Classes
DEA Class; Rx
Common Brand Names; Angiomax, Angiomax RTU
- Anticoagulants, Cardiovascular;
- Anticoagulants, Hematologic
Description
Intravenous direct thrombin inhibitor
Used for anticoagulation in patients undergoing PCI, including patients with HIT or HITTS
Associated with higher incidence of acute stent thrombosis in STEMI patients undergoing PCI compared to heparin
Indications
Use as anticoagulant in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) syndrome
Contraindications
Active major bleeding
Hypersensitivity
Adverse Effects
Back pain (42%)
General pain (15%)
Nausea (15%)
Hemorrhage, minor (13.6%)
Headache (12%)
Hypotension (12%)
Injection site pain (8%)
Insomnia (7%)
Pelvic pain (6%)
Hypertension (6%)
Anxiety (6%)
Vomiting (6%)
Bradycardia (5%)
Dyspepsia (5%)
Abdominal pain (5%)
Fever (5%)
Nervousness (5%)
Urinary retention (4%)
Hemorrhage, major (2.3%)
≥3g/dL fall in Hgb (1.9%)
TIMI minor bleeding (1.3%)
RBC transfusions (1.3%)
Pulmonary hemorrhage
Cardiac tamponade
INR increased
Warnings
Bleeding may occur
Use caution in renal impairment
Not for IM administration
Intended for use with aspirin
Hemorrhage may occur at any site; discontinue bivalirudin if unexplained fall in blood pressure or hematocrit occurs
Monitor for signs and symptoms of bleeding; monitor more frequently for bleeding, patients with disease states associated with increased risk of bleeding
An increased risk of thrombus formation, including fatal outcomes, reported with use of bivalirudin in gamma brachytherapy; if decision made to use bivalirudin during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within catheter or vessels
Bivalirudin affects international normalized ratio (INR); INR measurements made in patients treated with bivalirudin may not be useful for determining appropriate dose of warfarin
Acute stent thrombosis (<4 hr) reported at a greater frequency with bivalirudin compared to heparin treated patients; patients should remain for at least 24 hr in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia
Pregnancy and Lactation
There are no data available in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Not known whether drug is present in human milk; no data are available on effects on breastfed child or on milk production; developmental and health benefits of breastfeeding should be considered along with clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Maximum Dosage
1.75 mg/kg/hour continuous IV infusion.
1.75 mg/kg/hour continuous IV infusion.
Safety and efficacy have not been established; however, continuous infusions up to 0.55 mg/kg/hour IV for thrombosis not associated with mechanical circulatory support systems, and up 1.8 mg/kg/hour for ECMO and 3.9 mg/kg/hour for VAD anticoagulation have been reported.
Safety and efficacy have not been established; however, continuous infusions up to 0.55 mg/kg/hour IV for thrombosis not associated with mechanical circulatory support systems, and up 5 mg/kg/hour for CPB, 1.8 mg/kg/hour for ECMO, and 3.9 mg/kg/hour for VAD anticoagulation have been reported.
Safety and efficacy have not been established; however, continuous infusions up to 0.55 mg/kg/hour IV for thrombosis not associated with mechanical circulatory support systems, and up to 1.8 mg/kg/hour for ECMO and 3.9 mg/kg/hour for VAD anticoagulation have been reported.
Safety and efficacy have not been established; however, continuous infusions up to 0.55 mg/kg/hour IV for thrombosis not associated with mechanical circulatory support systems, and up to 1.8 mg/kg/hour for ECMO anticoagulation have been reported.
How supplied
Bivalirudin
injection, powder for reconstitution
- 250mg/vial
injection, ready-to-use solution
- 5mg/mL (250mg/50mL; 500mg/100mL)
