Prevymis

letermovir

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This is a summary of the European public assessment report (EPAR) for Prevymis. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Prevymis.

For practical information about using Prevymis, patients should read the package leaflet or contact their doctor or pharmacist.

What is Prevymis and what is it used for?

Prevymis is an antiviral medicine used to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant to replace their bone marrow. Allogeneic haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient’s bone marrow cells to form new bone marrow that produces healthy blood cells.

Many people have CMV in their body but it is usually inactive and it does not cause harm. However, CMV can become active in patients whose immune system is weakened such as those having stem cell transplants.

Because the number of patients with CMV disease is low, the disease is considered ‘rare’, and Prevymis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 April 2011.

Prevymis contains the active substance letermovir.

How is Prevymis used?

Prevymis can only be obtained with a prescription, and treatment should be started by a doctor experienced in managing patients who have had an allogeneic haematopoietic stem cell transplant. Doctors should consider official guidance on the use of antiviral medicines when using Prevymis.

Prevymis is available as tablets to be taken by mouth and as a concentrate that is made up into a solution for infusion (drip) into a vein and given over about an hour. The usual recommended dose by mouth or as an infusion is 480 mg once daily. If ciclosporin (a medicine that prevents rejection of the transplant) is used at the same time, the Prevymis dose is reduced to 240 mg once daily. Treatment with Prevymis is started on the day of the transplant or on any day up to 28 days afterwards and it is continued for 100 days after the transplantation; longer treatment may be considered in some patients. For further information, see the package leaflet.

How does Prevymis work?

For CMV to multiply, its genetic material (DNA) needs to be copied and packaged into protein shells to produce more viruses that can then infect other cells. Letermovir, the active substance in Prevymis, blocks a virus enzyme called ‘terminase’. Terminase is involved in packaging the DNA in the protein shells of the virus. By blocking the enzyme, the medicine prevents viruses from developing properly, so that CMV cannot multiply and infect other cells. This is expected to prevent CMV disease in transplant recipients who already have CMV in their body.

What benefits of Prevymis have been shown in studies?

A main study involving 570 adults found Prevymis was more effective than placebo (a dummy treatment) in preventing CMV infection after allogeneic haematopoietic stem cell transplantation. Of the patients receiving Prevymis, about 38% (122 out of 325) had signs of CMV becoming active 24 weeks after the stem cell transplant compared with 61% of the patients (103 out of 170) receiving placebo.

All patients in this study were CMV seropositive, meaning they had come into contact with the virus before and were likely to be carrying it in an inactive form.

What are the risks associated with Prevymis?

The most common side effects with Prevymis (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea and vomiting. For the full list of side effects reported with Prevymis, see the package leaflet.

Prevymis must not be used together with the medicine pimozide, or ergot medicines such as ergotamine and dihydroergotamine. The combination of Prevymis and ciclosporin must not be used with dabigatran, atorvastatin, pitavastatin, rosuvastatin and simvastatin. For the full list of restrictions, see the package leaflet.

Why is Prevymis approved?

Prevymis is effective in preventing CMV from becoming active and causing disease in adult recipients of a stem cell transplantation to replace the bone marrow. It has few side effects unlike other medicines used for the treatment of CMV disease which can damage bone marrow and affect blood cells. The European Medicines Agency therefore decided that Prevymis’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Prevymis?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Prevymis have been included in the summary of product characteristics and the package leaflet.

Other information about Prevymis

The European Commission granted a marketing authorisation valid throughout the European Union for Prevymis on 8 January 2018.

For more information about treatment with Prevymis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Prevymis can be found on the Agency’s website.

Name Language First published Last updated
Prevymis : EPAR - Summary for the public BG = bălgarski 2018-01-17  
Prevymis : EPAR - Summary for the public ES = español 2018-01-17  
Prevymis : EPAR - Summary for the public CS = čeština 2018-01-17  
Prevymis : EPAR - Summary for the public DA = dansk 2018-01-17  
Prevymis : EPAR - Summary for the public DE = Deutsch 2018-01-17  
Prevymis : EPAR - Summary for the public ET = eesti keel 2018-01-17  
Prevymis : EPAR - Summary for the public EL = elliniká 2018-01-17  
Prevymis : EPAR - Summary for the public EN = English 2018-01-17  
Prevymis : EPAR - Summary for the public FR = français 2018-01-17  
Prevymis : EPAR - Summary for the public IT = italiano 2018-01-17  
Prevymis : EPAR - Summary for the public LV = latviešu valoda 2018-01-17  
Prevymis : EPAR - Summary for the public LT = lietuvių kalba 2018-01-17  
Prevymis : EPAR - Summary for the public HU = magyar 2018-01-17  
Prevymis : EPAR - Summary for the public MT = Malti 2018-01-17  
Prevymis : EPAR - Summary for the public NL = Nederlands 2018-01-17  
Prevymis : EPAR - Summary for the public PL = polski 2018-01-17  
Prevymis : EPAR - Summary for the public PT = português 2018-01-17  
Prevymis : EPAR - Summary for the public RO = română 2018-01-17  
Prevymis : EPAR - Summary for the public SK = slovenčina 2018-01-17  
Prevymis : EPAR - Summary for the public SL = slovenščina 2018-01-17  
Prevymis : EPAR - Summary for the public FI = suomi 2018-01-17  
Prevymis : EPAR - Summary for the public SV = svenska 2018-01-17  
Prevymis : EPAR - Summary for the public HR = Hrvatski 2018-01-17  

This EPAR was last updated on 17/01/2018 .

Authorisation details

Product details

Product details for Prevymis
NamePrevymis
Agency product numberEMEA/H/C/004536
Active substance

letermovir

International non-proprietary name (INN) or common name

letermovir

Therapeutic area Cytomegalovirus Infections
Anatomical therapeutic chemical (ATC) code J05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Prevymis
Marketing-authorisation holder

Merck Sharp & Dohme Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union08/01/2018

Contact address:

Merck Sharp & Dohme Limited
Hertford Road
Hoddesdon
Hertfordshire EN11 9BU 
United Kingdom

Product information

Product information

08/01/2018  Prevymis -EMEA/H/C/004536 --

Name Language First published Last updated
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Product Information HR = Hrvatski 2018-01-17  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  
Prevymis : EPAR - All Authorised presentations HR = Hrvatski 2018-01-17  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Prevymis is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).

Consideration should be given to official guidance on the appropriate use of antiviral agents.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Prevymis : Orphan maintenance assessment report HR = Hrvatski 2018-01-17  
Prevymis : EPAR - Public assessment report HR = Hrvatski 2018-01-17  
CHMP summary of positive opinion for Prevymis HR = Hrvatski 2017-11-10