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Tirofiban Hydrochloride Injection 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). Tirofiban Hydrochloride Injection 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 )

Tirofiban Hydrochloride Injection is contraindicated in patients with: Severe hypersensitivity reaction to Tirofiban Hydrochloride Injection (i.e., anaphylactic reactions) [see Adverse Reactions ( 6.2 )] . A history of thrombocytopenia following prior exposure to Tirofiban Hydrochloride Injection [see Adverse Reactions ( 6.1 )] . Active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month [see Adverse Reactions ( 6.1 )] . Known hypersensitivity to any component of Tirofiban Hydrochloride Injection. ( 4 ) History of thrombocytopenia with prior exposure to Tirofiban Hydrochloride Injection. ( 4 ) Active internal bleeding, or history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month. ( 4 )

Tirofiban Hydrochloride Injection can cause serious bleeding. If bleeding cannot be controlled discontinue Tirofiban Hydrochloride Injection. ( 5.1 ) Thrombocytopenia: Discontinue Tirofiban Hydrochloride Injection and heparin. ( 5.2 ) 5.1 General Risk of Bleeding Bleeding is the most common complication encountered during therapy with Tirofiban Hydrochloride Injection. Most bleeding associated with Tirofiban Hydrochloride Injection 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. 5.2 Thrombocytopenia Profound thrombocytopenia has been reported with Tirofiban Hydrochloride Injection. Monitor platelet counts beginning about 6 hours after treatment initiation and daily thereafter. If the platelet count decreases to < 90,000/mm 3 , monitor platelet counts to exclude pseudothrombocytopenia. If thrombocytopenia is confirmed, discontinue Tirofiban Hydrochloride Injection and heparin. Previous exposure to a glycoprotein (GP) IIb/IIIa receptor antagonist may increase the risk of developing thrombocytopenia [see Adverse Reactions ( 6.1 )] .

8.1 Pregnancy Risk Summary While published data cannot definitively establish the absence of risk, available published case reports have not established an association with tirofiban use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant woman and fetus (see Clinical Considerations ). Studies with tirofiban HCl at intravenous doses up to 5 mg/kg/day (about 5 and 13 times the maximum recommended daily human dose for rat and rabbit, respectively, when compared on a body surface area basis) have revealed no harm to the fetus. The estimated background risk of major birth defects and …