Description
Letermovir injection is used alone or together with another medicine (eg, cyclosporine) to 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 who have a high risk for getting CMV disease.
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of letermovir injection in children younger than 6 months of age or weighing less than 6 kilograms (kg) who have received an allogeneic hematopoietic stem cell (bone marrow) transplant or in children younger than 12 years of age or weighing less than 40 kg who have received a kidney transplant. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of letermovir injection in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily 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
- Ergotamine
- Flibanserin
- Lomitapide
- Pimozide
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amprenavir
- Apalutamide
- Apixaban
- Aprepitant
- Aripiprazole
- Artemether
- Asciminib
- Astemizole
- Atazanavir
- Atorvastatin
- Atrasentan
- Avacopan
- Avapritinib
- Avatrombopag
- Axitinib
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Bictegravir
- Boceprevir
- Bosentan
- Bosutinib
- Brexpiprazole
- Brigatinib
- Budesonide
- Buprenorphine
- Buspirone
- Cabozantinib
- Cannabidiol
- Capivasertib
- Capmatinib
- Carbamazepine
- Cariprazine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Kidney disease, severe—Use with caution. May make this condition worse.
- Liver disease, severe—Use is not recommended in patients with this condition.
Proper Use
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.
Precautions
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 (eg, 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.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately 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. Also, your health care professional may 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 or 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.
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