This is a summary of the European public assessment report (EPAR) for Entyvio. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Entyvio.
For practical information about using Entyvio, patients should read the package leaflet or contact their doctor or pharmacist.
What is Entyvio and what is it used for?
Entyvio is a medicine that contains the active substance vedolizumab. It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn’s disease (a disease causing inflammation of the digestive tract). Vedolizumab is used to treat moderate to severe active disease when conventional therapy or medicines called
How is Entyvio used?
Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein. It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the diagnosis and treatment of ulcerative colitis or Crohn’s disease.
The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond.
Entyvio is given as an infusion that lasts 30 minutes. All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion. For more information, see the package leaflet.
Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.
© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.
How does Entyvio work?
The active substance in Entyvio, vedolizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body. Vedolizumab has been designed to attach to
Entyvio is produced by a method known as ‘recombinant DNA technology’; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.
What benefits of Entyvio have been shown in studies?
In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or
Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn’s disease. In one main study in adult patients with moderate to severe active Crohn’s disease in whom conventional therapy or
What are the risks associated with Entyvio?
The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain). For the full list of all side effects reported with Entyvio, see the package leaflet.
Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death). For the full list of restrictions, see the package leaflet.
Why is Entyvio approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio’s benefits are greater than its risks and recommended that it be approved for use in the EU. In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to
In Crohn’s disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with
What measures are being taken to ensure the safe and effective use of Entyvio?
A risk management plan has been developed to ensure that Entyvio is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients.
The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.
Further information can be found in the summary of the risk management plan.
Other information about Entyvio
The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
The full EPAR and risk management plan summary for Entyvio can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in