China's Emitasvir(磷酸依米他韦胶囊):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Emitasvir

As the first approved innovative drug of East Sunshine Pharmaceutical, its launch has not only filled the market gap for domestic NS5A inhibitors for hepatitis C and greatly improved the accessibility and affordability of drugs for hepatitis C treatment in China, but also provided an important domestic drug option for the prevention and treatment of hepatitis C in our country.

Indications

Emitasvir Phosphate Capsules must be used in combination with Sofosbuvir Tablets for the treatment of chronic hepatitis C of genotype 1 in adult patients without cirrhosis.

Emitasvir Phosphate Capsules must not be used as monotherapy.

Overview

Generic Name

Emitasvir Phosphate Capsules,磷酸依米他韦胶囊

Brand Name

东卫恩

Drug Type

Rx Drug

Approval No.

国药准字H20200015

Active Ingredient

Emitasvir Phosphate

Dosage Form

0.1g*28capsules

Specification

Capsules

Description

The contents of Emitasvir Phosphate Capsules are white to pale yellow powder.

Expiry Date

18 months

Manufacturer

Yichang East Sunshine Yangtze Pharmaceutical Co., Ltd.

Storage

Sealed, store below 30℃.

Dosage and Administration

The recommended dose of Emitasvir Phosphate Capsules is 1 capsule (0.1g) once daily, taken orally on an empty stomach (it is recommended that the interval between administration and meals be at least 2 hours). This product must not be used as monotherapy. It should be taken concomitantly with 400mg Sofosbuvir Tablets when administered. Consult a physician for the specific administration time.

Missed Dose

If a single dose of Emitasvir Phosphate Capsules is missed and it occurs within 18 hours after the scheduled administration time, the missed dose should be taken as soon as possible, and the next dose should then be taken at the patient's usual scheduled time. If more than 18 hours have passed, the missed dose should not be taken; the patient should wait and take the next dose at the usual scheduled time. A double dose must not be taken at one time.

For information on missed doses of Sofosbuvir Tablets in the treatment regimen, refer to its package insert.

Contraindications

Emitasvir must be used in combination with Sofosbuvir Tablets. For the contraindications for the use of Sofosbuvir Tablets, please refer to its package insert.

Emitasvir is contraindicated in patients with a history of hypersensitivity to Emitasvir or any ingredient in this product.

Emitasvir must not be co-administered with potent P-gp inducers, as this may cause a significant decrease in the plasma concentration of Emitasvir, which in turn reduces the therapeutic effect of the drug and may even result in therapeutic failure.

Adverse Reactions

Metabolism and Nutrition Disorders

Including hypercholesterolemia, hypertriglyceridemia, hyperuricemia, hypermagnesemia, and dyslipidemia.

Investigations

Including elevated blood creatine phosphokinase, elevated lipase, elevated blood lactate dehydrogenase, elevated amylase, decreased platelet count, decreased neutrophil count, elevated blood bilirubin, elevated blood pressure, and decreased white blood cell count.

Use in Special Populations

Use in Pregnant and Lactating Women

Pregnancy

No data are available on the use of Emitasvir Phosphate Capsules in pregnant women. Animal studies of emitasvir phosphate have shown that embryonic developmental toxicity was observed in rats at a dose of 1000 mg/kg in perinatal toxicity studies, with the emitasvir exposure at this dose being approximately 3.4-fold that at the clinically recommended dose. However, it is still not recommended to administer Emitasvir Phosphate Capsules during pregnancy.

Lactation

It is unknown whether emitasvir is excreted in human milk. Animal studies of emitasvir phosphate have shown that emitasvir is excreted in milk in lactating rats, with the concentration in milk being approximately 5 to 6 times that in plasma. No adverse effects on postnatal development or reproductive function were observed in the offspring of lactating rats exposed to emitasvir. However, results from animal studies cannot fully and accurately predict the risks of emitasvir phosphate to neonates/infants, and thus it is not recommended for use in lactating women.

Fertility

No data are available on the effects of emitasvir phosphate on human fertility. Animal studies have not demonstrated any adverse effects of emitasvir phosphate on fertility.

Pediatric Use

The safety and efficacy of Emitasvir Phosphate Capsules in pediatric patients have not been established.

Geriatric Use

A total of 426 patients were treated with Emitasvir Phosphate Capsules 0.1g in combination with Sofosbuvir Tablets 400mg in Phase II and III clinical studies, 34 of whom were aged 65 years and older. No overall differences in safety and efficacy were observed between these patients and the other patients.

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