注射用胶束化紫杉醇/L01CD01（Genexol PM Inj 30mg）

产地国家：韩国 处方药：是 所属类别： 30毫克/5毫升/瓶 10瓶/盒 包装规格： 30毫克/5毫升/瓶 10瓶/盒 计价单位：盒 生产厂家英文名：Samyang Biopharm 原产地英文商品名：Genexol-PM Inj（파클리탁셀）30mg/5mL/vial 10vial/Box 原产地英文药品名：Paclitaxel 中文参考商品译名：Genexol-PM注射用胶束（파클리탁셀）30毫克/5毫升/瓶 10瓶/盒 中文参考药品译名：胶束化紫杉醇 曾用名：L01CD01

简介：

部份中文：Genexol-PM[抗肿瘤纳米药]处方资料（仅供参考） 商标名称：Genexol-PM，Paclitaxel/L01CD01 通用名称：注射用胶束化紫杉醇 韩文药名：중 파클리탁셀 30mg/5mL, 100mg/16.7mL 适应症：乳腺癌，肺癌，卵巢癌的一线治疗。 剂量：以每3周3小时的剂量静脉内施用300mg/m2的剂量; 根据以下剂量静脉内施用3小时，然后静脉内以60mg/m2的剂量施用顺铂; 其以每3周3小时的剂量以260mg/m 2的剂量静脉内施用。 包装：30mg/瓶，100mg/瓶。 生产商：韩国 Samyang BiopharmGenexol PM Inj 用药方案： 紫杉醇Genexol PM是由Samyang开发的紫杉醇的专利新制剂。新制剂不含有毒的表面活性剂，并且允许向患者明显更高剂量的紫杉醇。 乳腺癌1）一线治疗转移性或复发性乳腺癌。2）标准化疗失败后转移性乳腺癌的二线治疗。 肺癌1）局部晚期或转移性非小细胞肺癌的一线治疗。 卵巢癌1）与其它化疗剂组合的一线治疗。 乳腺癌Genexol-PM以每3周3小时的初始剂量260mg/m 2静脉内施用。非小细胞肺癌根据以下剂量静脉内施用3小时Genexol-PM，然后静脉内以60mg/m 2的剂量施用顺铂。第一周期的Genexol-PM剂量：230mg/㎡第二周期的Genexol-PM的剂量卵巢癌Genexol-PM以每3周3小时的初始剂量260mg/m 2静脉内施用，其次是arboplatin AUC 5mg/mL·min。静脉内。 注射用胶束化紫杉醇（Genexol-PM，Paclitaxel/L01CD01）-是一种新型的抗肿瘤纳米药，为放射增敏剂的非小细胞肺癌、乳腺癌、卵巢癌治疗有效药

英文版说明：

Genexol® PM Inj.Breast Cancer, Lung cancer, Pancreatic caner(cytotoxic chemotheraphy)Full descriptionGenexol-PM is a polymeric micelle formulated paclitaxel, free of Cremophor EL. Objectives with Genexol-PM are to reduce Cremophor EL-related toxicities and to increase therapeutic efficacy. Polymeric micelles are composed of hundreds of amphiphilic diblock copolymers.Block copolymers include poly-(ethylene glycol) used as nonimmunogenic carriers and biodegradable core-forming poly-(D,L-lactic acid) to solubilize hydrophobic drug. Genexol-PM showed 3-times higher maximum tolerated dose in mice vs.Taxol. Genexol-PM (vs. Taxol) showed 2-3-fold higher levels of paclitaxel in tissues including liver, spleen, kidney, lung, and tumors. In vivo antitumor efficacy of Genexol-PM was significantly higher than Taxol.Based on results from Phase I and II trials in Korea/US, the therapeutic dose recommended is 300mg/m2, much higher than Taxol (175 mg/m2). With favorable results from Phase II studies - Breast/Lung Cancer, Genexol-PM obtained a pre-market approval in Korea in July 2006A phase IIa pancreatic cancer trial is on-going in US.Patent informationSamyang has registered patents for the drug composition and method ofpreparation for Genexol-PM.The patents are registered in eight countries,including Korea, US, Japan, China, Canada, Mexico, Australia and Europe(EP). Europe includes Great Britain, Germany, Spain, France, Italy, Holland,Belgium, Switzerland and Sweden.- Genexol PM Inj.Genexol-PM was launched in the Korean market for breast cancer and non-small cell lung cancerGenexol-PM was launched in the Korean market for breast cancer and non-small cell lung cancer in February 2007.Market products that utilize paclitaxel, in particular Taxol? (“Taxol”), have encountered limited use due to the toxic side effects of Cremophor EL, which is a component used in the delivery system.Genexol-PM is specifically designed to avoid the use of Cremophor EL by successfully delivering paclitaxel and securing effective results.Genexol-PM is a sterile, lyophilized polymeric micellar formulation of paclitaxel that employs a colloidal carrier system to allow intravenous delivery of paclitaxel without Cremophor EL.Genexol-PM is now undergoing phase IIa clinical trials in the US for the treatment of advanced pancreatic cancer and phase I clinical trials in Korea for the treatment of ovarian cancer.Genexol-PM PaclitaxelThe new formulation is free from toxic surfactant and allows significantly higher dosing of paclitaxel to the patients.Breast Cancer1) First-line treatment of metastatic or recurrent breast cancer.2) Second-line treatment of metastatic breast cancer after failure of standard chemotherapy.Lung Cancer1) First-line treatment of locally advanced or metastatic non-small cell lung cancer.Ovarian cancer1) First-line treatment in combination with other chemotherapeutic agents.Breast CancerGenexol-PM is administered at a dose of 300mg/㎡ intravenously over 3 hours every 3 weeks.Non-small cell lung cancerGenexol-PM is administered over 3 hours intravenously according to the dose below, followed by cisplatin at a dose of 60mg/㎡ intravenously.Dose of Genexol-PM for first cycle : 230mg/㎡Dose of Genexol-PM for second cycle and moreOvarian cancerGenexol-PM is administered at a dose of 260mg/㎡ intravenously over 3 hours every 3 weeks,followed by arboplatin AUC 5mg/mL·min. intravenously.Paclitaxel 30mg /vial , 100mg /vial30mg/5mL，100mg/16.7mLhttps://www.samyangbiopharm.com/eng/ProductIntroduce/injection01