PREVYMIS is an antiviral medicine that contains the active substance letermovir. PREVYMIS is a prescription 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.
1. What PREVYMIS is and what it is used for
2. What you need to know before you are given PREVYMIS
You should not be given 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).
You should not be given PREVYMIS if the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before you are given 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.
3. How you are given PREVYMIS
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 are given more PREVYMIS than you should
If you think you have been given too much PREVYMIS, tell your doctor straight away.
If you miss your appointment to get PREVYMIS
It is important that you do not miss or skip doses of PREVYMIS.
- If you miss your appointment to get PREVYMIS, call your doctor straight away to reschedule your appointment.
If you have any further questions on the use of PREVYMIS, ask your doctor, pharmacist or nurse.
4. Possible side effects
PREVYMIS can cause side effects. Not all side effects reported for PREVYMIS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PREVYMIS, please consult your doctor, pharmacist or other healthcare professionals for advice.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- allergic reaction (hypersensitivity) – the signs may include wheezing, difficulty breathing, rashes or hives, itchiness, swelling. These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
Frequent:
- diarrhoea
- feeling sick (nausea)
- being sick (vomiting).
Less frequent:
- loss of appetite
- changes in taste
- headache
- feeling like you are spinning (vertigo)
- stomach ache
- abnormalities in laboratory tests of liver function
- muscle spasms
- high blood creatinine - shown in blood tests
- feeling very tired (fatigue)
- swelling of hands or feet.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of PREVYMIS.
5. How to store PREVYMIS
Store all medicines out of reach of children. Do not use PREVYMIS 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. Store at or below 25 °C. Store in the 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 protect the environment.