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Bivalirudin

    Brands

    DEA Class; Rx

    Common Brand Names; Angiomax, Angiomax RTU

    • Anticoagulants, Cardiovascular; 
    • Anticoagulants, Hematologic

    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

    Use as anticoagulant in heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) syndrome

    For anticoagulation in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).
    For initial anticoagulation in patients with non-ST elevation acute coronary syndrome (unstable angina or acute myocardial infarction, NSTEMI) undergoing early invasive strategy.
    For anticoagulation in patients undergoing cardiac surgery, specifically cardiopulmonary bypass (CPB).

    Active major bleeding

    Hypersensitivity

    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

    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

    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

    Adults

    1.75 mg/kg/hour continuous IV infusion.

    Geriatric

    1.75 mg/kg/hour continuous IV infusion.

    Adolescents

    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.

    Children

    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.

    Infants

    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.

    Neonates

    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.

    Bivalirudin

    injection, powder for reconstitution

    • 250mg/vial

    injection, ready-to-use solution

    • 5mg/mL (250mg/50mL; 500mg/100mL)