Gilenya is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age 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.
Therapeutic Indication
### Therapeutic indication Gilenya is indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older: - 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 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Therapeutic Area (MeSH)
N/AATC Code
L04AA27
ATC Item
xl 04 aa 27
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| fingolimod hydrochloride | N/A | 芬戈莫德 |
EMA Name
Gilenya
Medicine Name
Gilenya
Aliases
N/ANo risk management plan link.
