英文药名：AVASTIN（Bevacizumab[Genetical Recombination]） 中文药名：贝伐单抗点滴静注用 生产厂家：中外製薬 アバスチン点滴静注用100mg／4mL／アバスチン点滴静注用400mg／16mL 治疗类别名称 抗肿瘤药 抗VEGF注1）人源化单克隆抗体 注1），VEGF：血管内皮生长因子（血管内皮生长因子） 批准日期（最新）2016年5月 商標名 AVASTIN 一般名 ベバシズマブ（遺伝子組換え） (Bevacizumab（Genetical Recombination））（JAN) 構造式 アミノ酸214個の軽鎖２分子とアミノ酸453個の重鎖２分子からなる糖たん白質 分子式 軽鎖（１－214残基）（C1034H1591N273O338S6） 重鎖（１－453残基）（C2235H3413N585O678S16） 分子量 約149,000 条件批准 在建立药品风险管理计划，要正确使用。 药效药理 贝伐单抗是针对人血管内皮细胞生长因子（VEGF）的重组人源化单克隆抗体。VEGF是参与血管通透性增加以控制细胞分裂促进血管内皮细胞的存活，表达在多种癌细胞中增强的细胞因子。 (1) 抗肿瘤作用 由人癌细胞系移植到裸鼠的A4.6.1施用抗体是贝伐单抗或亲本抗体（小鼠抗体），结肠癌（COLO205，HM7，LSLiM6），肺癌（A549），乳腺癌（MX-1，对前列腺癌（DU145）的MDA-MB-435），成胶质细胞瘤（U-87 MG），卵巢癌（SKOV-3），观察到的抗肿瘤活性，如广泛癌。此外，人结肠癌（HM7），在使用前列腺癌（DU145）的实验癌转移模型，抑制各肝脏，转移到肺部。组合使用贝伐单抗或亲本抗体的化疗或放射治疗，显示出抗肿瘤效果的增强作用。 (2) 作用机理 贝伐单抗，通过特异性结合人VEGF，以抑制对VEGF和血管内皮细胞中表达VEGF受体的结合。贝伐单抗通过阻断VEGF的生物活性，并在肿瘤组织中抑制血管生成，抑制肿瘤生长。还可以降低血管通透性是由血管内皮生长因子增强，减少肿瘤组织中增强了间隙的压力。 适应病症 *不能手术切除，晚期或复发性结直肠癌 *不能手术切除的晚期或复发的非小细胞肺癌不包括鳞状细胞癌 *卵巢癌 *进展或子宫颈癌的复发 *不能手术或复发性乳腺癌 *恶性胶质瘤 用法与用量 注：各类癌疾病用药以原处方为准。 包装规格 静脉注射 100毫克/4毫升：1瓶 400毫克/16ML：1瓶 制造厂商 中外制药有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/4291413A1022_1_18/ AVASTIN（Bevacizumab（Genetical Recombination）） Avastin IV for intravenous infusion 100mg/4mL/Avastin 400mg/16ml for intravenous infusion Release of "Avastin®" and promotion of proper use Chugai Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Tokyo; President: Osamu Nagayama) (Chugai Pharmaceutical Co., Ltd.) acquired approval for manufacture and marketing as an indication for "curative and recurrent colorectal cancer that is unresectable and curable" Avastin ®100mg/4mL, 400mg/16mL for intravenous drip IV "(hereinafter referred to as" Avastin®), which is a humanized anti-VEGF (vascular endothelial growth factor) humanized monoclonal antibody bevacizumab (genetical recombination) ) Will be released today from June 11 in response to the fact that it was included in the drug price standard today. "Avastin®" was created by Genentech (Headquarters: California, USA) and approved as a standard treatment for metastatic colorectal cancer in 88 countries (as of July 2006) in the United States and Europe (as of July 2006) Genentech, in other countries F. It was launched by Hoffmann La Roche (Basel City, Switzerland), and it is a drug that was on sale in Japan. "Avastin ®" has limited cases of clinical trials in Japan, so it is possible to become familiar with cancer chemotherapy for a certain period after release, to respond to emergency side effects, and provide medical cooperation for all cases survey It will be prescribed only by the agency. At the time of the launch of "Avastin®", Chugai Pharmaceutical has confirmed that the medical institution that desires prescription satisfies the above-mentioned conditions, explained on proper use to medical institutions, and conducted all cases survey We are preparing for such as. We will strive to collect and communicate information on proper use by medical personnel in charge of medical institutions to medical institutions after the release, but in addition we will establish a web site dedicated to "Avastin®" in Chugai website, By posting the information on, we will provide the latest safety information of this drug more widely. ① Outline of all cases survey ② Registration status of all cases survey (announcement results will be announced from the following week after launch, scheduled to be updated from time to time) ③ Side effect appearance status of all cases survey (announcement results will be announced from the following week after launch, scheduled to be updated from time to time) Chugai believes that "Avastin®" will be released in the country, so that it will contribute further to the treatment of colorectal cancer. In addition, we will strive to ensure the safety of patients to be administered and promotion of proper use, with the top priority when releasing "Avastin®". [Reference] Sales name: Avastin ® for intravenous infusion 100mg/4 mL Avastin ® for intravenous infusion 400mg/16 mL Common name: Bevacizumab (genetically modified) Indications/effects: Colorectal cancer of progression-recurrent, curative unresectable and curable Dosage/administration: In combination with other antineoplastic agents, adults are usually injected intravenously with 5mg/kg (body weight) or 10 mg/kg (body weight) once as bevacizumab by intravenous drip infusion. The administration interval shall be 2 weeks or longer. Drug price criterion Listing date: June 8, 2007 Release date: June 11, 2007 Expiration date: 2 years Approval Conditions: As the number of clinical trials in Japan is extremely limited, during the period from manufacturing and sales until data on a certain number of cases are accumulated, by conducting a usage result survey for all cases , Grasp the background information of patients using this drug, collect data on the safety and efficacy of this drug as soon as possible and take necessary measures for proper use of this drug. About the website of "Avastin®": For patients, families, "information for patients / medical consumers", medical personnel can be viewed from "information for medical staff". Regarding all cases of "Avastin®" (Specific Usage Results Survey): All cases The goal is to accumulate 2,500 cases and the study period is 18 months, but until the safety in the country is confirmed We plan to carry on continuously. After collecting 2,500 patients, we will evaluate the results obtained, and we will carefully examine the termination after considering the continuation of all cases survey and the necessity of changing the method and content. In addition, we will announce the analysis results of this survey not only to the regulatory authorities, but also at relevant academic meetings, academic conferences and so on. About Avastin®: "Avastin®" is the first therapeutic agent to inhibit angiogenesis (growth of the vascular network that supplies nutrition and oxygen to cancer tissues). "Avastin®" blocks the blood supply essential for cancer proliferation and systemic metastasis, targeting in vivo proteins called VEGF (vascular endothelial growth factor), an important factor in angiogenesis. "Avastin®" is a registered trademark of Genentech (USA).