Gilenya * Product Monograph Update

On July 12, 2012, Health Canada made revisions to its recommended use of Gilenya among patients with relapsing remitting MS. In order to ensure patient safety Novartis 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. On August 24, 2012, Health Canada included new recommendations to the Product Monograph to reduce the risk of effects on the heart, in people taking Gilenya.

The additional recommendations within the revised labeling advises that people who start Gilenya remain in the clinic or medical office for at least 6 hours after taking their first dose so that hourly measurements can be taken of their heart rate and blood pressure to identify if heart related side effects are occurring. This includes an electrocardiogram (ECG) obtained prior to and at 6 hours after the first dose.

The new 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 such as heart rhythm disturbance (i.e. dizziness, palpitations, chest pain, slow or irregular heartbeat), should report them immediately to their doctor. Individuals should not stop taking Gilenya without talking to their health care 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 speak with their doctor if they have current or past heart problems, if they have a history of sudden loss of consciousness (fainting) or if they are taking medicine for cardiac problems (i.e. beta blockers or calcium channel blockers) or high blood pressure.