Gilenya

fingolimod

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This is a summary of the European public assessment report (EPAR) for Gilenya. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. it is not intended to provide practical advice on how to use Gilenya.

For practical information about using Gilenya, patients should read the package leaflet or contact their doctor or pharmacist.

What is Gilenya and what is it used for?

Gilenya is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.

Gilenya contains the active substance fingolimod.

How is Gilenya used?

Gilenya can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in multiple sclerosis. Gilenya is available as capsules (0.5 mg), and the recommended dose is one capsule taken once a day by mouth.

Because Gilenya decreases the heart rate and can affect the heart’s electrical activity and rhythm, the patient’s blood pressure and heart activity is checked before treatment and after starting treatment, and also if Gilenya treatment is restarted after an interruption. Details on the recommendations for monitoring patients are found in the summary of product characteristics (SmPC).

How does Gilenya work?

In multiple sclerosis, the immune system (the body’s defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord. The active substance in Gilenya, fingolimod, prevents T cells (a type of white blood cell involved in the immune system) travelling from the lymph nodes towards the brain and spinal cord, thus limiting the damage they cause in multiple sclerosis. It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1-phosphate receptor, which is involved in controlling the movement of these cells in the body.

What benefits of Gilenya have been shown in studies?

Three main studies have found that Gilenya was more effective than placebo (a dummy treatment) and interferon beta-1a (another medicine for treating multiple sclerosis) in patients with relapsing-remitting multiple sclerosis. The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year.

In two studies involving a total of 2,355 patients, Gilenya was compared with placebo over two years. Patients treated with Gilenya had around half the number of relapses compared with relapses in patients given placebo.

In the third study involving 1,292 patients, Gilenya was compared with interferon beta-1a over one year. Patients receiving Gilenya had around half the number of relapses compared with patients given interferon beta-1a.

What are the risks associated with Gilenya?

The most common side effects with Gilenya (seen in more than 1 patient in 10) are flu, sinusitis (inflammation of the sinuses), headache, cough, diarrhoea, back pain and raised liver enzyme levels (a sign of liver problems). The most serious side effects are infections, macular oedema (swelling in the central part of the retina at the back of the eye) and atrioventricular block (a type of heart rhythm disorder) at the start of treatment. For the full list of side effects with Gilenya, see the package leaflet.

Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, patients with cancer or severe liver problems. Gilenya must also not be used in patients with certain diseases affecting the heart and blood vessels or in those who have had such diseases or problems with the blood supply to the brain. Women should not become pregnant while taking Gilenya and for two months after treatment has stopped. For the full list of restrictions with Gilenya, see the package leaflet.

Why is Gilenya approved?

The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis and noted that it had the benefit of being taken by mouth. However, because of its safety profile, the Agency concluded that Gilenya should only be used in patients who have a real need for the medicine either because their disease has not improved with at least one other disease-modifying therapy or because it is severe and getting worse rapidly. In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose. The Agency decided that Gilenya’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Gilenya?

The company that markets Gilenya will carry out a study to assess the risk of side effects on the heart and circulation. It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended. The checklist includes information on the tests and monitoring in patients before and after starting or when restarting treatment with Gilenya. The pack will also include information on the registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card with key safety information.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gilenya have also been included in the summary of product characteristics and the package leaflet.

Other information about Gilenya

The European Commission granted a marketing authorisation valid throughout the European Union for Gilenya on 17 March 2011.

For more information about treatment with Gilenya, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Gilenya : EPAR - Summary for the public BG = bălgarski 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public ES = español 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public CS = čeština 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public DA = dansk 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public DE = Deutsch 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public ET = eesti keel 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public EL = elliniká 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public EN = English 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public FR = français 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public IT = italiano 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public LV = latviešu valoda 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public LT = lietuvių kalba 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public HU = magyar 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public MT = Malti 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public NL = Nederlands 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public PL = polski 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public PT = português 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public RO = română 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public SK = slovenčina 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public SL = slovenščina 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public FI = suomi 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public SV = svenska 2011-03-30 2018-02-12
Gilenya : EPAR - Summary for the public HR = Hrvatski 2011-03-30 2018-02-12

This EPAR was last updated on 02/05/2018 .

Authorisation details

Product details

Product details for Gilenya
NameGilenya
Agency product numberEMEA/H/C/002202
Active substance

fingolimod hydrochloride 

International non-proprietary name (INN) or common name

fingolimod

Therapeutic area Multiple Sclerosis
Anatomical therapeutic chemical (ATC) code L04AA27
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Gilenya
Marketing-authorisation holder

Novartis Europharm Limited

Revision18
Date of issue of marketing authorisation valid throughout the European Union17/03/2011

Contact address:

Novartis Europharm Limited
Elm Park, Merrion Road
Dublin 4
Ireland

Product information

Product information

23/04/2018  Gilenya -EMEA/H/C/002202 -T/0048

Name Language First published Last updated
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02
Gilenya : EPAR - Product Information HR = Hrvatski 2011-03-30 2018-05-02

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27
Gilenya : EPAR - All Authorised presentations HR = Hrvatski 2011-03-30 2014-06-27

Name Language First published Last updated
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06
Gilenya : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2011-03-30 2012-07-06

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Gilenya is indicated as single disease-modifying therapy in highly active relapsing-remitting multiple sclerosis for the following adult patient groups:

  • patients patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1).

or:

  • patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by two or more disabling relapses in one year, and with one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Gilenya : EPAR - Public assessment report HR = Hrvatski 2011-03-30  
CHMP summary of positive opinion for Gilenya HR = Hrvatski 2011-01-21  

Authorised

This medicine is approved for use in the European Union

News

More information on Gilenya