吉妥单抗，吉妥单抗冻干粉注射剂Mylotarg 5mg Injection(Gemtuzumab Ozogamicin )

药店国别：无 产地国家：美国 处方药：是 所属类别： 5毫克/瓶 包装规格： 5毫克/瓶 计价单位：瓶 生产厂家中文参考译名：无 生产厂家英文名：Pfizer 原产地英文商品名：Mylotarg Injection 5mg/Vial 原产地英文药品名：Gemtuzumab Ozogamicin 中文参考商品译名：Mylotarg冻干粉注射剂 5毫克/瓶 中文参考药品译名：奥吉妥单抗，GO单抗 曾用名：无

简介

新药Mylotarg(gemtuzumab ozogamicin)冻干粉注射剂再次获FDA批准用于治疗表达CD33抗原的新诊断急性骨髓性白血病(AML)的成人患者近日，制药巨头辉瑞公司宣布，美国食品药品监督管理局（FDA）批准MYLOTARGTM（gemtuzumab ozogamicin）用于治疗新诊断的成人CD33阳性急性髓系白血病（AML），也可用于治疗年龄大于2岁儿童和成人难治性或复发性CD33阳性AML。MYLOTARG是第一个有治疗儿童AML适应症的药物。 也是第一个以CD33为靶点的AML治疗药物。近90%的患者的AML细胞表达簇分化抗原（CD）。新的给药方案后批准了Mylotarg(gemtuzumab ozogamicin)。审查表明这种治疗的好处超过风险， ”FDA肿瘤卓越中心主任兼FDA药品评价和研究中心的血液学与肿瘤产品办公室代理主任Richard Pazdur博士说：“Mylotarg的历史强调了检查癌症患者治疗的替代剂量、用药安排和用药管理的重要性，特别是那些最容易受到治疗副作用影响的患者。” 批准日期：2017年9月1日 公司：辉瑞（Pfizer）注射用MYLOTARGTM(gemtuzumab ozogamicin)，为静脉使用 美国初次批准：2000 作用机制 Gemtuzumab ozogamicin是一个指向CD33-抗体-药物结合物(ADC)。抗体部分(hP67.6)识别人CD33抗原。小分子，N-乙酰 ɣ calicheamicin，是一个细胞毒剂是通过一个连接物共价地附着至抗体。非临床数据提示gemtuzumab ozogamicin的抗癌活性是由于ADC的结合至CD33-表达肿瘤细胞，接着ADC-CD33复合物的内化，和N-乙酰ɣ calicheamicin dimethyl hydrazide通过连接物的水解裂解的细胞内释放。 N-乙酰ɣ calicheamicin dimethyl hydrazide的活化诱发双链DNA断裂，随后诱导细胞周期停止和凋亡细胞死亡。 适应证和用途 MYLOTARG是一个指向CD33抗体药物结合物适用为： ● 在成年中新诊断CD-33-阳性急性髓性白血病(AML)的治疗. ● 在成年和在儿童患者2岁和以上中复发或难治性CD33-阳性AML的治疗. 剂量和给药方法 ● 新诊断，从头开始AML(组合方案)： ● 诱导：3 mg/m2(直至一个4.5 mg小瓶)在天1，4，和7与柔红霉素和阿糖胞苷联用. ● 巩固：3 mg/m2在天1(直至一个4.5 mg小瓶)与柔红霉素和阿糖胞苷组合。 ● 新诊断AML(单药方案)： ● 诱导：6 mg/m2在天1和3 mg/m2在天8. ● 继续：对诱导后无疾病进展证据患者，直至8个继续疗程MYLOTARG 2mg/m2在天1每4周. ● 复发或难治性AML(单药方案)： ● 3 mg/m2在天1，4，和7. ● 预先给药MYLOTARG的一小时前用一种皮质激素，抗组织胺，和对乙酰氨基酚。 剂型和规格注射用：4.5 mg作为一冻干饼或粉在一个单次-剂量小瓶为重建和稀释. 禁忌证 对MYLOTARG或它的任何组分超敏性。 警告和注意事项 ● 出血：当MYLOTARG被用在推荐剂量可能发生严重，包括致命性，出血。频繁地监视血小板计数(5.3和6.1)。 ● 胚胎-胎儿毒性：可能致致命性危害。忠告生殖潜能女性对胚胎潜在风险和有效避孕的使用(5.6，8.1，和8.3)。 不良反应 最常见不良反应(大于15%)为出血，感染，发热，恶心，呕吐，便秘，头痛，增加AST，增加ALT，皮疹，和粘膜炎(6). 在特殊人群中使用哺乳：建议不要哺乳喂养。 包装规格/冷藏和处置 注射用MYLOTARG(gemtuzumab ozogamicin)是一种白色至灰白色冻干饼或粉在纸盒中供应(NDC 0008-4510-01)含一个4.5 mg单-剂量小瓶[见剂量和给药方法(2)]。 贮存和处置 冰箱(2-8°C；36-46°F)MYLOTARG小瓶和贮存在原始纸盒以避光保护。不要冻结。MYLOTARG 是一种细胞毒性药物。遵循可行的特殊处置和遗弃方法步骤1。

英文版说明

FDA Approves Return of Previously Withdrawn Cancer TreatmentThe Foo d and Drug Administration (FDA) has approved Mylotarg (gemtuzumab ozogamicin for injection; Pfizer) for the treatment of adults with newly diagnosed CD33-positive acute myeloid leukemia (AML). Mylotarg has also been approved for the treatment of relapse or refractory CD33-positive AML in adults and in pediatric patients 2 years of age and older.In May 2000, Mylotarg had received accelerated approval for the treatment of older patients with CD33-positive AML who had experienced a relapse, however, it was voluntarily withdrawn from the market in 2010 after confirmatory trials failed to show benefits and revealed safety concerns. This new approval for Mylotarg includes a new patient population, a lower recommended dose, and a different treatment schedule."We are approving Mylotarg after a careful review of the new dosing regimen, which has shown that the benefits of this treatment outweigh the risk," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug eva luation and Research.In patients with newly diagnosed CD33-positive AML, Mylotarg in combination with chemotherapy increased event-free survival compared to chemotherapy alone (17.3 months vs. 9.5 months, respectively). Mylotarg was eva luated as a stand-alone treatment in two separate trials, one involving newly diagnosed AML patients and one in patients who had experienced a relapse of disease. In the trial, patients with newly diagnosed AML who received Mylotarg survived longer than those who received best supportive care (4.9 months vs. 3.6 months, respectively). For those with previous relapse, treatment with Mylotarg resulted in 26% of patients achieving complete remission which lasted a median 11.6 months.Mylotarg carries a boxed warning regarding the risk of hepatotoxicity, including severe or fatal hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome.The product will be supplied in a carton containing one 4.5mg single-dose vial for reconstitution and dilution.