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
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）
Important Safety
Information
Infusion Reactions
•EMPLICITI can cause infusion reactions. Common symptoms include fever, chills, and hypertension. Bradycardia and hypotension also developed during infusions. In the trial, 5% of patients required interruption of the administration of EMPLICITI for a median of 25 minutes due to infusion reactions, and 1% of patients discontinued due to infusion reactions. Of the patients who experienced an infusion reaction, 70% (23/33) had them during the first dose. If a Grade 2 or higher infusion reaction occurs, interrupt the EMPLICITI infusion and institute appropriate medical and supportive measures. If the infusion reaction recurs, stop the EMPLICITI infusion and do not restart it on that day. Severe infusion reactions may require permanent discontinuation of EMPLICITI therapy and emergency treatment.
•Premedicate with dexamethasone, H1 Blocker, H2 Blocker, and acetaminophen prior to infusing with EMPLICITI.
Infections
•In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide/dexamethasone arm (ERd) and 74.4% in the lenalidomide/dexamethasone arm (Rd). Grade 3-4 infections were 28% (ERd) and 24.3% (Rd). Opportunistic infections were reported in 22% (ERd) and 12.9% (Rd). Fungal infections were 9.7% (ERd) and 5.4% (Rd). Herpes zoster was 13.5% (ERd) and 6.9% (Rd). Discontinuations due to infections were 3.5% (ERd) and 4.1% (Rd). Fatal infections were 2.5% (ERd) and 2.2% (Rd). Monitor patients for development of infections and treat promptly.
Second Primary Malignancies
•In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and
5.7% (Rd). The rate of hematologic malignancies were the same between ERd and Rd treatment arms (1.6%). Solid tumors were reported in 3.5% (ERd) and 2.2% (Rd). Skin cancer was reported in 4.4% (ERd) and 2.8% (Rd). Monitor patients for the development of SPMs.
Hepatotoxicity
•Elevations in liver enzymes (AST/ALT greater than 3 times the upper limit, total bilirubin greater than 2 times the upper limit, and alkaline phosphatase less than 2 times the upper limit) consistent with hepatotoxicity were 2.5% (ERd) and 0.6% (Rd). Two patients experiencing hepatotoxicity discontinued treatment; however, 6 out of 8 patients had resolution and continued treatment. Monitor liver enzymes periodically. Stop EMPLICITI upon Grade 3 or higher elevation of liver enzymes. After return to baseline values, continuation of treatment may be considered.
Interference with Determination of Complete Response
•EMPLICITI is a humanized IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis and immunofixation assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Pregnancy/Females and Males of Reproductive Potential
•There are no studies with EMPLICITI with pregnant women to inform any drug associated risks.
•There is a risk of fetal harm, including severe life-threatening human birth defects associated with lenalidomide and it is contraindicated for use in pregnancy. Refer to the lenalidomide full prescribing information for requirements regarding contraception and the prohibitions against blood and/or sperm donation due to presence and transmission in blood and/or semen and for additional information.
Adverse Reactions
•Infusion reactions were reported in approximately 10% of patients treated with EMPLICITI with lenalidomide and dexamethasone. All reports of infusion reaction were Grade 3 or lower. Grade 3 infusion reactions occurred in 1% of patients.
•Serious adverse reactions were 65.4% (ERd) and 56.5% (Rd). The most frequent serious adverse reactions in the ERd arm compared to the Rd arm were: pneumonia (15.4%, 11%), pyrexia (6.9%, 4.7%), respiratory tract infection (3.1%, 1.3%), anemia (2.8%, 1.9%), pulmonary embolism (3.1%, 2.5%), and acute renal failure (2.5%, 1.9%).
•The most common adverse reactions in ERd and Rd, respectively (>20%) were fatigue (61.6%, 51.7%), diarrhea (46.9%, 36.0%), pyrexia (37.4%, 24.6%), constipation (35.5%, 27.1%), cough (34.3%, 18.9%), peripheral neuropathy (26.7%, 20.8%), nasopharyngitis (24.5%, 19.2%), upper respiratory tract infection (22.6%, 17.4%), decreased appetite (20.8%, 12.6%), and pneumonia (20.1%, 14.2%).
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