1. Resources and Training
  2. Neuroscience
  3. Product resources and training
  4. First-dose observation

Prescribing information

 

First-dose observation

With GILENYACONNECT, a clinic will perform the required medical observations during the patient’s first dose of GILENYA.

GILENYA’s mode of action is well understood, and there are well-characterised cardiac effects after taking the first dose.1

To ensure a smooth initiation, our first-dose observation clinic will carry out the necessary medical check-ups as set out in the GILENYA Summary of Product Characteristics1 and risk management plan.2

The benefits of GILENYACONNECT for patients include:

  • Shorter waiting time.
  • Convenient monitoring.
  • First dose supported by dedicated nurse care and a range of helpful materials.

 

Over 3,000 patients have been supported through first-dose observation with
GILENYACONNECT

GILENYACONNECT is a healthcare service that is offered as a programme for patients prescribed GILENYA. It is not intended to replace the services of the patient’s NHS medical team.

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.3

References

  1. Brinkmann V, et al. Nat Rev Drug Discov 2010; 9: 883-897.
  2. GILENYA (fingolimod) risk management plan.
  3. GILENYA (fingolimod) Summary of Product Characteristics.
  4. Pamies P, et al. Poster P079 presented at the Annual Meeting of the Association of British Neurologists 20-22 May 2015, Harrogate, England.
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GIL19-C053d March 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]