China's Alfosbuvir(奥磷布韦片):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Alfosbuvir

Alfosbuvir Tablets is a pan-genotypic direct-acting antiviral agent for chronic hepatitis C. Clinical Phase III studies have shown that its combination therapy regimen achieves a sustained virologic response rate at 12 weeks post-treatment (SVR12) of 98.5%, and demonstrates superior efficacy in difficult-to-treat genotype 3 (GT-3) patients.

Indications

Alfosbuvir in combination with daclatasvir hydrochloride is indicated for the treatment of chronic hepatitis C virus (HCV) infection of genotypes 1, 2, 3 and 6 in adult patients who are treatment-naive or interferon-experienced, with or without compensated cirrhosis.

Overview

Generic Name

Alfosbuvir Tablets,奥磷布韦片

Brand Name

圣诺迪

Drug Type

Rx Drug

Approval No.

国药准字H20230010

Active Ingredient

Alfosbuvir

Dosage Form

100mg*42tablets

Specification

Tablets

Description

This product is a yellow film-coated tablet, appearing white or off-white after the coating is removed.

Expiry Date

12 months

Manufacturer

Nanjing Sanhome Pharmaceutical Co., Ltd.

Storage

Store in a sealed container, protect from light, and keep the temperature below 25℃.

Dosage and Administration

Alfosbuvir is administered orally, either on an empty stomach or with food.

Recommended Dosage and Administration

This product should be used in combination with daclatasvir hydrochloride.

The recommended dosage of this product is 600 mg (6 tablets) administered orally once daily for 12 consecutive weeks. Concomitantly, daclatasvir hydrochloride tablets should be administered orally at a dose of 60 mg (1 tablet) once daily for 12 consecutive weeks.

Carcinogenicity studies of alfosbuvir in animals have not been completed, and the total course of treatment with this drug shall not exceed 12 weeks.

Contraindications

Hypersensitivity to the active ingredient or any of the following excipients is a contraindication:

Tablet core: Crospovidone, Microcrystalline cellulose, Lactose, Croscarmellose sodium, Magnesium stearate.

Film coating: Hypromellose, Lactose, Triacetin, Titanium dioxide, Yellow ferric oxide.

Adverse Reactions

In key Phase III clinical trials, the main adverse reactions observed during treatment and within 12 weeks after drug discontinuation are listed in Table 1, including hypercholesterolemia, hyperlipidemia, hypertriglyceridemia, increased total bile acids, elevated blood bilirubin, elevated amylase, dizziness, neutropenia, elevated blood triglycerides, elevated lipase, elevated aspartate aminotransferase, hypothyroidism, elevated conjugated bilirubin and elevated blood cholesterol. Most adverse reactions are mild or moderate in severity.

Special Populations

Pregnancy and Lactation

Pregnancy

There are no available clinical data on the safety of Alfosbuvir in pregnancy. As a precautionary measure, Alfosbuvir is contraindicated in pregnant women. Strict contraceptive measures should be adopted during the treatment period. In case of pregnancy, the drug should be discontinued and the patient should consult an obstetrics and gynecology specialist immediately. For safety information of daclatasvir hydrochloride tablets in pregnant women, refer to the package insert of daclatasvir hydrochloride tablets.

Lactation

No study data are available on the use of Alfosbuvir in lactating women, and it is unknown whether this product and/or its metabolites are excreted in human milk. Animal experimental data show that Alfosbuvir and its metabolites are excreted in milk in small amounts, and the potential risks to neonates or infants cannot be excluded. Therefore, Alfosbuvir tablets should not be used during lactation.

Fertility

No data are available on the effects of Alfosbuvir on human fertility. In animal studies of fertility and early embryonic development toxicity, oral gavage administration of Alfosbuvir to rats at different doses did not result in abnormal effects on fertility and early embryonic development, and the no-observed-adverse-effect level (NOAEL) in this study was 1000 mg/kg.

Pediatric Use

The safety and efficacy of Alfosbuvir in patients under 18 years of age have not been established.

Geriatric Use

Phase Ⅱ/Ⅲ clinical studies of Alfosbuvir included 36 patients aged 65 years and older. Subgroup analysis showed no obvious correlation between age and virologic response rate. All patients aged 65 years and older achieved sustained virologic response at 12 weeks post-treatment, with a response rate basically consistent with that of younger patients. The incidence and severity of adverse reactions in patients aged 65 years and older were also generally comparable to those in younger patients.

For more detailed drug information, please consult the official package leaflet.