新型纳米抗肿瘤药—胶束化紫杉醇,为一种新型放射增敏剂的非小细胞肺癌、乳腺癌、卵巢癌治疗特效药
商标名称：Genexol-PM，Paclitaxel/L01CD01
通用名称：注射用胶束化紫杉醇
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 Biopharm
Genexol 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
Genexol® PM Inj.
Breast Cancer, Lung cancer, Pancreatic caner(cytotoxic chemotheraphy)
Full description
Genexol-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 information
Samyang has registered patents for the drug composition and method of
preparation 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 cancer
Genexol-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 Paclitaxel
The new formulation is free from toxic surfactant and allows significantly higher dosing of paclitaxel to the patients.
Breast Cancer
1) First-line treatment of metastatic or recurrent breast cancer.
2) Second-line treatment of metastatic breast cancer after failure of standard chemotherapy.
Lung Cancer
1) First-line treatment of locally advanced or metastatic non-small cell lung cancer.
Ovarian cancer
1) First-line treatment in combination with other chemotherapeutic agents.
Breast Cancer
Genexol-PM is administered at a dose of 300mg/㎡ intravenously over 3 hours every 3 weeks.
Non-small cell lung cancer
Genexol-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 more
Ovarian cancer
Genexol-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 /vial
30mg/5mL，100mg/16.7mL
http://www.druginfo.co.kr/cp/msd/detail/product_cp.aspx?cppid=203142