bivalirudin (Rx)

Brand and Other Names:Angiomax, Angiomax RTU
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, powder for reconstitution

  • 250mg/vial

injection, ready-to-use solution

  • 5mg/mL (250mg/50mL; 500mg/100mL)

Percutaneous Coronary Intervention

Indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia and thrombosis (HITT) syndrome

Has only been studied in patients receiving concomitant aspirin

0.75 mg/kg IV bolus, and then IMMEDIATELY 1.75 mg/kg/hr IV infusion for duration of procedure

Obtain activated clotting time (ACT) 5 min after administering the bolus dose; an additional IV bolus of 0.3 mg/kg should be given if needed

Consider extended duration of infusion following PCI at 1.75 mg/kg/hr for up to 4 hr postprocedure in patients with ST segment elevation MI (STEMI)

Dosage Modifications

Renal impairment

  • Bolus Dose
    • No reduction required for any degree of renal impairment
  • IV infusion
    • Moderate (CrCl 30-59 mL/min): 1.75 mg/kg/hr
    • Severe (CrCl <30 mL/min): 1 mg/kg/hr
    • Hemodialysis: 0.25 mg/kg/hr

Hepatic impairment

  • No dosage adjustment required

Dosing Considerations

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

Heparin-induced Thrombocytopenia (Off-label)

Initial: 0.15-0.2 mg/kg/hr IV; adjust to aPTT 1.5-2.5 times baseline value  

Anticoagulation & Risk of HIT (Orphan)

Orphan designation for use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome

Orphan sponsor

  • The Medicines Company; 8 Sylvan Way; Parsippany, NJ 07054

Safety and efficacy not established

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Interactions

Interaction Checker

and bivalirudin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Back pain (42%)

            General pain (15%)

            Nausea (15%)

            Hemorrhage, minor (13.6%)

            Headache (12%)

            Hypotension (12%)

            1-10%

            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%)

            Postmarketing Reports

            Pulmonary hemorrhage

            Cardiac tamponade

            INR increased

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            Warnings

            Contraindications

            Active major bleeding

            Hypersensitivity

            Cautions

            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

            Use with caution in patients with disease states associated with increased risk of bleeding; monitor patients on therapy for signs and symptoms of bleeding; monitor patients with disease states associated with an increased risk of bleeding more frequently for 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

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            Pregnancy & Lactation

            Pregnancy

            There are no data available in pregnant women to inform a drug-associated risk of adverse developmental outcomes

            Animal data

            • Reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times maximum recommended human dose (MRHD) of 15 mg/kg/day based on body surface area (BSA) during organogenesis, respectively, revealed no evidence of fetal harm

            Lactation

            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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive, direct thrombin inhibitor; thrombin enables fibrinogen conversion to fibrin during the coagulation cascade; Inhibition of fibrinogen conversion to fibrin inhibits thrombus development

            Inhibits both free and clot-bound thrombin and thrombin-induced platelet aggregation

            Synthetic analog of hirudin

            Pharmacokinetics

            Half-Life: 25 min (normal renal function); 57 min (severe renal impairment)

            Duration: ~ 1 hr after infusion discontinued

            Protein Bound: Minimal

            Clearance: 60-89 mL/min; Reduced in severe renal impairment

            Metabolism: Blood proteases

            Excretion: renal

            Dialyzable: Yes

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            Administration

            IV Incompatibilities

            No incompatibilities observed with glass bottles or polyvinyl chloride bags & administration sets

            Y-site: alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine (concentrations 4mg/mL or greater), prochlorperazine, reteplase, streptokinase, vancomycin

            IV Compatibilities

            Solution: D5W, NS

            Y-site: abciximab, alfentanil, ampicillin, ampicillin/sulbactam, azithromycin, ciprofloxacin, diphenhydramine, dobutamine (compatible at concentrations up to 4mg/mL; incompatible at 12.5mg/mL), dopamine, epinephrine, fentanyl, furosemide, heparin, lidocaine, lorazepam, MgSO4, midazolam, morphine SO4, KCl, NaHCO3, TMP-SMX, warfarin, most cephalosporins

            IV Preparation

            To each 250 mg vial add 5 mL SWI

            Gently swirl until all material is dissolved

            Dilute each vial in 50 mL of D5W or NS to yield a final concentration of 5 mg/mL

            If low-rate infusion is used after initial infusion, a lower concentration bag should be prepared

            Inspect for particulate matter and discoloration prior to administration

            Do not use preparations containing particulate matter

            Reconstituted drug will be a clear to slightly opalescent, colorless to slightly yellow solution

            IV Administration

            Initial bolus injection followed by continuous infusion

            Storage

            Store bivalirudin dosage units at 20-25°C (68-77°F); excursions of 15-30°C permitted

            Do not freeze reconstituted or diluted bivalirudin

            Reconstituted material may be stored at 2-8°C up to 24 hours

            Diluted bivalirudin with a concentration between 0.5mg/mL and 5mg/mL is stable at room temperature for up to 24 hours

            Discard any unused portion of reconstituted solution remaining in vial

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.