Language selection

Government of Canada

Search

Details for: PREVYMIS

Company: MERCK CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02469367PREVYMISLETERMOVIR20 MG / MLSOLUTIONINTRAVENOUS
02469405PREVYMISLETERMOVIR20 MG / MLSOLUTIONINTRAVENOUS
02469375PREVYMISLETERMOVIR240 MGTABLETORAL
02469383PREVYMISLETERMOVIR480 MGTABLETORAL
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Basis of Decision
Regulatory Decision Summary

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

PREVYMIS® is a prescription medicine to help to keep adults 18 years of age and older from getting ill from CMV (cytomegalovirus). CMV is a virus that a lot of people have, but they don’t even know it. For most people, CMV just stays in their body and it doesn’t 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.

What it does

PREVYMIS® is an antiviral medicine. It stops CMV from multiplying.

When it should not be used

  • are allergic to letermovir, or any of the other ingredients of PREVYMIS®
    • .
  • are taking any of the following medicines:
    • Pimozide (for Tourette’s syndrome).
    • Ergot alkaloids (for migraine headaches).

If you are taking PREVYMIS® with cyclosporine, do not take lovastatin, rosuvastatin, simvastatin, or bosentan.

What the medicinal ingredient is

letermovir

PREVYMIS® is available as either a tablet or an IV

What the non-medicinal ingredients are
  • Tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose and povidone 25.
    The tablets are film-coated with a coating material containing the following inactive ingredients: hypromellose 2910, iron oxide yellow, and (only for 480 mg tablets) iron oxide red, lactose monohydrate, titanium dioxide and triacetin. Carnauba wax is added as a polishing agent.
  • Injection (IV): hydroxypropyl betadex, sodium chloride, sodium hydroxide, and Water for Injection.

What dosage form it comes in

Tablet: 240 mg and 480 mg
Solution for injection: 20 mg/mL. Available in 240 mg/12 mL and 480 mg/24 mL

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PREVYMIS® . Talk about any health conditions or problems you may have, including if you:

  • have kidney disease.
  • have liver disease.
  • are a pregnant women or trying to get pregnant. It is not known if PREVYMIS® will harm your baby while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if PREVYMIS® gets in your breast milk and will be passed to your baby.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • If you take any of these medicines, be sure to tell your doctor:
    • Alfentanil, fentanyl (for severe pain)
    • Amiodarone (used to correct irregular heartbeats)
    • Midazolam (used as a sedative)
    • Cyclosporine, tacrolimus, sirolimus (used to prevent transplant rejection)
    • Voriconazole (for fungal infections)
    • Statins, such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin (for high cholesterol)
    • Omeprazole, pantoprazole (for stomach ulcers and other stomach problems)
    • Glyburide, repaglinide, rosiglitazone (for high blood sugar)
    • Carbamazepine, phenobarbital, phenytoin (for seizures or convulsions)
    • Warfarin (used as a blood thinner or for blood clots)
    • Rifabutin, rifampin (for mycobacterial infections)
    • Bosentan (for high blood pressure in the vessels of the lungs)
    • St. John’s wort (Hypericum perforatum) (an herbal product)
    • Efavirenz, etravirine, nevirapine (for HIV)
    • Modafinil (for wakefulness)
  • Know the medicines you take. Keep a list of medicines and show it to your doctor and pharmacist when you get a new medicine.
  • You can ask your doctor or pharmacist for a list of medicines that may interact with PREVYMIS®
    • .
  • Do not start or stop taking another medicine without telling your doctor first

Proper use of this medication

You can receive PREVYMIS® two different ways: as tablets or through an IV (intravenously). It is important that you do not miss or skip doses of PREVYMIS® .

Usual adult dose

If you take the tablets:

  • Take 1 tablet once a day.
    • Take it at the same time every day.
    • Take it with or without food.
    • Swallow the tablet whole. Do not break, crush, or chew the tablet.
  • Take this medicine exactly how your doctor tells you to take it.
  • Keep it in the original package until you are ready to take it.
  • Do not stop taking PREVYMIS® without talking to your doctor first.
  • Do not run out of your PREVYMIS®
    • .

If you receive PREVYMIS® through an IV (intravenously):

  • You will receive PREVYMIS® once a day and it will take about 1 hour.

Overdose

If you think you have taken too much PREVYMIS® , contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

If you take more PREVYMIS® , than your prescribed dose, call your doctor right away.

Missed Dose

If you forget to take the tablets:

If you forget to take your dose of PREVYMIS® , take it as soon as you remember.
If you do not remember until it is almost time for your next dose, skip your last dose and take the next dose at your usual time.

  • Do not take two doses of PREVYMIS® at the same time to make up for a missed dose.
  • If you are not sure what to do, call your doctor or pharmacist.

If you receive PREVYMIS® through an IV (intravenously):

  • If you miss your appointment, reschedule it right away.
Side effects and what to do about them

These are not all the possible side effects you may feel when taking PREVYMIS® . If you experience any side effects not listed here, contact your healthcare professional.

These are not all the possible side effects you may feel when taking PREVYMIS® . If you experience any side effects not listed here, contact your healthcare professional.

  • nausea
  • diarrhea
  • vomiting

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Tablet and solution for injection:

  • Keep PREVYMIS® in the original package until you are ready to take it.
  • Keep PREVYMIS® tablets at room temperature (15°C to 30°C).
  • If you have to keep PREVYMIS® injection at home, keep it at room temperature (15°C to 25°C). Protect from light.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information
  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php) or the Merck Canada website (www.merck.ca) or by calling Merck Canada at 1-800-567-2594.

To report an adverse event related to PREVYMIS® , please contact 1-800-567-2594.

This leaflet was prepared by Merck Canada Inc.

Last Revised May 8, 2020

® Merck Sharp & Dohme Corp. Used under license.
* All other trademarks are the property of their respective owners. © 2017, 2020 Merck Canada Inc. All rights reserved.

Date modified: