bivalirudin [IV]

Adult Dosing

Anticoagulation

PCI/PTCA procedure

0.75 mg/kg IV bolus dose immediately prior to procedure, followed by 1.75 mg/kg/hr for the duration of the procedure. Perform ACT 5 mins after the bolus dose and give additional bolus dose of 0.3 mg/kg if required
Can continue with 1.75 mg/kg/hr IV up to 4 hrs after the procedure, then additional 0.2 mg/kg/hr IV for up to 20 hrs (at the discretion of the treating physician)

HIT/HITTS patients (undergoing PCI)

0.75 mg/kg IV bolus dose immediately prior to procedure, followed by 1.75 mg/kg/hr for the duration of the procedure
Can continue with 1.75 mg/kg/hr IV up to 4 hrs after the procedure, then additional 0.2 mg/kg/hr IV for up to 20 hrs (at the discretion of the treating physician)
HIT = Heparin induced thrombocytopenia
HITTS = Heparin induced thrombocytopenia and thrombosis syndrome

Note Use with aspirin 300-325 mg/day

Acute Coronary Syndromes [Non-FDA Approved ]

Pediatric Dosing

[Outline]

Indications ⬆ ⬇

As an anticoagulant in combination with Aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA)
As an anticoagulant in combination with Aspirin in patients undergoing percutaneous coronary intervention (PCI)
In patients at risk of heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI

Note:

The safety and effectiveness have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI

Contraindications ⬆ ⬇

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment (Based on CrCl)

Hepatic Dose Adjustment

Warnings/Precautions ⬆ ⬇

For intravenous use only, not for intramuscular administration
Bivalirudin in PCI/PTCA can cause hemorrhage at the site of arterial puncture or at any site. Discontinue therapy if unusual fall in blood pressure or hematocrit.
Monitor patient for signs of bleeding throughout therapy. Use cautiously in patients at greater risk of bleeding
Use of bivalirudin in gamma brachytherapy may increase risk of thrombus formation, including fatal outcomes. Maintain meticulous catheter technique minimizing conditions of stasis within the catheter or vessels, with frequent aspiration and flushing

Cautions: Use cautiously in

Renal impairment
Bleeding disorders
Brachytherapy
Heparin-induced thrombocytopenia or heparin-induced thrombocytopenia-thrombosis syndrome

Pregnancy/Breast Feeding ⬆ ⬇

Pregnancy Category:B

Breastfeeding: Safety Unknown, as many drugs are excreted in human milk, caution should be exercised while administering nursing mothers.

Adverse Reactions ⬆ ⬇

Clinical Pharmacology ⬆ ⬇

Anticoagulant: inhibits the action of thrombin by specifically binding both to the catalytic site and to the anion-binding exosite of circulating and clot-bound thrombin
Metabolized by a combination of renal mechanisms and proteolytic cleavage
Renally excreted: Primarily
Half-life: Based on CrCl