What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PLGB 53095/0046, PLGB 53095/0047.


PREVYMIS 240 mg concentrate for solution for infusion

Package leaflet: Information for the patient

PREVYMIS® 240 mg concentrate for solution for infusion

PREVYMIS® 480 mg concentrate for solution for infusion

letermovir

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What PREVYMIS is and what it is used for
2. What you need to know before you are given PREVYMIS
3. How you are given PREVYMIS
4. Possible side effects
5. How to store PREVYMIS
6. Contents of the pack and other information

1. What PREVYMIS is and what it is used for

PREVYMIS is an antiviral prescription medicine that contains the active substance letermovir.

PREVYMIS is a medicine for adults who have recently had a bone marrow transplant. The medicine helps stop you from getting ill from CMV (‘cytomegalovirus’).

CMV is a virus that a lot of people have without knowing. Normally, CMV just stays in their body and it does not hurt them. However, if your immune system is weak after you get a bone marrow transplant, you may be at high risk of becoming ill from CMV.

2. What you need to know before you are given PREVYMIS

You should not be given PREVYMIS if:

  • you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
  • you take either of these medicines:
    • pimozide - used for Tourette’s syndrome
    • ergot alkaloids (such as ergotamine and dihydroergotamine) - used for migraine headaches.
  • you take the following herbal product:
    • St. John’s wort (Hypericum perforatum)

You should not be given PREVYMIS if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given PREVYMIS.

If you are taking PREVYMIS with ciclosporin, do not take the following medicines:

  • dabigatran - used for blood clots
  • atorvastatin, simvastatin, rosuvastatin, pitavastatin - for high cholesterol.

Warnings and precautions

If you are also taking a medicine for high cholesterol (see list of medicines in section “Other medicines and PREVYMIS” below) you must tell your doctor immediately if you have unexplained muscle aches or pains especially if you feel unwell or have a fever. Your medicine or dose may then need to be changed. See the package leaflet for your other medicine for further information.

Additional blood tests may be needed to monitor the following medicinal products:

  • Ciclosporin, tacrolimus, sirolimus
  • Voriconazole

Children and adolescents

PREVYMIS is not for use in children and adolescents under 18 years old. This is because PREVYMIS has not been tested in this age group.

Other medicines and PREVYMIS

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because PREVYMIS may affect the way other medicines work, and other medicines may affect how PREVYMIS works. Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines.

There are some medicines you must not take with PREVYMIS. See list under “Do not take PREVYMIS if you take either of these medicines.”

Also tell your doctor if you are taking any of the following medicines. This is because your doctor may have to change your medicines or change the dose of your medicines:

  • alfentanil - for severe pain
  • fentanyl - for severe pain
  • quinidine - for abnormal heart rhythms
  • ciclosporin, tacrolimus, sirolimus - used to prevent transplant rejection
  • voriconazole - for fungal infections
  • statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin - for high cholesterol
  • glyburide, repaglinide - for high blood sugar
  • carbamazepine, phenobarbital, phenytoin - for fits or seizures
  • dabigatran, warfarin - used to thin the blood or for blood clots
  • midazolam - used as a sedative
  • amiodarone - used to correct irregular heartbeats
  • oral contraceptive steroids - for birth control
  • omeprazole, pantoprazole - for stomach ulcers and other stomach problems
  • nafcillin - for bacterial infections
  • rifabutin, rifampicin - for mycobacterial infections
  • thioridazine - for psychiatric disorders
  • bosentan - for high blood pressure in the vessels in the lungs
  • efavirenz, etravirine, nevirapine, lopinavir, ritonavir - for HIV
  • modafinil - for wakefulness

You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. PREVYMIS is not recommended in pregnancy. This is because it has not been studied in pregnancy and it is not known if PREVYMIS will harm your baby while you are pregnant.

Breast-feeding

If you are breast-feeding or are planning to breast-feed, tell your doctor before taking this medicine. Breast-feeding is not recommended while taking PREVYMIS. This is because it is not known if PREVYMIS gets in your breast milk and will be passed to your baby.

Driving and using machines

PREVYMIS may have minor influence on your ability to drive and use machines (see section 4 Possible side effects below). Some patients have reported fatigue (feeling very tired) or vertigo (feeling like you are spinning) during treatment with PREVYMIS. If you experience any of these effects, do not drive or use machines until the effect wears off.

PREVYMIS contains sodium

PREVYMIS contains sodium. If you are on a low sodium diet, talk to your doctor before you are given this medicine.

Each 240 mg vial contains 23 mg sodium (main component of cooking/table salt). This is equivalent to 1.15% of the recommended maximum daily dietary intake of sodium for an adult.

Each 480 mg vial contains 46 mg sodium (main component of cooking/table salt). This is equivalent to 2.30% of the recommended maximum daily dietary intake of sodium for an adult.

PREVYMIS contains cyclodextrin

Each 240 mg dose (12 mL vial) of this medicine contains 1800 mg cyclodextrin.

Each 480 mg dose (24 mL vial) of this medicine contains 3600 mg cyclodextrin.

If you have a kidney disease, talk to your doctor before you receive this medicine.

3. How you are given PREVYMIS

The recommended dose of PREVYMIS is 480 mg once a day. If you also take ciclosporin, your doctor will decrease the dose of PREVYMIS to 240 mg once a day.

You will get PREVYMIS as an infusion (drip) into a vein and it will take about 1 hour.

You will get PREVYMIS once a day.

If you are given more PREVYMIS than you should

If you think you have been given too much PREVYMIS, tell your doctor straight away.

If you miss your appointment to get PREVYMIS

It is very important that you do not miss or skip doses of PREVYMIS.

  • If you miss your appointment to get PREVYMIS, call your doctor straight away to reschedule your appointment.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

  • diarrhoea
  • feeling sick (nausea)
  • being sick (vomiting)

Uncommon: may affect up to 1 in 100 people

  • allergic reaction (hypersensitivity) – the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling
  • loss of appetite
  • changes in taste
  • headache
  • feeling like you are spinning (vertigo)
  • stomach ache
  • abnormalities in laboratory tests of liver function
  • muscle spasms
  • high blood creatinine - shown in blood tests
  • feeling very tired (fatigue)
  • swelling of hands or feet

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PREVYMIS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions. Store in original carton to protect from light.

Chemical and physical in-use stability has been demonstrated for 48 hours at 25 °C and for 48 hours at 2 to 8 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Any unused portion of the infusion solution should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What PREVYMIS contains

The active substance is letermovir. Each vial contains 240 mg or 480 mg letermovir. Each mL of concentrate contains 20 mg/mL.

The other ingredients are: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), water for injections.

What PREVYMIS looks like and contents of the pack

PREVYMIS 240 mg and 480 mg concentrate for solution for infusion is a clear, colourless liquid and may contain a few product-related small translucent or white particles.

The 240 mg and 480 mg concentrate for solution for infusion is packaged in clear, glass vials. Each vial is packaged in a carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in Great Britain:

Merck Sharp & Dohme (UK) Limited
120 Moorgate
London
EC2M 6UR
UK

Marketing Authorisation Holder in UK (Northern Ireland):

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Manufacturer:

Schering-Plough Labo NV
Industriepark 30 – Zone A
B-2220 Heist-op-den-Berg
Belgium

For any information about this medicine, please contact:

Merck Sharp & Dohme (UK) Limited

This leaflet was last revised in March 2021.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

© Merck Sharp & Dohme (UK) Limited, 2021. All rights reserved.

PIL.PVM.IV.21.GB-NI.7649.Art61(3).RCN020215