英文药名：EMPLICITI for I.V. INFUSION（Elotuzumab[Genetical Recombination]）

中文药名：重组埃罗妥珠单抗静脉注射剂

生产厂家：施贵宝制药

エムプリシティ点滴静注用300mg／エムプリシティ点滴静注用400mg

治疗类别名称
抗肿瘤药
人源化抗人SLAMF7单克隆抗体
欧文商標名
EMPLICITI for I.V. INFUSION
一般名：
エロツズマブ（遺伝子組換え）
Elotuzumab（Genetical Recombination）
本質：
エロツズマブは，遺伝子組換えヒト化モノクローナル抗体であり，マウス抗ヒトSLAMファミリーメンバー7（SLAMF7）抗体の相補性決定部，並びにヒトIgG1のフレームワーク部及び定常部からなる。エロツズマブは，マウスミエローマ（NS0）細胞により産生される。エロツズマブは，449個のアミノ酸残基からなるH鎖（γ1鎖）2本及び214個のアミノ酸残基からなるL鎖（κ鎖）2本で構成される糖タンパク質（分子量：約148,000）である。
批准条件
1. 在建立药品风险管理计划，要正确用药
2. 由于在日本试验病人是非常有限的，上市后，直至有关一定数量的病例数据集成，通过实现对一切案件的使用，结果调查显示，该药物这使得能够早期识别患者的背景信息，数据收集这些药物的安全性和有效性，采取必要的措施在正确使用这种药物。
药效药理
作用机序
Erotsuzumabu是结合人信令淋巴细胞激活分子家族成员7（SLAMF7）人源化的IgG1单克隆抗体。SLAMF7已经报道了在多发性骨髓瘤细胞中高度表达。
Erotsuzumabu结合SLAMF7对骨髓瘤细胞膜，通过与经由Fc受体自然杀伤（NK）细胞的相互作用诱导抗体依赖性细胞毒性（ADCC），这表明肿瘤生长的抑制作用可以想象的。此外，Erotsuzumabu已经报道由NK细胞SLAMF7的结合表示具有直接活化NK细胞的效果。
抗肿瘤作用
Erotsuzumabu与人骨髓瘤衍生OPM2细胞系植入小鼠中，抑制肿瘤的生长。
适应病症
复发或难治性多发性骨髓瘤
用法与用量
在来那度胺和地塞米松，一般情况下，一次为10mg/kg静脉滴注作为Erotsuzumabu（基因重组）成人组合。28天为一个周期，前两个周期每周间隔四倍（1，8，15，第22天），三个循环之后两次在两周的时间间隔（1，第15天）静脉滴注到。
包装规格
300毫克×1瓶

400毫克×1瓶

制造厂商
施贵宝有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/4291434D1020_1_02/
EMPLICITI for I.V. INFUSION（Elotuzumab）
EMPLICITI for I.V. INFUSION 300mg（エムプリシティ点滴静注用300mg）
Brand name : EMPLICITI for I.V. INFUSION 300mg
　Active ingredient: Elotuzumab
　Dosage form: injection
　Print on wrapping: 
EMPLICITI for I.V. INFUSION 400mg（エムプリシティ点滴静注用400mg）
Brand name : EMPLICITI for I.V. INFUSION 400mg
　Active ingredient: Elotuzumab
　Dosage form: injection
　Print on wrapping:
Effects of this medicine
This medical agent is for patients with multiple myeloma, hematopoietic tumor, and belongs to the class of monoclonal antibody-medicine, humanized IgG1 monoclonal antibody. This agent is intravenously administrated by infusion, and targets specifically SLAMF7. SLAMF7 is expressed on myeloma and natural killer cell, and the pharmacological activity is caused by binding to the SLAMF7. This medical agent is approved for the patients with relapse/refractory multiple myeloma.
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, possibly pregnant or lactating.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. 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)
•It is used with lenalidomide and dexamethasone. In general, for adults, administer by intravenous infusion.
•Each treatment cycle is 28 days. For Cycles 1 and 2, administer 4 times at an interval of every 1 week (Days 1, 8, 15, and 22). For Cycles 3 and up, administer twice at an interval of every 2 weeks (Days 1 and 15).
•Consult with the doctor for the treatment duration.
Precautions while taking this medicine
•Infusion reactions such as fever, chills, and hypertension may occur. Infusion reactions are reported frequently at the first injection, however, they may occur at the second injection or thereafter. If you notice any abnormality, consult with your doctor immediately.
•Since lymphopenia may occur, periodic blood test should be performed.
•If you or your partner have a possibility of pregnancy, avoid pregnancy while you are taking this medicine and for a certain period after you discontinue this medicine. This medicine is used in combination with lenalidomide and dexamethasone.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fatigue, diarrhea, muscle spasm, insomnia, anemia, constipation, peripheral edema, fever, nausea and asthenia. 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 indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•fever, itch, increase in sweating, pimple, chills, diarrhea [infusion reaction]
•cold-like symptom, dullness, fever, vomiting [infection]
•fever, sore throat [lymphopenia]
•fever, dry cough, breathing difficulty, shortness of breath [interstitial pulmonary disease]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Bristol-Myers SquibbInjection
Published: 2/2017
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895