240 mg and 480 mg film-coated tablets
letermovir
What PREVYMIS is and what it is used for
PREVYMIS is a prescription antiviral medicine. It contains the active substance letermovir.
PREVYMIS is intended for adults who have recently undergone bone marrow transplantation. This medicine does not help you get CMV ( cytomegalovirus ).
CMV is a virus that many people have without knowing it. Normally, CMV is present in their body without harming them, but if your immune system is weakened after a bone marrow transplant, you may have a greater risk of getting CMV.
What you need to know before taking PREVYMIS
Do not take PREVYMIS if:
- you are allergic to letermovir or any of the other ingredients of this medicine (listed in section 6).
- you are taking any of the following medicines:
- pimozide – for the treatment of Tourette’s syndrome
- ergot alkaloids (eg ergotamine or dihydroergotamine) – are used for migraines.
- you are taking the following herbal remedies:
- St. John’s wort ( Hypericum perforatum )
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.
Do not take the following medicines if you are taking PREVYMIS with ciclosporin:
- dabigatran – used to prevent blood clots
- atorvastatin, simvastatin , rosuvastatin, pitavastatin – for high cholesterol
Warnings and cautions
If you are also taking medicines for high cholesterol (see list of medicines in the section “Other medicines and PREVYMIS” below), you should tell your doctor immediately if you have unexplained muscle pain, especially if you feel sick or have a fever. Your medicine or dose may need to be changed. See the package leaflet for your other medicines for more information.
Additional blood tests may be needed to monitor the following medicines:
- Ciclosporin, tacrolimus, sirolimus
- Voriconazole
Children and young people
PREVYMIS should not be used by persons under 18 years of age. This is because PREVYMIS has not been studied 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. PREVYMIS can affect the effectiveness of other medicines and other medicines can affect the effect of PREVYMIS. Your doctor or pharmacist will tell you if it is safe to take PREVYMIS with other medicines.
There are certain medicines you are not allowed to take with PREVYMIS (see the list under “Do not take PREVYMIS if you are taking any of the following medicines”).
There are additional medicines you must not take PREVYMIS with ciclosporin (see list under ‘Do not take the following medicines if you are taking PREVYMIS with ciclosporin:’).
Also tell your doctor if you are taking any of the following medicines. Your doctor may need to change your medication or change the dose .
- alfentanil – for severe pain
- fentanyl – for severe pain
- quinidine – for abnormal heart rhythm
- ciclosporin, tacrolimus, sirolimus – used to prevent transplant rejection
- voriconazole – for fungal infections
- statins, eg atorvastatin, fluvastatin, rusovastatin, simvastatin , pravastatin, pitavastatin – for high cholesterol
- glyburide, repaglinide – for high blood sugar
- carbamazepine, phenobarbital, phenytoin – for seizures or seizures
- dabigatran, warfarin – used to thin the blood or prevent blood clots
- midazolam – used as a sedative
- amiodarone – used to correct irregular heartbeats
- oral contraceptives – to prevent pregnancy
- omeprazole, pantoprazole – for stomach ulcers and other stomach problems
- nafcillin – against bacterial infection
- rifabutin, rifampicin – against mycobacterial infection
- thioridazine – for psychiatric disorders
- bosentan – for high blood pressure in the blood vessels of the lungs
- efavirenz, etravirine, nevirapine, lopinavir, ritonavir – for HIV
- modafinil – wakefulness regulator
You can ask your doctor or pharmacist for a list of medicines that may or may not be affected by 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 during pregnancy. This is because it has not been studied during pregnancy, and it is not known if PREVYMIS can harm the fetus during pregnancy.
Breast-feeding
If you are breastfeeding or planning to breastfeed, ask your doctor for advice before taking this medicine. Breastfeeding is not recommended during treatment with PREVYMIS. It is not known if PREVYMIS passes into breast milk and on to the baby.
Driving and using machines
PREVYMIS may have less effect on your ability to drive or use machines (see section 4 Possible side effects below). Some patients have reported fatigue or dizziness (a feeling of dizziness) during treatment with PREVYMIS. If you experience any of these effects, refrain from driving or using machines until the symptoms go away.
PREVYMIS contains lactose
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 medicine.
PREVYMIS contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take PREVYMIS
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended dose of PREVYMIS is one 480 mg tablet once daily. If you are also taking ciclosporin, your doctor will reduce the dose of PREVYMIS to a 240 mg tablet once a day.
- Take PREVYMIS at the same time each day.
- Take it with or without food.
How to take the medicine
- Swallow the tablet whole with water. The tablet must not be split, crushed, or chewed.
If you take more PREVYMIS than you should
Contact a doctor immediately if you have taken too much PREVYMIS.
If you forget to take PREVYMIS
You mustn’t miss or skip a dose of PREVYMIS.
- If you forget to take a dose , take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Take the next dose at the usual time.
- Do not take two doses of PREVYMIS at the same time to compensate for a missed dose.
- Contact your doctor or pharmacist if you are not sure what to do.
Do not stop taking PREVYMIS
Do not stop taking PREVYMIS without talking to your doctor first. Make sure you do not run out of PREVYMIS. This will give the medicine the greatest chance to help you avoid getting CMV after a bone marrow transplant.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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 users
- diarrhea
- nausea
- vomiting
Uncommon: may affect up to 1 in 100 people
- allergic reaction (hypersensitivity) – signs of this may be wheezing/wheezing, difficulty breathing, skin rash or hives, itching, swelling
- decreased appetite
- taste changes
- headache
- the feeling of spinning (dizziness)
- stomach ache
- abnormal liver values during laboratory tests
- muscle twitching
- high creatinine levels in the blood – shown in blood tests
- feeling tired
- swelling in hands or feet
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 blister after EXP. The expiration date is the last day of the specified month.
No special temperature instructions. Store in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Content declaration
The active substance is letermovir. One film-coated tablet contains 240 mg letermovir or 480 mg letermovir.
Other ingredients are:
Tablet core
Microcrystalline cellulose (E460), croscarmellose sodium (E468), povidone (E1201), colloidal anhydrous silicon (E551), magnesium stearate (E470b).
Film coating
Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172), red iron oxide (only 480 mg tablets) (E172), carnauba wax (E903).
What the medicine looks like and the contents of the pack
PREVYMIS 240 mg film-coated tablets
PREVYMIS 240 mg film-coated tablet is a yellow, oval tablet, debossed with “591” on one side and the MSD logo on the other. The tablet is 16.5 mm long and 8.5 mm wide.
The 240 mg tablets are packaged in a carton containing four (4) polyamide / aluminum / PVC blister cards of 7 tablets. Each carton contains a total of 28 tablets.
PREVYMIS 480 mg film-coated tablets
PREVYMIS 480 mg film-coated tablet is a pink, oval, biconvex tablet, debossed with “595” on one side and the MSD logo on the other. The tablet is 21.2 mm long and 10.3 mm wide.
The 480 mg tablets are packaged in a carton containing four (4) polyamide/aluminum / PVC blister cards of 7 tablets. Each carton contains a total of 28 tablets.
Marketing Authorization Holder and Manufacturer
| Holder of approvalfor saleMerck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands | ManufacturerSchering-Plow Labo NVIndustrial Park 30 – Zone AB-2220 Heist-op-den-BergBelgium |
Contact the representative of the marketing authorization holder to find out more about this medicine:
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