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- TRADE NAME: Xeljanz (Pfizer)
- INDICATIONS: Rheumatoid arthritis
- CLASS: Disease-modifying antirheumatic drug (DMARD), Janus kinase (JAK) inhibitor
- HALF-LIFE: ~3 hours
- FDA APPROVAL DATE: 11/06/2012
- CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
Azathioprine, Biologic disease-modifying antirheumatics, Cyclosporine, CYP3A4 inhibitors, Fluconazole, Ketoconazole, Live vaccines, Potent immunosuppressives, Rifampin, Strong CYP inducers, Strong CYP2C19 inhibitors, Tacrolimus
- See adverse reactions attributed to class:
Investigated for treating COVID-19.
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS (amended December 2021)
• INCREASED RISK OF SERIOUS BACTERIAL, FUNGAL, VIRAL, AND OPPORTUNISTIC INFECTIONS LEADING TO HOSPITALIZATION OR DEATH, INCLUDING TUBERCULOSIS (TB). INTERRUPT TREATMENT WITH TOFACITINIB ORAL SOLUTION IF SERIOUS INFECTION OCCURS UNTIL THE INFECTION IS CONTROLLED. TEST FOR LATENT TB BEFORE AND DURING THERAPY; TREAT LATENT TB PRIOR TO USE. MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN PATIENTS WITH INITIAL NEGATIVE LATENT TB TEST.
• HIGHER RATE OF ALL-CAUSE MORTALITY, INCLUDING SUDDEN CARDIOVASCULAR DEATH WITH TOFACITINIB VS. TNF BLOCKERS IN RHEUMATOID ARTHRITIS (RA) PATIENTS.
• MALIGNANCIES HAVE OCCURRED IN PATIENTS TREATED WITH TOFACITINIB. HIGHER RATE OF LYMPHOMAS AND LUNG CANCERS WITH TOFACITINIB VS. TNF BLOCKERS IN RA PATIENTS.
• HIGHER RATE OF MACE (DEFINED AS CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE) WITH TOFACITINIB VS. TNF BLOCKERS IN RA PATIENTS.
• THROMBOSIS HAS OCCURRED IN PATIENTS TREATED WITH TOFACITINIB. INCREASED INCIDENCE OF PULMONARY EMBOLISM, VENOUS AND ARTERIAL THROMBOSIS WITH XELJANZ VS. TNF BLOCKERS IN RA PATIENTS.
See full prescribing information for complete boxed warning.
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Page last updated 01/08/2025
