纳武单抗重组注射剂Opdivo 100mg Injection(Nivolumab)

药店国别： 产地国家：日本 处方药：是 所属类别： 100毫克/10毫升/瓶 包装规格： 100毫克/10毫升/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：Ono Pharmaceutical 原产地英文商品名：Opdivo injection 100MG/10ml/VIAL 原产地英文药品名：nivolumab 中文参考商品译名：Opdivo注射液100毫克/10毫升/瓶 中文参考药品译名：纳武单抗重组

简介

部份中文OPDIVO处方资料(仅供参考) 药物分类名称：-抗肿瘤剂-人抗人PD-1单克隆抗体 批准日期：2014年9月 商標名：OPDIVO 一般名：ニボルマブ(遺伝子組換え)Nivolumab(Genetical Recombination) 分子量約：145,000 本质：它是针对人PD-1的重组人IgG4单克隆抗体，第221位重链上的氨基酸残基用Pro替代。它是由2个由中国仓鼠卵巢细胞产生的440个氨基酸残基的重链和2个214个氨基酸残基的轻链组成的糖蛋白。 批准条件：制定药品风险管理计划，适当实施。 <恶性黑素瘤与根治治疗>由于日本的临床试验数量非常有限，通过对所有病例进行使用情况调查，直到制作销售后累积了一定数量的病例，除了掌握使用患者的背景资料外，尽快收集有关该药物安全性和有效性的资料，并采取必要措施，妥善使用该药。 <不可切除的进展性复发性非小细胞肺癌>由于日本的临床试验数量非常有限，通过对所有病例进行使用情况调查，直到制作销售后累积了一定数量的病例，除了掌握使用患者的背景资料外，尽快收集有关该药物安全性和有效性的资料，并采取必要措施，妥善使用该药。 <肾可切除或转移性肾细胞癌>由于日本的临床试验数量极为有限，通过对所有病例进行使用结果调查，直到制造销售后累积了一定数量的病例， 除了掌握使用患者的背景资料外，尽快收集有关该药物安全性和有效性的资料，并采取必要措施，妥善使用该药。 <经常性或难治性古典霍奇金淋巴瘤>由于日本的临床试验数量极为有限，通过对所有病例进行使用结果调查，直到制造销售后累积了一定数量的病例， 除了掌握使用患者的背景资料外，尽快收集有关该药物安全性和有效性的资料，并采取必要措施，妥善使用该药。 <复发或远处转移的头颈癌>由于日本的临床试验数量极为有限，通过对所有病例进行使用结果调查，直到制造销售后累积了一定数量的病例， 除了掌握使用患者的背景资料外，尽快收集有关该药物安全性和有效性的资料，并采取必要措施，妥善使用该药。 药效药理作用 机序Nibormarb是针对人PD-1的抗体，并且抑制PD-1及其配体PD-L1和PD-L2之间的结合以抑制癌抗原特异性T细胞的增殖，活化和细胞毒性 认为通过增强活性等抑制肿瘤生长。 适应病症 恶性黑色素瘤的根治治疗不可切除的进展性复发性非小细胞肺癌肾可切除或转移性肾细胞癌复发性或难治性古典霍奇金淋巴瘤头颈癌复发或远处转移癌症化疗加重治愈性不可切除的进行性/复发性胃癌。 用法与用量 可切除的恶性黑色素瘤化疗在未经治疗且有根治性治疗的根治性黑素瘤患者的情况下通常，成人每3周接受静脉滴注3mg/kg(体重)，作为nibolumab(遗传重组)。化疗治疗无法切除的恶性黑素瘤患者的根治治疗通常，成人每3周一次静脉滴注3 mg/kg(体重)，每3周一次，每次2mg/kg(体重)，作为nibolab(遗传重组)。 2.不可切除的进展性复发性非小细胞肺癌，根治性不可切除或转移性肾细胞癌，经典复发或难治性经典霍奇金淋巴瘤，癌症化疗后复发或远处转移的头颈癌 胃癌恶化，不可切除的进行性/复发性.通常，成人每3周接受静脉滴注3 mg/kg(体重)，作为nibolumab(遗传重组)。 包装规格 静脉滴注20毫克/2毫升：1瓶100毫克/10毫升：1瓶 制造销售 大野药业有限公

英文版说明书

Opdivo harvest Japanese market indications for kidney cancer, Ono drug prices continue to riseFiled nearly two years shining the global market of tumor drugs PD-1 monoclonal drug Opdivo, I am afraid most people will only think of Bristol-Myers Squibb. However, in addition to Bristol-Myers, Japan's Ono Pharmaceutical is Opdivo's original developer, and with Opdivo in the tumor market is irresistible, Ono's fate is completely changed. Opdivo is said to be the first approved drug in the past decade, and after the two indications of melanoma and non-small cell lung cancer, Opdivo has recently gained a third indication in Japan - renal cell carcinoma.In 2014, Ono Pharmaceutical struggled in the dilemma of patent cliffs and generic drugs, and at this time Opdivo was approved for listing, so that Ono immediately got out of trouble. Recently, Japan approved Opdivo for the treatment of metastatic, unresectable renal cell carcinoma, although not as melanoma and non-small cell lung cancer as a huge market, but still a small market. Renal cell carcinoma is the most common type of kidney cancer, the world each year led to 110,000 deaths, five-year survival rate of only 12%.Opdivo as a first-line treatment of NSCLC failed clinical trials, to the hundred times the United States and Ono drugs have caused a certain blow, and this time in Japan won the third indications, to some extent reversed the current unfavorable situation.Opdivo as a NSCLC first-line clinical trial is mainly responsible for the United States, the scope does not include Japan, South Korea and Taiwan. After the release of the data, the share price fell after the announcement, while the old rival Merck East is due to Keytruda NSCLC first-line treatment in the excellent clinical performance and overtake a bureau.However, Opdivo on the meaning of Ono Pharmaceutical can not be too exaggerated, especially the Japanese government is about to put pressure on drug prices. But Opdivo's sales are still staggering, and in the second quarter of this year, Opdivo's sales soared in Japan, reaching 25 billion yen (about $ 245 million), and another 4 billion yen from the 100% premium.As with Hundreds of America, Ono Pharma is also seeking Opdivo's breakthrough in more indications to compete against old rival Keytruda and a new immunotherapy new therapy. Currently Ono Pharmaceutical has filed a listing application for head and neck cancer and Hodgkin's lymphoma in Japan and has performed phase III clinical trials in gastric cancer, small cell lung cancer, esophageal cancer, liver cancer, brain cancer and bladder cancer. Gye Sagara, chairman of Ono Pharmaceuticals, said he hoped that this month's Hodgkin's lymphoma indications could be approved.