Prescribing information

 

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:

Preview image. GILENYA® discussion guide.

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.

Download

 

Resources for your patients:

Preview image. Recognising your MS symptoms guide.

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.

Download

Preview image. GILENYA® patient booklet.

PATIENT BOOKLET

A booklet which gives patients important information about taking GILENYA as well as practical advice about staying healthy while on treatment.

Download

Preview image. Young Person’s Guide to GILENYA®.

THE YOUNG PERSON’S GUIDE TO GILENYA

A booklet to help paediatric patients prescribed GILENYA to understand more about treatment with GILENYA.

Download

 
 

WHAT TO EXPECT WHEN STARTING GILENYA

A video to show patients what to expect when starting treatment with GILENYA.

 

Risk Management materials:

Preview image. GILENYA® Patient, Parent and Caregiver Guide.

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.

View

Preview image. GILENYA® Pregnancy-Specific Patient Reminder Card.

PREGNANCY-SPECIFIC PATIENT REMINDER CARD

A card to give to patients to explain the warnings and contrainindications related to pregnancy associated with GILENYA.

View

Preview image. GILENYA® Prescribers Checklist.

PRESCRIBER’S CHECKLIST

A checklist for prescribers listing important points to remember before, during and after a patient has been prescribed GILENYA.

View

 
 

*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

  1. GILENYA (fingolimod) Summary of Product Characteristics.
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UK | August 2023 | 285828-1

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]