Gilenya® (Fingolimod)


Gilenya is a disease modifying treatment available as a tablet shown to reduce relapses and disability progression in people with relapsing remitting MS.


How is Gilenya administered?

Gilenya is taken in capsule form (0.5mg), once a day.

The first dose of Gilenya is given in a clinic that has been set up and trained to administer the treatment.

Patients are observed for six hours to monitor heart rate and any adverse side effects.

Following the initial dose, one capsule is taken each day.


Benefits shown in clinical trials

Gilenya has been shown in clinical trials to:

  • Reduce the frequency of relapses. A two-year study comparing Gilenya to a placebo showed that it reduced relapse rates by 54 to 60 per cent.
  • Delay progression of physical disability.
  • There is also evidence it may have a direct effect in enhancing of damaged nerve cells.


Side effects

Gilenya is generally well-tolerated, although some people may experience side effects, some of them potentially quite serious.

Common side effects of Gilenya (affecting 1 in 10) include:

  • headache
  • diarrhoea
  • back pain
  • cough
  • dizziness

When you first take Gilenya it can cause your heart rate to slow down or become irregular. This may make you feel dizzy or tired. Because of the risk of cardiac toxicity, international requirements are that the administration of the first dose of this drug requires careful cardiac monitoring for six hours.

Gilenya lowers the numbers of white blood cells in your blood. As white blood cells fight infection, you may find that you pick up illnesses and infections more easily while taking Gilenya.

Very rarely, Gilenya can cause a problem with your vision, known as macular oedema. People taking this medication will routinely require a number of other screening tests, including a specialised eye test, Ocular Coherence Tomography (OCT)

It is too soon to know about other possible long-term side effects from Gilenya, but people taking the drug are being monitored, which should give a better picture for the future.



Special Authority must be approved by the Multiple Sclerosis Treatment Assessment Committee (MSTAC) before funding is approved. Applications will be considered by MSTAC at its regular meetings and approved subject to eligibility according to the Entry and Stopping criteria.

For details of the current criteria and how to apply for funded treatment see Disease Modifying Treatment Special Authority Criteria


Feedback from other patients

It is often helpful to review how other people with MS have liked or tolerated a treatments and the benefits and side effects they have experienced.

Patients Like Me – Gilenya

Gilenya Guides


What to do about a bad reaction to medication

Reports from health professionals are preferred as doctors and other prescribers, pharmacists and nurses usually are able to provide more detailed information about the medications in use and other medical history from patient records that are helpful in evaluating the adverse reaction. However anyone may report a suspected adverse event or reaction to medication taken to the Centre for Adverse Reactions Monitoring (CARM).

For instructions and further information


More information

Gilenya website

Gilenya Medsafe Sheet