罗拉吡坦片Rolapitant(Varuby film-coated tablets)

产地国家：英国 处方药：是 所属类别：90毫克/片 2片/盒 包装规格：90毫克/片 2片/盒 计价单位：盒 生产厂家英文名：Tesaro UK Limited 原产地英文商品名：Varuby filmcoated tablets 90mg/Tablets 2Tablets/box 原产地英文药品名：Rolapitant 中文参考商品译名：Varuby片 90毫克/片 2片/盒 中文参考药品译名：罗拉吡坦 批准时间：2017年4月26日 作用机理：Bedaquiline是一种diarylquinoline抗分枝杆菌药 用药方式：口服 生产企业：Tesaro Bio Germany GmbH

药品简介

新型止吐剂罗拉吡坦片Rolapitant(欧洲商标名：Varuby)获欧盟批准用于癌症患者化疗所致的恶心和呕吐预防化疗相关性呕吐(CINV)是一种发生频率高、致人虚弱的可预防的化疗副作用。 出现呕吐症状的原因是化疗导致患者体内释放一种称为p物质(Substance P，SP)的神经肽，这种神经肽与大脑中呕吐中枢的神经细胞上的神经激肽-1(Neurokinin-1，NK-1)受体相结合会导致患者产生恶心和呕吐的症状。 2017年4月26日，专注于癌症药物开发的生物公司Tesaro表示欧盟委员会(EC)批准Varuby(罗拉吡坦片)用于成人癌症患者的化疗所致的迟发性恶心和呕吐的预防。Rolapitant是一种口服的长效NK-1拮抗剂，通过阻断NK-1与SP的结合，可以改善接受化疗患者的呕吐症状，具有吸收快、清除慢的特点，血浆半衰期达7天。 在每个化疗周期开始前的2个小时内服用180mg(两片)Varuby(最短间隔时间为两周)，作为组合疗法的一部分。Varuby的3组临床3期研究已经证实，对于接受致吐化疗(卡铂、顺铂、蒽环类/环磷酰胺)的患者，服用Rolapitant可以显著降低呕吐的发作。同时，接受Varuby治疗的患者，影响患者正常生活的恶心症状也更低，多个周期化疗的呕吐发作率也更小。

英文版说明书

Varuby 90 mg film-coated tablets- Summary of Product CharacteristicsAbout VARUBI® (Rolapitant)VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist that is approved in the United States for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com(link is external).Rolapitant will be marked under the trade name VARUBY in Europe.About TESAROTESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com(link is external), and follow us on Twitter(link is external) and LinkedIn(link is external).