XELJANZ/XELJANZ XR (tofacitinib) – Risk of Major Adverse Cardiovascular Events, Malignancy, Thrombosis and Infection

A post-authorization safety study in RA patients 50 years of age or older with at least one additional CV risk factor showed an increased risk of MACE and malignancy in patients treated with XELJANZ (5 mg BID or 10 mg BID) in comparison to TNFi. An increased risk of thrombosis was observed with XELJANZ 10 mg BID compared to TNFi.

New safety information - Product safety

XELJANZ/XELJANZ XR (tofacitinib)

RA-63814