HIGHLIGHTS OF PRESCRIBING INFORMATION
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
INDICATIONS AND USAGE
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
Injection: 5 mg/100mL (50 mcg/mL) in 100 mL bag
Injection: 12.5 mg/250mL (50 mcg/mL) in 250 mL bag
Injection: 5 mg/100mL (50 mcg/mL) in 100 mL vial
Injection: 3.75 mg/15mL (250 mcg/mL) in 15 mL bolus vial
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 fibrinolytics, anticoagulants and antiplatelet agents, increases the risk of bleeding. (7)
USE IN SPECIFIC POPULATIONS
Renal Insufficiency: Reduce the dose in patients with severe renal insufficiency. (8.6)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 9/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration
2.3 Dose Adjustment for Renal Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 General Risk of Bleeding
5.2 Thrombocytopenia
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Insufficiency
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* 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 sy