What is the indication for Prevymis (Letermovir)?

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From the Guidelines

Letermovir is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult patients who are at high risk, specifically those undergoing hematopoietic stem cell transplantation.

Key Points

  • The recommended dose is 480 mg once daily, initiated between day 0 and day 28 post-transplantation, and continued through day 100 post-transplantation 1.
  • Primary prophylaxis with letermovir may be considered for CMV-seropositive recipients who undergo allogeneic HCT, with a dose reduction recommended if coadministered with cyclosporine due to drug interactions 1.
  • Letermovir lacks HSV and VZV coverage, and HSV/VZV prophylaxis should be continued 1.
  • Some centers consider the use of letermovir through day 100 post-HCT and continue CMV surveillance for patients at high risk for CMV reactivation, and in certain circumstances, up to day 200 can be considered 1.
  • The NCCN Guidelines panel recommends routine surveillance for CMV reactivation after allogeneic HCT, consisting of weekly monitoring by PCR, especially during alemtuzumab therapy and at least 2 months after completion of treatment 1.

From the FDA Drug Label

1 INDICATIONS AND USAGE 1.1 CMV Prophylaxis in Hematopoietic Stem Cell Transplant (HSCT) Recipients PREVYMIS® is indicated for 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). 1.2 CMV Prophylaxis in Kidney Transplant Recipients PREVYMIS is indicated for 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-]).

The indication for Prevymis (Letermovir) is for:

  • CMV prophylaxis in hematopoietic stem cell transplant (HSCT) recipients who are CMV-seropositive
  • CMV prophylaxis in kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative) 2

From the Research

Indication for Prevymis (Letermovir)

  • Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of allogeneic hematopoietic cell transplantation (allo-HCT) 3, 4, 5
  • The recommended dose is 480 mg orally or intravenously once daily, initiated between day 0 through day 28 post-allogeneic HSCT and continued through day 100 post-transplantation 4
  • The dose should be reduced to 240 mg daily if coadministered with cyclosporine 4, 6
  • Letermovir has also been used for secondary prophylaxis of CMV infection and disease after allogeneic hematopoietic cell transplantation, with a daily dose of 480 mg once daily and adjusted to 240 mg once daily when coadministered with cyclosporine 6
  • In pediatric patients, letermovir has been used off-label for CMV prophylaxis in hematopoietic stem cell transplantation, with a reduced incidence of clinically significant CMV DNAemia 7

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

5
Research

Outcomes of patients with detectable CMV DNA at randomization in the phase III trial of letermovir for the prevention of CMV infection in allogeneic hematopoietic cell transplantation.

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2020

6
Research

Letermovir for Secondary Prophylaxis of Cytomegalovirus Infection and Disease after Allogeneic Hematopoietic Cell Transplantation: Results from the French Compassionate Program.

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2020

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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