Abstract
BackgroundThe Swiss label of oral fingolimod (0.5 mg once daily) requires a 6-hour first dose observation (FDO) including an ECG prior to and 6 hours after the first intake but in comparison to other countries such as Austria, Australia and Canada there are no restrictions regarding the clinical settings of the FDO procedure in Switzerland. We present here our real-world experience of the 6 hour FDO procedure in three different clinical settings, following fingolimod treatment initiation. This is the first report on the FDO of fingolimod in these real-world clinical settings in Swiss patients with multiple sclerosis (MS).MethodsThis was a retrospective, multi-clinic, observational study of 136 patients with relapsing-remitting multiple sclerosis. Summary statistics have been used to present the data.ResultsOnly two patients (<1.5% [2/136]) experienced symptoms after the first dose of fingolimod. Atrioventricular conduction abnormalities were reported in 3% (4/136) of patients, which resolved spontaneously within 24 hours of treatment initiation. During the average 6.8 months follow-up, 96% (131/136) of the patients remained on therapyConclusionsThese findings support the safety and feasibility of FDO and tolerability of fingolimod in real-world clinical settings.
Highlights
The Swiss label of oral fingolimod (0.5 mg once daily) requires a 6-hour first dose observation (FDO) including an ECG prior to and 6 hours after the first intake but in comparison to other countries such as Austria, Australia and Canada there are no restrictions regarding the clinical settings of the FDO procedure in Switzerland
Fingolimod 0.5 mg once-daily (FTY720; GilenyaTM, Novartis Pharma AG, Basel, Switzerland), a sphingosine 1-phosphate (S1P) receptor modulator, is the first oral therapy approved by the Swiss Regulatory Agency for treating patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of relapses and delay disability progression [1]
Overview of FDO process and associated workload FDO measurements were performed in the daily clinical setting, which involved an ECG at the beginning and at the end of 6 hours and hourly recording of vital parameters (Figure 1)
Summary
The Swiss label of oral fingolimod (0.5 mg once daily) requires a 6-hour first dose observation (FDO) including an ECG prior to and 6 hours after the first intake but in comparison to other countries such as Austria, Australia and Canada there are no restrictions regarding the clinical settings of the FDO procedure in Switzerland. We present here our real-world experience of the 6 hour FDO procedure in three different clinical settings, following fingolimod treatment initiation. This is the first report on the FDO of fingolimod in these real-world clinical settings in Swiss patients with multiple sclerosis (MS). Already at the time of market authorization in January 2011, the Swiss label of fingolimod made it a
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