Important Safety Information | Aggrastat (tirofiban hydrochloride) injection

Important Safety Information

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 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.