替诺福韦艾拉酚胺tenofovir alafenamide,TAF(Vemlidy Tablets 25mg)说明书

产地国家:美国

处方药:是

所属类别: 25毫克/片 30片/瓶

包装规格: 25毫克/片 30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:Vemlidy 25mg/tablet 30tablets/bottle

原产地英文药品名:tenofovir alafenamide,TAF

中文参考商品译名:Vemlidy片 25毫克/片 30片/瓶

中文参考药品译名:替诺福韦艾拉酚胺

简介

近日,Gilead宣布FDA批准Vemlidy(替诺福韦艾拉酚胺,TAF)25mg每日1次用于治疗伴有代偿性肝病的慢性乙肝病毒(HBV)感染患者。Vemlidy是一种创新型、靶向性、Tenofovir(替诺福韦)前药,与先前产品300mg的Viread(tenofovir disoproxil fumarate, TDF) 相比,只需要少于十分之一的剂量便可获得相似的抗病毒效用。

批准日期:2016年11月10日

公司:Gilead Sciences,Inc.

VEMLIDY(替诺福韦艾拉酚胺 tenofovir_alafenamide)片,为口服使用

美国初始批准:2015

作用机制

替诺福韦艾拉酚胺是对乙型肝炎病毒的抗病毒药物[见微生物学].

适应证和用途

VEMLIDY是一种乙型肝炎病毒(HBV)核苷类似物逆转录酶抑制剂和是适用为在有代偿的肝病成年中慢性乙型肝炎病毒感染的治疗。

剂量和给药方法

测试:VEMLIDY开始前,测试患者HIV感染。有HIV感染患者不应单独使用VEMLIDY。VEMLIDY开始前和期间治疗后乙型肝炎的严重急性加重在所有患者当临床上适当评估血清肌酐,血清磷,估算肌酐清除率,尿糖,和尿蛋白。

推荐剂量:25mg(一片)与食物口服服用每天1次。● 肾受损:在有估算肌酐清除率低于15mL每分患者中建议不用VEMLIDY。● 肝受损:在有失代偿(Child-Pugh B或C)肝受损患者中建议不用VEMLIDY.剂型和规格片:25mg的替诺福韦艾拉酚胺.

禁忌证:无.

警告和注意事项

HBV和HIV-1共感染:建议不单独使用VEMLIDY为HIV-1感染的治疗。在这些患者中可能发生HIV-1耐药性。新发作或恶化的肾受损:建议VEMLIDY治疗乙型肝评估血清肌酐,血清磷,估算肌酐清除率,尿糖,和尿蛋白。

不良反应

最常见不良反应(发生率大于或等于5%,所有级别)是头痛,腹痛,疲乏,咳嗽,恶心,和背痛。

药物相互作用

VEMLIDY是一种P-糖蛋白(P-gp)和BCRP的底物。强烈影响P-gp和BCRP活性药物可能导致在VEMLIDY吸收中变化。在治疗前和期间咨询完整处方资料对潜在药物-药物相互作用。

如何供应/贮存和处置

VEMLIDY片含25mg的替诺福韦艾拉酚胺是黄色,圆形,薄膜-包衣,在一侧凹陷有“GSI”和另一侧上“25”。每小瓶含30片(NDC 61958-2301-1),一个硅胶干燥剂,聚酯线圈,和用防儿童开启封闭。贮存在30 °C(86 °F)以下。● 保持容器密闭。● 仅在原始容器内分发。

英文版说明书

Approved TAF [Vemlidy] for HBVFDA approved VEMLIDY (tenofovir alafenamide) 25 mg tablets. VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.Prior to initiation of VEMLIDY, test patients for HIV infection. VEMLIDY alone should not be used in patients with HIV infection. Assess serum creatinine, serum phosphorous, estimated creatinine clearance, urine glucose, and urine protein before initiating VEMLIDY and during therapy in all patients as clinically appropriate.The recommended dosage is 25 mg (one tablet) taken orally once daily with food No dosage adjustment of VEMLIDY is required in patients with mild, moderate, or severe renal impairment. VEMLIDY is not recommended in patients with end stage renal disease (estimated creatinine clearance below 15 mL per minute)No dosage adjustment of VEMLIDY is required in patients with mild hepatic impairment (Child-Pugh A). VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairmentWARNINGS AND PRECAUTIONS⋅HBV and HIV-1 coinfection: VEMLIDY alone is not recommended for the treatment of HIV-1 infection. HIV-1 resistance may develop in these patients.⋅New onset or worsening renal impairment: Assessment of serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein is recommended before initiating VEMLIDY therapy and during therapy as clinically appropriate.ADVERSE REACTIONSMost common adverse reactions (incidence greater than or equal to 5%, all grades) are headache, abdominal pain, fatigue, cough, nausea, and back pain.DRUG INTERACTIONSVEMLIDY is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions Established and Other Potentially Significant Drug InteractionsaCLINICAL STUDIES14.1 Clinical Trials in Adults with Chronic Hepatitis B Virus Infection and Compensated Liver DiseaseThe efficacy and safety of VEMLIDY in the treatment of adults with chronic hepatitis B virus infection with compensated liver disease are based on 48-week data from two randomized, double-blind, active-controlled studies, Study 108 (N=425) and Study 110 (N=873). In both studies, besides study treatment, patients were not allowed to receive other nucleosides, nucleotides, or interferon.In Study 108, HBeAg-negative treatment-naïve and treatment-experienced subjects with compensated liver disease (no evidence of ascites, hepatic encephalopathy, variceal bleeding, INR <1.5x ULN, total bilirubin <2.5x ULN, and albumin >3.0 mg/dL) were randomized in a 2:1 ratio to receive VEMLIDY 25 mg (N=285) once daily or tenofovir disoproxil fumarate 300 mg (N=140) once daily for 48 weeks. The mean age was 46 years, 61% were male, 72% were Asian, 25% were White, 2% were Black, and 1% were other races. 24%, 38%, and 31% had HBV genotype B, C, and D, respectively. 21% were treatment experienced [previous treatment with oral antivirals, including entecavir (N=41), lamivudine (N=42), tenofovir disoproxil fumarate (N=21), or other (N=18)]. At baseline, mean plasma HBV DNA was 5.8 log10 IU/mL, mean serum ALT was 94 U/L, and 9% of subjects had a history of cirrhosis.In Study 110, HBeAg-positive treatment-naïve and treatment-experienced subjects with compensated liver disease were randomized in a 2:1 ratio to receive VEMLIDY 25 mg (N=581) once daily or tenofovir disoproxil fumarate 300 mg (N=292) once daily for 48 weeks. The mean age was 38 years, 64% were male, 82% were Asian, 17% were White, and 1% were Black or other races. 17%, 52%, and 23% had HBV genotype B, C, and D, respectively. 26% were treatment experienced [previous treatment with oral antivirals, including adefovir (N=42), entecavir (N=117), lamivudine (N=84), telbivudine (N=25), tenofovir disoproxil fumarate (N=70), or other (n=17)]. At baseline, mean plasma HBV DNA was 7.6 log10 IU/mL, mean serum ALT was 120 U/L, and 7% of subjects had a history of cirrhosis.In both studies, randomization was stratified on prior treatment history (nucleoside naïve or experienced) and baseline HBV DNA (<7, ≥7 to <8, and ≥8 log10 IU/mL in Study 108; and <8 and ≥8 log10 IU/mL in Study 110). The efficacy endpoint in both trials was the proportion of subjects with plasma HBV DNA levels below 29 IU/mL at Week 48. Additional efficacy endpoints include the proportion of subjects with ALT normalization, HBsAg loss and seroconversion, and HBeAg loss and seroconversion in Study 110.Treatment outcomes of Studies 108 and 110 at Week 48 are presented in Table 9 and Table 10.a. Missing = failure analysisb. Adjusted by baseline plasma HBV DNA categories and oral antiviral treatment status strata.c. Treatment-naïve subjects received <12 weeks of oral antiviral treatment with any nucleoside or nucleotide analog including TDF or VEMLIDY.d. Includes subjects who discontinued due to lack of efficacy, adverse event or death, for reasons other than an AE, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc., or missing data during Week 48 window but still on study drug. In Study 108, the proportion of subjects with cirrhosis who achieved HBV DNA <29 IU/mL at Week 48 was 92% (22/24) in the VEMLIDY group and 93% (13/14) in the TDF group. The corresponding proportions in Study 110 were 63% (26/41) and 67% (16/24) in the VEMLIDY and TDF groups, respectively.a. Missing = failure analysisb. The population used for analysis of ALT normalization included only subjects with ALT above upper limit of normal (ULN) of the central laboratory range (>43 U/L for males aged 18 to <69 years and >35 U/L for males ≥69 years; >34 U/L for females 18 to <69 years and >32 U/L for females ≥69 years) at baseline. c. The population used for analysis of ALT normalization included only subjects with ALT above ULN of the American Association of the Study of Liver Diseases (AASLD) criteria (>30 U/L males and >19 U/L females) at baseline. d. The population used for serology analysis included only subjects with antigen (HBeAg) positive and anti-body (HBeAb) negative or missing at baseline.This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895

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