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vedolizumab

Entyvio · ATC code 6181

Key facts
Active substance
vedolizumab
ATC code
6181
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Entyvio 300 mg powder for concentrate for solution for infusion · Entyvio 108 mg solution for injection in pre-filled syringe / Entyvio 108 mg solution for injection in pre-filled pen
Marketing authorisation holder
Takeda Pharma A/S
Information as of
2026-10-27

Key facts

Vedolizumab is a gut-selective integrin antagonist (monoclonal antibody against α4β7 integrin). It is used for ulcerative colitis, Crohn's disease and chronic pouchitis.

What it is used for

  • Moderately to severely active ulcerative colitis in adults with inadequate response, loss of response or intolerance to conventional therapy or a TNF-alpha antagonist
  • Moderately to severely active Crohn's disease in adults under the same conditions
  • Infusion: moderately to severely active chronic pouchitis after proctocolectomy with inadequate response to antibiotics

Dosing

  • Intravenous (300 mg): infusion at weeks 0, 2 and 6, then every 8 weeks
  • Ulcerative colitis: discontinue if no benefit by week 10; with decreasing response, 300 mg every 4 weeks may help
  • Crohn's disease: non-responders may benefit from a dose at week 10; discontinue if no benefit by week 14
  • Subcutaneous (108 mg): after at least 2 intravenous infusions, every 2 weeks, the first dose in place of the next infusion
  • Initiated and supervised by experienced specialists

Contraindications

  • Hypersensitivity to the active substance or excipients
  • Active severe infections (e.g. tuberculosis, sepsis, cytomegalovirus, listeriosis) and opportunistic infections such as PML

Important warnings

  • Infusion-related and hypersensitivity reactions including anaphylaxis; observe patients during and after infusions
  • Potential increased risk of opportunistic infections and infections for which the gut is a barrier; screen for tuberculosis before starting
  • Progressive multifocal leukoencephalopathy (PML): monitor neurological symptoms; withhold if suspected, discontinue permanently if confirmed
  • Live vaccines, particularly oral live vaccines, only with caution

Side effects

  • Most common: infections (nasopharyngitis, upper respiratory tract infection, bronchitis, influenza, sinusitis)
  • Headache, nausea, pyrexia, fatigue, cough, arthralgia
  • Infusion-related reactions (e.g. dyspnoea, bronchospasm, urticaria, flushing)

Interactions

  • No interaction studies; corticosteroids, immunomodulators and aminosalicylates had no clinically meaningful effect on pharmacokinetics
  • Live vaccines: caution

Pregnancy and breastfeeding

  • Contraception during and for at least 18 weeks after the last treatment; preferably avoided in pregnancy unless benefits clearly outweigh risks
  • Detected in human milk; effects on breast-fed infants unknown

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

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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)

  • EntyvioTakeda Pharma A/S · EMEA/H/C/002782

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Entyvio
Liechtenstein
Entyvio
Norway
Entyvio

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

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Sources

  1. European Medicines Agency. Entyvio – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.