新型抗癌药Trabectedin(Yondelis)Ecteinascidin-743注射用曲贝替定-用于治疗转移性或晚期软组织肉瘤和卵巢癌
曲贝替定(Trabectedin)是首个海洋来源抗肿瘤药，为在海鞘中提取的四氢喹啉类生物碱的半合成品。除了可阻滞肿瘤细胞在G1／G2周期的分化外，还可抑制血管内皮细胞生长因子(VEGF)的分泌及VEGF受体(VEGFR)-1的表达。2004年，其在欧、美已被指定为治疗急性淋巴母细胞白血病、软组织肉瘤和卵巢癌的孤儿药。2007年，EMEA正式批准其用于进展型软组织肉瘤的二线治疗
YONDELIS(trabectedin)曲贝替定注射用，为静脉使用
初次批准：2015
作用机制
曲贝替定是一种烷化剂药物结合DNA小沟中鸟嘌呤残基，形成加合物和导致a bending of the DNA螺旋的弯曲趋向大沟。加合物形成激发事件的级联反应可能影响DNA结合蛋白的随后活性，包括有些转录因子，和DNA修复通路，导致细胞周期的扰动和最终细胞死亡。
适应证和用途
YONDELIS是一种烷化剂药物适用为有不可切除或转移脂肪肉瘤或平滑肌肉瘤患者接受一个以前含蒽环类药物[anthracycline]-方案的治疗。
剂量和给药方法
⑴ 在1.5mg/m2体表面积作为24-小时静脉输注给药，每3周通过一个中央静脉线。
⑵ 预先药物：地塞米松[dexamethasone]20mg IV，每次输注前30分。
剂型和规格
注射用：1mg无菌冰冻干燥粉在一单剂量小瓶
禁忌证
对曲贝替定已知超敏性
警告和注意事项
⑴  中性粒细胞减少败血症：可能发生严重，和致命性，中性粒细胞减少败血症。治疗期间监视嗜中性计数。对2级或更大中性粒细胞减少不给YONDELIS
⑵  横纹肌溶解综合征：可能发生横纹肌溶解综合征；对严重或威胁生命肌酸磷酸激酶水平增加不给YONDELIS
⑶  肝毒性：可能发生肝毒性。监视和如需要时延迟和/或减低剂量
⑷  心肌病变：可能发生严重和致死性心肌病变。有左心功能不全患者不给YONDELIS
⑸  胚胎胎儿毒性：可能致胎儿危害。忠告对胎儿潜在风险和使用有效避孕。
不良反应
最常见(≥20%) 不良反应是恶心，疲乏，呕吐，便秘，食欲减退，腹泻，周边水肿，呼吸困难，头痛。最常见(≥5%)3-4级实验室异常是：中性粒细胞减少，增加的ALT，血小板减少，贫血，增加的AST，和增加的肌酸磷酸激酶。
药物相互作用
⑴ CYP3A抑制剂：避免同时强CYP3A抑制剂
⑵ CYP3A诱导剂：避免同时强CYP3A诱导剂
特殊人群中使用
哺乳：建议不哺乳喂养

Yondelis I.V. infusion（ヨンデリス点滴静注用0.25mg／ヨンデリス点滴静注用1mg）
New release of anticancer agent "Yondelis intravenous infusion" new release - Taiho Pharmaceutical
Acquired manufacturing and marketing approval based on indications of refractory malignant soft tissue tumor
On November 26, Taiho Pharmaceutical Co., Ltd. announced that the anticancer agent "Yondelis (R) 0.25mg/1mg for intravenous infusion" (generic name: Traveectein) was listed as a drug price. Release is scheduled for December.
It is an antineoplastic agent that was created by Pharmamar, Spain. Taiho Pharmaceutical Co., Ltd. signed a licensing agreement with Pharmama for development and marketing in Japan after development in 2009, and in September this year, acquired marketing approval with indications of "malignant soft tissue tumor" did.
Malignant soft tissue tumor is a refractory malignant tumor that develops in the soft tissues of the body (muscle, connective tissue, fat, blood vessel lymphatic vessels, etc).
The annual morbidity rate in Japan is about 2 to 3 people per 100,000 people, and it is said that it is a rare disease of about 5,000 estimated patients.
Established synthetic method with natural material isolated from a kind of ascidian
It is a natural product (an alkaloid compound having three tetrahydroisoquinoline rings) originally isolated from Ecteinascidia turbinata (Ecteinasidia · turbinata) of a squirrel of the Caribbean sea, and now it has established a synthetic method. It is a drug that binds to DNA and has an effect by interfering with cell division, gene transcription, DNA repair mechanisms.
In September 2007, it was approved in Europe for the efficacy and effect of "treatment of advanced malignant soft tissue tumors ineffective for anthracyclines and ifosfamide, or not suitable for administration of these drugs". In the world, it is approved in 78 countries and regions including the United States, Europe, South America, Asia, etc.
Taiho Pharmaceutical Industry expects that it will be one of new treatment options for malignant soft tissue tumors with high unmet/medical needs.

http://www.info.pmda.go.jp/go/pack/4291431D1027_1_05/
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注：以下产品日本上市包装，不同规格和不同价格，采购以咨询为准！
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产地：日本
原产地英文商品名:
Yondelis I.V. infusion（ヨンデリス点滴静注用）0.25mg/vial
原产地英文药品名:
trabectedin
中文参考商品译名:
他比特定冻干粉输注（ヨンデリス点滴静注用）0.25毫克/瓶
中文参考药品译名:
曲贝替定
生产厂家中文参考译名:
大鹏药业
生产厂家英文名:
Taiho Pharmaceutical Co.Ltd

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产地：日本
原产地英文商品名:
Yondelis I.V. infusion（ヨンデリス点滴静注用）1mg/vial
原产地英文药品名:
trabectedin
中文参考商品译名:
他比特定冻干粉输注（ヨンデリス点滴静注用）1毫克/瓶
中文参考药品译名:
曲贝替定
生产厂家中文参考译名:
大鹏药业
生产厂家英文名:
Taiho Pharmaceutical Co.Ltd