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Letermovir parenteral

Updated 2 Feb 2023 | Cytomegalovirus (CMV)

Presentation

Infusions of letermovir.

Drugs List

  • letermovir 240mg/12ml concentrate for solution for infusion vial
  • PREVYMIS 240mg/12ml concentrate for solution for infusion vial
  • 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, 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

    Ciclosporin
    Ciclosporin co-administered with letermovir
    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.

    Missed dose
    If a dose is missed, the patient should take it as soon as they remember. If it is time for the next dose, skip the missed dose and resume the regular dosing schedule. Patients should not double their next dose.

    Administration

    For intravenous infusion only.

    Contraindications

    Children under 18 years
    Breastfeeding
    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

    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated by specialist
    Must be diluted before use
    Monitor regularly for cytomegalovirus (CMV) infection
    Monitor serum creatinine in patients with renal impairment
    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.

    The manufacturer recommends that letermovir is not used during pregnancy. There is no data on the use of letermovir in pregnant women. Animal studies have shown reproductive toxicity.

    Lactation

    Letermovir is contraindicated during breastfeeding.

    The manufacturer recommends either discontinuing breastfeeding or abstaining from letermovir treatment as a risk to the breast fed newborn cannot be excluded.

    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.

    Animal studies have shown excretion of letermovir in milk.

    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: January 2022

    Reference Sources

    Summary of Product Characteristics: Prevymis 240mg concentrate for solution for infusion. Merck Sharp & Dohme 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/NBK500949/
    Letermovir. Last revised: 07 February 2019
    Last accessed: 24 January 2022

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