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Prescribing information

 

Patient booklet

A booklet for you to give to your patients who have been prescribed GILENYA. The booklet provides background information about GILENYA, important information about taking GILENYA, and practical advice about wellbeing while on treatment. If you would like to receive copies of any of these materials, please contact your Key Account Manager.

Gd+: gadolinium enhancing; MRI: magnetic resonance imaging; RES: rapidly evolving severe; RRMS: relapsing remitting multiple sclerosis.

Indication: GILENYA is indicated as a single disease modifying therapy in highly active RRMS 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 ≥1 disease modifying therapy, or patients with RES RRMS defined by ≥2 disabling relapses in 1 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.1

Reference

  1. GILENYA (fingolimod) Summary of Product Characteristics.

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GIL19-C053e(1) June 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]