Dear Doctor Letter (Rote-Hand-Brief) on Xeljanz® (tofacitinib): increased risk of pulmonary embolism and mortality in patients with rheumatoid arthritis
2019.03.29
Active substance: tofacitinib
In agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), Pfizer Pharma would like to inform you that the recommended dose of Xeljanz® (active ingredient: tofacitinib) for the treatment of rheumatoid arthritis must not be exceeded.
The dose of 10 mg tofacitinib twice daily is not approved in the EU for use in rheumatoid arthritis
Risk information (available in German only)
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN