Prezes PTR
prof. dr hab. n. med. Marek Brzosko

Strona główna » Aktualności » EMA Communication: Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs

EMA Communication: Restrictions in use of Xeljanz while EMA reviews risk of blood clots in lungs

MA’s safety committee (PRAC) is recommending that doctors must not prescribe the 10 mg twice daily dose of Xeljanz (tofacitinib) in patients who are at high risk of blood clots in the lungs. These include
patients who have heart failure, cancer, inherited blood clotting disorders or a history of blood clots, as well as patients who take combined hormonal contraceptives, are receiving hormone replacement
therapy or are undergoing major surgery.

In addition, doctors should consider other factors that may increase the risk of blood clots in the lungs including age, obesity, smoking or immobilisation.

Xeljanz is currently authorised for the treatment of rheumatoid arthritis, psoriatic arthritis and severe ulcerative colitis.

The PRAC’s recommendation follows results from an ongoing study in patients with rheumatoid arthritis. This study showed an increased risk of blood clots in the lungs and death when the 10 mg twice daily dose was used, which is double the recommended dose for rheumatoid arthritis.

The new advice means that, since 10 mg is the only recommended starting dose for ulcerative colitis, patients with this condition who are at high risk of blood clots must not be started on Xeljanz. Patients at high risk currently taking this dose for any condition must be switched to alternative treatments.

Patients should not stop or change their dose of Xeljanz without talking to their doctor. They should seek medical attention immediately if they experience symptoms such as difficulty breathing, pain in the chest or upper back and coughing up blood, which could indicate the presence of a blood clot in the lungs.

The new recommendations are temporary and follow previous PRAC advice [6] not to exceed the recommended 5 mg twice daily dose when treating rheumatoid arthritis. The PRAC will now carry out a review of all available evidence, and updated guidance will be provided to patients and healthcare professionals once the review is concluded.

Please see the press release [7] for more details, including information for patients and healthcare professionals. For further information on his medicines, please click here [8].

For more information on the European regulatory system for medicines, please click here [9] (brochure available in all languages).