ANGIOMAX Solution for injection Ref.[27743] Active ingredients: Bivalirudin

2.1 Recommended Dosage

Angiomax has been studied only in patients receiving concomitant aspirin.

The recommended dose of Angiomax 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 30mL/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

Angiomax 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:

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 Angiomax.

Table 2. Drugs Not for Administration in the Same Intravenous Line with Angiomax:

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Angiomax 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 Angiomax. Reconstituted material may be stored at 2 to 8°C for up to 24 hours. Diluted Angiomax 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.

Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of Angiomax have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were due to failure to adjust the infusion dose of bivalirudin in persons with renal dysfunction including persons on hemodialysis [see Dosage and Administration (2.2)]. Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose. In cases of suspected overdosage, discontinue Angiomax immediately and monitor the patient closely for signs of bleeding. There is no known antidote to Angiomax. Angiomax is hemodialyzable [see Clinical Pharmacology (12.3)].

Store Angiomax dosage units at 20 to 25°C (68 to 77°F). Excursions to 15 to 30°C permitted [see USP Controlled Room Temperature].