Prevymis FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 4, 2024.
FDA Approved: Yes (First approved November 8, 2017)
Brand name: Prevymis
Generic name: letermovir
Dosage form: Tablets, Oral Pellets and Injection
Company: Merck
Treatment for: CMV Prophylaxis
Prevymis (letermovir) is a CMV DNA terminase complex inhibitor used for the prophylaxis of cytomegalovirus (CMV) infection.
- Prevymis is indicated for the:
- prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
- prophylaxis of CMV disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]). - Prevymis contains letermovir which is a CMV DNA terminase complex inhibitor. It works as an antiviral to prevent CMV infection by targeting the CMV DNA terminase complex (pUL51, pUL56, and pUL89) to inhibit viral replication.
- Prevymis is available in three dosage forms:
• tablets - administered orally with or without food.
• oral pellets - administered orally mixed with soft food or via nasogastric tube or gastric tube.
• injection - administered by intravenous infusion via a peripheral catheter or central venous line at a constant rate over 1 hour. - Warnings and precautions associated with Prevymis include significant drug interactions causing adverse reactions or reduced therapeutic effect.
- Common adverse reactions:
- in adult and pediatric HSCT patients include nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.
- in adult and pediatric kidney transplant patients include diarrhea.
Development timeline for Prevymis
Further information
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