Other names: fingolimod, FTY720

Gilenya is a disease modifying drug for relapsing remitting MS. You have fewer relapses than you might have had with no treatment and any relapses you do have should be less severe.

You take Gilenya as a pill once a day to reduce the number and severity of relapses.  It reduces the number of relapses by about one half (50%), compared to taking placebo. 

Common side effects include an increased risk of infections, cough, headache, back pain and diarrhoea.

What is Gilenya used for in MS?

Gilenya (fingolimod) is a disease modifying drug (DMD) for relapsing remitting MS.  You have fewer relapses than you might have had with no treatment and any relapses you do have should be less severe.

Gilenya is a more effective (category 1.2) DMD; in clinical trials people taking Gilenya had about 50% fewer relapses than people taking placebo.  In clinical trials, MRI scans showed that people taking Gilenya had fewer, smaller or no new areas of active MS (lesions).  Gilenya may also slow down the build-up of disability associated with MS.

Who can take Gilenya?

Across the UK, Gilenya can be prescribed if you are still having relapses after taking one of the beta interferon DMDs for at least one year.

In England and Scotland, Gilenya can be prescribed for additional groups:

In England, Gilenya can also be prescribed if you are still having relapses after taking Copaxone or Tecfidera or if you have a high risk of developing PML while taking Tysabri.

In Scotland, Gilenya can be prescribed if you are still having relapses after taking any one of the DMDs or if you have very active MS (two or more disabling relapses in one year and MRI evidence of new areas of MS activity).

Gilenya has been approved for use on the NHS since 2012.  It can only be prescribed by a neurologist.

Contraindications

It's important that you tell your MS team if you have any health problems or are taking other medicines. You should not start Gilenya if you have a lowered immune response, have a severe infection such as hepatitis or tuberculosis, have active cancer or severe liver problems.

If you have certain conditions, including heart problems, liver disease or a condition affecting your eyes, you may need additional medical assessment before Gilenya is prescribed and may need additional monitoring during treatment.  

Conception and pregnancy

You must not become pregnant while taking Gilenya.  If you do become pregnant while taking Gilenya you should contact your MS team.

Based on data in animal studies, there is an increased risk of having a baby with birth defects if Gilenya is taken during pregnancy.

Gilenya should not be started by women who are pregnant or planning to become pregnant in the near future.

Women of childbearing age must use an effective contraception during treatment and after stopping for at least two months.

Women who wish to become pregnant should stop taking the drug but continue to use effective contraception for two months to ensure that blood levels of Gilenya are low enough for it to be safe to become pregnant.

How do I take Gilenya?

You take Gilenya as a pill, once daily.  

The first dose is taken in a hospital or clinic under medical supervision as Gilenya is known to cause temporary changes in heart rate, heart beat and blood pressure. These symptoms are checked for six hours for any irregularity and this may involve continuous monitoring with an electrocardiogram (ECG).

Unless there are problems that require further monitoring after this first dose, Gilenya can be taken without supervision at home, with routine health reviews at the clinic.

What side effects could I get with Gilenya?

Common side effects include increased risk of infections, cough, headache, back pain, diarrhoea and increased liver enzyme levels.

Cases of basal cell carcinoma, a kind of skin cancer, have been reported in people taking Gilenya.  Basal cell carcinoma is a slow-growing skin cancer that almost never spreads to other parts of the body or becomes life-threatening but can be disfiguring if not treated promptly.

Gilenya may also cause a less common side effect (affecting less 1 in 100 people) macular oedema, a swelling in the back of the eye which can affect vision.

Common side effects (affecting more than 1 person in 100)

  • headache
  • back pain
  • diarrhoea
  • cough
  • raised liver enzyme levels
  • infections: herpes virus, fungal, flu
  • changes in heartbeat
  • dizziness, weakness
  • lowering of white blood cells
  • skin rash, itching
  • depression
  • eye pain, blurred vision
  • mild increase in blood pressure
  • basal cell carcinoma

Less common side effects (affecting less than 1 person in 100)

  • pneumonia
  • swelling in the back of the eye (macular oedema)
  • low mood
  • lowering of neutrophils (type of white blood cell)

Three cases of progressive multifocal leukoencephalopathy (PML) have been reported in people taking Gilenya. The risk of developing PML on Gilenya is considered very low but if you are worried discuss your concerns with your MS team.

When you start taking Gilenya, you should be informed of the early signs and symptoms of PML. These can be similar to an MS relapse, so it is important to report any new or worsening symptoms. If PML is suspected during treatment, an MRI scan should be performed and Gilenya treatment suspended until PML has been excluded.

A full list of side effects is included in the manufacturer's Patient Information Leaflet.

Assessment before treatment

Before starting Gilenya, you will have tests to check for immunity against the virus that causes chicken pox and your blood pressure and pulse will be measured.  You should have blood tests to measure blood cell counts and check liver function. It is recommended that your doctor should check your skin for any sores, lumps or damaged areas that may be a sign of cancer. It is also important that you have had a recent (within 3 months) MRI scan.

If you have a pre-existing health condition which affects the eye, such as diabetes, you may also have an eye examination.

As Gilenya must not be taken during pregnancy, women of child-bearing age may be offered a pregnancy test.

Assessment during treatment

Once you've started treatment, you'll have blood tests to measure blood cell counts and monitor liver function and your blood pressure will be measured. OPnce a year, your doctor should check your skin for any sores, lumps or damaged areas that may be a sign of cancer.

After about 3-4 months of starting treatment an eye test may be recommended to monitor for macular oedema.  If you have a pre-existing health condition which affects the eye, such as diabetes, you may have more frequent eye examinations during treatment.

How does Gilenya work?

Gilenya binds to the surface of white blood cells (lymphocytes) in the blood, and these cells are then trapped in the lymph glands, which prevents the lymphocytes from crossing into the central nervous system and causing inflammation and damage.

Gilenya research

Evidence for the effectiveness of Gilenya in relapsing remitting MS has come from three large clinical trials.

  • FREEDOMS I - Gilenya compared to placebo

This two year study compared two doses of Gilenya and placebo in 1,272 people with relapsing remitting MS. Compared to placebo, Gilenya reduced the relapse rate by 54% to 60%.  Both doses of Gilenya reduced the risk of worsening disability by about 30% compared to placebo.

  • FREEDOMS II - Gilenya compared to placebo

This two year study, conducted predominantly in the USA, compared two doses of Gilenya and placebo in 1,083 people with relapsing remitting MS.  Compared to placebo, Gilenya reduced the relapse rate by 48%.  There was no significant difference in worsening of disability between the groups.

  • TRANSFORMS - Gilenya compared to Avonex

TRANSFORMS was a one year study, comparing two doses of Gilenya with Avonex  in 1,292 people with relapsing remitting MS.  Compared to Avonex, Gilenya reduced the relapse rates by 38% to 52%.  There was no significant difference in worsening of disability between the two groups.

Primary progressive MS

Initial laboratory tests suggested that, in addition to its effect on the immune system, Gilenya might have an effect on nerve repair and might therefore have an effect on progressive MS.  The INFORMS study was designed to test whether Gilenya could reduce progression in people with primary progressive MS.

  • INFORMS - Gilenya compared to placebo

The INFORMS study compared Gilenya with placebo in 951 participants in a three year study.  Different aspects of disability were measured throughout the study. Results showed that Gilenya was no better than placebo at reducing the rate at which disability progressed in primary progressive MS.

References

  • National Institute for Health and Care Excellence (NICE). Fingolimod for the treatment of highly active relapsing-remitting multiple sclerosis. NICE technology appraisal guidance 254. Full guideline
  • NHS England. Clinical commissioning policy for MS disease modifying therapies - May 2014. Full guideline
  • Scottish Medicines Consortium (SMC). Advice: fingolimod (Gilenya) - September 2012. Full guideline
  • Scottish Medicines Consortium (SMC). Advice: fingolimod (Gilenya) - October 2014. Full guideline
  • Kappos L, et al. Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis. New England Journal of Medicine 2010;362(5):387-401. Full article
  • Calabresi PA, et al. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurology 2014;13(6):545-556. Summary
  • Cohen J, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. New England Journal of Medicine 2010;362:402-415. Full article
  • Lublin F, et al. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial Lancet 2016 (published online Jan 27) Summary

Last updated: 12 April 2016
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