引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| Australia: Tofacitinib: Update - Warning about increased risks of blood clots and of death at higher dose for certain patients (English only) |
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The Therapeutic Goods Administration (TGA) announces that the Product Information and Consumer Medicine Information documents for tofacitinib have been updated to include information about an increased risk of blood clots and of death when used at the higher dose (10 mg twice daily). The changes have been made in response to recent results from an ongoing safety study. To participate in the study, patients had to be at least 50 years of age and have at least one additional cardiovascular risk factor.
Tofacitinib is marketed in Australia under the brand name Xeljanz, and is used to treat adults with rheumatoid arthritis, psoriatic arthritis or ulcerative colitis.
Health professionals are advised that the 10 mg twice daily dose is not approved in Australia for the treatment of rheumatoid arthritis or psoriatic arthritis. The 10 mg twice daily dose is approved in Australia only for adult patients with moderately to severely active ulcerative colitis (UC). It should not be used as a first-line treatment, meaning patients will be prescribed other medicines first and will only receive this dose of tofacitinib if they do not respond well enough or are intolerant to those other treatments. Additionally, with UC patients, tofacitinib should be used at the lowest effective dose for the shortest duration needed.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/tofacitinib
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 4 cases of adverse drug reaction related to tofacitinib, of which one case is related to deep vein thrombosis.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 26 Feb 2019, with the latest update posted on 27 Jul 2019. Letters to inform local healthcare professionals were issued by DH on 29 Jul 2019. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Oct 16, 2019
Issued at HKT 16:00
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