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Novartis Updates U.S. Label on Gilenya®

4/24/2012

An updated Gilenya label provides further guidance to healthcare providers regarding treatment initiation with Gilenya in the United States. Additional prescribing information includes selection parameters to aid in the identification of candidates with relapsing forms of MS for Gilenya treatment.

Novartis made the announcement after the medication was reviewed by The US Food and Drug Administration (FDA). The drug company notes that the prescribing information does not alter treatment management of people with MS currently taking Gilenya, unless treatment is stopped, and then a need to reinitiate occurs.

The updated FDA label for Gilenya indicates that all patients initiating treatment with Gilenya should have an electrocardiogram (ECG) prior to the first dose of the medicine and after the six-hour first-dose observation period. Hourly measurement of blood pressure and heart rate are also advised.

The label update in the U.S.for Gilenya recommends that people with certain pre-existing cardiac conditions or those taking certain medications at the same time would require overnight monitoring following administration of first dose of medication. It may be suggested that some people be evaluated by a specialist prior to starting Gilenya. Experience with the use of Gilenya in such people was limited in the pivotal clinical trials, according to Novartis.

People who have discontinued Gilenya and want to go back on the medication should undergo the new recommended monitoring upon treatment re-initiation, according to the revised label. No one should make any changes to any medications they are taking, including Gilenya, without consulting his or her doctor.

Gilenya is contraindicated in people with history or presence of certain cardiac conditions, including heart attack or stroke in the past six months, second- and third-degree AV block and other serious cardiac rhythm disturbances, and in people treated with certain anti-arrhythmic drugs.

As of February 2012, approximately 36,000 people have been treated with Gilenya in clinical trials and in the post-marketing setting, Novartis reported.

 



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