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高剂量托法替尼治疗类风湿性关节炎可增加肺部血栓的风险

2019-03-21 不详 网络

EMA建议医疗保健专业人员和患者在治疗类风湿性关节炎时不要超剂量使用Xeljanz(托法替尼)。该建议遵循正在进行的类风湿性关节炎患者研究(A3921133)的早期结果,该研究表明,当超过正常剂量的两倍时,肺部血栓和死亡的风险增加。在欧盟,每日两次5mg托法替尼是类风湿性关节炎和银屑病关节炎的授权剂量,每天两次10mg托法替尼的较高剂量仅被批准用于溃疡性结肠炎患者的初始治疗。

EMA建议医疗保健专业人员和患者在治疗类风湿性关节炎时不要超剂量使用Xeljanz(托法替尼)。该建议遵循正在进行的类风湿性关节炎患者研究(A3921133)的早期结果,该研究表明,当超过正常剂量的两倍时,肺部血栓和死亡的风险增加。在欧盟,每日两次5mg托法替尼是类风湿性关节炎和银屑病关节炎的授权剂量,每天两次10mg托法替尼的较高剂量仅被批准用于溃疡性结肠炎患者的初始治疗。

类风湿性关节炎是一种以关节病变为主的慢性全身自身免疫性疾病。主要临床表现为小关节滑膜所致的关节肿痛,继而软骨破坏、关节间隙变窄,晚期因严重骨质破坏、吸收导致关节僵直、畸形、功能障碍。


原始出处:

http://www.firstwordpharma.com/node/1630596#axzz5ioDx2kLe

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    2021-09-09 1477ab07m21暂无昵称

    是否有必要在说明书中加入黑框警示?

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    2019-08-16 amy0550
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    2019-03-23 lmm397
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    2019-03-22 183****7028

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