Prescribing information

 

Prescribing information

The patient support programme which offers patients and healthcare professionals access to nurses and specially developed materials to help patients through the first year of their GILENYA®▼ (fingolimod) journey.

GilenyaConnect provides UK centres with specialist nurse support for GILENYA pre-initiation, first-dose observation and first-year monitoring.

This flexible programme allows you to choose the components which best suit the needs of your centre. Since the inception of GilenyaConnect, many RRMS patients have benefited from our services:

3,833 Total number of patients that attended first-dose observation1* / 275 Total number of patients with first-year monitoring1*

*As of the end of December 2018 since the beginning of the service.

How can GilenyaConnect benefit your RRMS patients?

To read opinions and experiences from centres where GilenyaConnect is live, download the case studies below.

 

 

Survey results from patients enrolled in the GilenyaConnect programme1

HCPs highlighted that this programme helped MS centres to effectively manage workload and provided a safety net when and where patients required it.1

Image of Survey results from patients enrolled in the GilenyaConnect programme

The majority of HCPs were totally satisfied with the quality of contact received as part of the GilenyaConnect service.2

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Expertise from the GilenyaConnect team makes the starting point of the programme as easy and efficient as possible. Once you have prescribed GILENYA and the patient has been enrolled, the GilenyaConnect team will contact them to arrange an appointment for the pre-initiation check.
 

 

Image detailing both a nurse specialist and a cardiology specialist

 

After these checks have been completed and reviewed by the team, you will receive a concise report of results to enable you to assess a patient’s suitability for GILENYA.

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.4

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.5

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The benefits of GilenyaConnect for patients include:

 

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Shorter waiting time

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Convenient monitoring

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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 GilenyaConnect1

 

GilenyaConnect provides access to nurse support to perform first-year monitoring for patients initiated on GILENYA.

During patients’ first year of treatment, it is recommended that liver transaminases are monitored at 1, 3, 6, 9 and 12 months and periodically thereafter in order to monitor liver function. The time points may be varied, depending on when your centre chooses to conduct them.

Assessments of complete blood count (CBC) are recommended periodically during treatment, at month 3 and at least yearly thereafter, to monitor white blood cells and immunity.

 

GilenyaConnect offers easy access to dedicated nurse teams, providing a unique service appropriate to the level of support your centre requires and the individual needs of your patients.

We recognise that you may not always need outside assistance for routine checks. With GilenyaConnect, you can choose when to access the services of our specialist nurses according to your requirements.

For more information and details on how to enrol your patients in the GilenyaConnect programme, please speak to your local Novartis account manager.

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.

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

ECG, electrocardiogram; Gd+, gadolinium-enhancing; HCP, healthcare professional; MRI, magnetic resonance imaging; MS, multiple sclerosis; RES, rapidly evolving severe; RRMS, relapsing-remitting multiple sclerosis.

References

  1. Novartis Data on File.
  2. Wong O, Ayer M. GilenyaConnect: Patient and healthcare professional satisfaction feedback. Poster.
  3. GILENYA (fingolimod) Summary of Product Characteristics.
  4. Brinkmann V et al. Nat Rev Drug Discov 2010;9:883–897.
  5. GILENYA (fingolimod) risk management plan.
  6. 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(1) November 2020.
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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]