New Indications for Ilaris
September 23, 2016 – The US FDA granted three new indications for Ilaris® (canakinumab), manufactured by Novartis. Ilaris is the first biological treatment to be FDA approved for treating familial Mediterranean fever (FMF), mevalonate kinase deficiency (MKD) and tumor necrosis factor-receptor associated periodic syndrome (TRAPS). MKD also may be called hyperimmunoglobulin D syndrome (HIDS). All three newly approved indications are for forms of the rare autoimmune disorder, periodic fever syndromes, which cause episodes of fever along with inflammation, joint and muscle pain, rashes and swelling. Ilaris originally was FDA approved in 2009 to treat patients four years of age and older who have another periodic fever syndrome, cryporin-associated periodic syndromes (CAPS). A second U.S. indication, to treat systemic juvenile idiopathic arthritis patients at least two years old, was approved in 2013. A monoclonal antibody that inhibits interleukin-1 beta (IL-1β), Ilaris is injected subcutaneously to decrease inflammation. Dosing depends on the patient’s body weight and dosing intervals depend on the condition being treated. It is dispensed in single-use vials containing 180mg of active drug after being mixed with 1mL of sterile preservative-free water. A Medication Guide supplied with Ilaris warns that patients using it have a higher than normal risk of developing serious infections.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.