Aggrastat® (tirofiban hydrochloride) Injection

Recommended Dosing Regimen

Aggrastat^® High-Dose Bolus (HDB): 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 bolus within 5 minutes followed by an infusion of 0.075 mcg/kg/min for up to 18 hours.

In clinical studies using the HDB regimen, Aggrastat^® was administered in combination with aspirin, clopidogrel and heparin or bivalirudin to over 8,000 patients for typically ≤24 hours.¹

Platelet Aggregation Inhibition

The HDB regimen achieves >90% inhibition of platelet aggregation within 10 minutes of bolus administration.²

Aggrastat^® Receives a Class I Recommendation in the following Guidelines:

• ACC/AHA Guideline for NSTE-ACS³
• ACC/AHA/SCAI Guideline for PCI⁴

Contact

Aggrastat^® Product Specialist

1-800-509-0544 (#7)
aggrastat@medicure.com

Medical Information

1-800-509-0544 (#3)
medinfo@medicure.com

Report an Adverse Reaction

1-800-509-0544 (#2)
adverse.events@medicure.com

Important Safety Information

Indication

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).

Contraindications

• Known hypersensitivity to any component of Aggrastat^®
• History of thrombocytopenia with prior exposure to Aggrastat^®
• Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month

Warnings and Precautions

• Aggrastat^® can cause serious bleeding. Most bleeding associated with Aggrastat^® occurs at the arterial access site for cardiac catheterization. Minimize the use of traumatic of potentially traumatic procedures such as arterial and venous punctures, intramuscular injections, nasotracheal intubation, etc. Concomitant use of fibrinolytics, anticoagulants and antiplatelet drugs increases the risk of bleeding. If bleeding cannot be controlled, discontinue Aggrastat^®.
• Thrombocytopenia: Discontinue Aggrastat^® and heparin

Adverse Reactions

• Bleeding is the most commonly reported adverse reaction

For additional information, refer to the full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch
or call 1-800-FDA-1088.

References

1. Valgimigli M et al. Eur Heart J 2010;31:35-49
2. Mardikar HM et al. Am Heart J 2007;154:344e1-344e5
3. Amsterdam EA et al. J Am Coll Cardiol 2014;64:2645-2687
4. Levine GN et al. J Am Coll Cardiol 2011;58:e44-e122

Download Aggrastat^® Prescribing Information

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