Drugs List

Therapeutic Indications

Uses

Short Bowel Syndrome: Treatment

Administration

The reconstituted solution should be injected subcutaneously once daily, alternating sites between 1 of the 4 quadrants of the abdomen. The thigh can also be used.

Contraindications

Children under 1 year
Breastfeeding
Colorectal polyps
Gastrointestinal malignancy
History of gastrointestinal malignancy within the last 5 years
Malignant neoplasm
Pregnancy

Precautions and Warnings

Fluid retention
Cardiovascular disorder
Dehydration
Hypertension
Renal impairment - creatinine clearance below 50ml/minute
Severe hepatic impairment

Exclude GI malignancy before starting treatment
Reduce dose in patients with creatinine clearance below 50ml/min
Advise patient ability to drive or operate machinery may be impaired
Perform colonoscopy before initiating treatment in children
Perform colonoscopy before, once yearly for 2 yrs & every 5 after in adults
Restore electrolyte & fluid balance in case of dehydration
Treatment to be initiated and supervised by a specialist
May contain trace amounts of tetracycline
Record name and batch number of administered product
Perform faecal occult blood test before treatment and annually in children
Monitor fluid and electrolyte status
Monitor for signs of dehydration
Monitor short bowel, gallbladder, bile ducts and pancreas function
Monitor weight for fluid retention in patients with cardiac insufficiency
Perform colonoscopy at 1 year and every 5 years thereafter in children
Review treatment if deterioration of cardiovascular disease
Review treatment if gallbladder or bile duct-related symptoms
Review treatment if pancreatic adverse events
Review treatment if recurrent intestinal obstruction
Advise patient to report weight gain, face/ankle swelling and/or dyspnoea
Discontinue if a malignancy develops during treatment
Discontinue if no improvement after treatment for one year
May affect the gastro-intestinal absorption of other drugs

An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient characteristics.

If a polyp is found, adherence to current polyp follow-up guidelines is recommended.

Assessment of parenteral nutrition needs should be conducted frequently during the first months of treatment.

Children should have a colonoscopy if they have unexplained blood in their stool.

Fluid overload occurred most frequently during the first 4 weeks of therapy in clinical trials and decreased over time.

Treatment should be reviewed after 12 weeks in children under 2 years of age.

Patients with short bowel syndrome are susceptible to dehydration that may lead to acute renal failure.

Parenteral support should be reduced carefully and should not be discontinued abruptly due to the risk of dehydration.

Pregnancy and Lactation

Pregnancy

Teduglutide is contraindicated during pregnancy.

The manufacturer advises avoiding the use of teduglutide during pregnancy.

There is no data from the use of teduglutide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Lactation

Teduglutide is contraindicated during breastfeeding.

The manufacturer advises avoiding the use of teduglutide during breastfeeding.

It is unknown whether teduglutide is excreted in human milk. In rats, mean teduglutide concentration in milk was less than 3% of the maternal plasma concentration following a single subcutaneous injection of 25 mg/kg. Risk to the newborn/infant cannot be excluded.

Side Effects

Abdominal distension
Abdominal pain
Anxiety
Cholecystitis
Colonic stenosis
Congestive cardiac failure
Cough
Decreased appetite
Dyspnoea
Erythema at injection site
Facial swelling
Flatulence
Fluid retention
GI stoma complication
Haematoma (injection site)
Headache
Hypersensitivity reactions
Influenza
Injection site reactions
Insomnia
Intestinal obstruction
Local pain (injection site)
Lower respiratory tract infection
Nasopharyngitis
Nausea
Pancreatic duct stenosis
Pancreatitis
Peripheral oedema
Polyps
Syncope
Upper respiratory tract infection
Vomiting

Presentation

Powder for solution for injection containing teduglutide.

This product has been produced by recombinant technology using E.coli.

Drugs List

Therapeutic Indications

Uses

Short Bowel Syndrome: Treatment

Dosage

Adults

Children

Patients with Renal Impairment

Additional Dosage Information

Administration

The reconstituted solution should be injected subcutaneously once daily, alternating sites between 1 of the 4 quadrants of the abdomen. The thigh can also be used.

Contraindications

Children under 1 year
Breastfeeding
Colorectal polyps
Gastrointestinal malignancy
History of gastrointestinal malignancy within the last 5 years
Malignant neoplasm
Pregnancy

Precautions and Warnings

Fluid retention
Cardiovascular disorder
Dehydration
Hypertension
Renal impairment - creatinine clearance below 50ml/minute
Severe hepatic impairment

Exclude GI malignancy before starting treatment
Reduce dose in patients with creatinine clearance below 50ml/min
Advise patient ability to drive or operate machinery may be impaired
Perform colonoscopy before initiating treatment in children
Perform colonoscopy before, once yearly for 2 yrs & every 5 after in adults
Restore electrolyte & fluid balance in case of dehydration
Treatment to be initiated and supervised by a specialist
May contain trace amounts of tetracycline
Record name and batch number of administered product
Perform faecal occult blood test before treatment and annually in children
Monitor fluid and electrolyte status
Monitor for signs of dehydration
Monitor short bowel, gallbladder, bile ducts and pancreas function
Monitor weight for fluid retention in patients with cardiac insufficiency
Perform colonoscopy at 1 year and every 5 years thereafter in children
Review treatment if deterioration of cardiovascular disease
Review treatment if gallbladder or bile duct-related symptoms
Review treatment if pancreatic adverse events
Review treatment if recurrent intestinal obstruction
Advise patient to report weight gain, face/ankle swelling and/or dyspnoea
Discontinue if a malignancy develops during treatment
Discontinue if no improvement after treatment for one year
May affect the gastro-intestinal absorption of other drugs

An individual assessment whether increased frequency of surveillance is necessary should be performed based on the patient characteristics.

If a polyp is found, adherence to current polyp follow-up guidelines is recommended.

Assessment of parenteral nutrition needs should be conducted frequently during the first months of treatment.

Children should have a colonoscopy if they have unexplained blood in their stool.

Fluid overload occurred most frequently during the first 4 weeks of therapy in clinical trials and decreased over time.

Treatment should be reviewed after 12 weeks in children under 2 years of age.

Patients with short bowel syndrome are susceptible to dehydration that may lead to acute renal failure.

Parenteral support should be reduced carefully and should not be discontinued abruptly due to the risk of dehydration.

Pregnancy and Lactation

Pregnancy

Teduglutide is contraindicated during pregnancy.

The manufacturer advises avoiding the use of teduglutide during pregnancy.

There is no data from the use of teduglutide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Lactation

Teduglutide is contraindicated during breastfeeding.

The manufacturer advises avoiding the use of teduglutide during breastfeeding.

It is unknown whether teduglutide is excreted in human milk. In rats, mean teduglutide concentration in milk was less than 3% of the maternal plasma concentration following a single subcutaneous injection of 25 mg/kg. Risk to the newborn/infant cannot be excluded.

Side Effects

Abdominal distension
Abdominal pain
Anxiety
Cholecystitis
Colonic stenosis
Congestive cardiac failure
Cough
Decreased appetite
Dyspnoea
Erythema at injection site
Facial swelling
Flatulence
Fluid retention
GI stoma complication
Haematoma (injection site)
Headache
Hypersensitivity reactions
Influenza
Injection site reactions
Insomnia
Intestinal obstruction
Local pain (injection site)
Lower respiratory tract infection
Nasopharyngitis
Nausea
Pancreatic duct stenosis
Pancreatitis
Peripheral oedema
Polyps
Syncope
Upper respiratory tract infection
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: December 2020

Reference Sources

Summary of Product Characteristics: Revestive 1.25mg powder and solvent for solution for injection. Shire Pharmaceuticals Ireland Limited. Revised May 2020.

Summary of Product Characteristics: Revestive 5mg powder and solvent for solution for injection. Shire Pharmaceuticals Ireland Limited. Revised May 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 December 2020