Prevymis (Intravenous)

Letermovir injection is used by itself or with another medicine (like cyclosporine) to help prevent cytomegalovirus (CMV) infection and disease in patients who have had an allogeneic hematopoietic stem cell (bone marrow) transplant or in patients who have had a kidney transplant and are at high risk for developing CMV disease.

This medicine should only be given by your doctor or under their direct supervision.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly and to check for any unwanted effects.

Do not use this medicine with pimozide (Orap®) or ergot medicines (for example, dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®).

Do not use pitavastatin (Livalo®) or simvastatin (Zocor®) while taking this medicine with cyclosporine (Gengraf®, Neoral®, Sandimmune®).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will need to consider the risks of the medicine against the benefits it may provide. Here are some important points to keep in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how letermovir injection affects children. Its safety and effectiveness in children have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the usefulness of letermovir injection.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might happen. If you are receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bromocriptine
• Dihydroergotamine
• Eliglustat
• Ergonovine
• Ergotamine
• Flibanserin
• Lomitapide
• Methylergonovine
• Methysergide
• Pimozide
• Pitavastatin
• Simvastatin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acalabrutinib
• Alprazolam
• Amiodarone
• Aprepitant
• Atorvastatin
• Avapritinib
• Bosutinib
• Brexpiprazole
• Brigatinib
• Buprenorphine
• Cilostazol
• Clozapine
• Cobimetinib
• Codeine
• Colchicine
• Cyclosporine
• Daridorexant
• Darolutamide
• Deflazacort
• Elacestrant
• Elexacaftor
• Enasidenib
• Encorafenib
• Entrectinib
• Eplerenone
• Fexinidazole
• Finerenone
• Fosaprepitant
• Fosphenytoin
• Gepirone
• Glyburide
• Ibrutinib
• Infigratinib
• Ivabradine
• Ivacaftor
• Ivosidenib
• Larotrectinib
• Leflunomide
• Lemborexant
• Leniolisib
• Lovastatin
• Lumateperone
• Lurasidone
• Lurbinectedin
• Mavacamten
• Midazolam
• Midostaurin
• Mitapivat
• Mobocertinib
• Naloxegol
• Olaparib
• Omaveloxolone
• Oxycodone
• Pacritinib
• Palovarotene
• Pemigatinib
• Pexidartinib
• Phenytoin
• Pralsetinib
• Repaglinide
• Rifampin
• Rimegepant
• Rosiglitazone
• Selpercatinib
• Selumetinib
• Sirolimus
• Sirolimus Protein-Bound
• Sonidegib
• Sparsentan
• Tacrolimus
• Tazemetostat
• Teriflunomide
• Tezacaftor
• Tolvaptan
• Trofinetide
• Ubrogepant
• Venetoclax
• Venlafaxine
• Voclosporin
• Voriconazole
• Warfarin
• Zanubrutinib
• Zolpidem

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Amlodipine
• Eltrombopag
• Suvorexant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Inform your doctor if you have any other medical problems, especially:

• Kidney disease, severe—Use with caution. May worsen this condition.

• Liver disease, severe—Use is not recommended for patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• rapid weight gain
• tingling of the hands or feet
• unusual weight gain or loss

Less common

• Black, tarry stools
• chest pain
• chills
• cough
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• lower back or side pain
• painful or difficult urination
• pale skin
• sore throat
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea
• headache
• nausea
• stomach pain
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Prevymis

Available Dosage Forms:

• Solution

Therapeutic Class: Antiviral

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed into one of your veins. It must be given slowly, so the needle should stay in place for over an hour.

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have questions.

You should receive this medicine only if you are unable to take the oral form. Your doctor may switch you to the oral form of the medicine once you can already take it by mouth.

• What is Prevymis used to treat?