Prevymis 480 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

PREVYMIS 240mg film-coated tablets

PREVYMIS 480mg film-coated tablets

letermovir

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What PREVYMIS is and what it is used for
2. What you need to know before taking PREVYMIS
3. How to take 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 a prescription antiviral medicine that contains the active substance letermovir.

PREVYMIS is a medicine for:

• adults and children weighing at least 15 kg who have recently undergone a stem cell (bone marrow) transplant.
• adults and children weighing at least 40 kg who have recently undergone a kidney transplant.

The medicine helps prevent you from getting the disease caused by CMV (cytomegalovirus).

CMV is a virus. In most people, CMV causes no harm. However, if your immune system becomes weakened after receiving a stem cell transplant or a kidney transplant, you may be at high risk of becoming ill due to CMV.

2. What you need to know before starting to take PREVYMIS

Do not take PREVYMIS:

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

Do not take PREVYMIS if any of the above situations apply to you. If you have any doubts, consult your doctor, pharmacist, or nurse before taking PREVYMIS.

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

• dabigatran – used to prevent blood clots
• atorvastatin, simvastatin, rosuvastatin, pitavastatin – used to treat high cholesterol

Warnings and precautions

If you are also taking a medicine to treat high cholesterol (see list of medicines in the section “Other medicines and PREVYMIS”), you must inform your doctor immediately if you experience unexplained muscle pain or discomfort, especially if you feel unwell or have a fever. Your medicine or dose may then need to be changed. For more information, please refer to the leaflet of your other medicine.

Additional blood tests may be needed to monitor the following medicines:

• cyclosporine, tacrolimus, sirolimus
• voriconazole

Children and adolescents

PREVYMIS should not be used in children weighing less than 5 kg who have received a stem cell (bone marrow) transplant, or in children weighing less than 40 kg who have received a kidney transplant. This is because PREVYMIS has not been studied in these groups.

Other medicines and PREVYMIS

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

There are some medicines that you must not take with PREVYMIS (see list in "Do not take PREVYMIS:").

There are additional medicines that you must not take with PREVYMIS and cyclosporine (see list in “If you are taking PREVYMIS with cyclosporine, do not take the following medicines:”).

In addition, inform your doctor if you are taking any of the following medicines. This is because your doctor may need to change your medicines or adjust their doses:

• alfentanil – for severe pain

• fentanyl – for severe pain

• quinidine – for heart rhythm disorders

• cyclosporine, tacrolimus, or sirolimus – used to prevent transplant rejection

• voriconazole – for fungal infections

• statins, such as atorvastatin, fluvastatin, rosuvastatin, simvastatin, pravastatin, pitavastatin – for treating high cholesterol

• glibenclamide, repaglinide – for high blood sugar

• carbamazepine, phenobarbital, phenytoin – for seizures or epileptic fits

• dabigatran, warfarin – used to thin the blood or prevent blood clots

• midazolam – used as a sedative

• amiodarone – used to correct irregular heartbeats

• oral steroid contraceptives – 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 lung blood vessels

• efavirenz, etravirine, nevirapine, lopinavir, ritonavir – for HIV

• modafinil – to help stay awake

You may request a list of medicines that may interact with PREVYMIS from your doctor or pharmacist.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Use of PREVYMIS during pregnancy is not recommended. This is because it has not been studied in pregnancy and it is unknown whether PREVYMIS could harm the unborn baby.

Breast-feeding

If you are breast-feeding or plan to breast-feed, consult your doctor before using this medicine. Breast-feeding is not recommended while taking PREVYMIS. This is because it is unknown whether PREVYMIS passes into breast milk and could pass to your baby.

Driving and using machines

PREVYMIS may have a 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 dizziness (sensation of spinning) during treatment with PREVYMIS. If you experience any of these effects, do not drive or use machines until the effect subsides.

PREVYMIS contains lactose

PREVYMIS contains lactose monohydrate. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

PREVYMIS contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially, it is “sodium-free”.

3. How to take PREVYMIS

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

Your dose of PREVYMIS depends on your body weight and whether you are also taking cyclosporine. Your doctor will tell you how many tablets to take.

• Take PREVYMIS exactly as directed once daily.
• Take PREVYMIS at the same time every day.
• You may take PREVYMIS with or without food.

The recommended oral doses of PREVYMIS are shown in Table 1 and Table 2.

Table 1: Recommended doses of PREVYMIS film-coated tablets without cyclosporine

Table 2: Recommended doses of PREVYMIS film-coated tablets with cyclosporine

How to take

• Swallow the tablet whole with some water. Do not split, crush, or chew the tablet, as these methods have not been studied.

If you take more PREVYMIS than you should

If you take more PREVYMIS than you should, contact your doctor immediately.

If you forget to take PREVYMIS

It is very important that you do not miss or skip any doses 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 your next dose at the usual time.
• Do not take a double dose of PREVYMIS at the same time to make up for a missed dose.
• If you are unsure what to do, contact your doctor or pharmacist.

Do not stop treatment with PREVYMIS

Do not stop treatment with PREVYMIS without first consulting your doctor. Do not run out of PREVYMIS. This way, the medicine will be more effective in preventing CMV disease after you have received a stem cell transplant or a kidney transplant.

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

4. Possible adverse effects

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

Frequent: may affect up to 1 in 10 people

• diarrhea
• nausea
• vomiting

Uncommon: may affect up to 1 in 100 people

• allergic reaction (hypersensitivity) – signs may include wheezing, difficulty breathing, rash or hives, itching, swelling
• loss of appetite
• taste disturbances
• headache
• sensation of spinning (vertigo)
• stomach pain
• abnormalities in laboratory tests to check liver function (e.g., elevated liver enzymes)
• muscle spasms
• elevated creatinine in blood tests
• feeling of tiredness (fatigue)
• swelling of hands or feet

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require special storage temperature conditions. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of PREVYMIS

The active substance is letermovir. Each film-coated tablet contains 240 mg of letermovir or 480 mg of letermovir.

The other components are:

Tablet core

Microcrystalline cellulose (E460), sodium croscarmellose (E468), povidone (E1201), colloidal anhydrous silica (E551), magnesium stearate (E470b).

Film coating

Lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, yellow iron oxide (E172), red iron oxide (only in the 480 mg tablets) (E172), carnauba wax (E903). See section 2 “PREVYMIS contains lactose” and “PREVYMIS contains sodium”.

Appearance of the product and contents of the pack

PREVYMIS 240 mg film-coated tablet (“tablet”) is supplied as a yellow, oval-shaped tablet, marked with "591" on one side and the company logo on the other side. The tablet measures 16.5 mm in length and 8.5 mm in width.

PREVYMIS 480 mg film-coated tablet (“tablet”) is supplied as a pink, biconvex, oval-shaped tablet, marked with "595" on one side and the company logo on the other side. The tablet measures 21.2 mm in length and 10.3 mm in width.

The 28x1 tablets are packaged in a box containing cardboard sleeves with a single-dose precut blister made of polyamide/aluminum/PVC-aluminum (a total of 28 tablets).

You may request further information regarding this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.