The Food and Drug Administration (FDA) has posted that Ilaris (canakinumab; Novartis) lyophilized powder for injection, 150mg, will be permanently discontinued.
The product discontinuation was a business decision made by Novartis and is not related to the safety, efficacy or quality of Ilaris. Ilaris for Injection (NDC #0078-0582-61) is packaged as 150mg strength lyophilized powder in single-dose vials for reconstitution. It is expected to be available through September 2017–January 2018.
Ilaris for Injection will be replaced by Ilaris Injection (solution) for subcutaneous use. This formulation does not require reconstitution and is already supplied as a 150mg/mL strength in single-dose vials for subcutaneous injection.
Ilaris, an interluekin-1beta blocker, is indicated to treat systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older; for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children ≥4yrs of age including: Familial Cold Autoinflammatory Syndrome (FCAS); Muckle-Wells Syndrome (MWS); and for the treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF) in adults and children.
For more information call (800) 693-9993 or visit Ilaris.com.