Rilonacept FGK Representative Service GmbH Rilonacept FGK Representative Service GmbH · Application withdrawn · ATC L04AC04
Therapeutic indication (EMA)
Treatment of idiopathic pericarditis
Active substance
Rilonacept
- US FDA 1
- EMA 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ARCALYST | 220MG | vial · single-use | KINIKSA PHARMACEUTICALS (UK), LTD. | Prescription | 27 Feb 2008 |
EMA European Union — centrally authorised medicines
Rilonacept Regeneron (previously Arcalyst) Regeneron UK Limited · Withdrawn · authorised 23 Oct 2009 · ATC L04AC08
Therapeutic indication (EMA)
Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.
Safety signals and safety-related labeling changes
- US FDA 18 Mar 2021 ARCALYST — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.