Revised SPCs: Xeljanz (tofacitinib) 5 and 10 mg film-coated tablets

Maintenance treatment section for ulcerative colitis has been added to SPC recommending maintenance dose of 5mg BD which can be stepped up to 10mg BD in patients not at increased risk for VTE but not recommended in those with VTE risks, unless no suitable alternative treatment.

SPS commentary:

Further information on VTE has also been added to SPC advising that serious VTE events including pulmonary embolism, some of which were fatal, and DVT, have been observed in patients taking tofacitinib. A dose dependent increased risk for VTE was observed in a clinical study with tofacitinib compared to TNF inhibitors. Tofacitnib should be used with caution in patients with known risk factors for VTE, regardless of indication and dosage.


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