Stelara Approved for Crohn
September 23, 2016 - The U.S. Food and Drug Administration (FDA) authorized Stelara® (ustekinumab), manufactured by Janssen Biotech for a new indication to treat Crohn’s Disease. Stelara is a monoclonal antibody that targets interleukins 12 and 23 (IL-12 and IL-23) and is now indicated to treat adults who have moderate to severe active Crohn’s disease that has not responded to corticosteroids, immunomodulators or tumor necrosis factor (TNFα) inhibitors. A first dose of up to 520mg is determined by the weight of the patient and infused intravenously (IV) by a healthcare provider. Then, beginning eight weeks after the initial dose, recommended dosing is 90mg of Stelara subcutaneously once every eight weeks. Stelara is already FDA approved for treating psoriasis and psoriatic arthritis.
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.