盐酸达卡他韦片DACLATASVIR (DAKLINZA 30MG TAB 28)说明书

产地国家:美国

处方药:是

所属类别:30毫克/片 28片/瓶

包装规格:30毫克/片 28片/瓶

计价单位:瓶

生产厂家英文名:ER SQUIBB & SONS LLC

原产地英文商品名:DAKLINZA 30MG TAB 28 =

原产地英文药品名:DACLATASVIR DIHYDROCHLORIDE

中文参考商品译名:DAKLINZA 30毫克/片 28片/瓶

中文参考药品译名:盐酸达卡他韦

简介:

近日,美国食品和药品监管局(FDA)批准Daklinza(daclatasvir)为与索非布韦[sofosbuvir]使用治疗丙型肝炎病毒(HCV)基因型3感染。Daklinza是第一个药物已显示安全性和疗效治疗基因型3 HCV感染无需共同给予干扰素[interferon]或利巴韦林[ribavirin],两个被FDA-批准药是乎预防中心,约2.7百万美国人被HCV感染其中,约10%是基因型3。FDA 的药品评价和研究中心抗微生物产品室主任Edward Cox,M.D. 说:“今天的批准对有基因型3 HCV患者提供一个新选择,包括那些不能耐受利巴韦林患者。”批准日期:2015年7月24日;原研公司:Bristol-Myers Squibb CompanyDAKLINZA™(daclatasvir)片为丙型肝炎病毒(HCV)基因型3感染口服治疗美国初次批准:2015

作用机制:

达卡他韦 是一种对丙型肝炎病毒直接作用抗病毒药(DAA) [见微生物学]。

适应证和用途:

DAKLINZA是一种丙型肝炎病毒(HCV)NS5A抑制剂适用为与索非布韦[sofosbuvir]使用为慢性HCV基因型3感染的治疗。

剂量和给药方法:

⑴ 60mg 口服每天1次有或无食物与索非布韦联用。⑵ 推荐治疗时间:12周。⑶ 剂量修饰与强CYP3A抑制剂减低剂量至30mg每天1次和与中度CYP3A诱导剂增加剂量至90mg每天1次。

剂型和规格:

片:60mg和30mg

禁忌证:

CYP3A的强诱导剂,包括苯妥英钠[phenytoin],卡马西平[carbamazepine],利福平[rifampin],和圣约翰草[St. John’s wort.]。

警告和注意事项:

心动过缓当与索非布韦和胺碘酮共同给药:在服用胺碘酮与索非布韦联用与另一个HCV直接作用药物患者可能发生严重症状性心动过缓,包括DAKLINZA(daclatasvir),尤其是还接受β受体阻滞剂或那些具有潜在心脏合并症和/或晚期肝病患者。建议胺碘酮与DAKLINZA与索非布韦联用不要共同给药。建议在无另外治疗选择患者中监视心脏。

不良反应:

DAKLINZA与索非布韦联用观察到最常见不良反应(≥10%)是头痛和疲乏。

药物相互作用:

DAKLINZA的共同给药可能改变其他药物的浓度和其他药物可能改变daclatasvir的浓度。

包装规格:

[注:以下产品不同规格和不同价格,采购以咨询为准]DAKLINZA 60MG TAB 28 DACLATASVIR DIHYDROCHLORIDE ER SQUIBB & SONS LLC 00003-0215-01DAKLINZA 30MG TAB 28 = DACLATASVIR DIHYDROCHLORIDE ER SQUIBB & SONS LLC 00003-0213-01DAKLINZA TAB 90MG 28 DACLATASVIR DIHYDROCHLORIDE ER SQUIBB & SONS LLC 00003-0011-01

英文版说明书:

Daklinza (daclatasvir)General InformationDaklinza (daclatasvir) is a NS5A replication complex inhibitor.Daklinza is specifically indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.Daklinza is supplied as tablets for oral administration. The recommended dose is 60 mg taken orally once daily with or without food in combination with sofosbuvir. The recommended treatment duration is 12 weeks. Dose modification: reduce dosage to 30 mg once daily with strong CYP3A inhibitors and increase dosage to 90 mg once daily with moderate CYP3A inducers.Clinical ResultsFDA ApprovalThe FDA approval of Daklinza was based on ALLY-3 (AI444-218), an open-label trial that included 152 subjects with chronic HCV genotype 3 infection and compensated liver disease who were treatment-naive (n=101) or treatment-experienced (n=51). Subjects received Daklinza 60 mg plus sofosbuvir 400 mg once daily for 12 weeks and were monitored for 24 weeks post treatment. Sustained virologic response (SVR) was the primary endpoint and was defined as HCV RNA below the LLOQ at post-treatment week 12 (SVR12). The Daklinza plus sofosbuvir regimen demonstrated SVR12 in 90% of treatment-naïve and 86% of treatment-experienced chronic HCV genotype 3 patients. SVR12 rates were higher (96%) in genotype 3 patients without cirrhosis, regardless of treatment history. In the more difficult-to-treat patients with cirrhosis, SVR12 rates were reduced (63%). These SVR12 rates were achieved with 12 weeks of therapy without the use of ribavirin.Side EffectsAdverse effects associated with the use of Daklinza may include, but are not limited to, the following:headachefatiguenauseadiarrheaDaklinza is contraindicated in combination with drugs that strongly induce CYP3A and, thus, may lead to lower exposure and loss of efficacy of Daklinza.Mechanism of ActionDaklinza (daclatasvir) is an inhibitor of NS5A, a nonstructural protein encoded by HCV. Daclatasvir binds to the N-terminus of NS5A and inhibits both viral RNA replication and virion assembly. Characterization of daclatasvir-resistant viruses, biochemical studies, and computer modeling data indicate that daclatasvir interacts with the N-terminus within Domain 1 of the protein, which may cause structural distortions that interfere with NS5A functions.

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