BIVALIRUDIN- bivalirudin injection, powder, lyophilized, for solution
Athenex Pharmaceutical Division, LLC.
Bivalirudin for Injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Bivalirudin for injection has been studied only in patients receiving concomitant aspirin.
The recommended dose of bivalirudin for injection is an intravenous bolus dose of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h 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 of 0.3 mg/kg should be given if needed.
Extended duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI).
No reduction in the bolus dose is needed for any degree of renal impairment.
In patients with creatinine clearance less than 30 mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h. Monitor anticoagulant status in patients with renal impairment.
Bivalirudin for injection is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution.
Preparation Instructions for Bolus Injection and Continuous Infusion
- To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP.
- Gently swirl until all material is dissolved.
- Withdraw and discard 5 mL from a 50 mL infusion bag containing 5% Dextrose in Water or 0.9% Sodium Chloride for Injection.
- 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).
- Adjust the dose to be administered according to the patient’s weight (see Table 1).
| Weight |
| Using 5 mg/mL |
| Bolus 0.75 mg/kg |
|Infusion 1.75 mg/kg/h (mL/h)|
No incompatibilities have been observed with administration sets.
Do not administer the drugs listed in Table 2 in the same intravenous line with bivalirudin for injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin for injection containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
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