Bivalirudin for injection

250mg/vial   Strength

Indication: Bivalirudin is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).

Clinical application:It is usedfor intravenous injection and intravenous drip.

INDICATIONS AND USAGE

1.1 Percutaneous Transluminal Coronary Angioplasty (PTCA)

Bivalirudin for Injection is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

1.2 Percutaneous Coronary Intervention (PCI)

Bivalirudin for Injection with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the

REPLACE-2 trial is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).

Bivalirudin for Injection is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.

1.3 Us e with Aspirin

Bivalirudin for Injection in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin.

1.4 Limitation of Use

The safety and effectiveness of bivalirudin for injection have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose

Bivalirudin for Injection is for intravenous administration only.

Bivalirudin for Injection is intended for use with aspirin (300 to 325 mg daily) and has been studied only in patients receiving concomitant aspirin.

For patients who do not have HIT/HITTS

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

GPI administration should be considered in the event that any of the conditions listed in the REPLACE-2 clinical trial description is present.

For patients who have HIT/HITTS

The recommended dose of bivalirudin for injection in patients with HIT/HITTS undergoing PCI is an IV bolus of 0.75 mg/kg. This should be followed by a continuous infusion at a rate of 1.75 mg/kg/h for the duration of the procedure.

For ongoing treatment post procedure

Bivalirudin for injection infusion may be continued following PCI/PTCA for up to 4 hours post procedure at the discretion of the treating physician.

In patients with ST segment elevation myocardial infarction (STEMI) continuation of the bivalirudin for injection infusion at a rate of 1.75 mg/kg/h following PCI/PTCA for up to 4 hours post-procedure should be considered to mitigate risk of stent thrombosis.

After four hours, an additional IV infusion of bivalirudin for injection may be initiated at a rate of 0.2 mg/kg/h (low-rate infusion), for up to 20 hours, if needed.

2.2 Dosing in Renal Impairment

No reduction in the bolus dose is needed for any degree of renal impairment. The infusion dose of bivalirudin for injection may need to be reduced, and anticoagulant status monitored in patients with renal impairment. Patients with moderate renal impairment (30 to 59 mL/min) should receive an infusion of 1.75 mg/kg/h. If the creatinine clearance is less than 30 mL/min, reduction of the infusion rate to 1 mg/kg/h should be considered. If a patient is on hemodialysis, the infusion rate should be reduced to 0.25 mg/kg/h.

2.3 Instructions for Administration

Bivalirudin for Injection is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution. To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Next, withdraw and discard 5 mL from a 50 mL infusion bag containing 5% Dextrose in Water or 0.9% Sodium Chloride for Injection. Then add the contents of the reconstituted vial to the infusion bag containing 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted according to the patient’s weight (see Table 1).

If the low-rate infusion is used after the initial infusion, a lower concentration bag should be prepared. In order to prepare this lower concentration, reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP. Gently swirl until all material is dissolved. Next, withdraw and discard 5 mL from a 500 mL infusion bag containing 5% Dextrose in Water or 0.9% Sodium Chloride for Injection. Then add the contents of the reconstituted vial to the infusion bag containing 5% Dextrose in Water or 0.9% Sodium chloride for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate to be administered should be selected from the right-hand column in Table 1.