Prevymis
Authorised
This medicine is authorised for use in the European Union
letermovir
MedicineHumanAuthorised
Overview
Prevymis is an antiviral medicine used to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant. 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 (the body’s natural defences) is weakened such as those having stem cell transplants.
CMV disease is rare, and Prevymis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 15 April 2011.
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 transplantation or up to 28 days afterwards and it is continued for 100 days after the transplantation; longer treatment may be considered in some patients. For more information about using Prevymis, see the package leaflet or contact your doctor or pharmacist.
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 can prevent CMV disease in transplant recipients who already have CMV in their body.
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.
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 of Prevymis, see the package leaflet.
Prevymis must not be used together with certain medicines because doing so can affect the way either Prevymis or the other medicine works, reducing their effects or leading to side effects. For the full list of restrictions, see the package leaflet.
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 it can be authorised for use in the EU.
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.
As for all medicines, data on the use of Prevymis are continuously monitored. Side effects reported with Prevymis are carefully evaluated and any necessary action taken to protect patients.
Prevymis received a marketing authorisation valid throughout the EU on 8 January 2018.
Product information
Latest procedure affecting product information: II/0033/G
15/11/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Prevymis
- Active substance
- Letermovir
- International non-proprietary name (INN) or common name
- letermovir
- Therapeutic area (MeSH)
- Cytomegalovirus Infections
- Anatomical therapeutic chemical (ATC) code
- J05
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic 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.
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