MC04
Patient Initiation of Fingolimod Treatment at Home: Cardiac Monitoring from the Gilenya@Home Program
Fingolimod (Gilenya®) 0.5 mg/day is approved for relapsing forms of multiple sclerosis and more than 160,000 patients have initiated fingolimod worldwide. Asymptomatic, transient heart rate (HR) decrease at treatment initiation is a pharmacodynamic effect of fingolimod. The US prescribing information requires a first-dose observation (FDO; HR, blood pressure) for at least the first 6 hours. The Gilenya@Home program now allows most US patients to initiate fingolimod at home. This program is conducted by trained clinicians and was developed to improve patient convenience when initiating fingolimod.
Objectives:
To report cardiac monitoring findings from patients initiating fingolimod under Gilenya@Home.
Methods:
Retrospective safety data were collated from patient records collected anonymously during the first 7 months of the program (October 2014 – April 2015). Extended monitoring was conducted, as per the product label, or if the HR was 45 bpm or lower at 6 hours. Cardiac safety and adverse events are descriptively reported.
Results:
Safety data were collected from 511 patients, of whom 354 (69.3%) were women. Mean (standard deviation) sitting HR was 73.7 (11.7) bpm at baseline and was 9.4 (9.4) bpm lower at 6 hours; 61 patients (11.9%) were monitored for more than 6 hours. Onset of first-degree atrioventricular block (AVB) during the 6 hour monitoring period was recorded in 9 patients (1.8%). No cases of second-degree or complete AVB were observed. Adverse events were reported for 154 (30.1%) patients; most frequent were dizziness (n = 31, 6.1%), and fatigue (n = 31, 6.1%). Three patients (0.6%) had palpitations (none associated with bradycardia). Two patients (0.4%) were referred for overnight continuous EKG monitoring in an emergency room because they had symptomatic bradycardia (symptoms reported were dizziness/ lightheadedness); they received standard of care until HR was normalized and they were released the next day.
Conclusions:
Fingolimod FDO was well tolerated in the home setting, and findings suggest that fingolimod can be safely initiated with Gilenya@Home.