Note: the content below do not include all the information needed to use Bivalirudin for injection safely and effectively. Please read the package insert carefully and follow the doctors’ instructions before use the product.

INDICATIONS AND USAGE

Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS)

DOSAGE AND ADMINISTRATION

• The recommended dosage is a 0.75 mg/kg intravenous bolus dose followed immediately by a 1.75 mg/kg/h intravenous infusion for the duration of the procedure. Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus dose of 0.3 mg/kg should be given if needed.

• Extending duration of infusion post-procedure up to 4 hours should be considered in patients with ST segment elevation MI (STEMI).

DOSAGE FORMS AND STRENGTHS

For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose vial for reconstitution