Bivalirudin

Dose Adjustment in Renal Impairment Bolus Dose No reduction in the bolus dose is needed for any degree of renal impairment. Maintenance Infusion 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.

In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h [see Use in Specific Populations, Clinical Pharmacology] .

Instructions for Preparation and Administration 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 ). [See table below.] Drug Compatibilities 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. [See table below.] 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.

Storage after Reconstitution Do not freeze reconstituted or diluted bivalirudin for injection. Reconstituted material may be stored at 2° to 8°C for up to 24 hours. Diluted bivalirudin for injection with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.