FDA Revises Label for Multiple Sclerosis Drug Gilenya

Patients with certain preexisting heart conditions, history of stroke, or those who are taking antiarrhythmic medications are being advised to use the oral MS agent Gilenya cautiously.

The FDA announced that it will list new contraindications for the multiple sclerosis (MS) drug Gilenya (fingolimod) in response to reports of a patient who died after taking his or her first dose of the drug. The agency also reevaluated clinical trial and postmarket data from a different patient who died of “cardiovascular events or unknown causes” last year while taking the drug.

There is no concrete evidence that Gilenya caused the patient deaths, but the FDA is still concerned about the cardiovascular effects of Gilenya after the first dose, which appear to peak “as late as 20 hours” in some patients, according to MedPage Today.

For patients beginning therapy with Gilenya, the FDA recommends measuring pulse and blood pressure on an hourly basis. Electrocardiogram (ECG) testing should be performed prior to dosing and at the end of the observation period. Cardiovascular monitoring should continue until any symptoms resolve, and ECG monitoring should continue overnight.

The FDA defined a high-risk patient as one:

• Who develops severe bradycardia after administration of the first dose of Gilenya
• With certain pre-existing conditions in whom bradycardia may be poorly tolerated
• Receiving therapy with other drugs that slow the heart rate or atrioventricular conduction
• With QT interval prolongation prior to starting Gilenya or at any time during the cardiovascular monitoring period
• Receiving therapy with other drugs that prolong the QT interval and that can cause a serious and life-threatening abnormal heart rhythm called Torsades de pointes.

The revised Gilenya drug label will now include specific recommendations for patient monitoring upon the start of therapy and will list the new contraindications for the use of Gilenya in certain patients.