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  3. GILENYA®▼ (fingolimod)

Prescribing information

 

GILENYA®▼ (fingolimod)

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*3:

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.

 

Resources to help you with your GILENYA patients

Resources for HCPs

Image of your guide to Gilenya document

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Resources for patients

Image of young person's guide to Gilenya document

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Risk management resources

Image of content from Gielnya patient guide

See more >

 

What does a typical GILENYA patient look like?

Meet the patients who are typical candidates for GILENYA.

Image of stethoscope and iPad on a desk

See more >

Patient education as an MS management tool

Watch the video from the Get Smart 4 series.
 

Image of stethoscope and iPad on a desk

Watch now >

 

Patient profiles are fictional. For illustrative purposes only.

 

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

References

  1. Ziemssen T et al. Poster P6.393 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
  2. Ziemssen T et al. Poster P5.365 presented at the 70th AAN Meeting, 21–27 April 2018, Los Angeles, CA, USA.
  3. GILENYA (fingolimod) Summary of Product Characteristics.
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Efficacy

See the long-term efficacy of GILENYA® ▼ (fingolimod) in clinical trials.Show more

Safety profile

Read more about the established safety and tolerability profile, including patient and physician assessments of long-term tolerability.Show more

GIL19-C053(1) November 2020.
Neuroscience
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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]