Telotristat ethyl oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of telotristat ethyl.
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
Mild hepatic impairment
Severe renal impairment
Advise patient ability to drive or operate machinery may be impaired
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.
Alanine aminotransferase increased
Aspartate aminotransferase increased
Gamma glutamyl transferase (GGT) increased
Increase in alkaline phosphatase
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 ).
Last Full Review Date: December 2020
Summary of Product Characteristics: Xermelo 250mg film-coated tablets. Ipsen Pharma Ltd. Revised November 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 December 2020
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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