英文药名：Zinbryta（daclizumab solution for injection）

中文药名：达利珠单抗长效注射剂

生产厂家：百健/艾伯维
药品介绍：
每月注射1次长效注射剂daclizumab（商标名 Zinbryta 中文名：达利珠单抗）获批用于成人反复型多发性硬化（MS）
Zinbryta每月皮下注射一次，可由患者自己注射给药。该药的上市，将为多发性硬化症患者提供另一种选择，其靶向作用机制(mechanism of action，MOA)不引发广泛和长期的免疫细胞消耗。
批准日期：2016年5月27日[美国批准] 2016年5月27日[欧盟批准]；公司：AbbVie，Inc.和Biogen
ZINBRYTA(达克珠单抗[daclizumab])注射液，为皮下使用
美国初次批准：2016
作用机制
不知道daclizumab在多发性硬化症中发挥治疗效应的精确机制但被假设通过与CD25结合，高-亲和力IL-2 受体的一个亚单位是涉及IL-2介导的淋巴细胞活化的调节。
适应证和用途
ZINBRYTA是一种白介素-2受体阻断抗体适用为有多发性硬化症(MS)的复发型成年患者的治疗。因为其安全性图形，ZINBRYTA的使用一般地应保留为对两种或更多适用为的治疗MS药物已有反应不佳的患者。
剂量和给药方法
⑴ 推荐剂量：150mg每月一次
⑵仅为皮下使用
⑶ 训练患者自身给药适当技术
⑷ 基线时和给药间隔时定期进行实验室测试监视潜在地严重不良反应的早期征象.
剂型和规格
注射液：150mg/mL溶液在单-剂量预装注射器
禁忌证
⑴ 预先存在肝病和肝受损，包括ALT或AST至少ULN的2倍
⑵ 自身免疫性肝炎病史或涉及肝脏其他自身免疫情况
⑶ 对daclizumab或制剂的任何其他组分超敏病史
警告和注意事项
⑴ 超敏性反应：过敏反应和血管水肿的风险。如发生过敏反应或其他过敏性反应终止和不要再开始ZINBRYTA
⑵ 感染：增加感的风险染。如发生严重感染，考虑不给ZINBRYTA直至感染解决
⑶ 抑郁和自杀：忠告患者立即报告抑郁和/或自杀意念的症状至他们的卫生保健提供者。如发生严重抑郁和/或自杀意念考虑终止
不良反应
对ZINBRYTA报道的最常见不良反应(发生率≥5%和发生率比对比药较高≥2%)为与AVONEX比较鼻咽炎，上呼吸道感染，皮疹，流感，皮炎，口咽痛，支气管炎，湿疹和淋巴结肿大；和与安慰剂比较上呼吸道感染，抑郁，皮疹，咽炎，和谷丙转氨酶增加(ALT)
药物相互作用
肝毒性药物：评价与同时使用肝毒性的风险增加的潜能
包装规格[注：本品德国上市包装，采购者以在线咨询为准]
150mg*1支包装，3支包装

制造商：百健/艾伯维
完整说明书附件：http://www.medicines.org.uk/emc/medicine/32330
Bacon and Albergo drug Zinbryta approved by the European Union
(Biocarb) and partner Eric (AbbVie) developed a monthly injection of multiple sclerosis (MS) monoclonal antibody Zinbryta (daclizumab, daclobutum, high-yielding process) recently in the United States and the European Union Regulatory aspects have been a major good news. In the United States, Zinbryta was approved by the FDA at the end of May; in the European Union, Zinbryta was approved by the European Commission (EC) on Tuesday for all patients with recurrent multiple sclerosis (RMS).
Zinbryta is injected subcutaneously once a month and can be administered by the patient himself. The listing of the drug will provide an alternative to patients with multiple sclerosis, and the mechanism of action (MOA) does not elicit extensive and long-term immune cell depletion.
The advantage of Zinbryta is its ability to reduce annual recurrence rates (AAR) and 24-week progression risk. This opinion is based on positive data from two clinical studies (DECIDE, SELECT). These studies were performed in patients with recurrent multiple sclerosis (RMM), with Zinbryta (subcutaneous, once every month, 150 mg) and Avonex (interferon beta-1a, intramuscularly, once weekly, 30 micrograms) and comfort Agents were compared. Data show that Zinbryta in the MS disease activity of key evaluation indicators have improved. In terms of safety, the incidence of adverse events was similar in the Zinbryta treatment group and the Avonex treatment group in the DECIDE study. Compared with the Avonex treatment group, the incidence of the following events was increased in the Zinbryta treatment group: severe infection (4% vs 2%), severe skin reaction (2% vs 1%), liver transaminase greater than 5 times normal upper limit (6 % Vs 3%), gastrointestinal disease (31% vs 24%), depression (8% vs 6%).
Avonex is one of the best-selling multiple sclerosis (MS) drugs, ranking MS market global TOP2, 2013 annual sales of 3 billion US dollars, the drug once a week intramuscular injection, the current 100 Jian Ai Di also launched Long-term version of Avonex, once every 2 weeks.
The results of the DECIDE study are encouraging, and Zinbryta has shown a strong effect compared to current MS standard care. Zinbryta has a novel mechanism of action, which, as a monthly subcutaneous injection therapy, will become an important treatment option for patients with multiple sclerosis (MS).
High-yielding Zinbryta is a subcutaneous dosage form of daclizumab and is currently being investigated for relapsing multiple sclerosis (RMS) treatment. Daclizumab is a novel humanized monoclonal antibody that selectively binds highly to the T cell surface of the interleukin 2 (IL-2) receptor subunit CD25. In patients with multiple sclerosis (MS), CD25 was highly expressed and T cells were abnormally activated. Daclizumab regulates IL-2 signaling without causing immune cell depletion.
T cells are thought to be abnormally active in autoimmune diseases such as multiple sclerosis (MS). Daclizumab is thought to play a role by reducing the activation of T cells and proinflammatory lymphoid tissue by reducing the activation of cells, increasing CD56bright NK cells. NK cells are a class of important cells that target the activation of immune cells that play a key role in multiple sclerosis (MS), helping to regulate the immune system.