New Indication for Xeljanz
May 30, 2018 – The U.S. FDA has approved a new indication for Xeljanz® (tofacitinib), manufactured by Pfizer. The medication is now indicated to treat adults who have moderate-to-severe active ulcerative colitis. It is the first oral medication approved for chronic use in this population. Other available medications for this indication must be administered via intravenous and subcutaneous injection.
An estimated 900,000 adults in the United States live with ulcerative colitis. The disease can lead to weight loss, severe diarrhea, abdominal pain, fever, and fatigue. In clinical trials, Xeljanz induced remission in up to 18% of patients after eight weeks, and 41% after one year.
Xeljanz should not be used in combination with biological therapies or with strong immunosuppressant treatments, including azathioprine and cyclosporine. A black box warning cautions that Xeljanz can increase the risk of serious infections, and patients should be tested for tuberculosis before starting treatment. The warning also indicates that use of the product has been associated with lymphoma and other types of cancer. In addition, the boxed warning cautions that the drug can lead to a higher incidence of Epstein Barr Virus-associated post-transplant lymphoproliferative disorder in renal transplant patients who receive both Xeljanz and immunosuppressant therapies.
Xeljanz was first approved in 2012. It holds additional indications for the treatment of rheumatoid arthritis 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 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.