- Indications and Usage Leritrelvir Tablets are indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adult patients.
- Dosage and Administration Standard Dosage: The recommended dosage is 400 mg (two tablets) taken orally three times daily with food. Duration: Treatment should continue for 5 days. The safety and efficacy of administration for more than 5 days have not been established. Timing: Letermovir should be initiated as soon as possible within 2 days of symptom onset. Dosage Adjustment: No dosage adjustment is required for patients with renal or hepatic impairment, as clinical studies have not demonstrated significant impact.
- Mechanism of Action Leritrelvir is a novel, selective inhibitor of the SARS-CoV-2 3CL protease (also known as the main protease or Mpro). By inhibiting this viral enzyme, it prevents the cleavage of the viral polyproteins, thereby blocking viral replication.
- Safety and Warnings Hepatotoxicity: Elevations in liver function tests have been observed during clinical trials. Liver function should be monitored during treatment. Hypersensitivity: Contraindicated in patients with known hypersensitivity to leritrelvir or any excipients. Drug Interactions: Leritrelvir is a substrate of CYP3A and P-glycoprotein (P-gp). Concomitant use with strong CYP3A or P-gp inhibitors may increase leritrelvir exposure, while inducers may decrease efficacy.
- Adverse Reactions and Clinical Research Adverse Reactions: The most common adverse reactions include metabolic disorders (e.g., hypertriglyceridemia, hypercholesterolemia, hyperuricemia), liver function abnormalities, and neutropenia. Clinical Research: In a pivotal randomized, double-blind, placebo-controlled Phase III clinical trial, leritrelvir significantly reduced viral load and accelerated symptom resolution compared to placebo without inducing significant resistance.
- Drug Interactions CYP3A/P-gp Inhibitors: Strong inhibitors may increase leritrelvir plasma concentrations, potentially increasing the risk of adverse reactions. CYP3A/P-gp Inducers: Strong inducers may decrease leritrelvir plasma concentrations, potentially reducing antiviral efficacy. Other Drugs: Concomitant use with other drugs metabolized by CYP3A or P-gp requires caution due to potential interactions.
- Pharmaceutical Information Composition: Active ingredient is leritrelvir. Excipients include lactose, microcrystalline cellulose, hypromellose, and magnesium stearate. Appearance: White to off-white film-coated tablets. Storage: Store at room temperature. Protect from moisture. Packaging: Available as 200 mg film-coated tablets.
Leruiling Leritrelvir Tablets
Brand Name: 乐睿灵 ®（Leruiling®）
Generic Name: Leritrelvir
Strength: 0.2 g per tablet, 30 tablets per box
Manufacturer: Guangdong Huanan Pharmaceutical Group Co., Ltd.
Marketing Authorization Holder: Guangdong Raynovent Biotech Co., Ltd.
Approval Date in China: March 24, 2023
Registration Number: 国药准字H20230007
Storage: Seal tightly and store at a temperature not exceeding 25°C, protected from light and moisture. Refer to the full package insert for detailed storage specifications.
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