Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis

Increased risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), leading to hospitalization or death. Interrupt tofacitinib treatment 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. (5.1)

Higher rate of all-cause mortality, including sudden cardiovascular (CV) death with tofacitinib vs. TNF blockers in rheumatoid arthritis (RA) patients. (5.2)

Malignancies have occurred in patients treated with tofacitinib. Higher rate of lymphomas and lung cancers with tofacitinib vs. TNF blockers in RA patients. (5.3)

Higher rate of major adverse CV events (defined as CV death, myocardial infarction, and stroke) with tofacitinib vs. TNF blockers in RA patients. (5.4)

Thrombosis has occurred in patients treated with tofacitinib. Increased incidence of pulmonary embolism, venous and arterial thrombosis with tofacitinib vs. TNF blockers in RA patients. (5.5)