AHFS/Drugs.com Monograph Routes of
administration Subcutaneous Legal status US: ℞-only | License data US FDA: Arcalyst ATC code L04AC04 (WHO) | |
Pregnancy
category US: C (Risk not ruled out) | ||
Rilonacept, also known as IL-1 Trap (marketed by Regeneron Pharmaceuticals under the trade name Arcalyst), is an interleukin 1 inhibitor.
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.
Rilonacept was given an "orphan drug" status by the United States Food and Drug Administration and is used for the treatment of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome, Muckle–Wells syndrome and neonatal onset multisystem inflammatory disease(not approved in the U.S. on this indication).
On May 8th, 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.