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Last reviewed: May 2023
Next review date: May 2026
This information is for people with Crohn’s or Colitis who are on vedolizumab (Entyvio) treatment or who are thinking about starting it. This information can help you to decide if this treatment is right for you. It looks at:
This information is about vedolizumab in general. It should not replace advice from your IBD team.
We need your help to improve our information to better support people with Crohn’s and Colitis. Fill in our short survey to let us know what we're doing well and how we can better meet your needs.
Vedolizumab is also known by the brand name Entyvio.
There are lots of things to think about when you start a new treatment. Your IBD team will discuss your options with you. When thinking about a new treatment you might want to consider the potential benefits, possible risks and the goals of your treatment. Some things to think about include:
Our Appointment guide has a list of questions you might want to ask. It can help you focus on what matters most to you. You might find our information about other medicines and surgery for Colitis helpful.
Use this tool to understand more about potential treatment options that suit your needs. The tool is designed to help you:
Vedolizumab belongs to a group of medicines called biologic medicines. Biologic medicines are made by a biological rather than a chemical process. They are produced in a lab by living cells.
As part of your body’s normal immune response, your immune system makes white blood cells. These cells travel to various parts of your body to fight infection. Some of these white blood cells move into the gut. In people with Crohn’s or Colitis, too many white blood cells enter the gut. This causes inflammation in the gut, leading to symptoms of Crohn’s or Colitis.
Vedolizumab is a ‘gut-selective integrin blocker’. It sticks to a protein called integrin. Integrin is found on the surface of the white blood cells that enter your gut. Blocking integrin stops these white blood cells entering the gut and reduces the amount of inflammation. This means that vedolizumab only targets the gut, rather than your whole body.
Vedolizumab is used to treat people over 18 years with moderate to severe Crohn’s or Colitis. Treatment with vedolizumab aims to get your Crohn’s or Colitis under control and keep it under control.
Vedolizumab can only be prescribed by a specialist IBD team and not your GP. Your IBD team might suggest treatment with vedolizumab if you have Crohn’s or Colitis and:
If you have Crohn’s Disease, you can only have vedolizumab on the NHS if:
Standard treatments include aminosalicylates (5-ASAs), steroids, or immunosuppressants such as azathioprine, mercaptopurine or methotrexate.
Anti-TNF medicines include adalimumab, golimumab and infliximab.
Use in children is not included in the licence for vedolizumab. The licence is the document that explains what a medicine can be used for. If you are under 18 and other treatments have not helped your condition, your IBD team may discuss whether vedolizumab could be an option for you.
Some people start feeling better within 6 weeks of starting treatment with vedolizumab. For others it may take longer. Vedolizumab might not work at all for some people.
If you have Colitis, you should start to feel better by 10 weeks. If not, your IBD team might suggest stopping vedolizumab.
If you have Crohn’s, vedolizumab can take up to 14 weeks to work. If you have not started to feel better after 14 weeks, your IBD team might suggest stopping vedolizumab.
Vedolizumab can help to get your Crohn’s or Colitis under control and keep it under control.
Find out more about how we talk about the effectiveness of medicines.
At first, the aim of vedolizumab treatment is to reduce the inflammation in your gut and get your Crohn’s or Colitis under control. This is induction treatment. Once your Crohn’s or Colitis is under control, treatment aims to keep it under control (in remission). This is maintenance treatment.
One large study looked at vedolizumab as both induction and maintenance treatment for Crohn’s. The study compared vedolizumab given by infusion with placebo (dummy treatment). Some of these people had already been treated with other anti-TNF medicines and some had not.
The table shows how well vedolizumab got Crohn’s under control after 6 weeks.
After 6 weeks, about twice as many people who took vedolizumab had their Crohn’s under control compared with those who took placebo.
People whose disease was under control after induction treatment with vedolizumab continued in the study for up to 1 year. They were given vedolizumab every 8 weeks or placebo.
The table shows how well vedolizumab kept Crohn’s under control after 1 year.
After 1 year, nearly twice as many people had their Crohn’s under control after taking vedolizumab compared with people who had been taking placebo. About 39% (39 in every 100 people) who took vedolizumab had their Crohn’s under control compared with 22% (22 in every 100 people) who had been taking placebo.
This study looked at vedolizumab given by intravenous infusion. More recent studies using vedolizumab given by subcutaneous injection showed similar effects.
These results come from a review that combines several studies. The review compared vedolizumab given by infusion with placebo (dummy treatment). Some of these people had already been treated with other anti-TNF medicines and some had not.
The table shows how well vedolizumab got Colitis under control after 6 weeks.
After 6 weeks, more than twice as many people who took vedolizumab had their Colitis under control compared with those who took placebo.
People who had a response to vedolizumab after 6 weeks continued in the study for up to 1 year. They were given vedolizumab every 8 weeks or placebo.
The table shows how well vedolizumab, given every 8 weeks, kept Colitis under control after 1 year.
After 1 year, more than twice as many people who took vedolizumab had their Colitis under control compared with those who took placebo. About 42% (42 in every 100 people) who took vedolizumab had their Colitis under control compared with 16% (16 in every 100 people) who took placebo.
This review looked at vedolizumab given by intravenous infusion. More recent studies using vedolizumab given by subcutaneous injection showed similar effects.
You are likely to have a planned course of treatment for up to a year if vedolizumab is working well for you. After that, your IBD team will assess you to see whether you are still benefitting from it. If you are, you will most likely continue treatment. If you continue treatment, your IBD team should assess you at least every 12 months. This is to make sure vedolizumab is still right for you.
There are a few reasons why you and your IBD team may think about stopping or changing your treatment. These include:
Do not stop taking your medicine without discussing it with your IBD team. If vedolizumab is no longer the best treatment for you, your IBD team should discuss other treatment options with you.
To begin with, you will have vedolizumab through a drip into a vein in your arm. This is called an intravenous infusion. You will have to go to hospital to have this, but it can often be given in a day unit. So you will only be there for a few hours. You will have at least two doses of vedolizumab through a drip. After that you might continue having vedolizumab through a drip. Or you might have further doses as an injection under your skin. This is called a subcutaneous injection. You can give yourself the injection under your skin at home using a pre-filled pen or syringe. Your doctor, nurse or pharmacist will teach you how to do this.
Discuss with your IBD team how you will be taking vedolizumab.
A doctor or nurse will give you the infusion through a drip into one of the veins in your arm. It usually takes about 30 minutes to have the dose. After this, the doctor or nurse will flush your drip through with a solution of saline (a mix of salt and water). This is to make sure that all the vedolizumab goes into your vein, and none is left in the drip. The flush should not be painful but it may feel a bit cold.
After each of your first two infusions your doctor or nurse will monitor you for about 2 hours. This is to make sure that you are not having a reaction to the infusion. After further infusions they will monitor you for about 1 hour. This may vary between IBD teams.
You will have a 300mg dose of vedolizumab during each infusion.
After this you will have a dose every 4 or 8 weeks, depending on how well your symptoms are being controlled.
You might hear the first few doses of intravenous infusion referred to as ‘loading doses’.
Even if you will be taking vedolizumab by injection, you will have at least your first two doses by infusion in hospital. See the section on infusions for more information.
You will usually have your first injection in hospital, or a nurse will give it to you at home. Your doctor, nurse or pharmacist will then teach you how to inject it yourself. If you prefer, it may be possible for them to teach someone else, such as a friend or family member, to give you the injections.
Vedolizumab injection comes ready to use in either a pre-filled syringe or a pre-filled injection pen. Each contains one dose of vedolizumab.
Delivery
A special delivery company will send your vedolizumab injections to your home. Vedolizumab can only be prescribed by a specialist in the hospital. It is not a medicine that your GP can prescribe for you to pick up from your local pharmacy.
Storage
Keep vedolizumab injections in the fridge, between 2°C and 8°C. Keep the injections in the original carton to protect them from light.
If needed, for example if you are travelling, you can keep vedolizumab injections out of the fridge for up to 7 days. You must keep them in the original carton at room temperature (up to 25°C). They must be out of direct sunlight. If the injections are left out of the fridge for more than 7 days do not use them. Ask your pharmacist to get rid of any unused medicines. Find out more about travelling with medicines in our information on Travelling with Crohn's or Colitis.
Pain at the injection site is a common side effect. You may also get redness, itching and swelling. You should expect to feel some pain, but these tips can help to make it easier to manage.
If you are having problems injecting your vedolizumab, ask your IBD team for help.
You will start having your vedolizumab injections when your next infusion would have been. After that you will have the injections every 2 weeks.
The dose of vedolizumab in each injection is 108mg. So, you will have 108mg vedolizumab by injection every 2 weeks.
In general, vedolizumab is safe and has low rates of side effects. But, like all medicines, you can get side effects when you take it. Some side effects can happen right away, others may happen after you have been taking vedolizumab for a while. Some side effects are mild and may go away on their own, or after you stop taking vedolizumab. Others may be more serious and could need treatment. Some side effects might mean that vedolizumab is not right for you.
Speak to your IBD team if you experience any side effects.
Some people might get serious side effects that need urgent treatment. These do not happen often, but it is important to know what to look out for.
Up to 1 in every 100 people taking vedolizumab might have an allergic reaction. But serious allergic reactions are very rare.
Contact NHS 111 or call 999 straight away if you think you are having an allergic reaction.
Signs to look out for include:
After the allergic reaction has been treated, contact your IBD team to let them know what has happened.
Overall, the rate of infections in people taking vedolizumab is low, and is likely to be lower than in people taking other biologics. This includes common respiratory infections and more serious infections such as pneumonia or shingles. But, infections of the gut may be more common with vedolizumab. This is because it targets the immune system of the gut rather than the whole body.
Contact your doctor or IBD team immediately if you think you have an infection. Signs to look out for include:
If you do get an infection your IBD team might advise you to stop vedolizumab while the infection is treated. This will depend on where the infection is, and how bad it is. You will usually be able to start vedolizumab again when the infection is under control.
Progressive multifocal leukoencephalopathy
It is very rare, but another medicine that works in a similar way to vedolizumab has been associated with an infection called progressive multifocal leukoencephalopathy or PML. Current data indicates that the risk of PML with vedolizumab is very small. Only one case has been reported so far, and that person had other risk factors for PML.
The manufacturer of vedolizumab advises that you should be aware of the symptoms of PML.
Seek medical help immediately if you have any of these symptoms:
In general, vedolizumab is safe and has low rates of side effects. In clinical trials, the risk of getting side effects was similar in people taking vedolizumab to people taking placebo.
The following side effects have been reported by more than 1 in every 10 people taking vedolizumab:
Other common side effects reported in people taking vedolizumab are listed below. These may affect up to 1 in every 10 people who take vedolizumab.
A small number of people feel dizzy after receiving vedolizumab. If you feel dizzy do not drive or use tools or machinery. Seek medical advice if you continue to feel dizzy.
This is not a full list of side effects. For more information see the Patient Information Leaflet. You can find the leaflet by searching for vedolizumab on the electronic medicines compendium.
We encourage you to report any side effects to the Medicines and Healthcare Products Regulatory Agency (MHRA). You can do this through the Yellow Card scheme online or by downloading the MHRA Yellow Card app (yellowcard.mhra.gov.uk). This helps collect important safety information about medicines.
Some treatments for Crohn’s and Colitis have been shown to increase the risk of certain types of cancer. This is because of the way they affect your immune system.
In clinical trials people taking vedolizumab had a similar rate of cancer to people with Crohn’s or Colitis who did not take vedolizumab. This suggests that vedolizumab does not increase the risk of getting cancer. The risk of cancer in longer term studies also appears to be no greater than in the general population of people with Crohn’s or Colitis. This continues to be monitored.
Having treatment that affects your immune system can mean that your body may not be able to fight off infections as well as it used to. Because it targets the gut, this risk is likely to be lower with vedolizumab than with other biologic medicines. Before you start vedolizumab, your IBD team may ask you some questions and do some tests. This is to make sure your risk from an infection is as low as possible. Tell your IBD team if:
Your IBD team may also ask about any vaccinations you have had. This is to make sure that your vaccinations are up to date before you start vedolizumab. Let them know if you are going to have any vaccinations, or you have had a vaccination recently.
After you start vedolizumab, you should have regular checks. These are to see how well it is working and to check for any side effects. It is important that you tell your IBD team about any new symptoms or side effects as soon as they occur.
After 12 months of treatment, your IBD team should give you a check-up to see whether you should continue having vedolizumab. Based on your symptoms they might recommend that you continue treatment. If your condition is in complete remission, they may discuss stopping vedolizumab. See the section on Stopping or changing treatment for more information.
You may take vedolizumab on its own or with other medicines for your Crohn’s or Colitis. Other medicines that you might take as well as vedolizumab include steroids or an immunosuppressant, such as azathioprine, mercaptopurine or methotrexate.
If you are taking steroids when you start vedolizumab, you might be able to stop them. Your IBD team will advise you about this.
It is important that you do not stop taking steroids without speaking to your IBD team.
You will not usually have vedolizumab at the same time as another biologic medicine.
Your IBD team will check that your vaccinations are up to date before you start treatment with vedolizumab.
Live vaccines contain weakened live strains of viruses or bacteria. People who are immunosuppressed should not have live vaccines. This is because the weakened virus could reproduce too much and cause a serious infection.
It is likely that the risk from live vaccines is lower with vedolizumab than with other immunosuppressants. This is because vedolizumab targets the immune system of the gut rather than the whole body. But we do not yet know for sure how safe it is for people to take live vaccines while they are on vedolizumab.
The current recommendation is not to have live vaccines while taking vedolizumab.
In the UK, live vaccines include:
There is a small risk that people who have received live vaccines could pass on (transmit) the weakened form of the virus to close contacts who are immunosuppressed. This could then cause an infection. For most of the live vaccines used in the UK the virus is not passed on to contacts. You can reduce the risk by following simple precautions such as:
The annual flu vaccine and pneumococcal and COVID-19 vaccines are not live vaccines. They are safe to have while you are taking vedolizumab.
You should not generally take vedolizumab with other types of biologic drugs that suppress your immune system. But there may be exceptions.
If you have ever taken natalizumab (a medicine used to treat multiple sclerosis) or rituximab (a medicine used to treat certain types of cancer and rheumatoid arthritis), tell your IBD team. They will decide if you can take vedolizumab.
Speak to your IBD team, doctor, or pharmacist if you are taking or plan to take any other medicines while you are taking vedolizumab. This includes medicines that you buy from a pharmacy or supermarket. It also includes any herbal, complementary or alternative remedies.
Alcohol is not known to interact with vedolizumab. To keep the health risks from drinking alcohol low it is best to stay within the recommended limits.
We do not know if vedolizumab affects fertility.
The manufacturers of vedolizumab advise that people who could get pregnant should use effective contraception while taking vedolizumab. This is to prevent pregnancy. They recommend carrying on using contraception for at least 18 weeks (4 to 5 months) after stopping vedolizumab.
There is not much research looking at the use of vedolizumab during pregnancy. From the limited information available, vedolizumab does not seem to cause problems during pregnancy or to babies exposed during pregnancy.
Experts agree that taking vedolizumab while you are pregnant is probably a low risk. Stopping vedolizumab during pregnancy may increase the risk of a flare-up or worsening of symptoms.
You and your IBD team should discuss whether the benefits of taking vedolizumab outweigh any risks to you and your baby.
Vedolizumab passes into the breastmilk in low levels. You cannot take biologic medicines like vedolizumab by mouth because they are broken down and destroyed by your gut. Vedolizumab in breastmilk is likely to be broken down in your baby’s gut. So very little will be absorbed by your baby.
There is little information about taking vedolizumab during breastfeeding. But experts agree this is unlikely to be harmful to your baby. Tell your IBD team if you are thinking about breastfeeding while taking vedolizumab. They can help you weigh up the benefits
We follow strict processes to make sure our information is based on up-to-date evidence and easy to understand.
Please email us at evidence@crohnsandcolitis.org.uk if:
You can also write to us at Crohn’s & Colitis UK, 1 Bishop Square, Hatfield, AL10 9NE, or contact us through our Helpline: 0300 222 5700
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We know it can be difficult to live with, or support someone living with these conditions. But you’re not alone. We provide up-to-date, evidence-based information and can support you to live well with Crohn’s or Colitis.
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