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Xeljanz® (tofacitinib): Increased risk of blood clots in lungs and death with higher dose for rheumatoid arthritis

Active substance: tofacitinib

EMA is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz® (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study (study A3921133) in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.

to the risk information full text (available in German only)

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