博纳吐单抗冻干粉注射剂Blincyto Injection 38.5mcg(Blinatumomab)

药店国别： 产地国家：瑞士 处方药：是 所属类别： 38.5微克/瓶 包装规格： 38.5微克/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：Amgen Switzerland AG 原产地英文商品名：BLINCYTO Injection 38.5mcg/VIAL 原产地英文药品名：Blinatumomab 中文参考商品译名：BLINCYTO冻干粉末注射剂 38.5微克/瓶 中文参考药品译名：博纳吐单抗 曾用名： 简介： 2015年11月26日，生物技术巨头安进(Amgen)研发的BiTE免疫疗法Blincyto(blinatumomab)获欧盟有条件批准，用于费城染色体阴性(Ph-)复发性或难治性前体B细胞急性淋巴细胞白血病(ALL)成人患者的治疗。此次批准，使 Blincyto成为欧洲批准的首个双特异性T细胞衔接器(BiTE)抗体药物。Blincyto的获批，是基于2项关键性II期研究(Study 211，Study 206)的积极数据，前一项研究中，Blincyto单药治疗组有高达42.9%的患者达到了完全缓解(CR)或部分血液学恢复的完全缓解(CRh)。Blincyto(blinatumomab)是全球首个BiTE免疫疗法，基于安进最先进的双特异性T细胞衔接系统(BiTE)开发，这是一种双特异性抗体，能够通过将肿瘤细胞上的CD19蛋白呈递给T细胞特异表达的CD3蛋白，进而激活免疫系统识别并杀灭肿瘤细胞。BiTE抗体技术代表了一种创新的免疫治疗方法，能够在很低浓度下起作用。安进于2012年耗资12亿美元收购Micromet公司后获得了BiTE技术。目前，安进正在广泛的难治性肿瘤类型中，探索BiTE创新疗法的潜力。此前，FDA和EMA均已授予blinatumomab治疗多种类型血液癌症的孤儿药地位及突破性疗法认定，包括急性淋巴细胞白血病(ALL)、慢性淋巴细胞白血病(CLL)、毛细胞白血病(HCL)、幼淋巴细胞白血病(PLL)和惰性B细胞淋巴瘤、套细胞白血病(MCL)。 适应症和用法 BLINCYTO是双特异性CD19定向CD3 T细胞扣合片表示为费城染色体阴性复发或难治的B细胞的前体急性淋巴细胞白血病(ALL)的治疗。这个指示下，加速审批核准。继续批准该适应症可能会在随后的试验验证的临床获益队伍。 用法用量 - 住院推荐的前9天的第一个周期的和的第2天的第二次循环的。- 治疗的单个循环由4周的连续静脉输注之后是2周无治疗间隔期。- 对于患者至少45公斤重，在周期1，管理BLINCYTO9微克/天的第1-7天，并在在8-28天28微克/天。对于后续周期，管理BLINCYTO在28微克/天的日子1-28。•管理- Premedicate地塞米松20mg的静脉内前1小时，以每个周期BLINCYTO的首次剂量之前，步骤剂量(如第1个周期第8天)，或4小时或更长时间中断后重新开始的输注时。- 管理作为连续静脉内输注用输液泵以恒定流速。- 该输液袋应注入超过24小时或48小时。- BLINCYTO应通过专用的腔注入。•准备- 四解稳定剂被提供并且被用于涂覆预充液IV袋之前加入复溶BLINCYTO的。- 重新构建BLINCYTO用注射用无菌水，USP，只。- 当准备输液的解决方案，因为BLINCYTO不含抗菌防腐剂无菌技术要严格遵守。- 使用掺混说明中描述的特定卷。 剂型和规格 •对于注射：在单次使用的小瓶用于重建35微克冻干粉末。 禁忌 •已知过敏blinatumomab或产品配方的任何成分。 警告和注意事项 •感染：监控病人的体征或症状和治疗适当。•效果上的驾驶能力和使用机器：建议患者自驾车和从事危险职业或活动，如操作重型或有潜在危险的机器，而BLINCYTO被给予克制。•编制和管理的错误：严格遵循说明准备(包括掺混)和管理。 不良反应 •最常见的不良反应(≥20%)为发热，头痛，血管神经性水肿，发热性中性粒细胞减少，恶心，低钾血症，震颤，皮疹，便秘等。 博纳吐单抗冻干粉注射剂英文版说明书 BLINCYTO® (blinatumomab) Risk eva luation and Mitigation Strategy (REMS)What is the BLINCYTO® REMS?A Risk eva luation and Mitigation Strategy (REMS) is a program to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.The purpose of the BLINCYTO REMS is to inform Healthcare Providers about the following serious risks:BOXED WARNING: Cytokine Release Syndrome•Serious adverse events that may be associated with CRS included pyrexia, headache, nausea, asthenia, hypotension, increased alanine aminotransferase, increased aspartate aminotransferase, and increasedtotal bilirubin.•The highest elevation of cytokines was observed in the first 2 days following start of BLINCYTO infusion•Hospitalization is recommended for the first 9 days of the first cycle and the first 2 days of the second cycle.BOXED WARNING: Neurological Toxicities•In patients receiving BLINCYTO in clinical trials, neurological toxicities have occurred in approximately 64% of patients.•The median time to onset of any neurological toxicity was 4 days.•Grade 3 or higher (severe, life-threatening or fatal) neurological toxicitiesfollowing initiation of BLINCYTO administration occurred in approximately 17% ofpatients and included encephalopathy, convulsions, speech disorders,disturbances in consciousness, confusion and disorientation, andcoordination and balance disorders. The majority of events resolved followinginterruption of BLINCYTO, but some resulted in treatment discontinuation.Monitor patients closely for signs and symptoms of these events and interruptor discontinue dosing of Blincyto.Preparation and Administration Errors•Preparation and administration errors have occurred with BLINCYTO treatment.•It is very important that the instructions for preparation (includingadmixing) and administration are strictly followed to minimize medication errors (including underdose and overdose).•Please note that the recommended dose for BLINCYTO is by patient weight. Patients greater than or equal to 45 kg receive a fixed-dose and for patients less than 45 kg, the dose is calculated using the patient’s body surface area (BSA).BLINCYTO Fact Sheet:A non-promotional REMS Fact Sheet reviewed by the FDA, with more detailed information on the serious risks associated with BLINCYTO is available in the“Materials for Healthcare Providers” section above.INDICATION:BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the