产地国家：美国

处方药：是

所属类别： 35微克/瓶

包装规格： 35微克/瓶

计价单位：瓶

生产厂家英文名：Amgen, Inc

原产地英文商品名：BLINCYTO Injection 35mcg/vial

原产地英文药品名：Blinatumomab

中文参考商品译名：BLINCYTO注射剂 35微克/瓶

中文参考药品译名：Blinatumomab

简介：

美国FDA批准安进BiTE免疫疗法Blincyto治疗儿科急性淋巴细胞白血病（ALL）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。FDA的药品评价和研究中心血液学和肿瘤学产品室主任Richard Pazdur，医学博士说：“免疫治疗，尤其是Blincyto有其独特的作用机制，对有白血病患者尤其鼓舞人有前途。“”“认识到这个新治疗的潜能，FDA与承办单位在我们突破性治疗指定程序下主动共事便于批准这个新型药物。” 突破性治疗指定，优先审评和孤儿产品指定，加速批准程序批准日期：12月3，2014；公司：Amgen Inc.BLINCYTO（blinatumomab）注射为静脉内使用批准日期：2014年12月23日 公司：Amgen Inc美国最初批准：2014年

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：（1）感染：监控病人的体征或症状和治疗适当。（2）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。（3）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。

英文版说明书：

BLINCYTO 35 mcg single-use vial containing a sterile, preservative-free, white to off-white lyophilized powder andOne IV Solution Stabilizer 10mL single-use glass vial containing a sterile, preservative-free, colorless to slightly yellow, clear solution. Do not use the IV Solution Stabilizer to reconstitute BLINCYTOBLINCYTO RxPharmacological Class:Bispecific CD19-directed CD3 T-cell engager.Active Ingredient(s):Blinatumomab 35mcg; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.CompanyAmgen, IncIndication(s):Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).Pharmacology:Blinatumomab binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. It activates endogenous T cells by connecting CD3 in the T-cell receptor complex with CD19 on benign and malignant B cells. It mediates the formation of a synapse between the T cell and the tumor cell, upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells, which result in redirected lysis of CD19+ cells.Clinical Trials:The safety and efficacy of Blincyto were eva luated in an open-label, multi-center, single-arm study (N=185). Patients were given Blincyto 9mcg/day for Week 1, then 28mcg/day for the remaining 3 weeks. The target dose of 28mcg/day was given in Cycle 2 and subsequent cycles.The primary endpoint was complete remission/complete remission with partial hematological recovery (CR/CRh*) rate within 2 cycles of treatment with Blincyto. Results showed 77/185 (41.6%) patients achieved CR/CRh* within the first 2 cycles, with 81% of responses occurring within Cycle 1 of treatment.Minimal residual disease response was seen in 75.3% of the CR/CRh* group (95% CI: 64.2–84.4). Duration of response/relapse-free survival was 6.7 months (range: 0.46–16.5) in the CR group and 5.9 months (range: 0.13–16.5) in the CR/CRh* group.For more clinical trial data, see full labeling.Legal Classification:RxAdults:Strictly follow preparation and administration instructions. Pre-medicate with IV dexamethasone 20mg 1 hour prior to 1st dose of each cycle, prior to a step dose, or when restarting infusion after interruption (≥4 hours). Hospitalization recommended for first 9 days of Cycle 1 and first 2 days of Cycle 2. One single cycle = 4 weeks of continuous IV infusion followed by a 2-week treatment-free interval. ≥18 years (≥45kg): Give by continuous IV infusion at a rate of 10mL/hr for 24 hours or 5mL/hr for 48 hours. Cycle 1: 9mcg/day on Days 1–7 and 28mcg/day on Days 8–28. Subsequent cycles: 28mcg/day on Days 1–28. Treat up to a total of 5 cycles. Dose adjustments: see full labeling.Children:<18 years: not established.Warnings/Precautions:Monitor for signs/symptoms of cytokine release syndrome or neurological toxicities; interrupt or discontinue as recommended (see full labeling). Monitor for infections; give antibiotic prophylaxis as appropriate. Monitor for tumor lysis syndrome; interrupt or discontinue as needed. Obtain lab tests (including WBC, ANC) during infusion; interrupt if prolonged neutropenia occurs. Monitor ALT, AST, GGT, and total bilirubin prior to and during treatment; interrupt if transaminases rise >5XULN or if bilirubin rises >3XULN. Risk of leukoencephalopathy, esp. in those with prior treatment with cranial irradiation and antileukemic chemotherapy (including high-dose methotrexate or intrathecal cytarabine). Renal impairment (CrCl <30mL/min) or hemodialysis. Elderly. Pregnancy (Category C). Nursing mothers: not recommended.Interaction(s)Caution with concomitant CYP450 substrates (esp. drugs with narrow therapeutic index); adjust dose as needed. Monitor for toxicity with warfarin. Monitor cyclosporine.Adverse Reaction(s)Pyrexia, headache, peripheral edema, febrile neutropenia, nausea, hypokalemia, tremor, rash, constipation; pneumonia, sepsis, neutropenia, device-related infection, tremor, encephalopathy, confusion, overdose, possible immunogenicity.How Supplied:Pack—1 (single-use vial + IV solution stabilizer)LAST UPDATED:3/13/2015