伊立替康脂质体注射剂Onivyde 5mg/ml 10mg(irinotecan liposome)

药店国别： 产地国家：法国 处方药：是 所属类别： 5毫克/毫升 10毫克/盒 包装规格： 5毫克/毫升 10毫克/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：Servier Laboratories Limited 原产地英文商品名：Onivyde solution infusion 5mg/ml 10mg/box 原产地英文药品名：irinotecan liposome 中文参考商品译名：Onivyde溶液输注 5毫克/毫升 10毫克/盒 中文参考药品译名：伊立替康脂质体

简介

部份中文伊立替康脂质体处方资料(仅供参考) 英文名：irinotecan 商品名：ONIVYDE 中文名：伊立替康脂质体注射液 生产商：施维雅 药品介绍 近日，EMA批准Shire的Onivyde用于治疗胰腺癌，这是继今年七月份该药物获得FDA批准后，再次获得的上市许可。此次EMA批准Onivyde与5-FU和甲酰四氢叶酸联用，用于既往接受过吉西他滨治疗的转移性胰腺癌患者。 作用机制 伊立替康脂质体注射液是一种拓扑异构酶1抑制剂包封在脂质双层囊泡或脂质体中。拓扑异构酶1通过诱导单链断裂减轻在DNA中的扭转变形。伊立替康及其活性代谢物的SN-38结合可逆的拓扑异构酶1-DNA复合体，并防止再结扎的单链断裂，导致曝光时间依赖双链DNA损伤和细胞死亡。在小鼠中携带人肿瘤异种移植物，伊立替康脂质体施用伊立替康盐酸等效剂量5倍低于伊立替康盐酸达到类似SN-38的肿瘤内照射。 适应症和用法 ONIVYDE是拓扑异构酶抑制剂所指出的，在结合氟尿嘧啶和甲酰四氢叶酸，用于治疗患有以下吉西他滨为基础的治疗疾病进展后胰腺的转移性腺癌的治疗： 使用: ONIVYDE限制没有指示为用于治疗患有胰腺转移性腺癌的治疗单一试剂. 用法用量 不要代替ONIVYDE含有盐酸伊立替康等药物。ONIVYDE的推荐剂量是70毫克/米2静脉输注在90分钟内每两个星期。ONIVYDE的纯合子患者UGT1A1推荐起始剂量*28是50毫克/米2每两个星期。没有推荐剂量ONIVYDE的患者的血清胆红素以上的正常上限。Premedicate与前30分钟ONIVYDE皮质类固醇和抗催吐剂。剂型和规格注射剂：美国 包装： 43毫克/10毫升单剂量小瓶欧洲包装：5毫克/10毫升单剂量小瓶 禁忌 严重过敏反应到ONIVYDE或伊立替康HCl中。 警告和注意事项 间质性肺病(ILD)：致命ILD中已经发生接收伊立替康盐酸请停止ONIVYDE患者如果ILD诊断.严重的过敏反应：永久停止ONIVYDE严重过敏反应.胚胎 – 胎儿毒性：可引起胎儿危害提醒女性的潜在风险生殖潜力的一个胎儿，并使用有效的避孕不良反应ONIVYDE:腹泻，疲劳/乏力，呕吐，恶心，最常见的不良反应(≥20%)，食欲下降，口腔炎和发热最常见的实验室异常(≥10%3或4级)分别为淋巴细胞和中性粒细胞减少。 药物相互作用强 CYP3A4诱导剂:避免使用强CYP3A4诱导剂如可能替代非酶诱导治疗至少2周前ONIVYDE的开始.强CYP3A4抑制剂：避免使用强CYP3A4或UGT1A1的抑制剂，如果可能的话，在开始治疗前至少1周停止强CYP3A4抑制剂. 特殊人群中使用哺乳期： 不要母乳喂养.

英文版说明书

ONIVYDE 5MG/ML SOL PERF FL 10ML 1Advice for healthcare professionals:be aware of reports of serious and fatal cases of thromboembolic events in patients receiving Onivyde for metastatic adenocarcinoma of the pancreasa thorough medical history should be obtained in order to identify patients with multiple risk factors in addition to the underlying neoplasmadvise patients to seek medical advice immediately if signs or symptoms of thromboembolism occur (for example, sudden pain and swelling in a leg or an arm, sudden onset of coughing, chest pain or difficulty breathing)report suspected adverse drug reactions (ADRs) to the Yellow Card Scheme – even if the risk is already known, reporting adds to information about the frequency or seriousness of ADRsReports of serious thromboembolic eventsA routine EU review assessed cases of serious thromboembolic events reported in patients receiving Onivyde. In the cumulative review (October 2015 – April 2018), 23 serious reports of thromboembolic events were identified, of which 4 were fatal. 20 cases of serious thromboembolic events were reported in a 6-month reporting period (October 2017–April 2018) in the EU.We have no Yellow Card reports of this reaction with this formulation in the UK and usage in the UK is very low, however all prescribers should be aware of this risk when using Onivyde.The reported events included pulmonary embolism, vena cava thrombosis, deep vein thrombosis, catheter site thrombosis, and subclavian vein thrombosis. There were also individual reports of superior vena cava syndrome, portal vein thrombosis, thrombosis, cerebrovascular accident, jugular vein thrombosis, and mesenteric artery thrombosis.The risk of thromboembolic events has been included in the product information for Onivyde since the time of licensing. However, due to the increased reporting frequency and the seriousness of the reported events, warnings have been added to the Summary of Product Characteristics on the need for a thorough medical history to identify patients with multiple risk factors.All patients should be informed of the signs and symptoms of thromboembolism and be advised to seek medical advice should they occur. Warnings on the signs and symptoms of thromboembolism have also been added to the Patient Information Leaflet.About Onivyde (irinotecan, liposomal formulations)Onivyde is indicated for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine-based therapy. Onivyde must only be prescribed and administered to patients by healthcare professionals experienced in the use of anti-cancer therapies.