Technology | Antiplatelet and Anticoagulation Therapies | October 28, 2016

FDA Approves Aggrastat Bolus Vial to Improve Delivery in the Cath Lab

Aggrastat Bolus Vial, IV antiplatelet agent

October 28, 2016 — Medicure Inc. recently received U.S. Food and Drug Administration (FDA) market clearance for its new bolus vial product format for Aggrastat (tirofiban HCl) IV administered antiplatelet drug. It contains tirofiban hydrochloride, a non-peptide antagonist of the platelet GP IIb/IIIa receptor, which inhibits platelet aggregation. It is indicated to reduce the rate of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

The newly approved product format is a concentrated, pre-mixed, 15 ml vial designed specifically for convenient delivery of the Aggrastat bolus dose (25 mcg/kg).  Development of the bolus vial was in response to feedback from interventional cardiologists and catheterization lab nurses from across the United States. 

Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. In patients with creatinine clearance ≤60 mL/min, give 25 mcg/kg within five minutes and then 0.075 mcg/kg/min.

In clinical studies with the HDB regimen, Aggrastat was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients for typically ≤24 hours.

For more information: www.medicure.com

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