These highlights do not include all the information needed to use AGGRASTAT® (tirofiban hydrochloride) safely and effectively. See full prescribing information for AGGRASTAT
AGGRASTAT® (tirofiban hydrochloride) injection, for intravenous use Initial U.S. Approval: 1998 RECENT MAJOR CHANGES
AGGRASTAT® is a platelet aggregation inhibitor 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). (1) DOSAGE AND ADMINISTRATION
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 5 minutes and then 0.075 mcg/kg/min. (2)
DOSAGE FORMS AND STRENGTHS
Intravenous injection premixed: 5 mg/100 mL (50 mcg/mL) and 12.5 mg/250 mL (50 mcg/mL) with sodium chloride. (3) CONTRAINDICATIONS
Known hypersensitivity to any component of AGGRASTAT. (4)
History of thrombocytopenia with prior exposure to AGGRASTAT. (4)
Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month. (4)
WARNINGS AND PRECAUTIONS
AGGRASTAT can cause serious bleeding. If bleeding cannot be controlled discontinue AGGRASTAT. (5.1)
Thrombocytopenia: Discontinue AGGRASTAT and heparin. (5.2)
ADVERSE REACTIONS
Bleeding is the most commonly reported adverse reaction. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Medicure at 1-800-509-0544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Coadministration of antiplatelet agents, thrombolytics, heparin, or aspirin increases the risk of bleeding. (7)
USE IN SPECIFIC POPULATIONS
Renal Insufficiency: Reduce the dose in patients with severe renal insufficiency. (8.6)
Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
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).
2 DOSAGE AND ADMINISTRATION
Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min (or 0.075 mcg/kg/min for patients with creatinine clearance ≤60 mL/min), for up to 18 hours. This is not the regimen that was used in studies that established effectiveness of AGGRASTAT [see Clinical Studies (14)].
The instructions by weight and creatinine clearance (CrCl) are tabulated in Table 1.
