June 26, 2014

Health Canada and Novartis Pharmaceuticals Canada Inc. Revise Gilenya Label

In accordance with Health Canada, Novartis has updated the Gilenya label to include revised guidance surrounding first dose monitoring, use in people with certain cardiovascular risk factors, and how to re-initiate treatment with Gilenya, should it be interrupted.

The revised labeling recommends that people have their blood pressure and heart rate measured hourly over a six-hour observation period, and that an electrocardiogram (ECG) be obtained prior to and at 6 hours after the first dose. The updated label also includes revised patient selection criteria based on certain cardiovascular considerations to help identify suitable candidates for treatment with Gilenya. The updated first-dose monitoring recommendations do not affect people who are already being treated with Gilenya unless treatment is reinitiated after discontinuation.

The updated Health Canada label for Gilenya recommends continued or extended monitoring (including overnight) following the first dose for people who meet the specific clinical criteria. Novartis stated that they are working with Canadian health care professionals and MS clinics to ensure the new prescribing guidelines are implemented as quickly as possible.

Individuals taking Gilenya who experience symptoms of heart problems should report them immediately to their doctor. Symptoms include chest pain, slow or irregular heartbeat, or feeling dizzy. Individuals should not stop taking Gilenya without talking to their healthcare professional. For further information or questions related to Gilenya’s safety, individuals are encouraged to contact the patient support line at Novartis Pharmaceuticals Canada Inc. at 1-855-745-5467 or their prescribing doctor.

Before starting treatment with Gilenya, individuals should inform their doctor if they are taking other medications such as drugs used to treat abnormal heart rhythms (i.e. beta blockers or calcium channel blockers) or if they have a history of heart-related problems such as low heart rate, heart rhythm disorders, congestive heart failure, or fainting.