部份中文博纳吐单抗重组处方资料（仅供参考）
商品名：Blincyto Infusion
英文名：Blinatumomab
中文名：博纳吐单抗重组冻干粉注射剂
生产商：安斯泰来制药
药品简介
201年09月27日,日本卫生劳动福利部（MHLW）已批准BiTE免疫疗法Blincyto（blinatumomab）用于复发性或难治性B细胞急性淋巴细胞白血病（ALL）儿童及成人患者的治疗。在日本，Blincyto由安进与安斯泰来的合资企业Amgen Astellas BioPharma K.K.（AABP）开发。
Blincyto是全球获批的首个也是唯一一个双特异性T细胞衔接（BiTE）免疫疗法，同是安进BiTE技术平台诞生的首个双特异性抗体产品，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。
ビーリンサイト点滴静注用35μg
药效分类名
抗恶性肿瘤剂/双重特异性抗体制剂
批准日期：2014年12月
商標名
BLINCYTO For I.V. Infusion 35μg
一般名
ブリナツモマブ（遺伝子組換え）
Blinatumomab（Genetical Recombination）
本質
Blinatumomab是遗传因子组的一个锁链抗体（scFv-scFv），第1-111是鼠标抗人CD 19单克拉抗体的L链的可变区域，127-250是鼠标抗人CD 19单克朗抗体的H链的可变区域，256-374是鼠标抗人CD 3单锁抗体的H锁链的可变区域，392-498是由鼠标抗人CD 3单调抗体的L链的可变区域构成的。布里纳兹莫马夫是由504个氨基酸残基组成的蛋白质。
分子量：约54 , 000
批准条件
1.在制定医药品风险管理计划的基础上，适当地使用。
2.早期收集剂的安全性及有效性的数据，以合理使用本剂的适当措施。
药效药理
1.作用机制
Blinatumomab是通过林克结合cd3和cd19的两种变体抗体的可变区域的基因重组蛋白。brittnimp是通过在t细胞细胞膜上发到的cd3和b细胞性肿瘤的细胞膜上连接到的cd19，通过架桥来激活t细胞，并被认为是对cd19阳性的肿瘤细胞进行伤害。
2.药理作用
(1) in vitro测试
在人末梢血单核体(pbmc)的存在下，印度人细胞性细胞性急性淋巴性白血病的nalm -6、kopn -8、sem细胞股等，显示出了增殖的作用。
(2)in vivo试验
布里纳兹蒙在与人pbmc一起在皮下移植的非肥胖型糖尿病/重度复合型免疫缺陷(nod/scid)鼠标中，表现出了抑制肿瘤增殖的作用。
另外，britemomave表示，将nalm-6细胞的股份与pbmc一同在静脉内移植的nod/scid鼠标中延长了生存期限。
适应症
复发性的b细胞性急性淋巴性白血病
用法与用量
通常，作为转基因(基因转换)，将以下的吸收量进行28天的持续点滴后，再进行14天的休药。把它作为一循环，最长5次循环。之后，作为转基因(基因转换)，28天持续进行点滴治疗，之后再服用56天。将此作为一循环，最长4次循环。另外，根据患者的状态，适当地使用。
体重超过45公斤的情况:第一循环的第1~7天为1日9μg，此后每天为28μg。体重不足45公斤的情况:
第1循环的第1~7天是一天5μg/m2(体表面积)，之后是1天15μg/m2(体表层面积)。但是，体重不要超过45公斤以上的患者。
包装：
点滴静注用35μg：1瓶（输液稳定性液10mL1瓶/附件）
存法·有效期
贮法
保存在2-8℃
有效期
60个月
制造销售
Amen Corporation
销售
安斯泰来製薬株式会社
注：以上中文资料不够完整，使用者以原处方资料为准。
完整说明附件：
https://www.info.pmda.go.jp/go/pack/4291445D1029_2_01/
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BLINCYTO for Drip Infusion 35mcg（Blinatumomab(genetical recombination)ビーリンサイト点滴静注用35μg）
Brand name:BLINCYTO for Drip Infusion 35mcg
Active ingredient:Blinatumomab(genetical recombination)
Dosage form:Lyophilized injection
Print on wrapping:
Effects of this medicine
This medicine helps cytotoxic T cells connect to leukemia cells (malignant B cells), adds damage against targetedmalignant cells and suppresses growth of cancer cells.
It is usually used to treat relapsed or refractory B-cell acute lymphoblastic leukemia.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is(( to be written by a healthcare professional))
・In general, you will receive this medicine by continuous intravenous infusion for 28 days, followed by a 14-daytreatment-free interval. This is counted as one cycle, and the cycle is repeated up to a maximum of five times.
After this, you will receive this medicine by continuous intravenous infusion for 28 days, followed by a 56-daytreatment-free interval. This is counted as one cycle, and the cycle is repeated up to a maximum of four times.
・Your doctor will eva luate your response to the treatment with this medicine after this medicine is beingadministered for a certain period of time, then decide the number of treatment cycles. Ask your doctor about thedetails of your treatment cycles.
Precautions while taking this medicine
・Refrain from driving and operating machinery or engaging in other hazardous activities while this medicine is beingadministered. This medicine may cause seizure or disturbance of consciousness.
・If you have a possibility of pregnancy, avoid pregnancy while you are taking this medicine and for a certain period oftime after the last dose of this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, cytokine release syndrome, abdominal pain, headache,and anemia. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets. If any of these symptoms occur, see your doctor immediately.
・headache, insomnia, dizziness [neurological events]
・fever, chills, tiredness [infections]
・nausea, headache, chest pain [cytokine release syndrome]
・depressed level of consciousness, decreased urination, shortness of breath [tumor lysis syndrome]
・palpitations, fever, nosebleeds [myelosuppression]
・severe abdominal pain, back pain, vomiting [pancreatitis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.
Injection
Published: 11/2018
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment.