英文药名:ERBITUX Injection(Cetuximab(Genetical Recombination))
中文药名:爱必妥(西妥昔单抗重组注射剂)
生产厂家:默克雪兰诺
アービタックス注射液100mg
治疗类别名称 抗肿瘤剂的抗人类EGFR 注2)单克隆抗体 注2)表皮生长因子受体:表皮生长因子受体(表皮生长因子受体) 批准日期:2012年11月 商標名 ERBITUX Injection 一般名: セツキシマブ (遺伝子組換え) Cetuximab (Genetical Recombination) 本質: 通过导入的cDNA的小鼠杂交瘤SP2/0-AG14细胞系产生214个编码由小鼠抗人表皮生长因子受体的单克隆抗体的可变区和人IgG1恒定区的人/鼠嵌合单克隆抗体氨基酸残基(C1025H1595N281O338S5;分子量:23,422.64)轻链2分子和449组成的氨基酸残基(C2208H3400N582O674S15;分子量:49,363.09)的重链2包括分子糖蛋白组成的(分子量:约151800) 药效药理 1.作用机制 西妥昔单抗是由恒定区和人IgG1的小鼠抗体的可变区的嵌合单克隆抗体,它以高亲和力与表达EGFR的细胞的表皮生长因子受体结合。 2. 抗肿瘤作用 在各种不同的EGFR阳性癌细胞系,西妥昔单抗的体外增殖抑制效果是浓度依赖性的。也已经在体内模型中使用西妥昔单抗的各种EGFR阳性癌细胞系(人结肠癌衍生GEO细胞系,人咽癌衍生FADU细胞系等)的生长抑制效果得到了证实。 适应病症 1.尚未建立这种药物作为辅助化疗的疗效和安全性。 2.在考虑的RAS基因(KRAS和NRAS)在使用本剂为EGFR阳性的不可切除晚期或复发结肠直肠癌的基因突变的存在或不存在的,进行选择自适应患者(“临床看到结果的一节“)。 3.熟悉的部分“临床结果”,疗效和这种药物的安全性的内容,也对全理解,患者适应性的选择。 用法与用量 成人,每周一次,首次超过400毫克/平方米(体表面积)持续2小时,第二次和随后在1小时内为250mg/平方米(体表面积)静脉滴注注。应当指出的是,根据该状态的患者用药。 包装规格 注射剂: 100毫克/20毫升(100毫克)1瓶
制造厂商 默克雪兰诺有限公司 完整资料附件:http://www.info.pmda.go.jp/go/pack/4291415A1021_1_10/ Anti-EGFR antibody "Erbitux" released Merck Serono, Bristol-Myers Merck Serono and Bristol-Myers launched a new anticancer drug "Erbitux Injection 100 mg" (generic name: cetuximab) on the 19th. Erbitux is a monoclonal antibody that targets human epidermal growth factor receptor (EGFR). The indication is EGFR positive treatment Secondary treatment of unresectable progression · recurrent colorectal cancer, combination therapy with irinotecan in the subsequent treatment·monotherapy Since both clinical trials in Japan are extremely limited, the two companies conducted a survey of the results of all cases of use after manufacture and sales, which were regarded as approval conditions, and early collection of efficacy and safety data with the goal of 1800 cases Aims to aim. For a certain period after release, sell only to medical institutions familiar with cancer chemotherapy, urgent response to side effects and all cases can be investigated. Erbitux has already been approved in 74 countries around the world as a treatment for colorectal cancer. In Europe this July, the content of approval expressed EGFR was revised to be used in conjunction with chemotherapy for patients with unresectable metastatic colorectal cancer with wild-type k-ras gene and also for use as primary therapy approved. Dosage regimen/dose is usually once a week for adults, as cetuximab, 400 mg/m 2 for the first time over 2 hours, from the second time to 250 mg/m 2 over 1hour with IV infusion. 100 mg 20 mL 1 bottle http://www.info.pmda.go.jp/go/pack/4291415A1021_1_10/
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