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Teduglutide parenteral


Powder for solution for injection containing teduglutide.

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

Drugs List

  • REVESTIVE 1.25mg powder + solvent for solution for injection
  • REVESTIVE 5mg powder + solvent for solution for injection
  • teduglutide 1.25mg powder + solvent for solution for injection
  • teduglutide 5mg powder + solvent for solution for injection
  • Therapeutic Indications


    Short Bowel Syndrome: Treatment



    0.05mg/kg body weight once daily.


    Children aged 1 year and older
    0.05mg/kg body weight once daily.

    Body weight less than 20kg: use 1.25mg strength vial.
    Body weight over 20kg: use 5mg strength vial.

    Patients with Renal Impairment

    Creatinine clearance less than 50ml/minute and end stage renal disease: Reduce dose by 50%.

    Additional Dosage Information

    A carefully monitored down-titration of the daily dose may be considered for some patients to optimise tolerability of the treatment. If a dose is missed, that dose should be taken as soon as possible on that day.

    There are no data available in paediatric patients after 6 months.


    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.


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

    Precautions and Warnings

    Fluid retention
    Cardiovascular disorder
    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


    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.


    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
    Colonic stenosis
    Congestive cardiac failure
    Decreased appetite
    Erythema at injection site
    Facial swelling
    Fluid retention
    GI stoma complication
    Haematoma (injection site)
    Hypersensitivity reactions
    Injection site reactions
    Intestinal obstruction
    Local pain (injection site)
    Lower respiratory tract infection
    Pancreatic duct stenosis
    Peripheral oedema
    Upper respiratory tract infection


    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: 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: Last accessed: 10 December 2020

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.