Letermovir (Intravenous)

Letermovir injection is used by itself or with another medicine (for example, cyclosporine) to help prevent cytomegalovirus (CMV) infection and disease in patients who have received an allogeneic hematopoietic stem cell (bone marrow) transplant or in patients who have received 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 check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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

Do not use pitavastatin (Livalo®) or simvastatin (Zocor®) when you take this medicine together with cyclosporine (Gengraf®, Neoral®, Sandimmune®).

Do not take other medicines unless they have been discussed 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 weigh the risks of taking it against the benefits it may offer. Consider the following for this medicine:

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 about any other allergies you may have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how letermovir injection affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems that would limit the usefulness of letermovir injection in older adults.

Breast Feeding

There are no adequate 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 at all, while others may be used together even if an interaction could occur. In these cases, your doctor may need to adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below when receiving this medicine. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may 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 cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the 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 using both may be the best treatment for you. If both are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine
• Eltrombopag
• Suvorexant

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, 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 intended effects, a medicine can 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 occur 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 be able to tell you about 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 happen 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.