1. Aschenbrenner, Diane S. MS, RN


* A required postmarketing clinical trial of tofacitinib (Xeljanz, Xeljanz XR) in the treatment of rheumatoid arthritis found an increased risk of pulmonary embolism and death when patients were treated with 10 mg twice daily compared with the currently approved 5 mg twice daily dose.


* NPs are encouraged to follow tofacitinib's dosing guidelines when treating rheumatoid arthritis.



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Tofacitinib (Xeljanz, Xeljanz XR), a Janus kinase inhibitor and immune modifier that decreases immune system activity, was approved for use in rheumatoid arthritis in 2012, psoriatic arthritis in 2017, and ulcerative colitis in 2018. After the initial approval of the drug, the Food and Drug Administration (FDA) required the manufacturer to conduct a postmarketing safety trial comparing two doses, 5 mg twice a day and 10 mg twice a day, in patients with rheumatoid arthritis to assess for cardiovascular complications, cancer risk, and opportunistic infections. Patients were required to be at least 50 years of age and to have at least one cardiovascular risk factor to participate. The trial compared tofacitinib plus methotrexate with a tumor necrosis factor inhibitor. The latest analysis of data from this ongoing trial found that those receiving the larger daily dose of tofacitinib were at an increased risk for pulmonary embolism and death.


Tofacitinib is currently approved at a dose of 5 mg twice daily to treat rheumatoid arthritis. The 10-mg twice daily dose is approved only for treating ulcerative colitis. The safety trial will continue until the end of 2019. Participants who had been receiving the larger dose have been switched to the lower dose for the remainder of the study. The FDA is evaluating the data and more information will be released after the agency completes its review.


NPs are encouraged to follow tofacitinib's dosing guidelines for the condition they are treating. Nurses should teach patients receiving tofacitinib about the signs and symptoms of pulmonary embolism (sudden shortness of breath, chest or back pain, coughing up blood, excessive sweating, and clammy or bluish skin), and tell them to seek immediate medical assistance if these occur. The FDA requests that nurses and consumers report any tofacitinib adverse effects to the FDA MedWatch program at For complete prescribing information for tofacitinib, go to,208246s006l.