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teduglutide

Revestive · ATC code A16AX08

Also known as: Teduglutid

Key facts
Active substance
teduglutide
ATC code
A16AX08
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Revestive 1.25 mg powder and solvent for solution for injection · Revestive 5 mg powder and solvent for solution for injection
Marketing authorisation holder
Takeda Pharmaceuticals International AG Ireland
Information as of
2026-10-28

Key facts

Teduglutide (Revestive) is a GLP-2 analogue given by subcutaneous injection. It is used in short bowel syndrome to improve intestinal absorption.

What it is used for

  • Patients 4 months corrected gestational age and above with short bowel syndrome who are stable after a period of intestinal adaptation following surgery.

Dosing

  • Children, adolescents and adults: 0.05 mg/kg body weight once daily subcutaneously.
  • Revestive 1.25 mg for children up to 20 kg (injection volume by weight table); use the 5 mg strength for children over 20 kg and for adults.
  • Moderate and severe renal impairment (creatinine clearance less than 50 ml/min) and end-stage renal disease: reduce the daily dose by 50%.
  • In children evaluate the effect after 6 months, below two years of age after 12 weeks; stop if there is no overall improvement.

Contraindications

  • Hypersensitivity to the active substance, any of the excipients or trace residues of tetracycline.
  • Active or suspected malignancy.
  • History of gastrointestinal malignancy, including hepatobiliary system and pancreas, within the last five years.

Important warnings

  • Colorectal polyps: colonoscopy with polyp removal at the start of treatment, yearly during the first 2 years, then at least every five years; discontinue in case of malignancy.
  • Intestinal obstruction, gallbladder, bile duct and pancreatic disorders have been reported.
  • Fluid overload or dehydration: adjust parenteral support carefully and monitor electrolytes.
  • Absorption of concomitant medicines may increase.

Side effects

  • Very common: abdominal pain and distension (45%), respiratory tract infections (28%), nausea (26%), injection site reactions (26%), headache (16%), vomiting (14%).
  • About 38% of patients with a stoma had stoma complications; mostly mild or moderate.

Interactions

  • No clinical interaction studies; does not inhibit cytochrome P450 enzymes.
  • Potential for increased absorption of other medicines, especially those with a narrow therapeutic index.

Pregnancy and breastfeeding

  • As a precaution, preferably avoid use during pregnancy and breast-feeding.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • TidonalleAdalvo Limited · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 6 more European countries
France
Teduglutide Adalvo, Téduglutide
Iceland
Revestive, Teduglutide Viatris
Liechtenstein
Revestive, Teduglutide Viatris
Norway
Niletto, Revestive, Teduglutide Viatris
Spain
Teduglutida Cipla
Sweden
Nilleto, Teduglutid Cipla, Teduglutide Adalvo, Tidonalle

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Revestive – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/revestive-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.