GILENYA is indicated as single disease modifying therapy in highly active relapsing-remitting multiple sclerosis for the following adult patient groups and paediatric patients aged 10 years and older:*1
- Patients with highly active disease despite a full and adequate course of treatment with at least 1 disease modifying therapy. Please consult the SmPC for information regarding exceptions and wash out periods.
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 Gd+ lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Resources for HCPs:
GILENYA DISCUSSION GUIDE
A guide for you to use in conversations with your patients who have been prescribed GILENYA, but which must not be given or sent to patients. The guide helps you introduce GILENYA and explain information that patients need to know before commencing treatment.
Resources for your patients:
RECOGNISING YOUR MS SYMPTOMS
A guide to help your patients recognise MS symptoms and what to do in case they think they are having a relapse.
PATIENT BOOKLET
A booklet which gives patients important information about taking GILENYA as well as practical advice about staying healthy while on treatment.
THE YOUNG PERSON’S GUIDE TO GILENYA
A booklet to help paediatric patients prescribed GILENYA to understand more about treatment with GILENYA.
WHAT TO EXPECT WHEN STARTING GILENYA
A video to show patients what to expect when starting treatment with GILENYA.
Risk Management materials:
PATIENT, PARENT AND CAREGIVER GUIDE
A booklet for GILENYA patients or their parents or caregivers which explains what GILENYA is and contains other important information about the treatment.
PREGNANCY-SPECIFIC PATIENT REMINDER CARD
A card to give to patients to explain the warnings and contrainindications related to pregnancy associated with GILENYA.
PRESCRIBER’S CHECKLIST
A checklist for prescribers listing important points to remember before, during and after a patient has been prescribed GILENYA.
*The safety and efficacy of GILENYA in children aged below 10 years have not been established. No data are available. There are very limited data available in children between 10 and 12 years old.
Gd+, gadolinium-enhancing; MRI, magnetic resonance imaging; MS, multiple sclerosis.
References
- GILENYA (fingolimod) Summary of Product Characteristics.