重组曲妥珠单抗注射剂KADCYLA inj 160MG/8mL

药店国别： 产地国家：日本 处方药：是 所属类别： 160毫克/8毫升/支 包装规格： 160毫克/8毫升/支 计价单位：支 生产厂家中文参考译名： 生产厂家英文名：Chugai Pharmaceutical Co., Ltd. 原产地英文商品名：KADCYLA(カドサイラ点滴静注用)160MG/8mLvial 原产地英文药品名：Trastuzumab Emtansine(Genetical Recombination) 中文参考商品译名：KADCYLA注射液(カドサイラ点滴静注用)160毫克/8毫升/支 中文参考药品译名：曲妥珠单抗

简介

英文药名：KADCYLA inj(Trastuzumab Emtansine[Genetical Recombination]) 中文药名：重组曲妥珠单抗注射剂 生产厂家：中外制药 药品介绍 治疗类别名称抗HER2注1)抗体的微管蛋白聚合抑制剂复杂注1)HER2：人类表皮生长因子受体2型(人表皮生长因子受体2型，也称为：中c-erbB-2) 批准上市日期：2014年4月 商标名：KADCYLA 一般名：トラスツズマブ　エムタンシン(遺伝子組換え)(Trastuzumab Emtansine(Genetical Recombination))(JAN) 構造式：曲妥珠单抗是一种糖蛋白，包括氨基酸的214条轻链2分子和重链2分子(基因重组)的450个氨基酸，3.5件，主要是赖氨酸残基Emutanshin平均值的ε氨基(4-({3 - [(3 - {[(1S)-2 - {[(1S，2R，3S，5S，6S，16E，18E，20R，21S)-11-氯-21-羟基-12,20-二甲氧基-2,5,9,16-四甲基-8,23-二氧代-4,24-二氧杂-9,22-二氮杂环四[19.3.1.110,14.03,5] Hekisakosa-10,12,14(26)，16,18- pentaene-6-基]氧基}-1-甲基-2-氧代乙基]甲基氨基}-3-氧代丙基)硫烷基] -2,5-二氧代吡咯烷-1-基}甲基)环己基)结合的抗体药物偶联物分子式Emutanshin：C47H62ClN4O13S 曲妥珠单抗(遗传学的重组)：轻链(C1032H1599N277O335S6)重链(C2198H3391N585O672S16)分子量Emutanshin：958.53曲妥珠单抗(遗传学的重组)：约148000曲妥珠单抗Emutanshin(转基因)：约151000 适应证和用途 KADCYLA是一种靶向HER2抗体和微管抑制剂结合物适用于，作为单药，为有HER2-阳性，转移乳癌，既往接受曲妥珠单抗和一种紫衫烷类，分开或联合应用患者的治疗。患者应有以下任一情况：(1)对转移疾病以前接受治疗，或(2)完成辅助治疗期间或6个月内疾病复发。 剂量和给药方法 (1)只为静脉输注。不要静推注或丸注。不要使用葡萄糖(5%)溶液。 (2)KADCYLA的推荐剂量是3.6mg/kg每3周(21-天周期)静脉输注给药直至疾病进展或不能接受毒性。不要给予剂量大于3.6mg/kg的KADCYLA。不要替代KADCYLA或用曲妥珠单抗。 (3)不良事件的处理(输注相关反应，肝毒性，左心室功能障碍，血小板减少，肺毒性或周围神经病变)可能需要暂时中断，减低剂量，或终止KADCYLA治疗。剂型和规格在单次使用小瓶冻干粉含100mg每小瓶或160mg每小瓶. 禁忌证 无。 警告和注意事项 (1)肺毒性：在被诊断有间质性肺病或肺炎患者中永久终止KADCYLA。 (2)输注相关反应，超敏性反应：输注期间和后监视体征和症状。如发生重要输注相关反应或超敏性反应，减慢或中断输注和给予适当医学治疗。对危及生命输注相关反应永久终止KADCYLA。 (3)血小板减少：每次给予KADCYLA前监视血小板计数。适当时调整剂量。 (4)神经毒性：监视体征和症状。对经受3或4级周围神经病变患者暂时不用给药。 (5)HER2检验：由有测试能力的实验室用FDA-批准的检验进行检验。不良反应用KADCYLA (n=884被治疗患者)最常见不良反应(频数> 25%)是疲乏，恶心，肌肉骨骼痛，血小板减少，头痛，转氨酶增加，和便秘。 在特殊人群中使用 (1)哺乳母亲：终止哺乳或终止KADCYLA考虑到药物对母亲的重要性。 (2)生殖潜能妇女：忠告女性关于预防和计划妊娠。 包装规格 静脉滴注100毫克：1瓶[附:日本药典注射用水1安瓿(5mL))160毫克：1瓶

英文版说明书

Kadcyla (ado-trastuzumab emtansine, T-DM1) approved by the Japanese Ministry of Labor and Welfare (MHLW) for non-surgical or recurrent HER2 positive The treatment of breast cancer.In February, Kadcyla received FDA approval for the first antibody conjugated drug (ADC) approved for HER2-positive metastatic breast cancer.The approval of Kadcyla is based on data from the Phase II clinical trial in Japan and the Phase III EMILIA trial.The EMILIA trial was conducted in patients with HER2-positive metastatic breast cancer previously treated with Herceptin (trastuzumab, trastuzumab, trastuzumab) and a taxane, and Kadcyla was compared with standard therapy Were compared. The data show that Kadcyla significantly improves overall survival (OS) and progression-free survival (PFS) compared with standard therapy, while fewer patients experience serious adverse events.Kadcyla was conjugated with the drug conjugated to DM1 cytotoxic agent from Roche Trastuzumab and ImmunoGen, both of which were conjugated by ImmunoGen linkers. Roche has Kadcyla's global development and commercialization rights.At present, Roche is conducting several studies eva luating the potential of Kadcyla for potential additional use, including first-line therapy for HER2-positive metastatic breast cancer, for the treatment of early HER2-positive breast cancer and advanced HER2-positive gastric cancer.This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact