MS drug Gilenya prescriptions slowing
Posted: Wed Jul 04, 2012 12:29 am
MS drug Gilenya prescriptions slowing due to lack of monitoring facilities
Novartis’ multiple sclerosis (MS) pill Gilenya faces slowing prescriptions in New York because of a lack of facilities to perform first-dose observations, neurologists told Biopharm Insight. However, Novartis has been in contact with a number of clinicians and is working on increasing the number of sites.
A US Food and Drug Administration (FDA) review was initiated after a patient died within 24 hours of taking the first dose of Gilenya. Regulatory authorities also re-evaluated study data regarding the drug’s effect on heart rate and blood pressure.
Gilenya is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or those taking certain antiarrhythmic drugs, according to FDA. Extended monitoring is recommended in patients with QT prolongation and in patients who are already taking medication that slows heart rate. Observation includes continuous overnight electrocardiography (ECG) monitoring.
A Novartis spokesperson said via email the company is committed to helping healthcare providers implement the updated prescribing information recommendations.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... geid/1309/
Novartis’ multiple sclerosis (MS) pill Gilenya faces slowing prescriptions in New York because of a lack of facilities to perform first-dose observations, neurologists told Biopharm Insight. However, Novartis has been in contact with a number of clinicians and is working on increasing the number of sites.
A US Food and Drug Administration (FDA) review was initiated after a patient died within 24 hours of taking the first dose of Gilenya. Regulatory authorities also re-evaluated study data regarding the drug’s effect on heart rate and blood pressure.
Gilenya is now contraindicated for use in patients with certain pre-existing or recent heart conditions or stroke, or those taking certain antiarrhythmic drugs, according to FDA. Extended monitoring is recommended in patients with QT prolongation and in patients who are already taking medication that slows heart rate. Observation includes continuous overnight electrocardiography (ECG) monitoring.
A Novartis spokesperson said via email the company is committed to helping healthcare providers implement the updated prescribing information recommendations.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... geid/1309/