产地国家：瑞士 处方药：是 所属类别： 375毫克/片 168片/盒 包装规格： 375毫克/片 168片/盒 计价单位：盒 生产厂家英文名：Janssen-Cilag 原产地英文商品名：Incivo tablets 375mgmg/tab 168tabs(4x42)/box 原产地英文药品名：telaprevir 中文参考商品译名：Incivo薄膜片 375毫克/片 168片(4x42)/盒 中文参考药品译名：特拉匹韦

简介

新型抗丙型药物telaprevir(商品名 Incivek/INCIVO)获欧美批准用于有或未接受基于干扰素药物治疗对其感染或对既往治疗反应不佳的患者。Incivek丸剂的用法为每日三次，进餐时服用，前12周需与聚乙二醇干扰素α和病毒唑联合使用。大多数接受Incivek和标准治疗(聚乙二醇干扰素α联用病毒唑)联合使用24周就可产生早期应答，而推荐的标准治疗需要使用48周。这种治疗药物属于蛋白酶抑制剂的一种，通过与病毒结合组织其复制行为发挥作用。Incivek 和聚乙二醇干扰素α以及病毒唑治联合使用中报道最常见的副作用包括皮疹、红细胞数量减少(贫血)、恶心、疲劳、头痛、腹泻、瘙痒、肛门或直肠刺激和疼痛。出现的皮疹可能非常严重，需要停止使用Incivek或治疗方法中的全部三种药物。 批准日期：2011年5月23日 公司 Vertex Pharmaceuticals IncorporatedINCIVEKTM (telaprevir)膜衣片 仅口服使用 作用机制 Telaprevir是一种对丙型肝炎病毒的直接-作用抗病毒药(DAA)[见微生物学]。适应证和用途INCIVEK是一种丙型肝炎病毒(HCV)NS3/4A蛋白酶抑制剂适用于，与聚乙二醇干扰素α和利巴韦林联用，对有代偿肝病成年患者中基因型1慢性丙型肝炎(CHC)的治疗，包括肝硬变，未治疗过患者或既往曾被基于干扰素治疗治疗过患者，包括既往零反应者(注：治疗期间丙型肝炎病毒负荷达到很小或无减低)，部分反应者，和复发者。(1)INCIVEK必须不用作单药治疗和必须只与聚乙二醇干扰素α和利巴韦林联用。(2)既往零反应者的高比例(尤其是有肝硬变患者)不达到持续病毒学反应(SVR)和有telaprevir出现对用INCIVEK治疗伴耐药取代。(3)对既往用包括INCIVEK或其它HCV NS3/4A蛋白酶抑制剂治疗方案已治疗失败患者，INCIVEK疗效尚未确定。 剂量和给药方法 (1)750 mg一天服用3次(间隔7-9小时)与食物(非低脂肪)。(2)对所有患者INCIVEK必须与聚乙二醇干扰素α和利巴韦林二者给予共12周，接着反应-指导方案或12或36另外周的聚乙二醇干扰素α和利巴韦林依赖于病毒反应和既往反应状态。(3)对聚乙二醇干扰素α和利巴韦林专门剂量说明，参阅其相应处方资料。 剂型和规格：375mg/片 禁忌证 (1)因为INCIVEK必须与聚乙二醇干扰素α和利巴韦林给药，对聚乙二醇干扰素α和利巴韦林所有禁忌证也应用。 (2)妊娠妇女和男性其女性伴侣妊娠：因为利巴韦林可能引起出生缺陷和胎儿死亡，在妊娠妇女和在男性其女性伴侣妊娠禁忌用telaprevir与聚乙二醇干扰素α和利巴韦林联用。 (3)与以下药物共同给药：1)对清除高度依赖于CYP3A和for which升高血浆浓度是伴随严重和/或危及生命事件。2)强烈诱导CYP3A 可能导致脚底保留和丧失INCIVEK疗效。 警告和注意事项 (1)妊娠：使用利巴韦林和Peg干扰素α：利巴韦林可能引起出生缺陷和胎儿死亡;在女性患者和男性患者的女性伴侣中避免妊娠。初始治疗前患者必须有阴性妊娠检验，采用至少2种有效避孕方法，和每月进行妊娠检验。(2)严重皮肤反应：严重皮肤反应包括药物皮疹有嗜酸粒细胞增多和全身症状和曾报道Stevens-Johnson综合征。对严重皮肤反应，应立即终止INCIVEK联合治疗的所有化合物。(3)皮疹：有轻至中度皮疹患者应监视进展。如皮疹进展和成为严重，应终止INCIVEK。(4)贫血：INCIVEK联合治疗前和期间定期监视血红蛋白。调整利巴韦林剂量;如需要终止INCIVEK。 不良反应 最常见对INCIVEK不良药物反应 (发生率用NCIVEK比对照至少较高5%)是皮疹，瘙痒，贫血，恶心，痔疮，腹泻，肛门直肠不适，味觉障碍，疲乏，呕吐，和肛门瘙痒。药物相互作用INCIVEK治疗与其它药物联用共同给药可能改变其它药物的浓度和可能改变telaprevir浓度的其它药物。对药物-药物相互作用潜能治疗期间和前咨询完整处方资料。 特殊人群中使用 (1)肝受损：尚未确定在有Child-Pugh评分大于或等于7(类型B和C)患者中安全性和疗效(2)共感染：尚未确定在HCV/HIV和HCV/HBV共感染患者中安全性和疗效。(3)儿童：尚未确定在儿童患者中安全性和疗效。(4)实体器官移植：尚未确定在进行实体器官移植患者中安全性和疗效。(5)可以得到利巴韦林妊娠注册。 产品特点 特拉匹韦(Telaprevir)是直接蛋白酶抑制剂，它通过结合病毒并防止其增殖来起作用。特拉匹韦和PEG化的干扰素&alPHa以及利巴韦林联合使用，用于治疗基因1型慢性丙肝。 开发上市情况 2011年5月23日，Vertex制药公司特拉匹韦项目获FDA批准上市，商品名为Incivek;2011年9月21日，欧盟批准Janssen制药的丙肝治疗新药特拉匹韦上市，商品名为Incivo;2011年8月，Incivek在加拿大也获得批准。

英文版说明书

INCIVO® Receives Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) for Twice Daily Dosing for Treatment of Genotype-1 Hepatitis C VirusOPTIMIZE study results presented at EASL show similar sustained virological response (SVR12) rates in patients with fibrosis or cirrhosis receiving an INCIVO®(telaprevir) combination treatment twice daily versus every eight hours -Janssen Infectious Diseases-Diagnostics BVBA (Janssen), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of twice daily (BID) dosing of INCIVO® (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin (PR).The CHMP positive opinion is a critical step in the approval process and will be considered by the European Commission, which has authority to approve medicines for use throughout the European Union. The current approved dose for INCIVO is 750 mg every 8 hours in combination with PR."This positive opinion from the CHMP is an important development for a more convenient treatment regimen for patients which should help lead to greater adherence, a critical factor in HCV treatment," said Gaston Picchio, Hepatitis Disease Area Leader at Janssen R&D."Telaprevir has already played a huge part in improving treatment outcomes for people living with hepatitis C with more than 80,000 people treated to date globally with telaprevir combination treatment. This recommendation is the next step in our commitment to improving the lives of more people living with hepatitis C and supporting healthcare professionals around the world."Janssen presented clinical trial results showing that the relative efficacy of a twice daily (BID) investigational dosing regimen of INCIVO® (telaprevir) 1125 mg combination treatment was similar to an every eight hours (q8h) regimen of INCIVO® (telaprevir) 750 mg combination treatment in HCV genotype-1 patients regardless of fibrosis or cirrhosis based on sustained virological response rates at 12 weeks after the last treatment dose (SVR12).These results, a sub-analysis from the OPTIMIZE Phase 3 trial, were presented during the 48th annual meeting of the European Association for the Study of the Liver (EASL) in Amsterdam (https://www.easl.eu/_the-international-liver-congress). Additional sub-analyses from this study eva luating anemia management, efficacy in patients by the IL28B genotype and patient adherence were also presented."Simplifying available treatment regimens for HCV, without compromising on cure rates is especially important for patients with fibrosis or cirrhosis.We know that telaprevir combination treatment offers patients improved cure rates over treatment with pegylated interferon and ribavirin alone. These results confirm that a twice daily dosing schedule for a telaprevir-based regimen gives patients a similar chance of achieving SVR12 as the current approved dose