Expanded Indication for Stelara
October 13, 2017 – The U.S. FDA has approved an expanded indication for Stelara® (ustekinumab), manufactured by Janssen Biotech, to treat adolescent patients 12 years of age or older who have moderate to severe plaque psoriasis and are candidates for systemic therapy or phototherapy. Moderate to severe plaque psoriasis, a chronic immune disorder, affects an estimated 1.5 million people in the United States. Stelara is a human monoclonal antibody that suppresses interleukin 12 and interleukin 23, two naturally occurring proteins implicated in immune-mediated inflammatory disorders.
Recommended dosing for Stelara is based on weight, regardless of the patient’s age. The drug is delivered as a subcutaneous injection, with the first two doses administered four weeks apart. Subsequent doses should be administered once every 12 weeks.
In addition to an indication for plaque psoriasis, Stelara carries an indication to treat active psoriatic arthritis, and moderate to severe active Crohn’s disease. Potential side effects include serious infections. Patients should be evaluated for tuberculosis before beginning treatment with Stelara.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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.