埃罗妥珠单抗冻干粉注射剂Empliciti Trockensub 400mg

药店国别:

产地国家:瑞士

处方药:是

所属类别: 400毫克/瓶

包装规格: 400毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Bristol-Myers Squibb SA

原产地英文商品名:EMPLICITI Trockensub 400mg/Vial

原产地英文药品名:Elotuzumab

中文参考商品译名:EMPLICITI冻干粉注射剂 400毫克/瓶

中文参考药品译名:埃罗妥珠单抗

曾用名:

简介:近日,欧盟委员会批准Empliciti(elotuzumab)以合并用药形式用于多发性骨髓瘤治疗。Empliciti被批准与来那度胺及地塞米松合并用于既往至少接受过一种治疗的患者。这次的批准代表了首个也是唯一在欧盟获批用于多发性骨髓瘤的免疫刺激性抗体。

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。

适应症

联合来那度胺和地塞米松治疗曾接受1-3次治疗疾病进展的多发性骨髓瘤规格300mg或400mg冻干粉

用法用量

1、用来那度胺和地塞米松:头两个疗程,10mg/kg,每周一次,静脉给予; 其后每2周一次,直至疾病进展或不耐受毒性。

2、用Empliciti前需预先给予地寒米松,苯海拉明,雷尼替丁和对乙酰氨基酚处理

不良反应

最常见不良反应(≥20%)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。

注意事项

1、输注反应:需要预先给药。如果出现2级或更高和对严重输注反应,应中断EMPLICITI或永久终止。2、感染:监视发热和感染的其他征象,发现后及时治疗。

3、第二原发癌(SPM):临床试验观察,接受EMPLICITI多发性骨髓瘤患者到SPM的发生率较高。

4、肝毒性:监视肝功能,如怀疑肝脏毒性停止EMPLICITI。

5、干扰完全缓解率的测定: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。特殊人群三药疗法对胚胎胎儿有毒性作用生产厂家百时美&艾伯维

埃罗妥珠单抗冻干粉注射剂英文版说明书

Empliciti (elotuzumab) is an immunostimulatory antibody indicated for the treatment of multiple myeloma.The drug was developed by Bristol-Myers Squibb (BMS) in collaboration with AbbVie.BMS received approval for Empliciti from US Food and Drug Administration (FDA) for the treatment of multiple myeloma in November 2015, making it the first and only FDA approved immunostimulatory antibody drug.It was approved to be used as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in multiple myeloma patients who received one to three therapies before.The drug was granted breakthrough therapy designation by the FDA in May 2014.The marketing authorisation application (MAA) for Empliciti for the treatment of multiple myeloma was validated for review by the European Medicines Agency (EMA) in July 2015.In addition, the drug was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of EMA.Multiple myelomaMultiple myeloma is a type of blood cancer that originates in the bone marrow. It is characterised by the accumulation of cancerous white blood cells in the bone marrow. Symptoms include bone pain, fatigue, kidney impairment and infections.It is estimated that more than 750,000 people worldwide are living with multiple myeloma. It is also estimated that 24,050 new cases of multiple myeloma were diagnosed and more than 11,000 people died from this type of blood cancer in the US in 2014.Empliciti’s mechanism of actionEmpliciti contains an immunostimulatory antibody that targets the Signalling Lymphocytic Activation Molecule family member 7 (SLAMF7) glycoprotein.It also targets SLAMF7 on myeloma cells and facilitates the interaction with natural killer cells to mediate the killing of myeloma cells through antibody dependent cellular cytotoxicity (ADCC).The drug is available for intravenous administration in 300mg and 400mg vials.Clinical trials on elotuzumabFDA approval for Empliciti was based on results from a Phase III clinical trial known as ELOQUENT-2 (CA204-004). It was a randomised, open-label clinical study that eva luated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone.The study enrolled 646 relapsed or refractory multiple myeloma patients that received one to three prior therapies.Patients were randomised in 1:1 ratio to receive either Empliciti 10mg/kg in combination with Rd (ERd) or Rd alone in four-week cycles until disease progression or unacceptable toxicity.Co-primary endpoints of the study included progression-free survival (PFS), which was assessed by ratio, and overall response rate (ORR) as determined by a blinded Independent Review Committee using the European Group for Blood and Marrow Transplantation response criteria.Results of the study demonstrated that patients treated with ERd witnessed a 30% reduction in the risk of disease progression or death compared to those treated with Rd alone.The PFS rates in the ERd arm were 68% versus 57% in the Rd arm after one year, while the PFS rates in ERd and Rd arms were 41% versus 27% respectively after two years.atients treated with the ERd regimen showed a significant improvement by achieving an ORR of 78.5% compared to 65.5% in the Rd arm. The median PFS in the ERd group was 19.4 months compared to 14.9 months in the Rd group.The most frequent serious adverse reactions found in the ERd arm during the clinical study were pneumonia, pyrexia, respiratory tract infection, anaemia, pulmonary embolism, and acute renal failure.

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