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埃罗妥珠单抗注射剂|Empliciti (Elotuzumab for Injection)

2016-03-25 10:49:10  作者:新特药房  来源:互联网  浏览次数:2  文字大小:【】【】【
简介: 新型抗癌注射剂Empliciti(elotuzumab 中文药名:埃罗妥珠单抗)为一种新免疫刺激治疗新药,获美国FDA批准治疗多发性骨髓瘤。FDA的药品评价和研究中心中血液学和肿瘤室主任Richard Pazdur,M.D.说:“我们 ...

新型抗癌注射剂Empliciti(elotuzumab 中文药名:埃罗妥珠单抗)为一种新免疫刺激治疗新药,获美国FDA批准治疗多发性骨髓瘤。
FDA的药品评价和研究中心中血液学和肿瘤室主任Richard Pazdur,M.D.说:“我们正在继续学习关于与不同类型癌,包括多发性骨髓瘤免疫系统相互作用途径,”“今天的批准是第二个被批准治疗有多发性骨髓瘤患者的第二个单克隆抗体和作用与另外被批准的治疗提供另外获益。” 突破性治疗,优先审评和孤儿药物
批准日期:
2015年11月30日;公司:Bristol-Myers Squibb公司和AbbVie
EMPLICITI™(埃罗妥珠单抗 elotuzumab )注射剂,供静脉使用
美国初次批准:2015
作用机制
埃罗妥珠单抗是一个人源化IgG1单抗特异性地靶向SLAMF7(信号淋巴细胞活化分子家族的成员7)蛋白。SLAMF7是表达在骨髓瘤细胞无关的细胞遗传学异常。SLAMF7还表达在自然杀伤细胞,浆细胞,和造血细胞系谱已分化的细胞免疫细胞亚组上较低水平表达。
埃罗妥珠单抗通过SLAMF7途径和Fc受体两方面直接地活化自然杀伤细胞。埃罗妥珠单抗也靶向在骨髓瘤细胞上SLAMF7和促进与天然杀伤Killer细胞相互作用介导通过抗体-依赖细胞毒性(ADCC)骨髓瘤细胞的杀死。在临床前模型中,埃罗妥珠单抗和来那度胺的联用导致自然杀伤细胞活化的增强比任一单独时影响更大和增加体外和体内抗肿瘤活性。
适应证和用途
EMPLICITI是一种针对SLAMF7免疫抗体适用与来那度胺和地塞米松联用为有多发性骨髓瘤曽接受1至3次以前治疗患者的治疗。
剂量和给药方法
⑴ 用来那度胺和地塞米松:10mg/kg对头两个疗程每周静脉给予和其后每2周直至疾病进展或不可接受的毒性。
⑵ 预先给药用地塞米松,苯海拉明[diphenhydramine],雷尼替丁[ranitidine]和对乙酰氨基酚[acetaminophen]。
剂型和规格
注射用:300mg或400mg冰冻干燥粉在单剂量小瓶为重建。
禁忌证
无。
警告和注意事项
⑴ 输注反应:需要预先给药。 中断EMPLICITI for 2级或更高和对严重输注反应永久终止。
⑵ 感染:监视发热和感染的其他征象和及时治疗。
⑶ 第二原发恶性病(SPM):有多发性骨髓瘤接受EMPLICITI患者对照临床试验观察到SPM的较高发生率.
⑷ 肝脏毒性:监视肝功能和如怀疑肝脏毒性停止EMPLICITI。
⑸ 干扰完全缓解的测定:EMPLICITI可干扰用于监视M-蛋白分析。这个干扰可能影响完全缓解的测定。
不良反应
最常见不良反应(20%或更高)是疲乏,腹泻,发热,便秘,咳嗽,周围神经病变,鼻咽炎,上呼吸道感染,食欲减退,肺炎.
在特殊人群中使用
妊娠:用三药剂量联用方案胚胎胎儿毒性。
供应/贮存和处置
EMPLICITI(埃罗妥珠单抗)是白色至灰白色冰冻干燥粉可得到如下:
EMPLICITI 300MG SDV LYO PWD 1/EA  ELOTUZUMAB     00003-2291-11 
EMPLICITI 400MG SDV LYO PWD 1/EA  ELOTUZUMAB     00003-4522-11 
贮存:
EMPLICITI在冰箱在2°C至8°C(36°F-46°F)。用前EMPLICITI避光保护贮存在原始包装。不要冻结或摇动。


Generic Name: elotuzumab
Dosage Form: injection, powder, lyophilized, for solution

SELECTED IMPORTANT SAFETY 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%).
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%).
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80686b7e-f6f4-4154-b5c0-c846425e2d91

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