PREVYMIS (Letermovir) Tablets

Basic Drug Information
Generic Name‌: Letermovir
Brand Name‌: PREVYMIS
Dosage Form & Strength‌:
film coated tablet: 240mg / 480mg
oral pellets: 120mg per packet
Initial U.S. Approval‌: 2017
Drug Class‌: Antiviral, CMV DNA terminase complex inhibitor
Indications and Usage

Letermovir is indicated for:

Prevention of cytomegalovirus (CMV) infection and disease in ‌adult and pediatric patients 6 months of age and older weighing at least 6kg‌ who are CMV seropositive [R+] recipients of allogeneic hematopoietic stem cell transplant (HSCT).
Prevention of CMV disease in ‌adult and pediatric patients 12 years of age and older weighing at least 40kg‌ who are high-risk kidney transplant recipients (donor CMV seropositive / recipient CMV seronegative [D+/R-]).
Dosage and Administration
For patients 12 years of age and older weighing ≥ 30kg (HSCT) or ≥ 40kg (kidney transplant):
Standard dose‌: 480 mg orally once daily
Concomitant use with cyclosporine‌: Reduce dose to ‌240 mg orally once daily‌
Duration‌:
HSCT: Continue dosing until 100 days after transplant, can extend to 200 days for high-risk patients
Kidney transplant: Continue dosing until 200 days after transplant
For pediatric patients 6 months to 12 years old, or 12 years and older weighing < 30kg (HSCT):
15kg ≤ weight < 30kg: 240 mg once daily
7.5kg ≤ weight < 15kg: 120 mg once daily
6kg ≤ weight < 7.5kg: 80 mg once daily
Use of oral pellets is required for patients weighing less than 30kg, tablet use is not recommended
All doses are given once daily starting between Day 0 and Day 28 after transplant, continuing until Day 100 after transplant, can extend to 200 days for high-risk patients
Letermovir tablets can be taken with or without food.
Contraindications

Letermovir is contraindicated for concomitant use with:

Pimozide
Ergot alkaloids (ergotamine, dihydroergotamine)
Pitavastatin or simvastatin when combined with cyclosporine
Warnings and Precautions

Risk of adverse reactions or reduced therapeutic effect due to drug interactions: Concomitant use of letermovir with certain drugs may cause clinically significant drug interactions, which can lead to severe adverse reactions or reduced efficacy. Please check full prescribing information for contraindications and dose adjustment recommendations before use.