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 53095/0048, PLGB 53095/0049.
PREVYMIS 240 mg film-coated tablets
PREVYMIS® 240 mg film-coated tablets
PREVYMIS® 480 mg film-coated tablets
▼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 take PREVYMIS
3. How to take 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.
Do not take PREVYMIS if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking 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 “Do not take 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 lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of PREVYMIS is one 480 mg tablet once a day. If you also take ciclosporin, your doctor will decrease the dose of PREVYMIS to one 240 mg tablet once a day.
How to take
If you take more PREVYMIS than you should, call your doctor straight away.
It is very important that you do not miss or skip doses of PREVYMIS.
Do not stop taking PREVYMIS without talking to your doctor first. Do not run out of PREVYMIS.
This will give the medicine the best chance to keep you from becoming ill from CMV after you get a bone marrow transplant.
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 blister card after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
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 film-coated tablet contains 240 mg letermovir or 480 mg letermovir.
The other ingredients are:
Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), colloidal anhydrous silica (E551), magnesium stearate (E470b).
Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide yellow (E172), iron oxide red (only for 480 mg tablets) (E172), carnauba wax (E903).
PREVYMIS 240 mg film-coated tablets
PREVYMIS 240 mg film-coated tablet is a yellow oval tablet, debossed with “591” on one side and corporate logo on the other side. The tablet is 16.5 mm long and 8.5 mm wide.
The 240 mg tablets are packaged into a carton containing four (4) 7-count Polyamide/Aluminium/PVC
PREVYMIS 480 mg film-coated tablets
PREVYMIS 480 mg film-coated tablet is a pink oval, bi-convex tablet, debossed with “595” on one side and corporate logo on the other side. The tablet is 21.2 mm long and 10.3 mm wide.
The 480 mg tablets are packaged into a carton containing four (4) 7-count Polyamide/Aluminium/PVC
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For any information about this medicine, please contact:
This leaflet was last revised in August 2023.
© 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.