english.prescrire.org > Spotlight > Archives : 2014 > Multiple sclerosis: monitor for the cardiac risks of fingolimod (Gilenya°)

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Multiple sclerosis: monitor for the cardiac risks of fingolimod (Gilenya°)

Starting a treatment with fingolimod, or resuming it after a break, exposes the patient to excessive slowing of the heart rate and requires close cardiac monitoring for several hours.

Fingolimod is authorised for the treatment of multiple sclerosis in patients who do not respond to beta interferon therapy, or who have a severe, rapidly progressing disease. Compared with beta interferon treatment, fingolimod appears to reduce slightly the risk of multiple sclerosis relapses. But no improvement has been demonstrated in terms of halting the progression of disability.

When it was commercialised in France, fingolimod’s known adverse effects were numerous and included infections, such as the herpes virus, and liver, eye and cardiac disorders.

At the end of 2011, the reporting of several sudden deaths, including one that occurred within 24 hours of the first dose of fingolimod, prompted the European Medicines Agency to review this drug’s harm-benefit balance. In mid-2012, additional cardiovascular monitoring procedures were put in place: electrocardiogram and blood pressure monitoring both before and 6 hours after the first dose, blood pressure and heart rate monitoring once an hour during those 6 hours, more frequently in the case of decreased heart rate.

At the beginning of 2013, additional warnings were included in fingolimod’s package leaflet recommending the same close cardiovascular monitoring after a break in the treatment too.
In practice, the convenience of this drug (oral administration) should not be a reason for choosing it from the outset. Until its harm-benefit balance is better established, it is better to reserve fingolimod for patients who do not respond to beta interferon treatment, in the context of clinical trials with careful patient monitoring.

©Prescrire 1 January 2014

"Fingolimod. Check cardiovascular status again on treatment resumption" Prescrire Int 2014; 23 (145): 13. (Pdf, subscribers only).
Download the full review.
Pdf, subscribers only

For more information:

Fingolimod:
cardiovascular deaths
Prescrire Int 2012;
21 (126): 99.
Pdf, subscribers only

Fingolimod: just another
immunosuppressant
for multiple sclerosis
(July 2011)
Free

Fingolimod (Gilenya°):
EMA's lack of transparency
spells danger for patients
(April 2012)
Free