Medicure Inc, a specialty pharmaceutical company, announced that the United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen.
Aggrastat is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).
The dosing change and label modification was requested by the company to help health care professionals more efficiently meet patient-specific administration needs and to optimize the implementation of Aggrastat at new hospitals.
The newly approved labelling supplement now allows the delivery duration of the Aggrastat high-dose bolus (25 mcg/kg) to occur anytime within 5 minutes, instead of the previously specified duration of 3 minutes. This change is part of Medicure's ongoing regulatory strategy to expand the applications for Aggrastat.
"We believe the revised dosing time window will offer health care professionals greater flexibility in the administration of Aggrastat, allowing the duration of the bolus dose to be tailored to the needs of the patient," stated Dawson Reimer, president and chief operating officer, Medicure Inc."
“As Aggrastat utilization continues to expand across the United States, the label modification is part of our strategy to best position our product in the evolving field of interventional cardiology."
The Aggrastat HDB regimen was originally approved by the FDA in October 2013 as a part of the company's supplemental New Drug Application (sNDA). The total bolus dose (25 mcg/kg), maintenance infusion (0.15 mcg/kg/min) and indication for Aggrastat have not been modified as a part of the labelling supplement. With the FDA approval letter announced, the infusion duration for delivery of the bolus in the Aggrastat prescribing information has been changed from "over 3 minutes" to "within 5 minutes".
Bleeding which is the most common complication encountered during therapy with Aggrastat. occurs at the arterial access site for cardiac catheterization. Besides this, profound thrombocytopenia has been reported with Aggrastat.