部分中文易普利姆玛重组处方资料（仅供参考）

英文名：Ipilimumab（Genetical Recombination）

商标名：YERVOY Injection

中文名：易普利姆玛重组注射剂

日文名：ヤーボイ点滴静注液50mg

生产商：百时美施贵宝

药品简介
Yervoy是一种重组人单克隆抗体，阻断细胞毒性T淋巴细胞相关抗原4（CTLA-4）。CTLA-4是一种T细胞活化的负调控因子，Yervoy与CTLA-4结合后，能阻断CTLA-4与其配体CD80/CD86的相互作用。阻断CTLA-4已被证明能够增强T细胞的活化和增殖。Yervoy在黑色素瘤患者中的疗效作用机制，是间接通过T细胞介导的抗肿瘤免疫反应。 

药物分类名称

抗肿瘤药

人型抗人CTLA-4单克隆抗体

批准日期：2015年8月

欧文商標名

YERVOY Injection

一般名：

イピリムマブ（遺伝子組換え）

Ipilimumab（Genetical Recombination） 

本質

Ipilimumab是针对人细胞毒性T淋巴细胞抗原-4的重组人IgG1单克隆抗体。 Ipirimumab由中国仓鼠卵巢细胞产生。 Ipilimumab是一种糖蛋白（分子量：约148,000），由2个H链（γ1链）组成，由448个氨基酸残基组成，2个链（κ链）由215个氨基酸残基组成。。

批准条件

1.制定药品风险管理计划并适当实施。

2.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结果调查，直到制造和销售后累积一定数量的病例数据为止， 除了掌握使用该药物的患者的背景信息外，还应尽快收集有关该药物安全性和有效性的数据，并采取必要措施正确使用该药物。

药用药理学

作用机制

Ipilimumab是抗细胞毒性T淋巴细胞抗原-4（CTLA-4）的抗体，它是抗原呈递细胞上抗CTLA-4及其配体B7.1（CD80）和B7.2（CD86）分子的抗体。 通过阻断结合，它抑制活化T细胞中的抑制性调节并通过增殖，肿瘤抗原特异性T细胞的活化和细胞毒活性的增强来抑制肿瘤生长。 此外，据认为，由于调节性T细胞（Treg）功能降低和肿瘤组织中Tregs数量减少，依泽替米贝增加肿瘤免疫应答并表现出抗肿瘤作用。

适应症

恶性黑色素瘤的根治方法

用法与用量

化疗未经治疗：

通常，作为对成人的ipilimumab（遗传重组），以3mg/kg（体重）每天一次给予静脉内滴注4次，间隔3周。 当与其他抗肿瘤药物联合使用时，与nibormab联合使用（遗传重组）。

化疗在以前的治疗中：

通常，作为对成人的ipilimumab（遗传重组），以3mg/kg（体重）每天一次给予静脉内滴注4次，间隔3周。

包装

输注IV 

50mg：10mL 1小瓶

制造供应商：百时美施贵宝

联盟

小野制药有限公司

完整资料附件：http://www.info.pmda.go.jp/go/pack/4291430A1026_1_09/

The world's first approved immunity checkpoint inhibitor approved in Japan

On July 3, Bristol-Myers Co., Ltd. announced that with regard to humanized anti-human CTLA-4 monoclonal antibody "YAVOI (R) infusion intravenous solution 50 mg" (generic name: ipilimumab (genetical recombination)), malignant black Announced that it acquired production and marketing approval from the Ministry of Health, Labor and Welfare with the tumor as indication.

Yahboi block inhibitory regulation in activated T cells by inhibiting the action of cytotoxic T lymphocyte antigen-4 (CTLA-4), a regulatory factor that suppresses the activation of T cells, It promotes antigen-specific T cell activation and proliferation, and suppresses tumor growth. It is also thought that the tumor immune response is enhanced by the decrease in the function of regulatory T cells (Treg) and the decrease in the number of Tregs in the tumor tissue, thus exhibiting the antitumor effect.In the oversea Phase III trial of malignant melanoma patients who can not be treated with radical cure, this agent has a statistically significant overall survival (OS) prolongation compared to the control group regardless of BRAF mutation The first medicine shown in the world. It is also the first drug approved in the world as an immunity checkpoint inhibitor called cancer immunotherapy which has gained much attention in cancer treatment in recent years.New treatment options for which long-term survival can be xpected

Yahboi has been approved in more than 50 countries worldwide including Europe, Australia and Canada since March 2011 in the United States after being approved for the treatment of unresectable or metastatic malignant melanoma. Regardless of the treatment history of anticancer drugs in many countries, it is used as a standard therapy for malignant melanoma which can not be cured remarkably.The dosage and dose for indication of "radical curable melanoma incompetent in Japan" approved in Japan this time is 3 times a day 3mg/kg (body weight) as ipilimumab (gene recombination) four times at 3 week interval Note, has become. As for approval, "Before the data on a certain number of cases are accumulated, by conducting the use performance survey for all cases, we will grasp the background information of the patient using this drug, We will also collect data on the safety and efficacy of the drug at an early stage and take necessary measures for the proper use of this drug. "

The company hopes that the new approval option will be added to Japanese patients who fight malignant melanoma that can not resect curatively by long-term survival due to this approval

Yahboi's product overview

Product name: Yavoi (R) infusion IV 50 mg

Common name: ipilimumab (genetically modified)Indications/effects: radical malignant melanoma with radical cure Dosage regimen: For adults, intravenous drip infusions of 3mg/kg (body weight) once a day as an ipilimumab (genetical recombination) 4 times at intervals of 3 weeks.

Manufacturing marketing approval acquisition date: July 3, 2015

Manufacturer selling agency: Bristol-Myers Co., Ltd.

Approval condition:

1. Formulate a pharmaceutical risk management plan and implement it appropriately.

2. after the number of clinical trials in Japan is extremely limited, by conducting a usage result survey for all cases until a certain number of cases are accumulated after manufacturing and sales, In addition to grasping background information on 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.