Fingolimod (Gilenya)

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

Who can take fingolimod (Gilenya)?

Across the UK you can have fingolimod (Gilenya) if:

• you’re already taking a DMT but still had a relapse in the last year. Or there are new, active or growing lesions on your MRI scans
• you’re taking natalizumab (Tysabri or Tyruko) but you need to come off it because you’re at high risk of the brain infection PML. Fingolimod is one of several DMTs you can switch to

In Scotland and Wales you can also have fingolimod if you have ‘rapidly evolving severe relapsing remitting MS’. This is when you’ve had two or more serious relapses and there are new lesions on your MRI scans.

Children

Doctors can use a range of DMTs to treat children aged 10 up to 18. But fingolimod is one of only two DMTs that have a licence for this. The rules on prescribing for children are the same as for adults. 

Fingolimod isn’t used much now. But as well as the Gilenya brand, generic versions of fingolimod from other companies are available. These work just as well as Gilenya. 

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How does fingolimod (Gilenya) work?

Fingolimod (Gilenya) works by targeting B and T cells. These are special types of white blood cells in your immune system. It’s thought that these cells cause a lot of the damage in MS. They normally kill viruses and bacteria that get into your body. But in MS they attack and damage myelin. That’s the protective covering around nerves in your brain and spinal cord.

Fingolimod (Gilenya) 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.

Fingolimod might also help repair nerves, or directly stop them being damaged. 

Fingolimod (Gilenya) is a tablet you take once a day.

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How well does fingolimod (Gilenya) work?

The effectiveness of fingolimod (Gilenya) is classed as 'good'. Each DMT can be rated as ‘moderate’, ‘good’ or ‘high’ based on two things. One is how much it reduces relapses. The other is how much it slows down disability getting worse. 

Fingolimod (Gilenya) is classed as ‘good’ mostly because of how much it reduces relapses. It was less clear in early trials how well it slows down how fast people’s disability gets worse.

Early trials compared fingolimod against other MS drugs used at the time or against a placebo. That’s a dummy treatment with no drug in it. A trial that compares a drug against a placebo will appear to get better results. 

Some fingolimod trials were two years long, while one lasted just a year. Longer trials can give a more accurate picture, especially about how fast people’s disability gets worse. Bear this is mind when comparing trial results.

The TRANSFORMS trial

The TRANSFORMS trial lasted a year. It compared fingolimod (Gilenya) against beta interferon, a less hard-hitting MS drug. You usually get fingolimod when a less hard-hitting drug fails to control your MS. So this trial is useful because it showed fingolimod was a better drug.

In the TRANSFORMS trial…

Relapses dropped by: 

52% compared to beta interferon. 

This means that in this trial, on average, people saw a 52% drop in the number of relapses they had. This was compared to people who took beta interferon.

In this trial 83% of people were still relapse-free after one year. This compares with 70% of the people who took the beta interferon.

Disability getting worse:

There was no significant difference between the two drugs in how fast people’s disability got worse. A trial lasting just one year may not be long enough to show a drug’s true effect on disability. 

Other benefits

People on fingolimod (Gilenya) got fewer lesions. And their brains shrunk at a slower rate. All brains slowly shrink as we get older, but this happens faster in MS. Brain shrinkage is linked to problems with memory and thinking.

The FREEDOM trials

Each of these two trials, FREEDOM 1 and FREEDOM 2 lasted two years. They both compared fingolimod (Gilenya) to a placebo.

In these two trials…

Relapses dropped by: 

48-54% compared to a placebo

This means that, on average, people saw their relapses fall about a half. The drop was 48% in one trial and 54% in the other. This is compared to people who took the dummy drug.

70% of people on fingolimod stayed free of relapses over two years. Only 46% of people on the placebo stayed free of relapses.

Disability getting worse was slowed down by:

30% compared to a placebo 

In the FREEDOMS 1 trial, on average, people saw a 30% drop in the risk of their disability getting worse over two years. This was compared to people who took a placebo.

In the FREEDOMS 2 trial fingolimod was no better than the placebo at slowing down disability.

Fingolimod reduced how many brain lesions people got. It also slowed down the speed at which people’s brains got smaller.  

How well does fingolimod (Gilenya) work over many years?

Fingolimod (Gilenya) carries on working over many years. Studies have followed people for up to 14 years. The good results seen in early trials lasted many years. 

Side effects are largely the ones already seen in early trials. As trials followed people for longer, it became clear that fingolimod does slow down how fast people’s disability gets worse.  One study followed people for ten years. Six out of ten people didn’t see their disability get worse.

Long-term trials have also shown: 

• in a long-term study of over 3,000 people nearly half were relapse-free after 10 years on fingolimod
• In a trial of over 1,500 people, those on fingolimod were less likely to see their relapsing MS turn into secondary progressive MS. This was compared to people on beta interferon and glatiramer acetate
• fingolimod can slow down brain shrinkage to near normal levels
• in trials people on fingolimod had fewer and smaller lesions, or none at all 

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Fingolimod (Gilenya) side effects

Side effects of fingolimod (Gilenya) are mostly due to infections which follow the drop in white blood cells that the drug causes. 

Very common side effects (more than 1 in 10 people get them):

Very common side effects include:

• a higher chance of infections. These usually aren’t serious, like sinusitis (pressure or pain in the spaces around your nose). But they can be more serious like flu. The most common infections include those caused by herpes viruses (like shingles)
• diarrhoea
• back pain
• a cough
• headache
• feeling weak or tired
• pain in your belly, arms or legs
• raised levels of liver enzymes in your blood (this causes no symptoms) 

Common side effects (between 1 in 100 and 1 in 10 people get them): 

Around one in ten people on fingolimod get some hair loss. 

Skin

About 1 in 100 people get basal carcinoma. This is a kind of skin cancer that grows slowly and is easy to remove. It almost never spreads to other parts of the body or becomes life-threatening. You or your doctor should check your skin while on fingolimod. Avoid sunbeds and sunbathing, and protect yourself from the sun.

Uncommon side effects (between 1 in 100 and 1 in 1,000 people get them)

Eyes

Fluid can build up at the back of your eye. This is called macular oedema. Less than one in a hundred people get this. It’s most likely during the first three to four months. But it could happen at any time. Diabetes makes it more likely. It should get better if you stop taking the drug. 

Macular oedema causes:

• blurred or wavy vision
• distorted lines
• faded colours
• problems reading
• and sometimes blind spots

Heart

Fingolimod (Gilenya) can slow down your heartbeat, or it stops being regular. This happens to under 1 in 100 people. If this happens, it’s likely to be during the first dose. A heartbeat that’s not regular should go back to normal within a day. A slow heartbeat should return to normal within a month. A change in heartbeat can cause dizziness, tiredness and palpitations (but fewer than one in 100 people in a trial had this).

Up to 1 in 100 people get pneumonia.

PML: a very rare side effect of fingolimod (Gilenya)

PML is short for progressive multifocal leukoencephalopathy. It’s a very serious brain infection caused by a virus. It can be fatal or leave you seriously disabled. 

The risk of getting PML with fingolimod is extremely small (less than 1 in 10,000). No one has died of PML because they took fingolimod. Your MS team will tell you more about PML and how to spot it.

Read more about PML 

Find out more about all the possible side effects of fingolimod (Gilenya)  

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Stopping fingolimod (Gilenya)

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

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What tests do you need with fingolimod (Gilenya?)

Tests before treatment begins

Before treatment starts you’ll have an MRI scan of your brain. Your neurologist can compare this scan with ones you might have later to see if the drug is working.

Fingolimod can harm a baby in the womb. So, if you can get pregnant, you’ll need a negative pregnancy test before your first dose.

Before you start this drug you’ll be checked for any health problems that rule out treatment with fingolimod. You can’t take it if you’ve had a stroke or certain heart problems in the last six months. Or if you have tuberculosis (TB), liver problems like hepatitis, HIV, or a cancer that’s active. 

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

Heart

Fingolimod (Gilenya) can change your heartbeat for a while. An electrocardiogram (ECG) will measure this before and after your first dose (maybe also during it). You’ll have checks on your heart rate and blood pressure.

Eyes

If you have diabetes, you might be checked for the eye condition macular oedema.

Skin

Before you start fingolimod (Gilenya) your doctor should look at your skin. If your doctor doesn’t do this, check it yourself. If your skin has a lot of moles, take photographs. As treatment goes on, you can then compare your skin with how it was before you started. 

Tests during treatment 

Heart

Your first dose of fingolimod (Gilenya) can cause your heart to slow down, or its beat stops being regular. That’s why you get your first dose of fingolimod in hospital. You’re monitored for at least six hours in case it affects your heart. An irregular heartbeat usually goes back to normal with 24 hours. After your first dose you take all other doses at home without any monitoring.

Blood

You’ll have regular blood tests. These will check how your liver is working. They’ll also check your levels of white blood cells (the cells that fingolimod targets). This will show how well your immune system is working. 

Eyes

You should be checked for macular oedema three to four months after treatment begins. This may happen more often if you’ve ever had uveitis, an inflammation in the eye. Or if you have diabetes. If these eye check-ups don’t happen, your doctor will ask you to monitor yourself and report any eye problems.

Skin

Your doctor should check your skin once or twice a year. If it doesn’t heal in four weeks, ask your doctor to check any:

• lump
• ulcer
• lesion
• or change in colour

If your doctor doesn’t do this, check your skin yourself. Let your doctor know if you find  anything you have concerns about. Avoid sunbeds and sunbathing. Protect yourself from the sun, and check your skin.

Other tests

You might have other tests on your heart or lungs. Your neurologist might want you to have an MRI scan once a year to see if the drug is working. But how often you have scans depends on what your neurologist thinks you need. If your MS seems stable, you might have scans less often.

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Fingolimod (Gilenya) and pregnancy, breastfeeding and contraception

Pregnancy

You must avoid getting pregnant while on fingolimod (Gilenya). It can harm unborn babies. If you do become pregnant, your neurologist will take you off this drug. They’ll suggest you switch to another DMT during your pregnancy.

If you stop taking fingolimod (for example, to have a baby), you need to keep using contraception for two months afterwards. Two months is this drug’s ‘washout period’. That’s how long it takes for it to leave your body.

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

Breastfeeding

Fingolimod (Gilenya) might pass into breast milk. So it’s not safe to breastfeed while you take it, or for two months afterwards if you come off it. 

Contraception

Because fingolimod (Gilenya) can harm unborn babies, you must use reliable contraception if you can get pregnant. This can be condoms, the ‘pill’, an implant, injection or a coil. If you come off the drug, you must keep using contraception for two months.

Read more about pregnancy, breastfeeding and contraception and DMTs 

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