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letermovir

Prevymis · ATC code J05

Key facts
Active substance
letermovir
ATC code
J05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
PREVYMIS 240 mg film-coated tablets / PREVYMIS 480 mg film-coated tablets · PREVYMIS 240 mg concentrate for solution for infusion / PREVYMIS 480 mg concentrate for solution for infusion · PREVYMIS 20 mg granules in sachet / PREVYMIS 120 mg granules in sachet
Marketing authorisation holder
Merck Sharp & Dohme B.V.
Information as of
2026-10-29

Key facts

Letermovir (Prevymis) is an antiviral against cytomegalovirus (CMV) used to prevent CMV reactivation and disease after allogeneic stem cell transplant or kidney transplant.

What it is used for

  • Prophylaxis of CMV reactivation and disease in CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT): tablets from 15 kg, infusion and granules from 5 kg body weight.
  • Prophylaxis of CMV disease in CMV-seronegative patients weighing at least 40 kg who received a kidney transplant from a CMV-seropositive donor [D+/R-].

Dosing

  • HSCT, at least 30 kg (tablets or infusion): 480 mg once daily; with cyclosporine 240 mg once daily. Start on the day of transplant and no later than 28 days post-HSCT, continue through 100 days post-HSCT.
  • HSCT, children 15 kg to less than 30 kg (tablets): 240 mg once daily, with cyclosporine 120 mg (as granules). Granule and infusion dosing for lower weights see the full text.
  • Kidney transplant, at least 40 kg: 480 mg once daily, start on the day of transplant and no later than 7 days after, continue through 200 days post-transplant.
  • No dose adjustment in mild to moderate hepatic impairment; not recommended in severe hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Concomitant pimozide, ergot alkaloids or St John's wort.
  • When combined with cyclosporine: dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin.

Important warnings

  • Monitor CMV DNA in HSCT recipients; stop prophylaxis and start pre-emptive therapy for clinically significant CMV DNAemia or disease.
  • Many significant interactions may cause adverse reactions or reduced effect of other medicines.
  • Increased monitoring of cyclosporine, tacrolimus and sirolimus during the first 2 weeks after starting and ending letermovir; therapeutic drug monitoring of voriconazole is recommended.

Side effects

  • Most common (HSCT trial): nausea (7.2%), diarrhoea (2.4%) and vomiting (1.9%).
  • Most frequent reasons for discontinuation: nausea (1.6%), vomiting (0.8%) and abdominal pain (0.5%).

Interactions

  • Increases levels of CYP3A substrates such as cyclosporine, tacrolimus, sirolimus, statins and amiodarone.
  • Lowers levels of CYP2C9/2C19 substrates such as warfarin, voriconazole and proton pump inhibitors.
  • Avoid dabigatran (reduced efficacy).

Pregnancy and breastfeeding

  • Not recommended during pregnancy and in women of childbearing potential not using contraception.
  • Breast-feeding: weigh breast-feeding against therapy.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • PrevymisMerck Sharp & Dohme B.V. · EMEA/H/C/004536

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Prevymis
Liechtenstein
Prevymis
Norway
Prevymis

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

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Sources

  1. European Medicines Agency. Prevymis – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/prevymis-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.