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注射用恩夫韦肽(Enfuvirtide,Fuzeon)

2010-12-22 22:26:49  作者:新特药房  来源:中国新特药网天津分站  浏览次数:434  文字大小:【】【】【
简介: 【药品名称】 恩夫韦肽 【通用名称】 注射用恩夫韦肽 【功能/功效】 恩夫韦肽与其它抗逆转录病毒药物联合,用于治疗HIV-1感染的患者。 【注意事项】 与其它抗逆转录病毒药物一样,Fuzeon必须作为联合方 ...

【药品名称】 恩夫韦肽
【通用名称】 注射用恩夫韦肽
【功能/功效】 恩夫韦肽与其它抗逆转录病毒药物联合,用于治疗HIV-1感染的患者。
【注意事项】 与其它抗逆转录病毒药物一样,Fuzeon必须作为联合方案中的一部分使用。
Fuzeon治疗中偶见过敏反应,再次给药后过敏反应复发的现象罕见。不良反应事件包括皮疹、发烧、恶心呕吐、颤抖、僵直、低血压和血清肝转氨酶..
【不良反应】 临床研究中的经验
Fuzeon总体安全性资料来源于不同临床研究中1192名接受至少1剂Fuzeon治疗的患者。安全性研究人群包括1153名成人,其中608名患者已经使用推荐剂量超过24周,和39名儿童患者。
【成人
对成人使..
【孕妇及哺乳期妇女用药】
在应用剂量比人用治疗剂量高8.9倍时,采用大鼠和家兔进行的致畸实验中没有观察到恩夫韦肽对胚胎的发育产生不良影响。但尚未对孕妇进行充分的并且严格对照的研究。只有当潜在利益大于对..
【用法与用量 恩夫韦肽为冻干粉末,使用前需以无菌水溶解后皮下注射给药。如果溶液溶解后不能立即使用,必须保存于2~8℃冰箱中,并在24小时内使用。冷藏的溶液注射前必须加热至室温(例如握在手中5分钟),并且注射前应检查确保溶..
【规格】 每瓶内含恩夫韦肽108毫克,使用时用无菌水溶解成每1毫升含90毫克恩夫韦肽的注射液。
【贮藏】 30℃下保存。
如果本品溶解后不能立即使用,必须保存于2~8℃冰箱中,并在24小时内使用。
【禁忌】 已知对Fuzeon或者其成份过敏的患者禁用

Fusion Inhibitor

Introduction
Please take advantage of the 6th Annual Treatment Guide for positive living with AIDS. Below is a list of current information provided by HIVMagazine.com.
Fuzeon (Enfuvirtide)
The standard dose of Fuzeon is 90 mg,whichisinjected into the upper arm, thigh or abdomen after being “reconstituted,” or mixed with sterile water, twice a day. It is important to rotate the injection site with each dose.

Evaluation: Fuzeon was approved by the FDA in March, 2003. Fuzeon represents a new class of HIV drugs: It is a “fusion inhibitor,” which means that it prevents HIV from fusing with your t-cells.

Fuzeon gives those who have developed resistance to other HIV drugs a second chance. The drug was not tested on newly diagnosed patients, but instead tests were conducted among long-term HIV patients who had taken an average of a dozen anti-HIV drugs in the past. Those who added Fuzeon to a multiple-drug regimen selected by their doctor were much more likely to have increased T-cell counts and undetectable viral loads than those who did not.

There are drawbacks to the drug, however. For one thing, it doesn’t come in pill form. It is an injectable medication, which means that those who take it have to give themselves two shots a day. The process of “reconstituting” the drug—mixing it with sterile water before you inject it—is time-consuming and has to be done just right. Many people have an adverse reaction at the injection site. And because the drug is very difficult to manufacture, it is very expensive—reportedly as much as $25,000 for a year’s supply.

When Fuzeon was first approved it was expected that demand would far exceed supply—but that hasn’t happened so far. Many people have had trouble getting reimbursement for the drug through ADAP or Medicaid, and others are reluctant to use an injection drug. It is still a valuable resource for those who have run out of other options.

产品名称 注射用恩夫韦肽
英文名称 Enfuvirtide for Injection
英文商品名 Fuzeon
产品分类 抗感染药\抗病毒药\抗HIV药\其它抗HIV药
注册证号 H20050550
产品剂型 粉针剂
产品规格 108mg
包装规格 60瓶/盒,60支/盒
生产企业 Roche Pharma(Schweiz)Ltd.

责任编辑:admin


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Fuzeon是第一个也是惟一个用于治疗HIV的融合(fusion)抑制剂的24周ⅡB期临床试验
 

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