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 launched by Medicure Inc, a specialty pharmaceutical company. Aggrastat is Antiplatelet drug. It 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 modification in label and change in dose 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 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.
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.
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 changed as a part of the labelling supplement. As per FDA approval letter 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. Besides this, profound thrombocytopenia has been reported with Aggrastat.
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