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What tests should I have done before I take Gilenya for my MS?

The Food and Drug Administration (FDA) label for Gilenya indicates that all people with multiple sclerosis (MS) 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 measurements of blood pressure and heart rate are also advised.

Gilenya's manufacturer, Novartis, recommends that people with certain pre-existing cardiac conditions, or those taking certain medications at the same time, should have 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 recommended monitoring upon treatment re-initiation. No one should make any changes to any medications they are taking, including Gilenya, without consulting his or her doctor.

Says Multiple Sclerosis Foundation Senior Medical Advisor Ben Thrower, MD, “Injectible therapies for MS have been of great value in slowing disability and decreasing relapses for people with MS. Unfortunately, many people are struggling with continuing their shots year after year. Gilenya was welcomed as the first oral therapy for MS in 2010. The convenience and effectiveness of Gilenya need to be balanced with concerns about safety. Due to a handful of people with MS experiencing serious events while on Gilenya, including some deaths, the manufacturer has updated their label giving more guidance to healthcare providers working with the drug.”

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.