What are the recommendations for the use of fingolimod (Gilenya) in the treatment of relapsing-remitting multiple sclerosis (MS) (RRMS) with preexisting cardiovascular conditions?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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Answer

The following are recommendations for the use of fingolimod in patients with preexisting cardiovascular conditions:

  • Patients with some preexisting conditions (eg, ischemic heart disease, history of myocardial infarction, congestive heart failure, history of cardiac arrest, cerebrovascular disease, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, and sinoatrial heart block) may poorly tolerate the fingolimod-induced bradycardia or may experience serious rhythm disturbances after the first dose of fingolimod.

  • Prior to treatment, these patients should have a cardiac evaluation by a physician appropriately trained to conduct such an evaluation, and, if treated with fingolimod, should be monitored overnight with continuous ECG in a medical facility after the first dose.

  • Since initiation of fingolimod treatment results in decreased heart rate and may prolong the QT interval, overnight continuous ECG monitoring is recommended in patients who have prolonged QTc interval before or during the 6-hour observation (>450 ms males, >470 ms females), are at higher risk for QT prolongation (eg, hypokalemia, hypomagnesemia, congenital long-QT syndrome), are on concurrent therapy with drugs that prolong the QT interval, and have a known risk of torsades de pointes. The list of drugs associated with risk of torsades de pointes can be found at AzCERT (CredibleMeds).


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