What are the Licensed Indications?

Entyvio is the first and only gut-selective biologic approved for the treatment of adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).1

What are the Licensed Indications?

What are the Licensed Indications?

Entyvio is indicated for the treatment of adults with moderately to severely active UC or CD who have experienced an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.1

How is Entyvio Administered?

How is Entyvio Administered?

Vedolizumab is given by intravenous infusion. The recommended dose of 300 mg is given over a period of 30 minutes. After the initial treatment, patients are given repeat treatment 2 and 6 weeks later, and then every 8 weeks thereafter.1

How Does Entyvio Work?

How Does Entyvio Work?

The active ingredient vedolizumab belongs to a group of biological medicines called monoclonal antibodies. Vedolizumab has been designed to specifically antagonise the alpha-4, beta-7 (α4β7) integrin. As such, it is known more generally as an integrin antagonist.

The α4β7 integrin is expressed on a subset of circulating white blood cells that have been shown to play a role in mediating the inflammatory process in CD and UC9,10. Thus, by selectively blocking this particular integrin, vedolizumab is able to specifically reduce inflammation in the gastrointestinal tract in both UC and CD.

Clinical Trial Data

Clinical Trial Data

The safety and efficacy of Entyvio is supported by the results of the GEMINI™ Studies5,6,15,16. These phase III studies involved 2,400 individuals with UC or CD who were recruited from nearly 40 countries1. GEMINI is the largest phase III clinical trial programme to date that evaluated a new treatment for UC or CD concurrently.

The most common adverse events reported were nausea, infection or inflammation of the nasopharynx (nasopharyngitis), upper respiratory tract infection, joint pain (arthralgia), fever (pyrexia), fatigue, headache and cough.1

More info

If you have been prescribed Entyvio and get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed within this website or in the Patient Information Leaflet for Entyvio.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See https://yellowcard.mhra.gov.uk/ for how to report side effects.