Novartis has updated the prescribing information for Gilenya (fingolimod), a once daily oral therapy indicated to reduce the number of relapses and slow disability progression in patients with relapsing forms of multiple sclerosis (MS), to include updated patient selection parameters based on certain cardiovascular considerations. The changes follow the FDA review announced in December 2011 and also confirm that Gilenya is an important treatment option for appropriate patients.

The updated prescribing information includes:

  • Patients initiating treatment should have an electrocardiogram (ECG) prior to dosing and at the end of the six-hour observation period along with hourly measurement of blood pressure and heart rate.
  • Patients with certain pre-existing cardiac conditions or those taking concomitant heart rate lowering medications should be evaluated by a physician prior to the first dose. If treated with Gilenya, these patients should be monitored overnight with continuous ECG in a medical facility after the first dose. 
  • Gilenya is contraindicated in patients with history or presence of certain cardiac conditions, including heart attack or stroke in the past six months, second- and third-degree atrioventricular (AV) block and other serious cardiac rhythm disturbances, and in patients treated with certain anti-arrhythmic drugs.

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