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Telotristat ethyl oral


Oral formulations of telotristat ethyl.

Drugs List

  • telotristat ethyl 250mg tablets
  • XERMELO 250mg tablets
  • Therapeutic Indications


    Diarrhoea associated with carcinoid syndrome

    Treatment of carcinoid syndrome diarrhoea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy.



    250mg three times daily.

    Patients with Hepatic Impairment

    Mild hepatic impairment (Child-Pugh score A)
    250mg two times daily, depending on tolerability.

    Moderate hepatic impairment (Child-Pugh score B)
    250mg once daily, depending on tolerability.


    Children under 18 years
    End stage renal disease
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    Precautions and Warnings

    Females of childbearing potential
    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Mild hepatic impairment
    Severe renal impairment

    Advise patient ability to drive or operate machinery may be impaired
    Contains lactose
    Advise patient to take with or after food
    Monitor hepatic function before treatment and regularly during treatment
    Advise patient to report constipation
    Monitor patients with hepatic impairment for adverse effects
    Monitor patients with severe renal impairment for adverse effects
    Review if an adequate response not obtained within 3 months
    Advise patient to report any new or worsening depression/suicidal ideation
    Discontinue in liver dysfunction; only restart after clinical evaluation
    Consider dose reduction in hepatic impairment
    Female: Ensure adequate contraception during treatment

    Pregnancy and Lactation


    Telotristat ethyl is contraindicated during pregnancy.

    The manufacturer states that telotristat ethyl is not recommended during pregnancy. Animal studies have shown reproductive toxicity, including increased early and late foetal resorptions.

    Women of childbearing potential are advised to use adequate contraception.


    Telotristat ethyl is contraindicated during breastfeeding.

    The manufacturer recommends that patients should not breastfeed during telotristat ethyl treatment. It is not known whether this agent or its metabolites are excreted in human breast milk.


    Advise patient to take telotristat ethyl with or after food.

    Advise patient that if they miss a dose of telotristat ethyl, they should continue with their dosing schedule as normal, and should not take a double dose to make up for a missed dose.

    Advise patient to report any new or worsening depression or suicidal ideation.

    Advise patient to report constipation.

    Advise female patients to ensure adequate contraception during treatment.

    Advise patient that their ability to drive or operate machinery may be impaired.

    Side Effects

    Abdominal distension
    Abdominal pain
    Alanine aminotransferase increased
    Aspartate aminotransferase increased
    Decreased appetite
    Depressed mood
    Gamma glutamyl transferase (GGT) increased
    Increase in alkaline phosphatase
    Intestinal obstruction
    Peripheral oedema


    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: December 2020

    Reference Sources

    Summary of Product Characteristics: Xermelo 250mg film-coated tablets. Ipsen Pharma Ltd. Revised November 2020.

    NICE Evidence Services Available at: Last accessed: 15 December 2020

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