Prevymis FDA Approval History
Last updated by Judith Stewart, BPharm on June 14, 2023.
FDA Approved: Yes (First approved November 8, 2017)
Brand name: Prevymis
Generic name: letermovir
Dosage form: Tablets 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 pophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT), and the prophylaxis of CMV disease in adult 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 tablets are administered orally once daily. Prevymis injection is administered intravenously once daily, but is only used in patients who cannot take the oral tablets.
- Warnings and precautions associated with Prevymis include significant drug interactions causing adverse reactions or reduced therapeutic effect.
- Common adverse reactions in HSCT patients include nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.
Common adverse reactions in kidney transplant patients include diarrhea.
Development timeline for Prevymis
Further information
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