Gilenya: cardiac monitoring requirements strengthened

The cardiac monitoring requirements for patients with multiple sclerosis starting Gilenya (fingolimod) have been updated owing to cardiac concerns, including unexplained death in six patients.

Gilenya is a sphingosine 1-phosphate receptor modulator and is licensed for the treatment of multiple sclerosis
Gilenya is a sphingosine 1-phosphate receptor modulator and is licensed for the treatment of multiple sclerosis

The MHRA has issued the new advice for Gilenya to reduce the risk of transient bradycardia and heart block.

Updated advice

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

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