Active Ingredient: Bivalirudin
Bivalirudin is indicated for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
0.1 - 0.25 mg per kg of body weight
From 0.1 To 0.25 mg per kg of body weight once every day for 3 day(s)
0.1 mg per kg of body weight
0.25 mg per kg of body weight
The recommended starting dose of bivalirudin for patients with ACS is an intravenous bolus of 0.1 mg/kg followed by an infusion of 0.25 mg/kg/h. Patients who are to be medically managed may continue the infusion of 0.25 mg/kg/h for up to 72 hours.
If the patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the duration of the procedure.
Following PCI, the reduced infusion dose of 0.25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary.
For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the intravenous (IV) infusion of bivalirudin should be continued until the time of surgery. Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h infusion for the duration of the surgery.
For patients who proceed to CABG surgery on pump, the IV infusion of bivalirudin should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin (UFH).
The safety and efficacy of a bolus only dose of bivalirudin has not been evaluated and is not recommended even if a short PCI procedure is planned.
The activated clotting time (ACT) may be used to assess bivalirudin activity.
In order to reduce the potential for low ACT values, the reconstituted and diluted product should be thoroughly mixed prior to administration and the bolus dose administered by a rapid intravenous push.
ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds. If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered.
Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75 mg/kg infusion dose is properly administered.
The arterial sheath can be removed 2 hours after discontinuation of the bivalirudin infusion without further ACT monitoring.
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