其 他 安 全 警 示
|
| |
| The United Kingdom: Tofacitinib (Xeljanz): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing (English only) |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications introduced. The 10 mg twice-daily dose of tofacitinib (authorised for ulcerative colitis) must not be used in patients at high risk of pulmonary embolism.
A European safety review of tofacitinib (Xeljanz) has begun following results from an ongoing study (study A3921133) in patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. The findings show an increased risk of pulmonary embolism and overall mortality, compared with a TNF inhibitor, when patients were treated with 10 mg of tofacitinib twice-daily (twice the recommended dose for rheumatoid arthritis of 5 mg twice-daily).
Since the 10 mg twice-daily dose is recommended for the initial treatment (for up to 16 weeks) in ulcerative colitis, until the review has concluded, patients with ulcerative colitis at high risk of pulmonary embolism should not start treatment with tofacitinib. Patients who are already being treated with the 10 mg twice-daily dose of tofacitinib who are at high risk of pulmonary embolism should be switched to alternative treatments. For more information on the measures, please refer to the news released by EMA on 17 May 2019.
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. Please refer to the news released by EMA on 17 May 2019 for details on information for patients.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/tofacitinib-xeljanz-restriction-of-10-mg-twice-daily-dose-in-patients-at-high-risk-of-pulmonary-embolism-while-safety-review-is-ongoing
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, Health Canada, EMA and Therapeutic Goods Administration, and was posted on the Drug Office website on 26 Feb 2019, 16 Mar 2019 and 21 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/Saturday, May 18, 2019
Issued at HKT 17:00
|
| |
|
