Pfizer Europe would like to inform you in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that the European Medicines Agency (EMA) is reviewing the benefits and risks of Xeljanz® (tofacitinib) in all authorised indications following results from an ongoing clinical study, A3921133, which showed an increased risk of pulmonary embolism (PE) with the tofacitinib 10 mg twice daily dose.

The following measures have been agreed until this review is finalized:

• Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of following conditions:

  • use of combined hormonal contraceptives or hormone replacement therapy,
  • heart failure,
  • previous venous thromboembolism, either deep venous thrombosis or pulmonary embolism,
  • inherited coagulation disorder,
  • malignancy
  • or patients undergoing major surgery.
• Additional risk factors that should be considered in determining the patient’s risk for pulmonary embolism are age, obesity, smoking status and immobilisation.
• Patients who are currently being treated with the 10 mg twice daily dose and who are at high risk for pulmonary embolism should be switched to alternative treatments.
• Patients receiving tofacitinib, irrespective of indication, should be monitored for the signs and symptoms of pulmonary embolism, and be advised to seek medical attention immediately if they experience them.

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Xeljanz

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN 2019.05.28 PDF, 294KB, File is accessible