- Indications and Usage Indicated in combination with sofosbuvir for the treatment of adult patients with genotype 1 chronic hepatitis C (HCV) without cirrhosis . It cannot be used as monotherapy .
- Dosage and Administration Standard Dosage: The recommended dosage is one 0.1g capsule taken once daily, administered orally . Administration Timing: Must be taken alongside sofosbuvir 400 mg on the same day . Fasting Requirement: Administration should be on an empty stomach; patients should wait at least 2 hours before or after returning to a meal . Missed Dose: If a dose is missed within 18 hours of the normal dosing time, it should be taken as soon as possible, followed by the next dose at the regular time. If more than 18 hours have passed, the missed dose should be skipped, and no double doses should be taken .
- Mechanism of Action Emitasvir is a novel direct-acting antiviral (DAA) agent that targets the hepatitis C virus non-structural protein 5A (NS5A) . By inhibiting NS5A, it disrupts viral RNA assembly and the formation of new virus particles, thereby exerting an effective antiviral effect .
- Safety and Warnings Hepatitis B Reactivation: In the process of treating HCV with direct-acting antivirals, cases of Hepatitis B virus (HBV) reactivation have been reported, including fulminant hepatitis, hepatic failure, and death . All patients must be screened for HBV before initiating treatment, and acute hepatitis flares or HBV reactivation must be monitored during and after HCV treatment . Combination Therapy Restrictions: Regarding the safety and contraindications of sofosbuvir, please refer to the sofosbuvir prescribing information . Hypersensitivity: The drug is contraindicated for patients with a history of hypersensitivity to emitasvir or any components of the product .
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: The most frequently observed adverse reactions include upper respiratory tract infection, headache, fatigue, abdominal pain, dizziness, and rash . Clinical Research: Clinical data demonstrate good efficacy and safety in treating genotype 1 non-cirrhotic chronic hepatitis C with a favorable tolerability profile .
- Drug Interactions P-gp Inducers: The concurrent use with strong P-gp inducers is prohibited because it may cause a significant decrease in emitasvir plasma concentration, leading to reduced efficacy or even treatment failure . Combination Therapy: This product must be used in conjunction with sofosbuvir; regarding contraindications of sofosbuvir, refer to the sofosbuvir prescribing information .
- Pharmaceutical Information Composition and Appearance: This product is a capsule, and the contents are white to pale yellow powder . Chemical Identification: The active ingredient is emitasvir phosphate; its chemical formula is C49H58N8O6·2H3PO4, and the molecular weight is 1051.03 . Packing Specification: 0.1g (calculated as C49H58N8O6) .
Dongwei’en Emitasvir Phosphate Capsules
Brand Name: 东卫恩 ®（Dongwei’en®）
Generic Name: Emitasvir Phosphate
Strength: 0.1 g per capsule; 7 capsules per blister, 4 blisters per box (28 capsules total)
Manufacturer: Yichang Dongyangguang Changjiang Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Yichang Dongyangguang Changjiang Pharmaceutical Co., Ltd.
Approval Date in China: January 15, 2020
Registration Number:国药准字 H20200015
Storage: Seal tightly, store below 30°C, protect from light and moisture. Refer to the full package insert for detailed storage specifications.
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