Details
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.