Ozanimod (Zeposia)

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• Who can take ozanimod (Zeposia)?
• How does ozanimod (Zeposia) work?
• How well does ozanimod (Zeposia) work?
• Ozanimod (Zeposia) side effects
• Stopping ozanimod (Zeposia)
• What tests do you need with ozanimod (Zeposia)?
• Ozanimod (Zeposia) and pregnancy, breastfeeding and contraception

Who can take ozanimod (Zeposia)?

In Scotland you can have ozanimod if:

• you have active relapsing MS. That means you’ve had a recent relapse and/or MRI scans show new, active or growing lesions (areas of damage) in your brain or spinal cord. It’s for people who want to take a tablet, or who have a problem taking a DMT in another way 

Elsewhere in the UK

Ozanimod (Zeposia) isn’t available to treat MS on the NHS in England, Wales or Northern Ireland. 

The National Institute for Health and Care Excellence (NICE) decided in 2021 that this drug shouldn’t be available on the NHS in England. They said it wasn’t cost effective. That means they felt it didn’t make enough difference to people’s MS to be worth what its makers wanted to charge the NHS. They also said it wasn’t clear how well ozanimod could slow down how fast people’s disability gets worse.  Wales and Northern Ireland followed the NICE decision. 

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How does ozanimod (Zeposia) work?

Ozanimod (Zeposia) works by targetting B and T cells. These are special types of cells white blood cells that are part of your immune system. They kill viruses and bacteria. But in MS these cells attack and damage myelin. That’s the protective covering around nerves in your brain and spinal cord. 

Ozanimod (Zeposia) is in the group of drugs called ‘sphingosine-1-phosphate (S1P) receptor modulators’. Any DMT that ends with ‘mod’ is one of these drugs. 

These drugs stick to the surface of B and T cells. This stops many of them leaving your lymph nodes, where they’re made. Fewer of them can get into your bloodstream, then into your brain and spinal cord. That means they can’t attack myelin around the nerves there and cause lesions and relapses.

Ozanimod (Zeposia) is a tablet you take once a day.

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How well does ozanimod (Zeposia) work?

The effectiveness of ozanimod (Zeposia) is classed as 'good'. Each DMT can be rated as ‘moderate’, ‘good’ or ‘high’. This is based on how much it can reduce relapses and slow down disability getting worse.

A trial called RADIANCE compared ozanimod (Zeposia) to beta interferon, a drug already used to treat MS.

Ozanimod (Zeposia) was a lot better than beta interferon at two things. The first was reducing how many relapses people had. The second was lowering the number of lesions on their MRI scans.

Relapses dropped by: 38% compared to beta interferon.

This means that after this two year long trial, on average, people saw a 38% drop in the number of relapses they had. This was compared to people who took the beta interferon.

Ozanimod reduced how many lesions people got in their brain. But when it comes to people’s disability getting worse, it wasn’t clear in this two year trial how much ozanimod slowed this down.

How well does ozanimod (Zeposia) work over many years?

A trial called DAYBREAK lasted five years. It found that ozanimod (Zeposia) kept working as well as it did in earlier, shorter trials. People on ozanimod had much less brain shrinkage. In MS there's a link between brain shrinkage and poorer memory and thinking. In this longer trial ozanimod controlled how fast people’s disability got worse. Most people didn’t see theirs get worse.

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Ozanimod (Zeposia) side effects

Common side effects (up to 1 in 10 people get them) or very common ones (more than 1 in 10 people get them):

Ozanimod (Zeposia) causes a drop in T and B cells, the white blood cells that fight off infections. So, colds, coughs and chest infections are common or very common. This is true for urinary tract infections too, like bladder or kidney infections.

One side effect is shingles (herpes zoster), a painful skin rash. So, you’ll have a vaccination against the virus that causes this if you don’t already have natural immunity to it. You’re immune if you’ve had chickenpox (it’s caused by the same virus). Back pain and headache are also among the most common side effects.

Ozanimod side effects become less common over time. People who take it for years have fairly low rates of both serious and non-serious infections.

It’s common for ozanimod to raise your blood pressure. Another common side effect is that your heartbeat slows down when you take your first dose. This soon goes back to normal after a few days. This is why your first dose will be smaller, then increased over the first week.

Other possible side effects:

Up to 1 in 100 people might get macular oedema. This is a build-up of fluid in the eye that can cause blurred vision or sight loss if left untreated. These symptoms go away once you stop taking ozanimod.

Other side effects include a rise in liver enzymes, which causes unusual liver test results. On rare occasions liver damage can happen.

It’s possible that ozanimod (Zeposia) might raise your risk of some types of skin cancer. These types are usually easy to treat and rarely spread to other parts of the body. These are mostly basal cell carcinomas. Because of this risk, you should limit how long you’re in the sun, cover up and use high factor sunscreen.

Two side effects can affect the brain, but both are rare. Up to one in a thousand people might get them. Posterior Reversible Encephalopathy Syndrome (PRES) affects blood vessels in the brain. Its symptoms are a very bad headache, confusion, seizures and problems with your sight. It usually goes away once it’s treated.

The other rare side effect is a very serious brain infection. It’s called PML (progressive multifocal leukoencephalopathy). In a study of nearly 2,500 people with MS who took ozanimod for five years, there was one case of PML.

Find out more about all the possible side effects of ozanimod (Zeposia) 

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Stopping ozanimod (Zeposia)

You should never stop taking a DMT without telling your doctor. With some DMTs, if you suddenly stop, there’s a risk of ‘rebound’. This is when your MS gets much worse within a few weeks or months. 

Ozanimod (Zeposia) is from a family of drugs where rebound can happen. If you need to stop taking this drug, your doctor might lower your dose in stages. If you need to switch to another DMT, your doctor might change you to the new drug quickly to reduce the risk of rebound.

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What tests do you need with ozanimod (Zeposia)?

Some health problems mean you can’t take ozaninod (Zeposia). So, before you start, blood tests will look for certain infections. Tests will check how your liver is working. You'll have these tests all the time you’re taking ozanimod.  

Your blood pressure may be checked at regular intervals.

Before you start ozanimod you’ll have an MRI scan of your brain. You’ll have scans while taking this drug to see how your treatment is working. How often will depend on how stable your MS is.

You can’t take ozanimod if you have certain heart issues. So, you’ll have a painless test called an electrocardiogram (ECG) to check your heart before you start this drug.

You might need eye tests before and during your treatment. But this is only needed if you have diabetes or you’ve ever had a type of eye inflammation called uveitis. This is to check for macular oedema, another possible side effect of this drug. 

Ozanimod (Zeposia) might increase your risk of skin cancer. But these are usually not the dangerous kinds. Your doctor should check your skin for any changes at the start of your treatment and during it.

Vaccination

Like most DMTs, this drug makes infections more likely. Before you start it, your neurologist will check if you have protection against some of the infections it puts you at risk of. 

Your neurologist will check you’re up to date on your vaccines. This includes childhood ones like chickenpox (that vaccine protects you against shingles) and the MMR vaccine for measles, mumps and rubella. Some ‘live’ vaccines, like these two, aren’t safe to have once you’ve started many DMTs. Your MS team or GP can tell you whether a vaccine is ‘live’ or not. 

You’ll have any vaccines you need a few weeks before you start this drug. 

You can safely have the annual flu jab while taking this DMT. 

Read more about vaccines 

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Ozanimod (Zeposia) and pregnancy, breastfeeding and contraception

Pregnancy

There’s no research on whether ozanimod (Zeposia) can harm unborn babies. But we know it can do this in animals. For that reason, you must avoid getting pregnant while taking ozanimod. If you can get pregnant, you need a negative pregnancy test result before you start this treatment. 

If you want to get pregnant, or you plan to, ozanimod (Zeposia) is not the DMT for you.

If you want to have a child, discuss this with your neurologist. If you think you’ve become pregnant, let your medical team know at once. Never stop your DMT without first getting their advice.

Breastfeeding

Studies in animals show ozanimod (Zeposia) can get into breast milk. That’s why you shouldn’t breastfeed while on this drug.

Contraception

If you can get pregnant, you must use reliable contraception when you’re on ozanimod (Zeposia). This means the ‘pill’, condoms, an implant, injection or coil.  If you stop taking this drug, you must keep using contraception for three months after your final dose. 

Read more about pregnancy, breastfeeding and contraception and DMTs 

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