A 12-lead ECG reading should be taken before starting treatment and repeated with concurrent BP and heart rate monitoring for at least 6 hours after the first dose. If any clinically relevant cardiac effects are noted, monitoring should be continued until they are resolved. Relevant effects include new-onset second or third degree cardiac block or symptomatic bradycardia, heart rate less than 40bpm or persistent second degree AV block 6 hours after the initial dose, or a decrease in heart rate of more than 20bpm compared with baseline.
The increased monitoring requirements should be repeated if treatment is interrupted for more than 2 weeks.
More frequent LFTs
In addition, the manufacturer now also recommends more frequent monitoring of liver functioning, which should be performed at baseline, after 1, 3, 6, 9 and 12 months of treatment and periodically thereafter.
MHRA Drug Safety Update – February 2012
View Gilenya drug record
Further information: Novartis