This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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
PREVYMIS® 240 mg concentrate for solution for infusion
PREVYMIS® 480 mg concentrate for solution for infusion
▼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.
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
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.
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 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:
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.
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 “You should not be given PREVYMIS if:”).
There are some additional medicines you must not take with PREVYMIS and ciclosporin (see list under “If you are taking PREVYMIS with ciclosporin, do not take the following 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:
You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS.
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.
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.
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. 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.
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.
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 think you have been given too much PREVYMIS, tell your doctor straight away.
It is very important that you do not miss or skip doses of PREVYMIS.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
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.
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.
The active substance is letermovir. Each vial contains 240 mg or 480 mg letermovir. Each mL of concentrate contains 20 mg.
The other ingredients are: hydroxypropylbetadex (cyclodextrin), sodium chloride, sodium hydroxide (E524), water for injections.
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.
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This leaflet was last revised in August 2023.
© 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.