替诺福韦艾拉酚胺薄膜包衣(Vemlidy filmcoated Tablets 25mg)说明书

产地国家:英国

处方药:是

所属类别: 25毫克/片 90片/瓶

包装规格: 25毫克/片 90片/瓶

计价单位:瓶

生产厂家英文名:Gilead Sciences International Ltd

原产地英文商品名:Vemlidy filmcoated tablets 25mg/tablet 90tablets/bottle

原产地英文药品名:tenofovir alafenamide,TAF

中文参考商品译名:Vemlidy薄膜包衣片 25毫克/片 90片/瓶

中文参考药品译名:替诺福韦艾拉酚胺

简介

英文药名:Vemlidy filmcoated Tablets(tenofovir alafenamide,TAF)

中文药名:替诺福韦艾拉酚胺薄膜包衣片

生产厂家:Gilead Sciences International Ltd.

药品介绍

VEMLIDY(替诺福韦艾拉酚胺 tenofovir_alafenamide)片,为口服使用原研公司:GileadSciences Inc作用机制替诺福韦艾拉酚胺是对乙型肝炎病毒的抗病毒药物[见微生物学].

适应证和用途

VEMLIDY是一种乙型肝炎病毒(HBV)核苷类似物逆转录酶抑制剂和是适用为在有代偿的肝病成年中慢性乙型肝炎病毒感染的治疗。

剂量和给药方法

测试:VEMLIDY开始前,测试患者HIV感染。有HIV感染患者不应单独使用VEMLIDY。VEMLIDY开始前和期间治疗后乙型肝炎的严重急性加重在所有患者当临床上适当评估血清肌酐,血清磷,估算肌酐清除率,尿糖,和尿蛋白。

推荐剂量:25mg(一片)与食物口服服用每天1次。● 肾受损:在有估算肌酐清除率低于15mL每分患者中建议不用VEMLIDY。● 肝受损:在有失代偿(Child-Pugh B或C)肝受损患者中建议不用VEMLIDY.剂型和规格片:25mg的替诺福韦艾拉酚胺.禁忌证无.警告和注意事项● HBV和HIV-1共感染:建议不单独使用VEMLIDY为HIV-1感染的治疗。在这些患者中可能发生HIV-1耐药性。● 新发作或恶化的肾受损:建议VEMLIDY治疗乙型肝评估血清肌酐,血清磷,估算肌酐清除率,尿糖,和尿蛋白。

不良反应

最常见不良反应(发生率大于或等于5%,所有级别)是头痛,腹痛,疲乏,咳嗽,恶心,和背痛。

药物相互作用

VEMLIDY是一种P-糖蛋白(P-gp)和BCRP的底物。强烈影响P-gp和BCRP活性药物可能导致在VEMLIDY吸收中变化。在治疗前和期间咨询完整处方资料对潜在药物-药物相互作用。

英文版说明书

European CHMP Adopts Positive Opinion for Gilead’s Vemlidy® (Tenofovir Alafenamide, TAF) for the Treatment of Chronic Hepatitis B Virus Infection– Vemlidy Demonstrated Similar Efficacy with Improvements in Renal and Bone Laboratory Safety Parameters Compared to Viread in Phase 3 Studies –Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Vemlidy® (tenofovir alafenamide, TAF) 25 mg, an investigational, once-daily tablet for the treatment of chronic hepatitis B virus (HBV) infection in adults and adolescents (≥ 12 years and ≥ 35 kg body weight). The data included in the application support the use of TAF in treatment-naïve and treatment-experienced adults and adolescents with HBeAg-negative and HBeAg-positive HBV infection.TAF is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at one-tenth the dose of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF) 245 mg. Data show that because TAF has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to TDF, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, TAF improved certain renal and bone laboratory safety parameters compared to TDF in clinical trials.The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway and Iceland.The MAA for TAF includes data from two international Phase 3 studies (Studies 108 and 110) in 1,298 treatment-naïve and treatment-experienced patients with HBV infection. Study 108 randomized 425 HBeAg-negative patients to receive either TAF or TDF, and Study 110 randomized 873 HBeAg-positive patients to receive either TAF or TDF. The full data from Studies 108 and 110 were presented at the International Liver Congress™ (ILC) earlier this year.TAF as a single-agent for HBV is an investigational product and its safety and efficacy have not yet been established.About Gilead SciencesGilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.

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