Letermovir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulation of letermovir.
Drugs List
Therapeutic Indications
Uses
Prophylaxis of CMV infection in haematopoietic stem cell transplant pts
Prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients (R+) of an allogeneic haematopoietic stem cell transplant (HSCT).
Dosage
Adults
480mg once daily.
Letermovir can be started any time between the day of transplant (after the HSCT), and up to 28 days after transplant. Letermovir may be started before or after engraftment. Treatment should continue for 100 days post-transplant. Use beyond 100 days post-transplant may be of benefit in patients at high risk for late CMV reactivation, but has not been studied in clinical trials.
Additional Dosage Information
Letermovir tablets and concentrate for solution for infusion may be interchanged with no dose adjustment required.
Ciclosporin
Letermovir co-administered with ciclosporin
240mg once daily.
Ciclosporin initiated after starting letermovir
Next dose of letermovir should be decreased to 240mg once daily.
Ciclosporin discontinued after starting letermovir
Next dose of letermovir should be increased to 480mg once daily.
Temporary interruption to ciclosporin treatment due to high ciclosporin levels
No dose adjustment needed.
Contraindications
Children under 18 years
Breastfeeding
Galactosaemia
Moderate hepatic impairment with moderate or severe renal impairment
Pregnancy
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Precautions and Warnings
Females of childbearing potential
End stage renal disease
Glucose-galactose malabsorption syndrome
Lactose intolerance
Advise ability to drive/operate machinery may be affected by side effects
Treatment to be initiated by specialist
Contains lactose
Advise patient on concurrent use of proton pump inhibitors
Monitor patients receiving concurrent anticoagulants
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
Pregnancy and Lactation
Pregnancy
Letermovir is contraindicated during pregnancy.
There is limited data on the use of letermovir during pregnancy. The manufacturer does not recommend using letermovir in pregnancy and in women of childbearing potential not using contraception.
Animal studies have shown reproductive toxicity.
Lactation
Letermovir is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues letermovir treatment or discontinues breastfeeding.
The presence of letermovir in human breast milk is unknown but due to its high plasma protein binding the amount present in breast milk would likely to be low.
Side Effects
Abdominal pain
Alanine aminotransferase increased
Aspartate aminotransferase increased
Decreased appetite
Diarrhoea
Dysgeusia
Fatigue
Headache
Hypersensitivity reactions
Muscle spasm
Nausea
Peripheral oedema
Serum creatinine increased
Vertigo
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2022
Reference Sources
Summary of Product Characteristics: Prevymis 240mg film-coated tablets. Merck Sharp & Dohme (UK) Limited. Revised January 2021.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Letermovir. Last revised: 07 February 2019
Last accessed: 20 January 2022
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