U.S. FDA and European Medicine Agency Update Prescribing Recommendations for Gilenya to Better Manage Potential Heart Risks at the Time the First Dose Is Taken

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have revised prescribing information for the oral MS therapy Gilenya® (fingolimod, Novartis). The recommendations were based on independent safety reviews initiated by the agencies after deaths had been reported among patients taking Gilenya. The revised prescribing information defines who should avoid using this MS therapy based on pre-existing medical conditions, and alters the recommended testing and heart monitoring that occurs when the first dose is given.

“The revised prescribing information brings better clarity to determining which patients should or should not be recommended to take Gilenya,” noted Dr. Timothy Coetzee, Chief Research Officer of the National MS Society. “This will help people with MS and their health care providers make informed treatment decisions regarding this oral disease-modifying therapy and other treatment options.”

In the U.S., the prescribing information updates include recommendations that:

• All those starting treatment with Gilenya should have an electrocardiogram prior to dosing and after the 6-hour observation period. During the observation period, blood pressure and heart rate should be measured hourly.
• People whose first-dose monitoring indicates potentially unsafe heart events may require longer monitoring, and any who require treatment for low heart rate during the first-dose monitoring will need to be monitored overnight.
• Gilenya is not advisable for people who have had a history or presence of specific heart and vascular conditions, including heart attack, stroke, and heartbeat irregularities, and people taking heart rate-lowering medication. 
• If anyone with a pre-existing heart condition is started on Gilenya, after the first dose the patient should be monitored overnight with continuous electrocardiogram in a medical facility. 
• The heart function monitoring applies only to people initiating their first dose, and not to people who are already taking daily doses of Gilenya.  There are also revised recommendations for people who re-initiate treatment after discontinuing Gilenya. People should not make changes to their Gilenya therapy without consulting their prescriber.

Download detailed, revised U.S. FDA-approved prescribing information (.pdf).

Read results of the FDA's safety review, posted 5/14/12.

Read the EMA’s announcement and other information on its Website.

Download the updated Medication guide (.pdf)

Listen to an FDA Drug Safety Podcast for Healthcare Professionals about revised recommendations for cardiovascular monitoring and use of Gilenya.

Individuals who have questions about Gilenya’s safety should contact the Novartis patient support line at 888-NOW-NOVA
(888-669-6682) or the individual’s prescribing doctor.