苯达莫司汀,苯达莫司汀TREAKISYM Injection 100mg( トレアキシン点滴静注用)

药店国别:

产地国家:日本

处方药:

所属类别: 100毫克/毫升/瓶

包装规格: 100毫克/毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:Eisai Co.Ltd

原产地英文商品名:TREAKISYM(トレアキシン点滴静注用)100mg/ml/vial

原产地英文药品名:Bendamustine Hydrochloride

中文参考商品译名:TREAKISYM冻干粉(トレアキシン点滴静注用)100毫克/毫升/瓶

中文参考药品译名:盐酸苯达莫司汀

曾用名:

简介

部份中文盐酸苯达莫司汀处方资料(仅供参考)

通用名称:盐酸苯达莫司汀冻干粉针

商标名:TREAKISYM Injection

规格:25mg

适应症:

1.慢性淋巴细胞白血病(CLL)。不同于苯丁酸氮芥的一线疗法的疗效尚未确立。

2.在利妥昔单抗(rituximab,美罗华)或含利妥昔单抗方案治疗过程中,或者治疗6个月内,病情仍然进展的惰性B细胞非霍奇金淋巴瘤(NHL)患者。

作用机理

本品是一种双功能基烷化剂,可以导致DNA单链和双链通过烷化作用交联,打乱DNA 的功能和DNA的合成,使DNA和蛋白之间,以及蛋白和蛋白之间产生交联,从而发挥抗肿瘤作用。国内外生产使用情况盐酸苯达莫司汀于1963年在德国耶拿的微生物试验*研制成功。

1971~1992年由Jenapharm公司以商品名Cytostasan®生产。

1993年后,由Ribosepharm公司以商品名Ribomustine®在德国上市销售用于治疗乳腺癌、慢性淋巴细胞性白血病。

2008年3月20日,由Cephalon公司开发并经美国FDA批准用于治疗慢性淋巴细胞白血病(CLL),商品名为Treanda®;同年10月31日该药又获准用于惰性B细胞非霍奇金淋巴瘤(NHL)的治疗。

2010年10月获日本批准上市,用于低度恶性B细胞非霍奇金淋巴瘤和套细胞淋巴瘤和慢性淋巴细胞白血病。

商品名为:TREAKISYM Injection®

产品特点

①疗效确切,能明显降低复发率与死亡率,且不良反应小,安全性好,起效迅速,作用持久;

②本品在31至84岁人群中的药代动力学指标(AUC和Cmax)显示:65周岁以上或以下患者之间没有明显区别;

③在儿童患者上的有效性虽尚未建立。但通过白血病儿童患者的I、II期临床试验评估,其安全性与成人体内基本相似;

④随着深入临床研究,未来可能扩大到儿童用药;

⑤R-CHOP方案(环磷酰胺、多柔比星、长春新碱、泼尼松加利妥昔单抗)是目前晚期惰性淋巴瘤和套细胞淋巴瘤老年患者的一线标准治疗。

苯达莫司汀单药治疗利妥昔单抗耐药的B细胞惰性淋巴瘤可提高疗效,且耐受性良好。研究发现苯达莫司汀联合利妥昔单抗较之传统R-CHOP更有效且毒性更小,耐受性更好。《柳叶刀》杂志的一项研究,苯达莫司汀联合利妥昔单抗治疗方案可以替代标准治疗,用于新诊断的惰性非霍奇金淋巴瘤(NHL)和套细胞淋巴瘤(MCL)患者。

英文版说明

Anticancer agent "Treaxin ® for intravenous infusion 100 mg", released in JapanEisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced that in Japan, an anti-cancer agent "Treaxin ® for intravenous drip infusion 100 mg" for indications of low-grade B cell non-Hodgkin's lymphoma and mantle cell lymphoma (Generic name: bendamustine hydrochloride, hereinafter "Treaxin ®") on December 10th.This product will be the first anti-cancer drug in Japan in Japan, and will be fully deployed to the oncology field in Japan following the United StatesSymbio Pharmaceutical Co., Ltd. (Head office: Tokyo, President: Fumi Yoshida, hereinafter, Symbio) got approval for manufacturing and marketing on October 27 this year and was listed on the drug price on December 10. Based on the license agreement in Japan concluded with Symbio, we will sell.Our company's promotion system of cancer area in Japan will arrange specialized academic staff specializing in cancer area in each area and about 1,400 domestic MRs will provide information. Regarding this drug, we will smoothly carry out the specified use record survey (all cases study) which is specified as the approval condition and promote effective, safe and proper use of this drug."Torexin®" is a new type of anticancer drug with an alkylating agent having a nitrogen mustard skeleton and an antimetabolite-like structure. This product has a high response rate and long-term progression-free survival in Japanese clinical trials, and excellent efficacy was confirmed. In particular, a single complete response to recurrent mantle cell lymphoma confirmed a high complete response rate. The main side effects are reported as myelosuppression, nausea, vomiting, infectious diseases, vasculitis, vascular pain, etc. but shows a manageable and well tolerable safety profile. Today, Symbio is conducting Phase II clinical trials for relapse or refractory middle- and high-grade B-cell non-Hodgkin's lymphoma and untreated multiple myeloma with the aim of adaptation addition.It is estimated that the number of non-Hodgkin's lymphomas in Japan is about 12,000 per year, and it is said to be increasing trend in recent years. Among them, patients with low-grade malignancy often repeat recurrence even if initial remission is observed by initial treatment, and it is known that there are very few cases where the life-extension period is long but the case of recovery is complete. In addition, mantle cell lymphoma is a disease type with less frequent onset, it is often found in advanced stages, and standard treatment is not yet established.We regard the oncology field as a top priority area, and following the "Torexin®" product, the first anti-cancer drug in Japan, a new anti-cancer drug that we are applying for in adaptation for breast cancer We will further enhance products in the field of cancer-related diseases in Japan, such as agent "Eribulin" (generic name), and will further contribute to the satisfaction of diverse needs of cancer patients and their families.[An overview of bendamustine hydrochloride and products and product photographs are attached as reference materials]Reference material1. About bendamustine hydrochlorideBendamustine hydrochloride is an anticancer drug synthesized by Jena Pharma AG of the former East Germany and is now being used as a therapeutic agent for non-Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia, etc. in European countries "Ribomustin® "Or" Levact® "under the product name. In the United States, it is marketed under the product name "TREANDA®" as a remedy for chronic lymphocytic leukemia and recurrent B-cell non-Hodgkin's lymphoma.We have exclusive licensing agreement for joint development and sales in Japan in August 2008 with Symbio in relation to this product, exclusive for development and sales targeting two countries in Singapore and Korea in May 2009 We have a license agreement. In Singapore, our Singapore subsidiary, Eisai (Singapore) Pte. Ltd., has been on sale in September 2010 under the product name "Symbenda®" as a treatment for low grade non-Hodgkin's lymphoma and chronic lymphocytic leukemia2. Product overview of "Torexin®"product name:Treaxin for intravenous drip infusion 100 mgcommon name:Bendamustine hydrochlorideIndications/effects:Recurrent or refractory diseaseLow-grade B-cell non-Hodgkin's lymphomaMantle cell lymphomaDosage/administration:Usually, adults receive 120 mg / ㎡ (body surface area) as bendamustine hydrochloride intravenously over 1 hour once a day. Dose is administered for 2 consecutive days, followed by withdrawal for 19 days. Repeat administration with this as one cycle. Incidentally, weight reduction is made according to the condition of the patient.

 

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