a dimeric fusion protein consisting of the ligand-binding domains of the extracellular portions of the human interleukin-1 receptor component (IL-1R1) and IL-1 receptor accessory protein (IL-1RAcP) linked in-line to the fragment-crystallizable portion (Fc region) of human IgG1 that binds and neutralizes IL-1.[7]


Rilonacept was given an orphan drug designation by the U.S. Food and Drug Administration (FDA).[8] [9] Rilonacept is the first drug approved by the FDA to treat recurrent pericarditis.[8] On May 8, 2012 an FDA Advisory Panel voted 11–0 against the approval of rilonacept for the treatment of gout, stating that the benefits did not outweigh the risks associated with the drug.[10]


  1. 1.0 1.1 1.2 1.3 "Rilonacept Monograph for Professionals". Retrieved 17 October 2021.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 "Arcalyst- rilonacept injection, powder, lyophilized, for solution". DailyMed. Retrieved 18 March 2021.
  3. "Rilonacept Regeneron (previously Arcalyst) EPAR". European Medicines Agency (EMA). Retrieved 18 March 2021.
  4. "Rilonacept (Arcalyst) Use During Pregnancy". Retrieved 17 October 2021.
  5. "Rilonacept Regeneron (previously Arcalyst)". Retrieved 17 October 2021.
  6. "Arcalyst Prices, Coupons & Patient Assistance Programs". Retrieved 17 October 2021.
  7. "Molecule of the month. Rilonacept". Drug News & Perspectives. 21 (4): 232. May 2008. PMID 18560622.
  8. 8.0 8.1 "FDA Approves First Treatment for Disease That Causes Recurrent Inflammation in Sac Surrounding Heart". U.S. Food and Drug Administration (FDA). 18 March 2021. Retrieved 18 March 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  9. "Arcalyst FDA Approval History -". Archived from the original on 2012-05-16. Retrieved 2012-05-08.
  10. "Medical News: FDA Panel Nixes Gout Drug - in Rheumatology, General Rheumatology from MedPage Today". Archived from the original on 2012-05-21. Retrieved 2012-05-08.

External links

External sites: