- Indications and Usage Letermovir tablets are 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 orally once daily. Administration: Tablets can be taken with or without food. They must be swallowed whole and should not be divided, crushed, or chewed. Duration: Treatment should begin on the day of HSCT or no later than 28 days after transplantation and must 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.
- 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. Contraindications: Letermovir is contraindicated in patients with known hypersensitivity to letermovir or any of its excipients. Organ Transplant Rejection: In allogeneic HSCT recipients, potent inhibitors of organic anion transporter polypeptide (OATP) 1B1/3 and P-glycoprotein (P-gp) (e.g., cyclosporine) and/or UDP-glucuronosyltransferase (UGT) 1A1/3 enzymes may increase letermovir plasma concentrations.
- 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. Appearance: White to off-white film-coated tablets. Storage: Store at room temperature. Protect from moisture. Packaging: Available as 240 mg and 480 mg film-coated tablets.
Prevymis Letermovir Tablets
Brand Name: 普瑞明 ®（Prevymis®）
Generic Name: Letermovir Tablets
Strength: 240 mg per tablet, 28 tablets per box
Manufacturer: MSD International GmbH T/A MSD Ireland (Ballydine)
Marketing Authorization Holder: Merck Sharp & Dohme B.V. (MSD)
Approval Date in China: January 6, 2022
Registration Number: 国药准字HJ20210085
Storage: Store tightly sealed at temperature not exceeding 30°C, avoid direct light and moisture. Refer to the full package insert for detailed storage specifications.
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