BOXED WARNING  (ADDED MARCH 2023) (FOR THE TOPICAL FORMULATION OF RUXOLITINIB APPROVED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS AND NONSEGMENTAL VITILIGO).

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

SERIOUS INFECTIONS LEADING TO HOSPITALIZATION OR DEATH, INCLUDING TUBERCULOSIS AND BACTERIAL, INVASIVE FUNGAL, VIRAL, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE OCCURRED IN PATIENTS RECEIVING JANUS KINASE INHIBITORS FOR INFLAMMATORY CONDITIONS.

HIGHER RATE OF ALL-CAUSE MORTALITY, INCLUDING SUDDEN CARDIOVASCULAR DEATH HAVE BEEN OBSERVED IN PATIENTS TREATED WITH JANUS KINASE INHIBITORS FOR INFLAMMATORY CONDITIONS.

LYMPHOMA AND OTHER MALIGNANCIES HAVE BEEN OBSERVED IN PATIENTS TREATED WITH JANUS KINASE INHIBITORS FOR INFLAMMATORY CONDITIONS.

HIGHER RATE OF MACE (INCLUDING CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE) HAS BEEN OBSERVED IN PATIENTS TREATED WITH JANUS KINASE INHIBITORS FOR INFLAMMATORY CONDITIONS.

THROMBOSIS, INCLUDING DEEP VENOUS THROMBOSIS, PULMONARY EMBOLISM, AND ARTERIAL THROMBOSIS, SOME FATAL, HAVE OCCURRED IN PATIENTS TREATED WITH JANUS KINASE INHIBITORS FOR INFLAMMATORY CONDITIONS.