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Larotrectinib oral

Updated 2 Feb 2023 | Larotrectinib


Oral formulations of larotrectinib.

Drugs List

  • larotrectinib 100mg capsules
  • larotrectinib 20mg/ml oral solution sugar-free
  • larotrectinib 25mg capsules
  • VITRAKVI 100mg capsules
  • VITRAKVI 20mg/ml oral solution sugar-free
  • VITRAKVI 25mg capsules
  • Therapeutic Indications


    Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion +ve solid tumours

    Treatment of adult and paediatric patients with solid tumours with Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indications should be consulted.


    100mg twice daily.


    100mg per metre squared twice daily. Maximum of 100mg twice daily.

    Patients with Hepatic Impairment

    Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment: Reduce starting dose by 50%.

    Additional Dosage Information

    Co-administration with strong CYP3A4 inhibitor should be avoided, however if co-administration is necessary, reduce dose by 50%. After the strong CYP3A4 inhibitor has been discontinued for 3 to 5 elimination half-lives, larotrectinib should be resumed at the dose taken prior to initiation of the CYP3A4 inhibitor.

    Dose modification

    Missed dose
    If a dose was missed or the patient vomited after administration, next dose should be taken at the next scheduled time.

    Adult and paediatric patients with body surface area of at least 1 metre squared First dose modification: 75mg twice daily. Second dose modification: 50mg twice daily. Third dose modification: 100mg once daily.

    Paediatric patients with body surface area less than 1 metre squared First dose modification: 75mg/metre squared twice daily. Second dose modification: 50mg/metre squared twice daily. Third dose modification: 25mg/metre squared twice daily.

    Paediatric patients on 25mg/metre squared twice daily should remain on this dose even if BSA becomes greater than 1 metre squared. The maximum dose should be 25mg/metre squared twice daily at the third dose modification.
    For all grade 2 adverse reactions
    Continue the dose and follow the laboratory elevations for 1 to 2 weeks until resolved to establish whether a dose interruption or reduction is required.

    For grade 3 or 4 adverse reactions Withhold treatment until resolves or improves to baseline or grade 1, then resume treatment at next dose modification. If adverse reaction does not resolve within 4 weeks, permanently discontinue. Treatment should be permanently discontinued if patient is unable to tolerate after three dose modifications.



    Precautions and Warnings

    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance
    Moderate hepatic impairment

    Reduce dose in patients with moderate hepatic impairment
    Advise ability to drive/operate machinery may be affected by side effects
    Confirm positive NTRK gene fusion status of tumour prior to treatment
    Treatment to be initiated and supervised by a specialist
    Presentations with sorbitol unsuitable in hereditary fructose intolerance
    Some formulations contain hydroxybenzoate
    Some formulations contain propylene glycol
    Some formulations contain sucrose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Exclude pregnancy prior to initiation of treatment
    Monitor hepatic function before, monthly for 3 months, then periodically
    Monitor for signs of neurological toxicity
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid grapefruit products
    Female: Contraception required during and for 1 month after treatment
    Male & female: Two methods of contraception required (including barrier)
    Male: Use barrier contraception during and for 1 month after treatment
    Breastfeeding: Do not breastfeed during and for 3 days after treatment

    Pregnancy and Lactation


    Larotrectinib is contraindicated during pregnancy.
    The manufacturer recommends that larotrectinib is avoided during pregnancy. There is no data of use of larotrectinib in pregnant women. Animal studies did not show direct or indirect reproductive toxicity.


    Larotrectinib is contraindicated during breastfeeding.
    The manufacturer recommends that breastfeeding should be discontinued during larotrectinib treatment, and for 3 days following the last dose. It is not known whether larotrectinib is excreted in human milk and therefore a risk to the breastfeeding infant cannot be excluded.

    Side Effects

    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Gait abnormality
    Increase in alkaline phosphatase
    Muscle weakness
    Weight gain


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2021

    Reference Sources

    Summary of Product Characteristics: Vitrakvi 20mg/ml oral solution. Bayer plc. Revised August 2020.
    Summary of Product Characteristics: Vitrakvi 20mg/ml oral solution (Strawberry flavour). Bayer plc. Revised September 2021.
    Summary of Product Characteristics: Vitrakvi 25mg hard capsules. Bayer plc. Revised August 2020.
    Summary of Product Characteristics: Vitrakvi 100mg hard capsules. Bayer plc. Revised August 2020.

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