Tell your healthcare provider if you are a current or past smoker or have had any type of cancer. The updated Boxed Warning regarding cancer discusses a higher risk of certain cancers, including lymphoma and lung cancer in patients taking XELJANZ, especially if you are a current or past smoker. The updated Boxed Warning information regarding Mortality discusses the increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor taking recommended doses of XELJANZ. Specific risks associated with certain dosing are noted.Īs a result of this review, an additional warning for Major Cardiovascular Events, and updated warnings for Mortality, Cancer, and Blood Clots were included in the Boxed Warning and related Warnings and Precautions section of the prescribing information and in the Most Important Information I Should Know section of the patient Medication Guide for XELJANZ. The safety information below applies to all marketed formulations of XELJANZ. Your healthcare provider should consider the benefits and risks of XELJANZ.
Talk to your healthcare provider if you have any questions or concerns about this safety update. FDA’s completed review of the ORAL Surveillance trial, a post-marketing required safety study.
full prescribing information for XELJANZ ® (tofacitinib) has been updated based on the U.S. Pfizer issued a media statement announcing that the U.S. Food and Drug Administration (FDA) updated the XELJANZ full prescribing information.