Drugs List

Therapeutic Indications

Uses

Diarrhoea associated with carcinoid syndrome

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

Contraindications

Children under 18 years
Breastfeeding
End stage renal disease
Galactosaemia
Pregnancy
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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Abdominal pain
Alanine aminotransferase increased
Aspartate aminotransferase increased
Constipation
Decreased appetite
Depressed mood
Depression
Faecaloma
Fatigue
Flatulence
Gamma glutamyl transferase (GGT) increased
Headache
Increase in alkaline phosphatase
Intestinal obstruction
Nausea
Peripheral oedema
Pyrexia

Presentation

Oral formulations of telotristat ethyl.

Drugs List

Therapeutic Indications

Uses

Diarrhoea associated with carcinoid syndrome

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

Dosage

Adults

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Breastfeeding
End stage renal disease
Galactosaemia
Pregnancy
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

Pregnancy

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.

Lactation

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.

Counselling

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
Constipation
Decreased appetite
Depressed mood
Depression
Faecaloma
Fatigue
Flatulence
Gamma glutamyl transferase (GGT) increased
Headache
Increase in alkaline phosphatase
Intestinal obstruction
Nausea
Peripheral oedema
Pyrexia

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: December 2020

Reference Sources

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