Ozanimod

Ozanimod works to ease inflammation in your bowel. It does this by affecting your body’s immune response.

Ozanimod is a type of medicine called a sphingosine-1-phosphate (S1P) receptor modulator. S1P is a molecule in your body that is involved in inflammation. Ozanimod works by stopping S1P attaching to a type of white blood cell called a lymphocyte. This stops the lymphocytes from travelling around your body and into your gut. This eases inflammation in your gut and helps with the symptoms of Ulcerative Colitis.

Because ozanimod affects your immune response, it can make you more likely to get infections. Medicines that affect how your immune system works are known as immunosuppressants.

Ozanimod is used to treat adults with moderate to severe, active Ulcerative Colitis when other treatments are not suitable or have not worked. It aims to get your condition under control and keep it under control.

It is not used to treat people with Crohn’s as studies have not found it to be effective for this.

Ozanimod can only be prescribed by a specialist in a hospital. You will usually need to have tried at least two or three other treatments first. These may include standard treatments for Ulcerative Colitis, as well as biologics and other targeted medicines. Your IBD team may suggest ozanimod if these other treatments:

• Are not suitable for you
• Do not control your symptoms
• Have stopped working
• Cause bad side effects

Standard treatments for Ulcerative Colitis include:

• 5-ASAs (aminosalicylates)
• Oral steroids 
• Azathioprine and mercaptopurine  

You do not need to have tried all of these medicines before being offered ozanimod.

Sometimes, you may need to take other medicines for Ulcerative Colitis alongside ozanimod. For example, you may have to start or continue taking steroids or 5-ASAs. Your IBD team will discuss this with you. We have more information below about taking ozanimod with other medicines.

If you have a severe, active infection, your IBD team may need to delay starting treatment until you are better.

Deciding which medicine to take

Your IBD team will discuss your treatment options with you. They might give you a choice of different treatments. It’s important to consider the possible benefits and risks of all your treatment options. Think about what your goal from treatment is too, and what is most important to you. Things you may want to consider for each option include:

• How you take it
• How well it works
• How quickly it may work
• Side effects you could get
• Whether you need ongoing tests or checks
• Other medicines you are taking
• If you are planning to get pregnant or breastfeed in the next few years
• How to access the medicine
• Whether there is a prescription charge for the medicine

You do not have to think about these things or make the decision on your own. Your IBD team can talk it through with you. You might find it helpful to prepare before any appointments with your IBD team. Our appointment guide has a list of questions you might want to ask during your appointment. It can help you focus on what matters most to you. You might find our information about other medicines and surgery for Colitis helpful too.

You will have some tests and checks before you start treatment with ozanimod. These are to check whether ozanimod is safe for you to take. Your IBD team will tell you exactly what tests you need. They may include:

• An ECG (electrocardiogram) to check for any problems with your heart. If you have a slow heart rate or certain heart conditions, your IBD team may need to monitor you more closely during treatment.
• Blood tests to check how well your liver is working. You may also need these at regular intervals throughout treatment.
• A Full Blood Count (FBC) to check your levels of red and white blood cells and platelets.
• Checks to confirm whether you have ever had chicken pox or shingles. This may include blood tests to check whether you are immune to the chicken pox and shingles virus. If you are not immune, you may be able to have a vaccination before starting treatment.
• An eye test, if you have diabetes or a history of eye problems. This allows your IBD team to watch for any changes throughout your treatment.
• A pregnancy test, if you are able to get pregnant. Your doctor will need to confirm you are not pregnant before starting treatment. They may ask for confirmation with further tests throughout treatment.

Ozanimod can be effective at improving your Ulcerative Colitis symptoms and keeping them under control. But it does not work for everyone. Different medicines work for different people, and it may take time to find the medicine that is right for you.

Below, we show the results of a clinical trial for ozanimod. Clinical trials are used to test a medicine to check it is safe and see how well it works. You can find out more about clinical trials in our information on talking about the effectiveness of medicines.

Getting Ulcerative Colitis under control

The first part of the clinical trial looked at how well ozanimod was able to get Ulcerative Colitis under control. It included 645 people with moderately to severely active Ulcerative Colitis that was not controlled by either 5-ASAs or steroids. It compared ozanimod to placebo. A placebo is something that looks the same as the treatment but does not have any medicine in it.

The people who took part carried on taking 5-ASAs or steroids throughout the trial, as well as either ozanimod or placebo.

After 10 weeks:

• Around 2 in 10, or 18% of people who took ozanimod had their symptoms under control. For people who took placebo, less than 1 in 10, or 6% had their symptoms under control. 
• Around 3 in 10, or 30% of people who took ozanimod, had some improvement in their symptoms but were not fully under control. This compared to 2 in 10 people, or 20% on placebo. 
• Around 5 in 10, or 52% of people on ozanimod did not improve. For people who took placebo, more than 7 in 10, or 74% did not improve.

The bar chart below shows how these results compare for ozanimod and placebo, after 10 weeks of treatment. 

Keeping Ulcerative Colitis under control

Over 450 people took part in the second part of the trial. This looked at how well ozanimod kept Ulcerative Colitis symptoms under control after a year of treatment.

After a year:

• Nearly 4 in 10, or 37% of people who took ozanimod had their symptoms under control. For people who took placebo, 2 in 10, or 19% had their symptoms under control
• For both ozanimod and placebo, about 2 in 10 people had some improvement in their symptoms, without being completely under control. This was 23% of people taking ozanimod and 22% of people taking placebo.
• Around 4 in 10, or 40% of people who took ozanimod did not have any noticeable improvement in their symptoms. This compared to around 6 in 10, or 59% of people for placebo.

The bar chart below shows how these results compare for ozanimod and placebo, after a year of treatment.

Studies have continued to monitor people who have taken ozanimod for Ulcerative Colitis for up to 5 years. These have shown that ozanimod continues to be safe and effective over this time period.

Everyone responds differently to a new medicine. Some people notice an improvement in symptoms as early as two weeks after starting ozanimod. Some people may even find their symptoms are completely under control within this time.  But for others, it can take up to 10 weeks of treatment or even longer to work. It’s possible that after this time, ozanimod may still not have worked for you.

It can be difficult waiting to see whether a new medicine works for you. You can still ask for help and support during this time. If you need support or become more unwell, contact your GP or IBD team. Our helpline service may also be able to signpost you towards the right support.

If ozanimod does not help to control your symptoms, your IBD team might suggest stopping it and trying a different treatment. See the section on stopping or changing treatment for more information.

Ozanimod is a capsule that you take once per day. Here are some tips for taking it:

• Swallow the capsule whole.
• Do not try to split, open or chew it. This could change how well the medicine works in your body.
• You can take it with or without food.

What dose to take

When you start taking ozanimod, you usually begin with a low dose and gradually increase it. This is to lower the risk of certain side effects, such as a low heart rate. Your treatment will include the following.

Treatment induction pack

This is a pre-prepared pack with labelled capsules that you take for the first seven days. It has:

• Four light-grey capsules for days 1 to 4. These contain the lowest dose of ozanimod, which is 0.23mg.
• Three light-grey and orange capsules for days 5 to 7. These contain a slightly higher dose of ozanimod, which is 0.46mg.

Maintenance pack

You will start taking capsules from a ‘maintenance pack’ from day 8 of treatment. This pack has orange capsules containing the higher, recommended dose of ozanimod, which is 0.92mg. You will take one of these capsules each day from day 8 onwards.

The dose that you are prescribed may be individual to you. Be sure to follow your advice from the healthcare professional who prescribed your medicine.

All medicines can have side effects, but not everyone will get them. Some side effects can happen right away, others may happen later. Some can even last for a short time after you stop treatment.

Some side effects are mild and may go away on their own or after you stop taking ozanimod. Others may be more serious and could need treatment. Some side effects might mean that ozanimod is not right for you.

You will have regular tests before and during treatment with ozanimod, to monitor for certain side effects. We have more on this in the next section.

Common side effects

Very common side effects that affect more than 1 in 10 people taking ozanimod include:

• Low levels of a type of white blood cell called lymphocytes. This means your body might not be able to fight off infections as well. We have more information on infections below.
• Infections of the nose, mouth and throat, causing a cold.

Common side effects that affect between 1 and 10 in 100 people taking ozanimod include:

• Other respiratory tract infections, such as sinusitis and chest infections
•  Sore throats
• Urinary tract infections (UTIs)
• Cold sores
• Shingles
• Slow heart rate
• High blood pressure
• Feeling dizzy when you stand up
• Headache
• Swelling of your ankles and feet, due to fluid retention
• Increased liver enzymes in blood tests, which can be a sign of liver problems
• Lung problems, which can cause breathlessness

Infections

Ozanimod affects your immune system and can make infections more likely. This is because it lowers your level of a type of white blood cell called lymphocytes. Lymphocytes fight off infections in your body. This means that while you are taking ozanimod, you may get more infections than you used to. Or they might last longer or be more serious than usual.

If you have inactive viruses in your body, there is a risk of them becoming active again. If you have previously had chickenpox, this can become reactivated and cause shingles.

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.

Blurred vision

Blurred vision can be a symptom of a condition called macular oedema. This is swelling of part of the tissue at the back of your eye. It affects fewer than 1 in 100 people taking ozanimod.  It is more likely if you have diabetes, or a history of eye inflammation or other eye problems. If you have one of these conditions, your IBD team will carry out an eye test before starting ozanimod and monitor for any changes throughout your treatment.

Tell your IBD team if you notice changes in your vision while taking ozanimod.

Allergic reaction

The signs and symptoms of a medicine allergy usually happen soon after taking the medicine. Fewer than 1 in 100 people taking ozanimod may have an allergic reaction. This may involve a rash and itchy skin.

Infection of the brain

Some people taking ozanimod can get a rare infection of the brain. This is known as progressive multifocal leukoencephalopathy (PML). It affects fewer than 1 in 1,000 people. It can cause:

• Changes in vision
• Confusion
• Memory problems
• Difficulty with speech and communication

Tell your doctor or IBD team straight away if you develop these symptoms while taking ozanimod or for up to 3 months after stopping treatment.

Liver damage

Damage to the liver has been reported in fewer than 1 in 1,000 people taking ozanimod. If you unexpectedly develop any of the following symptoms while taking ozanimod, speak to your GP or IBD team straight away:

• Feeling sick, known as nausea, or being sick
• Pain on the right side of your tummy
• Tiredness
• Loss of appetite
• Yellowing of your skin or the whites of your eyes
• Darker pee than is usual for you

Skin cancer

There is a small chance that ozanimod may increase your risk of developing a type of skin cancer. This cancer is known as non-melanoma skin cancer. It’s not known how many people develop this while taking ozanimod. Because of this risk, your doctor may ask to check your skin. You should also take measures to protect yourself from the sun while taking ozanimod. We have more on this in the section below, Lowering risks of ozanimod.

More information on side effects

We may not cover every side effect of ozanimod here. There is information about less common side effects of ozanimod in the Patient Information Leaflet. This is also called a Package Leaflet. It should be in the box with your medicine. You can also get it on the Electronic Medicines Compendium website.

You will have some tests and checks regularly throughout your treatment. These are to check how well ozanimod is working. They may also help to spot certain side effects early on.

They will include blood tests and blood pressure checks. You may also have ongoing eye tests if you are at increased risk of eye problems.

Sometimes you may need to travel to a particular clinic or hospital to have these tests, and this can be difficult. But they are important. Talk to your IBD team if travel is an issue.  

Everyone is different, and you may not be able to avoid every side effect from ozanimod. But there are things you may be able to do to lower some risks and help keep yourself safe.

Preventing infections

Ozanimod can affect your immune system and make infections more likely. There are some important things you can do to avoid risk of infections.

Vaccinations

You should not have live vaccines while you are taking ozanimod. Live vaccines are made using weakened versions of living viruses or bacteria. If you have a lowered immune system, there is a possibility that they might cause serious infections.

Live vaccines used in the UK include:

• BCG vaccine for tuberculosis
• Chickenpox vaccine.
• Measles, mumps and rubella (MMR) vaccine.
• Nasal flu vaccine used in children. The injected flu vaccine used in adults is not live.
• Rotavirus vaccine.
• Yellow fever vaccine.
• Oral typhoid vaccine. The injected typhoid vaccine is not live.

If anyone in your family or household is due to have a live vaccine, check with your IBD team whether you need to take any special precautions.

Your IBD team will check that your vaccinations are up to date before you start ozanimod. This may include vaccines for:

• Shingles
• Chickenpox
• BCG

The standard flu, pneumococcal and COVID-19 vaccines are not live vaccines and are safe to have while you are taking ozanimod. It’s important to keep up to date with these vaccinations when you are taking ozanimod. It can lower your risk of getting these infections.

Sun safety

There is a chance that ozanimod may increase your risk of skin cancer. This risk is very small. This increase in risk is due to its immunosuppressant effects. Because of this, it’s important to be aware of any changes to your skin. Contact your GP if you notice any changes. Your IBD team may also suggest monitoring your skin.

You can protect your skin from the sun by:

• Wearing protective clothing and sunglasses
• Spending time in the shade between 11am and 3pm
• Using sunscreen at least factor 30 SPF when you are in the sun
• Avoiding sunbeds

The NHS website has more advice on sun safety.

Limiting certain foods

Tyramine is a substance found in certain foods and drinks. It’s possible that tyramine may increase the risk of high blood pressure while taking ozanimod. There has been no evidence that this has happened to anyone taking ozanimod. It is based on what we know about how ozanimod works.

For this reason, you may be told to avoid or limit foods and drinks that contain very high amounts of tyramine. These may include:

• Aged cheeses
• Soy sauce
• Cured or smoked meats, like chorizo and salami
• Fermented or pickled foods, like kimchi and sauerkraut
• Certain types of draft or craft beer

If you are only eating small amounts of these foods while taking ozanimod, it’s not expected to cause significant problems.

If you are taking or planning to take other medicines at the same time as ozanimod, it’s important to check whether this is safe. These may include other medicines for Ulcerative Colitis, as well as medicines for any other condition you may have.

Medicines for Ulcerative Colitis

If needed, you can take steroids or 5-ASAs alongside ozanimod.

Because ozanimod can affect your immune system, you should not take it with other immunosuppressants, such as azathioprine and mercaptopurine.

Clinical trials have not looked at whether it is safe to take ozanimod alongside biologic medicines.

Other medicines

Other medicines that can affect the way ozanimod works include:

• Medicines that affect your immune system
• Clopidogrel, a medicine used to prevent blood clots
• Rifampicin, an antibiotic for treating tuberculosis and other serious infections
• Medicines called monoamine oxidase inhibitors, for treating depression or Parkinson’s disease
• Medicines that slow your heart rate, such as beta blockers or calcium channel blockers

This is not a full list of medicines that may affect ozanimod. Tell your doctor, IBD team or pharmacist about any other medicines you are taking or plan to take, while you are on ozanimod. This includes:

• Prescribed medicines
• Over-the-counter medicines, such as cold or flu medicines
• Multi-vitamins or supplements
• Herbal, complementary or alternative therapies.

There is no evidence that alcohol has an effect on ozanimod. It’s still best to follow NHS guidance on drinking alcohol to keep your health risks low. The NHS recommends that you do not drink more than 14 units of alcohol a week on a regular basis.

You will usually be able to continue taking ozanimod if it works well for you. Your IBD team will continue to monitor you.​ If you or your IBD team feel that it is no longer right for you, you should discuss other treatment options together.

There are a few reasons why you or your IBD team might think about stopping or changing your treatment:

• You have side effects
  If you have side effects that are serious or hard to manage, stopping ozanimod might be the best option for you.
• Ozanimod has not worked
  You will have regular checks to see if your condition is improving and ozanimod is working for you. If it is not working well, your IBD team might suggest stopping ozanimod and trying a different treatment.
• Ozanimod has stopped working so well
  It’s also possible that ozanimod could stop working over time. If this happens, your IBD team might suggest stopping ozanimod and trying another treatment.
• You want to try for a baby
  You should not take ozanimod if you are pregnant or trying to get pregnant. Talk to your IBD team if you are planning a pregnancy. We have more about this in our pregnancy section below.

You should not stop taking ozanimod without discussing it with your IBD team first.

It can take up to 3 months for ozanimod to be fully cleared from your body.

Fertility

The effect of ozanimod on human fertility is not yet known. But in studies with animals, ozanimod had no effect on male or female fertility.

We have more information on reproductive health and fertility.

Contraception

If you are able to get pregnant, you must make sure you are using effective contraception while taking ozanimod. You should also continue this for three months after you stop treatment. This is to prevent pregnancy while taking ozanimod.

Pregnancy

You should not take ozanimod if you are pregnant. This advice is due to studies in animals, that have shown it can be harmful to a developing baby.

Scientists are not sure whether it has the same effect in humans. There is some data from clinical trials that included people who took ozanimod in early pregnancy. This did not show any increased risk of harmful effects on pregnancy due to ozanimod. However, more research on the potential effects of ozanimod in pregnancy is needed.

If you are able to get pregnant, before starting treatment with ozanimod your doctor will:

• Explain the potential risks to an unborn baby if you become pregnant while taking ozanimod.
• Confirm you have had a negative pregnancy test. This may be repeated throughout your treatment.
• Make sure you are using effective contraception. You must continue this while taking ozanimod and for 3 months after you stop taking it. 

Planning pregnancy

If you are planning to get pregnant, speak with your IBD team as soon as possible. You should stop taking ozanimod 3 months before planning a pregnancy. This will allow time to make sure ozanimod is fully cleared from your body. It will also give you time to review your treatment options and make sure your condition is controlled as well as possible.

Unplanned pregnancy

If you are taking ozanimod and find out you are pregnant, contact your IBD team straight away. If you cannot contact your IBD team, speak to your GP. Your GP may be able to help you contact your IBD team. 

Your IBD team will give you advice on stopping ozanimod. They will also talk to you about the possible risks to your pregnancy and specialist care you may need. Do not stop taking your medicine until you have spoken to a healthcare professional.

We have more information on pregnancy and birth.

Breastfeeding

Ozanimod can pass into breast milk. It is not yet known if this could affect your baby. For this reason, you should not take ozanimod if you are breastfeeding.

We have more information on postnatal care and breastfeeding.

We understand that taking medicines and managing side effects can be difficult. We’re here to help.

Our Helpline can answer general questions about treatment options and can help you find support from others with Crohn’s or Colitis. Your IBD team are also there to help. You can talk to them about:

• Your dosage
• How they’ll be monitoring you
• What other medicines options there might be

You should also get in touch with your IBD team if you have any new symptoms or side effects.

It can take time to find the medicine that’s right for you. Don’t be afraid to ask questions and seek out extra support when you need it.

This information is general and does not replace specific advice from your health professional. Talk to your GP or IBD team for information that’s specific to you.

We follow strict processes to make sure our information is based on up-to-date evidence and is easy to understand. We produce it with patients, medical advisers and other professionals. It is not intended to replace advice from your own healthcare professional.

We hope that you’ve found this information helpful. Please email us at evidence@crohnsandcolitis.org.uk if:

• You have any comments or suggestions for improvements
• You would like more information about the 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 you can contact us through our Helpline by calling 0300 222 5700.

We do not endorse any products mentioned in our information.