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Novartis has agreed with FDA to update US prescribing informationon fingolimod (Gilenya) to include updated patient selectionparameters based on certain cardiovascular considerations to aid inthe identification of candidates for Gilenya . The updated prescribing information also includes specificrecommendations for treatment initiation for patients withrelapsing forms of multiple sclerosis (MS). The update marks the conclusion of discussions initiated inDecember 2011 when the death in the United States of a MS patientless than 24 hours after taking the drug prompted FDA to start areview of the benefits and risks of fingolimod, according to MedPage Today . The cause of that death is still unexplained, although currentlabeling on the drug warns about bradycardia and/oratrioventricular conduction block in the first hours after startingthe drug. "The updated prescribing information for Gilenya recommendsthat all patients initiating treatment should have anelectrocardiogram [ECG] prior to dosing and at the end of the6-hour observation period along with hourly measurement of bloodpressure and heart rate," Novartis spokesperson Julie Masow,told Drug Topics. The updated prescribing information does not affect the managementof patients currently on Gilenya, unless they discontinue treatmentand need to reinitiate. There are revised recommendations on how toreinitiate therapy should Gilenya be discontinued. Patients shouldnot make any changes to any medications they are taking, includingGilenya, without consulting their doctor, Masow added. The updated prescribing information recommends that patients withcertain pre-existing cardiac conditions or those taking concomitantheart rate lowering medications be evaluated by a physician priorto the first dose. If treated with Gilenya, these patients shouldbe monitored overnight with continuous ECG in a medical facilityafter the first dose. Experience with the use of Gilenya in suchpatients is limited. The updated prescribing information includes new contraindications.Gilenya is contraindicated in patients with history or presence ofcertain cardiac conditions, including heart attack or stroke in thepast 6 months, second-degree and third-degree AV block, and otherserious cardiac rhythm disturbances, and in patients treated withcertain anti-arrhythmic drugs. If therapy is interrupted for patients who are already takingGilenya, they should undergo the new recommended monitoring upontreatment re-initiation as per the revised recommendations on theduration of interruption depending on duration of prior treatment. Gilenya was approved by FDA in September 2010 and is the first andonly oral medication approved for relapsing-remitting MS. As ofFebruary 2012, approximately 36,000 patients have been treated withGilenya in clinical trials and in the post-marketing setting. I am an expert from stainless-steelsheets.com, while we provides the quality product, such as China Stainless Steel Chequered Plate , China Stainless Steel Protective Film, Hot Rolled Steel Plate,and more.
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