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MANAGEMENT OF FINGOLIMOD FIRST DOSE OBSERVATION (FDO) IN THE UK
  1. P Pamies1,
  2. B Webber2,
  3. E Pull1
  1. 1Novartis Pharmaceuticals, Frimley, UK
  2. 2Regent's Park Heart Clinics

Abstract

Background Fingolimod (Gilenya) is a sphingosine 1-phosphate receptor (S1PR) modulator approved for use in relapsing-remitting multiple sclerosis. Fingolimod can lead to reduced pacemaker cell excitability, slowing heart rate (HR) and, possibly, atrioventricular block. Cardiac monitoring is required for a minimum of 6 hours on commencing the first dose of fingolimod.

Regent's Park Heart Clinics (RPHC) is a cardiology services provider engaged by Novartis Pharmaceuticals UK to provide NHS clinicians with a fingolimod FDO service.

Objective To describe the results of a UK FDO service for fingolimod.

Methods RPHC provides a cardiac physiologist/nurse to visit sites between 0800–1700 hrs with electrocardiography (ECG) equipment. 12-lead ECG is performed at baseline and six hours after initiation with continuous cardiac monitoring throughout. Blood pressure and HR measurement is performed hourly. Where patients have evidence of clinically important cardiac effects, monitoring is extended up to eight hours or overnight as required.

Results From 4/July/2012 to 26/January/2015, RPHC provided FDO for 1013 patients. 975 (96%) were discharged at six hours; 29 (3%) were discharged at eight hours. 9 (1%) required an overnight stay. 1 patient discontinued treatment.

Conclusion 96% of 1013 fingolimod patients were discharged at 6-hours post-first dose. No patients required pharmacological intervention.

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