Arcalyst
These highlights do not include all the information needed to use ARCALYST safely and effectively. See full prescribing information for ARCALYST. ARCALYST (rilonacept) for injection, for subcutaneous use Initial U.S. Approval: 2008
Approved
Approval ID
ad965f38-dd22-4607-a673-2fb92f3b527a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2023
Manufacturers
FDA
Kiniksa Pharmaceuticals (UK), Ltd.
DUNS: 224568777
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rilonacept
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73604-914
Application NumberBLA125249
Product Classification
M
Marketing Category
C73585
G
Generic Name
rilonacept
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 8, 2023
FDA Product Classification
INGREDIENTS (6)
RILONACEPTActive
Quantity: 160 mg in 2 mL
Code: 8K80YB5GMG
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT