索非布韦片SOFOSBUVIR(SOVALDI TAB 400mg)说明书

产地国家:美国

处方药:是

所属类别: 400毫克/片 28片/瓶

包装规格: 400毫克/片 28片/瓶

计价单位:瓶

生产厂家英文名:GILEAD SCIENCES INC

原产地英文商品名:SOVALDI 400MG/Tablets 28Tablets/bottle

原产地英文药品名:SOFOSBUVIR

中文参考商品译名:SOVALDI 400毫克/片 28片/瓶

中文参考药品译名:索非布韦

简介

近日,美国食品药品监督管理局(FDA)批准Sovaldi(sofosbuvir)治疗慢性丙型肝炎病毒(HCV)感染。Sovaldi是第一个无需与干扰素的共同给药的药物已被证实安全和有效治疗某些类型HCV感染。FDA药物评价和研究中心抗微生物产品室主任Edward Cox,医学博士说:“今天批准代表对有慢性丙型肝炎患者治疗范例的显著转变”。批准日期:2013年12月6日;公司:Gilead SciencesSOVALDITM (sofosbuvir)片,为口服使用美国初次批准:2013

作用机制

Sofosbuvir是一种对丙型肝炎病毒直接作用抗病毒药[见微生物学].

适应证和用途

SOVALDI是一种丙型肝炎病毒(HCV)核苷酸类似物NS5B聚合酶抑制剂适用为慢性丙型肝炎(CHC)感染的治疗作为组合抗病毒治疗方案的一个组分。(1)SOVALDI疗效已在有HCV基因型1,2,3或4感染受试者中被确定,包括有肝细胞癌符合米兰[Milan]标准(等待肝移植)和有HCV/HIV-1共-感染受试者。

剂量和给药方法

(1)一片400 mg片每天1次有或无食物服用。(2)应与利巴韦林[ribavirin]联用或与聚乙二醇化干扰素[pegylated干扰素]和利巴韦林联用为CHC的治疗。建议联合治疗:(3)SOVALDI与利巴韦林联用共24周干扰素不合格可被考虑为被基因型1感染CHC患者。(4)在有肝细胞癌等待肝移植直至48周或直至肝移植患者应被与联用利巴韦林为CHC的治疗,以先发生为准。(5)对有严重肾受损或肾病终末期患者不能建议剂量。

剂型和规格片:400mg。

禁忌证

(1)当与聚乙二醇干扰素α/利巴韦林或单独利巴韦林联用时,对聚乙二醇干扰素α和/或利巴韦林的所有禁忌证也都应用于SOVALDI联合治疗。(2)因为利巴韦林可能引起出生缺陷和胎儿死亡,在妊娠妇女和男性其女性伴侣妊娠时禁忌SOVALDI与聚乙二醇干扰素α/利巴韦林或利巴韦林联用。

警告和注意事项

妊娠:利巴韦林可能致出生缺陷和胎儿死亡和动物研究已证明干扰素有流产效应;女性患者和男性患者的女性伴侣避免妊娠。治疗开始前患者必须有一个阴性妊娠测试,使用至少2种有效非激素避孕方法和每月妊娠测试。

不良反应

SOVALDI与利巴韦林联用观察到最常见不良事件(发生率大于或等于20%,所有级别)是疲乏和头痛。SOVALDI与聚乙二醇干扰素α和利巴韦林联用观察到最常见不良事件是疲乏,头痛,恶心,失眠和贫血。

药物相互作用

药物是强肠道P-gp诱导剂(如,利福平[rifampin],圣约翰草[St. John’s wort])可能改变sofosbuvir的浓度。对潜在药物-药物相互作用使用前咨询完整咨询资料。

特殊人群中使用

(1)有HCV/HIV-1共-感染患者: 曾研究安全性和疗效。(2)有肝细胞癌等待肝移植患者: 曾研究安全性和疗效。

包装供应/贮存和处置

SOVALDI片是黄色,胶囊形,薄膜包衣片含400 mg sofosbuvir一侧凹陷有“GSI”和另一侧“7977” 。每瓶含28片(NDC 61958-1501-1),硅胶干燥剂,聚酯线圈和用一种阻止儿童盖关闭。贮存在室温低于30 °C (86 °F)。只在原装容器内分发。如果瓶密封盖打开破坏或丢失时不要使用。

英文版说明书

TORONTO – Health Canada has approved a once-daily tablet for the treatment of chronic hepatitis C that could transform treatment of the disease for thousands of Canadians.The drug Sovaldi (sofosbuvir) is to be taken in combination with older medications to treat the main forms of hepatitis C, which is caused by a blood-borne virus. Left untreated, the disease can lead to liver failure, cirrhosis and cancer.An estimated 250,000 Canadians are living with chronic hepatitis C. But because the disease can take many years to progress without causing noticeable symptoms – even up to two or three decades -about 35 per cent have no idea they are infected.Baby boomers are disproportionately affected by hepatitis C: they are five times more likely than people of other age groups to have contracted the virus, often from sharing needles for IV drug use or having sex with an infected person during their youth.The Canadian Liver Foundation recommends that all Canadians born between 1945 and 1965 be tested for the virus.Current treatments for the hepatitis C virus (HCV), which can take up to a year to complete, involve weekly injections of a drug that causes flu-like side-effects and cures about three out of four patients.In clinical trials, 90 per cent of patients taking a single daily Sovaldi pill in combination with an older drug cocktail were cured in 12 weeks. However, the length of treatment and specific drug combination used depends on which of several genetic subtypes of the virus has caused a person’s infection.The current standard of care for HCV in Canada involves up to 48 weeks of therapy with an interferon drug, which may not be suitable for certain patients.”I believe sofosbuvir has the potential to transform HCV treatment in Canada as it addresses many unmet patient needs,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital. “The high cure rates, shortened treatment duration and potential to eliminate or reduce interferon injections give us our best opportunity to successfully treat Canadians with hepatitis C.”Sovaldi is made by Gilead Sciences Inc., based in Foster City, Calif., one of a half-dozen companies battling over the market for more effective hepatitis C treatments.Gilead Sciences Canada said Monday the cost of Sovaldi to consumers won’t be available until the prescription drug goes on sale in pharmacies in early January, as the company is currently finalizing the price with regulatory authorities.In the U.S., where the drug was approved by the FDA about two weeks ago, the parent company said a 12-week supply of Sovaldi would cost $84,000. That price could as much as double for patients with a subtype of the disease that would require them to take the drug longer.Gilead Sciences Canada said it will launch a program Jan. 6 to provide support services for patients and health-care providers, including access to case managers to help with insurance-related needs. Another program will provide financial assistance for eligible patients who need help paying for out-of-pocket medication costs.

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