Tirofiban

What it is and how it works

Mechanism of Action Tirofiban hydrochloride injection is a reversible antagonist of fibrinogen binding to the GP IIb/IIIa receptor, the major platelet surface receptor involved in platelet aggregation. When administered intravenously, tirofiban hydrochloride injection inhibits ex vivo platelet aggregation in a dose- and concentration-dependent manner. When given according to the PRISM-PLUS regimen of 0.4 mcg/kg/min over 30 minutes followed by a 0.1 mcg/kg/min maintenance infusion, > 90% inhibition of platelet aggregation is attained by the end of the 30-minute infusion.

Indications

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).

Dosage and administration (summary)

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. Recommended Dosage The recommended dosage is 25 mcg/kg administered intravenously within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours. Administration For intravenous use only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. To open the 250 mL premixed bag, first tear off its foil overpouch.

Contraindications

Tirofiban hydrochloride injection is contraindicated in patients with: Severe hypersensitivity reaction to tirofiban hydrochloride injection (i.e., anaphylactic reactions) . A history of thrombocytopenia following prior exposure to tirofiban hydrochloride injection . Active internal bleeding or a history of bleeding diathesis, major surgical procedure or severe physical trauma within the previous month . Known hypersensitivity to any component of tirofiban hydrochloride injection.

Warnings and precautions

Tirofiban hydrochloride injection can cause serious bleeding. If bleeding cannot be controlled discontinue tirofiban hydrochloride injection. Thrombocytopenia: Discontinue tirofiban hydrochloride injection and heparin. 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.

Pregnancy

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.

Storage and supply

Storage Conditions Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Do not freeze. Protect from light during storage. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, PVC-free. The container closure is not made with natural rubber latex.

Source: Tirofiban Hydrochloride (Tirofiban Hydrochloride) — US FDA prescribing information, 2024-11-09, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.