Patient Initiation of Fingolimod Treatment at Home: Cardiac Monitoring from the Gilenya@Home Program

Thursday, May 25, 2017
B2 (New Orleans Convention Center)
John Osborne, MD , State of the Heart Cardiology, Grapevine, TX
Ashish Pradhan, MD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Jamie L Weiss, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Xiangyi Meng, PhD , Novartis Pharmaceuticals Corporation, East Hanover, NJ
Brandon Brown, PharmD , Novartis Pharmaceuticals Corporation, East Hanover, NJ


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.


To report cardiac monitoring findings from patients initiating fingolimod under Gilenya@Home.


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.



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.


Fingolimod FDO was well tolerated in the home setting, and findings suggest that fingolimod can be safely initiated with Gilenya@Home.