bivalirudin for injection - VIAL Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Bivalirudin has been studied only in patients receiving concomitant aspirin.

The recommended dose of bivalirudin 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).

2.2 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 (8.6), Clinical Pharmacology (12.3)].

2.3 Instructions for Preparation and Administration

Bivalirudin 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).
Table 1: Dosing Table
Weight
(kg)		Using 5 mg/mL
Concentration
Bolus
0.75 mg/kg
(mL)		Infusion
1.75 mg/kg/h
(mL/h)
43 to 47716
48 to 527.517.5
53 to 57819
58 to 62921
63 to 671023
68 to 7210.524.5
73 to 771126
78 to 821228
83 to 871330
88 to 9213.531.5
93 to 971433
98 to 1021535
103 to 1071637
108 to 11216.538.5
113 to 1171740
118 to 1221842
123 to 1271944
128 to 13219.545.5
133 to 1372047
138 to 1422149
143 to 1472251
148 to 15222.552.5

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.

Table 2:Drugs Not for Administration in the Same Intravenous Line with Bivalirudin
Alteplase
Amiodarone HCl
Amphotericin B
Chlorpromazine HCl
Diazepam
Dobutamine
Prochlorperazine Edisylate
Reteplase
Streptokinase
Vancomycin HCl

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.

2.4 Storage after Reconstitution

Do not freeze reconstituted or diluted bivalirudin. Reconstituted material may be stored at 2 to 8°C for up to 24 hours. Diluted bivalirudin 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.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Bivalirudin has been studied only in patients receiving concomitant aspirin.

The recommended dose of bivalirudin 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).

2.2 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 (8.6), Clinical Pharmacology (12.3)].

2.3 Instructions for Preparation and Administration

Bivalirudin 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).
Table 1: Dosing Table
Weight
(kg)		Using 5 mg/mL
Concentration
Bolus
0.75 mg/kg
(mL)		Infusion
1.75 mg/kg/h
(mL/h)
43 to 47716
48 to 527.517.5
53 to 57819
58 to 62921
63 to 671023
68 to 7210.524.5
73 to 771126
78 to 821228
83 to 871330
88 to 9213.531.5
93 to 971433
98 to 1021535
103 to 1071637
108 to 11216.538.5
113 to 1171740
118 to 1221842
123 to 1271944
128 to 13219.545.5
133 to 1372047
138 to 1422149
143 to 1472251
148 to 15222.552.5

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.

Table 2:Drugs Not for Administration in the Same Intravenous Line with Bivalirudin
Alteplase
Amiodarone HCl
Amphotericin B
Chlorpromazine HCl
Diazepam
Dobutamine
Prochlorperazine Edisylate
Reteplase
Streptokinase
Vancomycin HCl

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.

2.4 Storage after Reconstitution

Do not freeze reconstituted or diluted bivalirudin. Reconstituted material may be stored at 2 to 8°C for up to 24 hours. Diluted bivalirudin 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.
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