Higher-Dose Tofacitinib Linked to Pulmonary Embolism, Death in RA Patients

By Amy Orciari Herman

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

Tofacitinib (Xeljanz) at a dosage of 10-mg twice daily is associated with increased risks for pulmonary embolism and death in patients with rheumatoid arthritis, the FDA warned on Monday.

The oral Janus kinase inhibitor is approved for RA patients only at a dosage of 5-mg twice daily, but the higher dosage is approved for ulcerative colitis. The increased risks were noted in a postmarketing safety trial evaluating higher- and lower-dose tofacitinib in RA patients.

The FDA urges clinicians to prescribe tofacitinib only according to the dosages and indications listed on the prescribing information. They should also monitor patients for symptoms of pulmonary embolism and advise patients to seek care right away should such symptoms occur.