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Xeljanz▼ (tofacitinib) in treating rheumatoid arthritis - safety update

Xeljanz▼, for Rheumatoid arthritis and Psoriatic arthritis from Pfizer Ltd

The European Medicines Agency (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 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.

In the EU, 5 mg twice daily is the authorised dose for rheumatoid arthritis and psoriatic arthritis. The higher dose of 10 mg twice daily is approved for the initial treatment of patients with ulcerative colitis.

The EMA is assessing the early results and will consider if any regulatory action is needed. In the meantime, patients with rheumatoid arthritis who are receiving Xeljanz at 10 mg twice daily in the study will have their dose reduced to 5 mg twice daily for the remaining duration of the study.

The EMA have published the follow information for patients and healthcare professionals.

Information for patients
  • A new ongoing study in patients with rheumatoid arthritis showed that when Xeljanz was given at a high dose of 10 mg twice daily there was an increased risk of dangerous blood clots in the lungs and death.
  • This dose is higher than the approved dose of 5 mg twice daily for rheumatoid arthritis.
  • If you are being treated with Xeljanz, you should not change the dose or stop taking the medicine without discussing it with your doctor.
  • You should seek medical attention immediately if you experience the following symptoms which may be signs of a blood clot in your lungs:
    - difficulty breathing
    - chest pain or pain in your upper back
    - coughing up blood
    - excessive sweating
    - bluish skin
If you have any concerns about your medicine, you should discuss them with a healthcare professional.

Information for healthcare professionals
  • An increased risk of pulmonary embolism and overall mortality has been seen in a study with tofacitinib 10 mg twice daily in rheumatoid arthritis.
  • These results come from study A3921133, an ongoing open-label clinical trial evaluating the safety of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily compared with a tumour necrosis factor (TNF) inhibitor in patients with rheumatoid arthritis. Patients in the study are 50 years of age or older with at least one additional cardiovascular risk factor.
  • The preliminary results of the study showed the overall incidence of pulmonary embolism to be 5-fold higher in the tofacitinib 10 mg twice daily arm of the study compared with the TNF inhibitor arm, and approximately 3-fold higher than tofacitinib in other studies across the tofacitinib program. Additionally, all-cause mortality in the 10 mg twice daily arm was higher compared with the tofacitinib 5 mg twice daily and the TNF inhibitor groups.
  • As a consequence, patients receiving tofacitinib 10 mg twice daily in study A3921133 will have their dose reduced to 5 mg twice daily for the remaining duration of the study.
  • While further assessment of the study results continues, prescribers should continue to adhere to the authorised dose of 5 mg twice daily for the treatment of rheumatoid arthritis.
  • 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.
  • A letter is being sent to all healthcare professionals expected to prescribe the medicine to inform them of the preliminary results of the study and the current treatment recommendations.

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Xeljanz was first made available in the EU in 2017. It is manufactured by Pfizer.

European Medicines Agency website page for Xeljanz
Accessed 14/04/19
Links available in full article

LINK to EMA information on Xeljanz in rheumatoid arthritis

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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