Xeljanz▼ (tofacitinib) in treating rheumatoid arthritis - safety update
Xeljanz▼, for Rheumatoid arthritis and Psoriatic arthritis from Pfizer Ltd
- 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
- 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.
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 yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.
Sharable Article Link : https://keepmeinformed.eu/Article?articleGuid=e357e264-578c-4f2c-8e19-7dd0e2ab0e96