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Novartis Announces Agreement With FDA On Label Changes For Gilenya - Quick Facts

Novartis (NVS) said it agreed with the US Food and Drug Administration on label changes for Gilenya, or fingolimod.

The update to the Gilenya prescribing information includes patient selection parameters to aid in the identification of candidates for Gilenya treatment and more specific recommendations for treatment initiation for patients with relapsing forms of MS in the United States. The company noted that the update marks the conclusion of discussions initiated in December 2011.

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram prior to the first dose of the medicine and after the six-hour first-dose observation period in addition to hourly measurement of blood pressure and heart rate. Additionally, specific initiation guidance for patients is now provided to better aid healthcare providers. Further, there are revised recommendations on how to re-initiate therapy should Gilenya be interrupted.

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.

by RTT Staff Writer

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