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 the 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 or 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. In reference to tirofiban hydrochloride, Medicure data on file
2. AGGRASTAT® (tirofiban hydrochloride) Prescribing Information
3. Mardikar HM et al. Am Heart J. 2007;154:344e1-5
4. Valgimigli M et al. JACC Card Int 2012; 5(3):268-277
5. Amsterdam EA et al. J Am Coll Cardiol. 2014;64:2645-2687
6. Levine GN et al. J Am Coll Cardiol. 2011;58:e44-e122
