Prescribing information

 

Read more about what types of patients could benefit from GILENYA®▼ (fingolimod) treatment.

GILENYA indication2

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*:

Patients with highly active disease despite a full and adequate course of treatment with at least 1 disease modifying therapy

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
 

*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.

GILENYA patients

What you want for your patients:

 
 

 

ARR, annualised relapse rate; DMT, disease modifying therapy; EDSS, expanded disability status scale; Gd+, gadolinium-enhancing; MRI, magnetic resonance imaging.

References

  1. Novartis data on file.
  2. GILENYA (fingolimod) Summary of Product Characteristics.
  3. Giovannoni G et al. Mult Scler Relat Disord 2016;9:S5–S49.
  4. MS Trust. Childhood MS. Available at: www.mstrust.org.uk/a-z/childhood-ms. Accessed September 2020.
  5. Gorman MP et al. Arch Neurol 2009;66(1):54–59.
UK | December 2020 | 101096
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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.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]