Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk

Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.

Advice for healthcare professionals:

  • fingolimod can cause serious ventricular arrhythmias, particularly in the first year of use
  • fingolimod is now contraindicated in patients with:
    • myocardial infarction or unstable angina
    • cerebrovascular disease (transient ischaemic attacks, stroke)
    • decompensated heart failure (requiring inpatient treatment), or New York Heart Association (NYHA) class III/IV heart failure in the previous 6 months
    • severe cardiac arrhythmias requiring treatment with class Ia (eg, quinidine, procainamide, disopyramide) and class III (potassium‐channel blockers—eg, amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmic drugs
    • second‐degree Mobitz type II atrioventricular (AV) block or third‐degree AV block, or sick‐sinus syndrome, if they do not have a pacemaker
    • pre-treatment QT intervals ≥500 milliseconds
  • report all suspected adverse drug reactions with fingolimod on a Yellow Card

Fingolimod is authorised to treat relapsing-remitting multiple sclerosis in patients whose disease has failed to respond to at least 1 disease-modifying therapy or which is severe and rapidly progressive.

Fingolimod can cause transient bradycardia and second-degree or third-degree atrioventricular (AV) block in early treatment. In January 2013, we highlighted the need for cardiac monitoring after the first dose of fingolimod. However, some patients can have persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.

A recent routine EU review identified 44 post-marketing reports of serious ventricular tachyarrhythmia and 6 reports of sudden death worldwide in patients taking fingolimod up to the end of February 2017. To this date, cumulative exposure to fingolimod post-marketing was estimated to be 397,764 patient-years. The routine EU review recommended that warnings against the use of fingolimod in patients with underlying cardiac disorders should be strengthened to contraindications.

Further information

Direct Healthcare Professional Communication. Fingolimod. November 2017.

Fingolimod (Gilenya▼): not recommended for patients at known risk of cardiovascular adverse events. Drug Safety Update. May 2012.

Fingolimod (Gilenya▼): bradycardia and heart block. Drug Safety Update. January 2013.

Article citation: Drug Safety Update volume 11 issue 5; December 2017: 5.

Published 14 December 2017