In order to minimise the cardiovascular risk with fingolimod (Gilenya), Novartis is informing healthcare professionals about important additional recommendations to strengthen the monitoring of cardiovascular status for 6 hours after initiating treatment, and to extend it, when necessary.
Fingolimod is known to cause a transient bradycardia and might be associated with AV block, after the first dose as reflected in the current product information. The additional recommendations follow case reports of cardiovascular events including a patient who died of unknown cause after the first dose. In agreement with the European Medicines Agency, the following recommendations are effective immediately for patients treated with this drug.
For all patients starting treatment, monitoring during the first 6 hours after dosing should include: 12-lead ECG at baseline and 6 hours after the first dose, continuous 6-hour ECG monitoring and BP and heart rate measurement every hour
In those patients with evidence of clinically important cardiac effects, monitoring should be extended until resolution. The following criteria for extended monitoring are recommended:
• The presence at the 6-hour time point after first dose of:
-Heart rate < 40 beats per minute
-Decrease in heart rate >20 beats per minute compared with baseline
-Persistent new-onset 2nd degree AV block, Mobitz type I (Wenckebach)
• The occurrence at anytime during the 6-hour monitoring of:
-Symptomatic bradycardia
-New onset 2nd degree AV block, Mobitz type II
-New onset 3rd degree AV block
Novartis has received case reports of cardiovascular events including a spontaneous report of a 59 year-old female patient with MS and being treated with metoprolol and amlodipine for hypertension, who died within 24 hours of taking the first dose of fingolimod; the exact cause of death remains unknown at present.
At the request of the EMA, Novartis is conducting a complete review of cardiovascular events including data from clinical trials and post-marketing experience.