

Miripla 米铂冻干粉注射剂

通用中文 | 米铂冻干粉注射剂 | 通用外文 | miriplatin |
品牌中文 | 品牌外文 | Miripla | |
其他名称 | (ミリプラ)(70mg/vial+4ml/vial)/kit | ||
公司 | 住友(Sumitomo) | 产地 | 日本(Japan) |
含量 | 70mg/4ml | 包装 | 1瓶/盒 |
剂型给药 | 注射针剂 | 储存 | 室温 |
适用范围 | 治疗肝细胞癌。肝癌 |
通用中文 | 米铂冻干粉注射剂 |
通用外文 | miriplatin |
品牌中文 | |
品牌外文 | Miripla |
其他名称 | (ミリプラ)(70mg/vial+4ml/vial)/kit |
公司 | 住友(Sumitomo) |
产地 | 日本(Japan) |
含量 | 70mg/4ml |
包装 | 1瓶/盒 |
剂型给药 | 注射针剂 |
储存 | 室温 |
适用范围 | 治疗肝细胞癌。肝癌 |
部份中文Miripla处方资料(仅供参考)
通用名:米铂
英文名:Miriplatin Hydrate
商品名:Miripla
原研企业:日本住友制药株式会社
适应症:治疗肝细胞癌。
用法用量:将70mg 本品溶于3.5 mL 本品专用混悬液中,通过插入肝动脉内的导管注射进肝脏,直至药液充满肿瘤血管内时结束。给药上限为每次6 mL(含本品120mg),且需重复给药时要设4周以上的观察期。
国内外上市情况
本品是溶于专用碘化罂粟子油脂肪酸乙酯、肝动脉内给药的抗癌药物,其与碘化罂粟子油脂肪酸乙酯的亲和性高,且肝动脉内给药后滞留于肿瘤部位,混悬液中的铂成分可长时间缓慢释放进入血液或组织中,铂二价化合物与DNA结合,通过阻止DNA合成抑制癌细胞增殖,提高了抗癌效果。临床试验显示,不论是首次接受此项治疗肝细胞癌患者,还是一些接受过肝切除等其他治疗方法的复发患者,本品都表现出良好的抗癌效果。而且产生副作用均为这类治疗中常见的副作用,在精通这类疗法的医疗机构接受本品治疗,这些副作用都控制在耐受范围。
Miriplatin Hydrate是大日本住友制药株式会社开发的脂溶性铂复合物抗癌药,于2009年10月16日获得日本厚生劳动省批准,用于治疗肝细胞癌。本品专用混悬液已于同年8月20日获得批准。2010年1月20日,Miriplatin Hydrate及其专用混悬液同时上市销售。
2009--Dainippon Sumitomo Pharma Co., Ltd. (Head Office: Osaka, ; President: Masayo Tada) announces that the Company has obtained a manufacturing and marketing approval for “MIRIPLA® for intra-arterial injection 70 mg” (generic name: miriplatin hydrate), a therapeutic agent for hepatocellular carcinoma in as of October 16, 2009 from Ministry of Health, Labor and Welfare.
“MIRIPLA®” is first suspended in an oily lymphographic agent and then administered through hepatic artery into hepatocellular carcinoma. As such an oily lymphographic agent, the Company has “MIRIPLA® suspension vehicle 4 mL” (generic name: iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil), which is approved for suspending MIRIPLA®. The manufacturing and marketing approval for this suspension vehicle was obtained on August 20, 2009 from the competent Ministry.
“Lipiodolization” or “Chemo-lipiodlization” is one of the standard methods for treating hepatocellular carcinoma , where an anticancer drug is suspended in an oily lymphographic agent (iodine addition products of the ethylesters of the fatty acids obtained from poppyseed oil, Lipiodol) and then administered into hepatic artery. The Company has carried out a research program to discover an anticancer drug suitable for this treatment and succeeded in development of a lipophilic platinum complex, miriplatin which has high affinity to Lipiodol.
MIRIPLA®has a high suspensibility in “MIRIPLA® suspension vehicle 4 mL “. Some of the characteristics of MIRIPLA®are: it accumulates and stays in a tumor after the administration into hepatic artery, platinum component is released gradually over a long duration and yet exposure to entire body is minor. In clinical tests on hepatocellular carcinoma, satisfactory anti-tumor effects were confirmed not only on patients of initial treatment but also on patients who relapsed after treatment such as hepatic resection. Some side effects were observed, but they were regarded as those generally observed under chemo-lipiodolization therapy, and they were thought to be tolerable at medical institutions familiarized with this treatment. There was no adverse event on vessel disorder in hepatic artery related to this drug.
The Company has an intention to launch both “MIRIPLA® for intra-arterial injection 70 mg” and “MIRIPLA® suspension vehicle 4 mL” after they are listed on the national health insurance drug price standard. As a result of launching of MIRIPLA®, the Company expects to increase the line-up of products for the liver diseases, which includes Sumiferon®, a natural interferon-alpha product, and to further contribute to the total care of liver diseases.