吉匹普雷韦Mavyret(glecaprevir and pibrentasvir Tablets)说明书

产地国家:美国

处方药:是

所属类别: 100毫克/40毫克/片 84片/盒

包装规格: 100毫克/40毫克/片 84片/盒

计价单位:盒

生产厂家英文名:AbbVie

原产地英文商品名:Mavyret Tablet 100mg/40mg/TAB 84TAB/box

原产地英文药品名:glecaprevir/pibrentasvir

中文参考商品译名:Mavyret复方片 100毫克/40毫克/片 84片/盒

中文参考药品译名:吉匹普雷韦/pibrentasvir

简介

近日,丙肝复方新药Mavyret(glecaprevir/pibrentasvir)获FDA批准上市,用于治疗全部6种基因型(GT1-6)慢性丙型肝炎病毒(HCV)成人患者,该药主要面向尚未出现肝硬化的HCV患者,以及HCV初治患者。此外,对于患有代偿性肝硬化或者治疗选择受限(如慢性肾病)的HCV患者,该复方药物同样适用。Maviret由固定剂量的2种特定抗病毒药物组成,其中glecaprevir(G,100mg)是一种NS3/4A蛋白酶抑制剂,pibrentasvir(P,40mg)则是一种NS5A抑制剂。该药治疗疗程为8周。临床试验显示,HCV患者按疗程服用Maviret后,病毒学治愈率达到98%,该疗效优势成为FDA批准其上市的主要理由。批准日期:20178月3期;公司:AbbVie Inc.Mavyret(glecaprevir/pibrentasvir)片 供口服使用美国最初批准:2017年

作用机制

MAVYRET是一种glecaprevir和pibrentasvir的固定剂量组合,它是对丙型肝炎病毒直接作用抗病毒药物[见微生物学]。

适应证和用途

MAVYRET是适用为成年患者有慢性丙型肝炎病毒(HCV)基因型1,2,3,4,5或6感染无肝硬化或有代偿的肝硬化(Child-Pugh A)的治疗。MAVYRET还适用为有HCV 基因型1感染成年患者的治疗,患者以前曽被一个含HCV NS5A抑制剂或一个NS3/4A蛋白酶抑制剂(PI)方案治疗,但不是两者[见剂量和给药方法和临床研究]。

剂量和给药方法

用MAVYRET开始治疗HCV前测试所有患者对当前或以前的证据HBV感染通过测量乙型肝炎表面抗原(HBsAg)和乙型肝炎核心抗体(抗-HBc)[见警告和注意事项]。在成年中推荐剂量MAVYRET是一个固定剂量组合产品在每片含glecaprevir 100mg/pibrentasvir 40mg。MAVYRET的推荐口服剂量是三片(总每天剂量:glecaprevir 300mg/pibrentasvir 120mg)每天1次与食物服用[见临床药理学]。肝受损在有中度肝受损(Child-Pugh B)患者不推荐MAVYRET和在患者有严重肝受损(Child-Pugh C)

剂型和规格

每片MAVYRET含100mg的glecaprevir和40mg的pibrentasvir。片是粉色,椭圆形,膜-包衣,和一侧凹陷有“NXT”。

禁忌证

在有严重肝受损(Child-Pugh C)患者禁忌MAVYRET[见剂量和给药方法,在特殊人群中使用和临床药理学]。MAVYRET是禁忌与阿扎那韦或利福平[见药物相互作用和临床药理学]。

警告和注意事项

在患者与HCV和HBV共感染乙型肝炎病毒再活化的风险乙型肝炎病毒(HBV)再活化曽被报道在HCV/HBV共感染患者正在进行或已完成用HCV直接作用抗病毒药治疗,和患者没有接受HBV抗病毒治疗。有些病例曽导致暴发型肝炎,肝衰竭和死亡。曽报道病例在为HBsAg阳性患者和还有在患者有血清学HBV感染解决的证据(即,HBsAg阴性和抗-HBc阳性)。在接受某些免疫抑制剂或化疗药物患者中也曽报道HBV再活化;在这些患者伴随用HCV直接作用抗病毒药治疗HBV再活化的风险可能被增加。HBV再活化特征为一个在HBV复制突然增加表现为在血清HBV DNA水平中迅速增加。在患者有已解决的HBV感染中可能发生HBsAg的再出现。肝炎可能伴随HBV复制的再活化,即,转氨酶水平增加和,在严重病例中,胆红素水平增加,可能发生肝衰竭,和死亡。开始用MAVYRET治疗HCV前通过测量HBsAg和抗- HBc测试所有患者对当前或以前的证据HBV感染。在患者有血清学HBV感染的证据,用MAVYRET治疗HCV期间和治疗后随访期间监视对临床和实验室肝炎复燃或HBV再活化征象。当临床上有适应证时开始对HBV感染适当处理患者。

包装规格/贮存和处置

MAVYRET被发放在一个4-周(每月)或一个8-周纸盒。每个每周纸盒含7次每天天剂量药包[wallets]。每个每月纸盒含有四个每周纸盒。每个8周纸盒含有2个每月纸盒。每个防儿童每天剂量药包含有三个100mg/40mg glecaprevir/pibrentasvir片。MAVYRET片是粉色,膜包衣,椭圆形,双凹在一侧凹陷有“NXT”。NDC号为:●4-周纸盒:0074-2625-28●8-周纸盒:0074-2625-56贮存在或低于30°C(86°F).

英文版说明书

Receives U.S. FDA Approval of MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT 1-6) in as Short as 8 WeeksThe Food and Drug Administration (FDA) recently approved AbbVie’s Mavyret, the newest treatment for chronic hepatitis C virus infection for people without cirrhosis or with compensated cirrhosis. Mavyret (glecaprevir 100 mg and pibrentasvir 40 mg) is taken once daily (three tablets for a total daily dose of glecaprevir 300 mg and pibrentasvir 120 mg) to treat genotypes 1 through 6.What You Need to Know about MavyretAbbVie’s Mavyret is one pill containing two drugs. Both are direct-acting antivirals (DAAs) which means they directly interfere with hepatitis C virus replication. One drug, glecaprevir is an HCV NS3/4A protease inhibitor. The second drug is pibrentasvir, an NS5A inhibitor.Here is a brief summary of Mavyret:•Mavyret is limited to patients without cirrhosis or with compensated cirrhosis defined as Child-Pugh A.•The recommended dose of Mavyret for people without cirrhosis who have never been treated for hepatitis C is three pills taken daily with food for 8 weeks.•People without cirrhosis who have genotype 1,2,4,5, or 6 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 8 weeks.•People with compensated cirrhosis who have genotype 1,2,4,5, or 6 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 12 weeks.•People with or without cirrhosis who have genotype 3 and prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor are also treated for 16 weeks.•People with or without cirrhosis who have genotype 1 and prior treatment experience with regimens containing ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin are treated for 16 weeks.•People with or without cirrhosis who have genotype 1 and prior treatment experience with regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin are treated for 12 weeks.Warning: The FDA gave Mavyret a boxed warning in its product label concerning the risk of hepatitis B virus reactivation among those coinfected with HBV and HCV. This warning applies to all direct-acting antiviral treatments for hepatitis C.Drug InteractionsMavyret should not be taken with atazanavir or rifampin. Mavyret interferes with some other drugs, most notably carbamazepine, efavirenz and St. John’s wort. Let your doctor and pharmacist know all the drugs (prescription and nonprescription) and supplements that you are taking. Other drugs may interact with Mavyret, but may still be taken as long as they are taken under medical supervision. Some examples are acid-reducing drugs, statins, certain anti-seizure medications, and some HIV and TB drugs.Although some herbs and drugs have the potential to interact with Mavyret, this doesn’t mean you can’t take drugs that may potentially interact. It usually means that your doctor or pharmacist will advise you on how to space out the timing of your medications. To see if a medication you are taking has the potential to interact with Mavyret, see the prescribing information.Adverse Events (Side Effects)The majority of reported side effects were mild; headache, fatigue and nausea were the most common.Pregnancy/breastfeeding Mavyret should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Similarly, the effects of Mavyret on infants whose mothers are breastfeeding are unknown.How effective is Mavyret?Data from nine clinical trials reported cure rates ranging between 92 and 100 percent.

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