Vedolizumab

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:

• How you will take it
• How well it works
• How quickly it is likely to work
• Side effects you might experience
• Whether you need ongoing tests or checks
• Other medicines you are taking

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.

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.

Induction treatment and maintenance treatment

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.

If you have Crohn’s Disease

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.

Getting Crohn’s under control with vedolizumab

The table shows how well vedolizumab got Crohn’s under control after 6 weeks.

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After 6 weeks, about twice as many people who took vedolizumab had their Crohn’s under control compared with those who took placebo.

Keeping Crohn’s under control with vedolizumab

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.

Click to view at full size

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.

If you have Ulcerative Colitis

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.

Getting Colitis under control with vedolizumab

The table shows how well vedolizumab got Colitis under control after 6 weeks.

Click to view at full size

After 6 weeks, more than twice as many people who took vedolizumab had their Colitis under control compared with those who took placebo.

Keeping Colitis under control with vedolizumab

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.

Click to view at full size

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.

Stopping or changing treatment

There are a few reasons why you and your IBD team may think about stopping or changing your treatment. These include:

• Your Crohn’s or Colitis is under control
  If your Crohn’s or Colitis stays under control for a year or more, you might be able to stop taking vedolizumab. But if you become unwell again (relapse) after treatment has stopped, you should be able to start vedolizumab again. About 6 in 10 people who stop vedolizumab will relapse within a year. Restarting treatment will be successful in about 7 out of 10 people within 14 weeks. And about 6 out of 10 people who restart treatment will stay in remission for up to 1 year.
• Vedolizumab has not worked
  If vedolizumab does not seem to be helping with your symptoms at all after 10 to 14 weeks, your IBD team may advise stopping treatment and trying a different option.
• Vedolizumab stops working well
  Some people develop antibodies to vedolizumab over time, which can stop it working.
• You have side effects
  If you have side effects that are serious, affecting your daily life or are hard to manage, stopping vedolizumab might be the best option.

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.

Infusion

How is the infusion given?

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.

Dosage information for infusion

You will have a 300mg dose of vedolizumab during each infusion.

• You will have your first dose of vedolizumab.
• You will have your second dose 2 weeks later.
• You will have your third dose 4 weeks later (6 weeks after the first infusion).
• If you have Crohn’s and you are not improving after your third dose of vedolizumab, your doctor may feel you need another dose. This will usually be 4 weeks after your third infusion (10 weeks after the first infusion).

After this you will have a dose every 4 or 8 weeks, depending on how well your symptoms are being controlled.

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You might hear the first few doses of intravenous infusion referred to as ‘loading doses’.

Injection

How to take vedolizumab by injection

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.

Tips on injecting

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.

• Let your medicine warm to room temperature
  It might be uncomfortable if you inject yourself with vedolizumab straight from the fridge. Take it out of the fridge about 30 minutes before you inject it, so it can warm to room temperature. Do not warm the injection in any other way, such as in hot water or a microwave.
• Apply an ice pack before you inject
  You might find it helpful to apply an ice pack to the area for 2 to 3 minutes before you inject. If you do this, put a thin towel under it or wrap it in a cloth so it does not damage your skin.
• Choose your injection site
  The upper thigh or tummy (away from the belly button) are good places for the injection. Avoid any areas where the skin is red, scarred, bruised or hard. Do not use the same place every time.
• Wash your hands and clean the skin at the injection site
  Wash your hands with soap and water. Make sure the skin at the injection site is clean before you inject. This is to reduce the risk of infection.
• Use a good injection technique
  If you use a syringe, gently pinch the skin at the injection site between your thumb and finger. Use a quick, dart-like motion to insert the needle into your pinched skin. Push the plunger slowly and evenly to inject all the medicine. Keep pressure on the plunger head and keep your skin pinched. If you use a syringe the injection will take about 2 to 5 seconds.
  If you use a pen, place the pen at 90 degrees to the injection site and push down as far as it will go to begin the injection. Hold it down for about 10 seconds so that all the medicine is injected.
• Use an ice pack after you inject
  Applying an ice pack or cold damp towel to the area after you have injected may help with pain at the injection site. Do this for about 10 to 15 minutes. Remember to put a thin towel under the ice pack or wrap it in a cloth.
• Wear loose clothing
  Wear loose clothing to avoid rubbing or pressure on the injection site.

If you are having problems injecting your vedolizumab, ask your IBD team for help.

Dosage information for injection

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.

Possible serious 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.

Allergic reactions

Up to 1 in every 100 people taking vedolizumab might have an allergic reaction. But serious allergic reactions are very rare.

After the allergic reaction has been treated, contact your IBD team to let them know what has happened.

Infections

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.

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.

Common side effects

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:

• Nasopharyngitis – common symptoms include a cough, sore throat and a blocked or runny nose.
• Joint pain
• Headaches

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 tear or wound in the lining of the gut near your bottom. This can become infected.
• Changes in how your liver works. Rarely inflammation of the liver can occur. This is known as hepatitis. Let your GP or IBD team know if the whites of your eyes or your skin become yellow, you develop a pain in the right side of your stomach, or you bruise more easily than you usually do.
• Changes to your skin such as itching, rashes, redness, prickling, or tingling. Or you may develop eczema or acne.
• Gastroenteritis – a tummy bug that causes sickness, diarrhoea, and a mild fever.
• Gut problems such as bloating, wind, constipation, piles (haemorrhoids), and indigestion. Some of these will be like the symptoms of Crohn’s or Colitis. Speak to your IBD team if you’re not sure what may be causing your symptoms.
• High blood pressure.
• Infection in the chest, throat, or sinus.
• Night sweats.
• Pain in your arms or legs or back, muscle cramps and weakness.

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.

Risk of cancer

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.

You will not usually have vedolizumab at the same time as another biologic medicine.

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 have any comments or suggestions for improvements
• You would like more information about the sources of evidence we use
• You would like details of any conflicts of interest

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