其 他 安 全 警 示
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| European Union: Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis (English Only) |
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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 (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. 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.
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 study A3921133 will have their dose reduced to 5 mg twice daily for the remaining duration of the study.
While full results are awaited, EMA is recommending that healthcare professionals monitor patients for signs and symptoms of blood clots in the lungs. Patients should not stop or change their dose of Xeljanz without talking to their doctor. Patients should seek medical attention immediately if they experience symptoms such as difficulty breathing, pain in the chest or upper back and coughing up blood.
There are other ongoing clinical trials in the EU with Xeljanz at a dose of 10 mg twice daily. Patients taking part in clinical trials with Xeljanz should speak to the doctor giving it to them if they have any questions or concerns.
Healthcare professionals are advised:
- 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/increased-risk-blood-clots-lungs-death-higher-dose-xeljanz-tofacitinib-rheumatoid-arthritis
In Hong Kong, Xeljanz Tablets 5mg (HK-63303) and Xeljanz XR Extended Release Tablets 11mg (HK-66141) are registered pharmaceutical products containing tofacitinib. Both products are registered by Pfizer Corporation Hong Kong Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction related to tofacitinib, but these cases are not related to blood clots in the lungs. Related news was previously issued by the US Food and Drug Administration and Health Canada, and was posted on the Drug Office website on 26 Feb 2019 and 16 Mar 2019 respectively. As the clinical trial is ongoing, the DH will remain vigilant on the results of the trial and safety update of the drug issued by various overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Mar 21, 2019
Issued at HKT 16:00
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