- Indications and Usage Letermovir injection is indicated for the prevention of cytomegalovirus (CMV) infection and CMV disease in adult recipients of an allogeneic hematopoietic stem cell transplant (HSCT) who are CMV seropositive or at high risk for CMV infection.
- Dosage and Administration Standard Dosage: The recommended dosage is 480 mg administered once daily by IV infusion over approximately 60 minutes. Duration: Treatment should begin on the day of HSCT or no later than 28 days after transplantation and should be continued for 100 days following HSCT. Dosage Adjustment with Cyclosporine: When co-administered with cyclosporine, the dosage must be reduced to 240 mg once daily. Administration: The injection must be diluted prior to administration and administered through an in-line 0.2 μm or 0.22 μm polyethersulfone (PES) filter. It must not be administered as an IV push.
- Mechanism of Action Letermovir is a selective inhibitor of the CMV DNA terminase complex. By inhibiting this viral enzyme complex, letermovir interferes with the processing of unit-length viral genomes and the maturation of viral particles, thereby preventing viral replication.
- Safety and Warnings Hepatotoxicity: Elevations in liver transaminases have been observed. Liver function should be monitored during treatment. Infusion-Related Reactions: Hypersensitivity reactions, including dyspnea, have been reported. Cardiac Arrhythmias: Cardiac arrhythmias have been reported in patients receiving letermovir. Contraindications: Contraindicated in patients with severe hepatic impairment unless no alternative exists.
- Adverse Reactions and Clinical Research Adverse Reactions: The most common adverse reactions (incidence ≥1% and more frequent than placebo) include nausea, diarrhea, vomiting, abdominal pain, and thrombocytopenia. Clinical Research: In a pivotal randomized trial, letermovir significantly reduced the incidence of CMV infection or CMV disease compared to placebo without inducing significant resistance.
- Drug Interactions Cyclosporine: As noted above, cyclosporine significantly increases letermovir exposure; the letermovir dose must be reduced to 240 mg. CYP3A Substrates: Letermovir is a moderate inhibitor of CYP3A. It may increase plasma concentrations of midazolam, triazolam, or other sensitive CYP3A substrates, potentially increasing their toxicity. HMG-CoA Reductase Inhibitors: Concomitant use with simvastatin or lovastatin is not recommended.
- Pharmaceutical Information Composition: Active ingredient is letermovir. Excipients include hydroxypropyl betacyclodextrin, sodium chloride, and water for injection. Appearance: A clear to slightly opalescent, colorless to pale yellow liquid. Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light.
Prevymis Letermovir Injection
Brand Name: 普瑞明 ®（Prevymis®）
Generic Name: Letermovir
Strength: 12 mL: 240 mg per vial, 1 vial per box
Manufacturer: Merck Sharp & Dohme B.V.
Marketing Authorization Holder: MSD (Merck Sharp & Dohme)
Approval Date in China: 2021
Registration Number: 国药准字HJ20210043
Storage: Store at controlled room temperature 20°C–25°C, excursions permitted between 15°C–30°C. Keep tightly sealed, avoid moisture and direct light. Do not freeze. Refer to the full package insert for detailed storage specifications.
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