New Indication for Xeljanz and Xeljanz XR
December 14, 2017 – The U.S. FDA has approved a new indication for Xeljanz® (tofacitinib) and Xeljanz® XR (tofacitinib extended release), both manufactured by Pfizer. The drugs are now indicated to treat psoriatic arthritis (PsA) in adults who are unable to obtain adequate relief with other disease-modifying antirheumatic drugs (DMARDs).
Recommended dosing under the new indication is one tablet twice daily for Xeljanz, and one tablet once per day for Xeljanz XR. Both Xeljanz and Xeljanz XR should be used in conjunction with a conventional DMARD, such as methotrexate, when used to treat psoriatic arthritis. Neither form of Xeljanz should be used with a biologic DMARD, such as Humira® (adalimumab), or with an immunosuppressant, including cyclosporine.
A black box warning cautions that both Xeljanz and Xeljanz XR may increase the risk of severe infection, including tuberculosis. Patients should be tested for tuberculosis before beginning either form of the drug. This testing should continue throughout therapy with Xeljanz or Xeljanz XR, and for a period of several months after treatment ends. The warning also cautions that Xeljanz and Xeljanz XR may be associated with lymphoma and other cancers in children and adolescents.
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.