依沙匹隆冻干粉注射剂IXEMPRA KIT FOR INJ 15MG SDV

药店国别:

产地国家:美国

处方药:是

所属类别: 15毫克/套件

包装规格: 15毫克/套件

计价单位:套件

生产厂家中文参考译名:

生产厂家英文名:R-PHARM US

原产地英文商品名:IXEMPRA KIT FOR INJ 45MG SDV 1/EA

原产地英文药品名:IXABEPILONE

中文参考商品译名:IXEMPRA冻干粉注射剂 15毫克/套件

中文参考药品译名:伊沙匹隆

简介

部份中文依沙匹隆处方资料(仅供参考)

英文药名: Ixempra(Ixabepilone Injections)

中文药名: 伊沙匹隆注射剂

研发厂家:施贵宝公司

药品介绍

Ixempra(Ixabepilone,伊沙匹隆)是一种类似紫杉醇微管蛋白聚合和抑制微管解聚活性的埃坡霉素(epothilones)类抗肿瘤化疗新药,由施贵宝公司研发生产。

2007年10月FDA批准Ixempra单药或与卡培他滨联用用于治疗蒽环类、紫杉烷衍生物和卡培他滨治疗无效的转移性或局部进展的晚期乳腺癌。埃坡霉素(epothilones):是一类十六元环的大环内酯类药物,最早由Holfe和Reichenbach两人在1992年从粘细菌Sorangium cellulosum种中分离得到,Ixabepilone(BMS-247550)是半合成epothilone β内酰胺类似物,属于新一代抗有丝分裂药物,其作用机制与紫杉醇类药物(taxanes)类似,可与微管蛋白结合导致癌细胞无法顺利进行有丝分裂,进而使癌细胞产生凋亡,在抗肿瘤谱、抗肿瘤活性、安全性、水溶性及合成方法等方面均优于紫杉醇。

Ixempra是第一个埃博霉素类全新抗肿瘤药物,可与微管蛋白结合而导致癌细胞不能顺利进行有丝分裂,最终使肿瘤细胞凋亡。Ixempra具有全新的化学结构,与紫杉类具有不同的微管结合位点,因此具有更强的抗肿瘤活性。而且,Ixempra对肿瘤耐药机制易感性低。

英文版说明书

IXEMPRA RxGeneric Name and Formulations:Ixabepilone 15mg/vial, 45mg/vial; pwd for IV infusion after constitution and dilution; diluent contains alcohol, polyoxyethylated castor oil.Company:Bristol-Myers SquibbIndications for IXEMPRA:Metastatic or locally advanced breast cancer: In combination with capecitabine after failure of an anthracycline and a taxane; and as monotherapy after failure of an anthracycline, a taxane, and capecitabine.Adult:Pretreat with both H1 and H2 blockers 1hr before infusion; and with steroid if previous hypersensitivity reaction occurred. 40mg/m2 by IV infusion over 3hrs, once every 3wks. Use max body surface area (BSA) of 2.2m2 to calculate dose if BSA >2.2m2. Moderate hepatic impairment (as monotherapy): initially 20mg/m2 per dose; max 30mg/m2 per dose (see literature). Neuropathy, myelosuppression, concomitant strong CYP3A4 inhibitors: reduce dose. Concomitant strong CYP3A4 inducers: consider gradual dose increases. See literature.Children:Not recommended.Pharmacological Class:Epothilone microtubule inhibitor.Contraindications:Baseline neutrophils <1500cells/mm3 or platelets <100,000cells/mm3. AST or ALT >2.5XULN or bilirubin >1XULN (in combination with capecitabine).Warnings/Precautions:Monitor CBC and liver function at baseline, then periodically. Hepatic impairment (ALT or AST >10XULN or bilirubin >3XULN: not recommended; ALT or AST >5XULN: limited data, use caution). Diabetes. Neuropathy. Cardiac disease (discontinue if cardiac ischemia or cardiac dysfunction occurs). Monitor for signs/symptoms of neuropathy, neutropenia. Pregnancy (Cat.D), nursing mothers: not recommended.Interactions:Potentiated by strong CYP3A4 inhibitors (eg, azole antifungals, protease inhibitors, certain macrolides, nefazodone, grapefruit juice); avoid. Caution with mild or moderate CYP3A4 inhibitors; consider alternative agents. Antagonized by strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, dexamethasone, phenobarbital); avoid. Avoid St. John’s wort.Adverse Reactions:Peripheral sensory neuropathy, fatigue, asthenia, myalgia, arthralgia, alopecia, GI upset, stomatitis, mucositis, musculoskeletal pain, palmar-plantar erythrodysesthesia syndrome, anorexia, abdominal pain, nail disorder, constipation; myelosuppression (neutropenia, leukopenia, anemia, thrombocytopenia); hypersensitivity reactions; others.How Supplied:Kit—1 vial (w. diluent)

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