Classes
DEA Class; Rx
Common Brand Names; Aggrastat
- Antiplatelet Agents, Cardiovascular;
- Glycoprotein IIb/IIIa Inhibitors
Description
Intravenous nonpeptide, platelet glycoprotein IIb/IIIa inhibitor
For rate reduction of thrombotic cardiovascular events in patients with non-ST elevation acute coronary syndromes
Reversible platelet inhibition within 4—8 hours of discontinuation
Indications
Indicated to reduce rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in NSTE-ACS
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 syndromes including acute myocardial infarction, NSTEMI and unstable angina.
Contraindications
Severe hypersensitivity reaction to drug (i.e., anaphylactic reactions) or excipients
History of thrombocytopenia following prior exposure to therapy
Active internal bleeding or history of bleeding diathesis, major surgical procedure or severe physical trauma within previous month
Adverse Effects
Bleeding, minor (11%)
Pelvic pain (6%)
Coronary artery dissection (5%)
Bradycardia (4%)
Dizziness (3%)
Lower extremity pain (3%)
Edema (2%)
Sweating (2%)
Bleeding, major (1-2%)
Thrombocytopenia (1.5%)
Warnings
Bleeding is most common complication encountered during therapy; most bleeding associated with therapy occurs at arterial access site for cardiac catheterization; minimize 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 risk of bleeding
Profound thrombocytopenia reported; monitor platelet counts beginning about 6 hr after treatment initiation and daily thereafter; If platelet count decreases to < 90,000/mm3, monitor platelet counts to exclude pseudothrombocytopenia; if thrombocytopenia confirmed, discontinue therapy and heparin; previous exposure to a glycoprotein (GP) IIb/IIIa receptor antagonist may increase risk of developing thrombocytopenia
Pregnancy and Lactation
While published data cannot definitively establish the absence of risk, available published case reports have not established an association with therapy during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
There is no data on presence of drug in human milk, effects on breastfed infant, or on human milk production
Maximum Dosage
25 mcg/kg IV bolus followed by 0.15 mcg/kg/minute for up to 18 hours.
25 mcg/kg IV bolus followed by 0.15 mcg/kg/minute for up to 18 hours.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tirofiban hydrochloride
premixed IV infusion solution
- 5mg/100mL (50mcg/mL)
- 12.5mg/250mL (50mcg/mL)
IV solution vials
- 5mg/100mL vial (50mcg/mL)
- 3.75mg/15mL bolus vial (250mcg/mL)