Prevymis

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Read the Patient Information Leaflet if available from your pharmacist before you start taking letermovir and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food, as directed by your doctor, usually once daily. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Children's dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Swallow the tablet whole. Do not crush or chew because the drug has a bitter taste.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

Continue to take this medication until the full prescribed amount is finished. Stopping the medication too early may result in an infection.

Nausea, diarrhea, vomiting, swelling ankles/feet, cough, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include asunaprevir, elacestrant, elagolix, elbasvir/grazoprevir, ergot alkaloids (such as ergotamine, dihydroergotamine), flibanserin, lomitapide, pimozide, certain statin drugs (such as pitavastatin, simvastatin), tovorafenib, among others.

Other medications can affect the removal of letermovir from your body, which may affect how letermovir works. Examples include bosentan, certain HIV NNRTIs (such as efavirenz, etravirine, nevirapine), nafcillin, rifamycins (such as rifabutin, rifampin), St. John's wort, thioridazine, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later to prevent another infection unless your doctor tells you to.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original package at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.