Novartis updates Gilenya label to include stronger cardiac warnings after FDA review

April 24, 2012

Novartis has agreed with FDA to update US prescribing information on fingolimod (Gilenya) to include updated patient selection parameters based on certain cardiovascular considerations to aid in the identification of candidates for Gilenya.

Novartis has agreed with FDA to update US prescribing information on fingolimod (Gilenya) to include updated patient selection parameters based on certain cardiovascular considerations to aid in the identification of candidates for Gilenya. The updated prescribing information also includes specific recommendations for treatment initiation for patients with relapsing forms of multiple sclerosis (MS).

The update marks the conclusion of discussions initiated in December 2011 when the death in the United States of a MS patient less than 24 hours after taking the drug prompted FDA to start a review of the benefits and risks of fingolimod, according to MedPage Today. The cause of that death is still unexplained, although current labeling on the drug warns about bradycardia and/or atrioventricular conduction block in the first hours after starting the drug.

“The updated prescribing information for Gilenya recommends that all patients initiating treatment should have an electrocardiogram [ECG] prior to dosing and at the end of the 6-hour observation period along with hourly measurement of blood pressure and heart rate,” Novartis spokesperson Julie Masow, told Formulary.

The updated prescribing information does not affect the management of patients currently on Gilenya, unless they discontinue treatment and need to reinitiate. There are revised recommendations on how to reinitiate therapy should Gilenya be discontinued. Patients should not make any changes to any medications they are taking, including Gilenya, without consulting their doctor, Masow added.

The updated prescribing information recommends that patients with certain pre-existing cardiac conditions or those taking concomitant heart rate lowering medications 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. Experience with the use of Gilenya in such patients is limited.

The updated prescribing information includes new contraindications. Gilenya is contraindicated in patients with history or presence of certain cardiac conditions, including heart attack or stroke in the past 6 months, second-degree and third-degree AV block, and other serious cardiac rhythm disturbances, and in patients treated with certain anti-arrhythmic drugs.

If therapy is interrupted for patients who are already taking Gilenya, they should undergo the new recommended monitoring upon treatment re-initiation as per the revised recommendations on the duration of interruption depending on duration of prior treatment.

Gilenya was approved by FDA in September 2010 and is the first and only oral medication approved for relapsing-remitting MS. As of February 2012, approximately 36,000 patients have been treated with Gilenya in clinical trials and in the post-marketing setting.