Do not take PREVYMIS if:
- you are allergic to letermovir or any of the other ingredients of PREVYMIS (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).
Do not take PREVYMIS if the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before taking 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.
Report any muscle pain or tenderness while taking a statin.
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
Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)
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.”
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.
Human reproduction
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking PREVYMIS. PREVYMIS is not recommended during pregnancy or in women of childbearing potential not using contraception.
Breastfeeding
Mothers receiving PREVYMIS should not breastfeed their babies. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking PREVYMIS.
Driving and using machines
PREVYMIS may have an 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.