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bivalirudin (Rx)Brand and Other Names:Angiomax, Angiox

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

powder for injection

  • 250mg
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Anticoagulant in Patients Undergoing PTCA/PCI or PCI with HITS/HITTS

Intended for use with aspirin (300 to 325 mg daily)

0.75 mg/kg IV bolus, initially, followed by continuous infusion at rate of 1.75 mg/kg/hr for duration of procedure  

Perform activated clotting time (ACT) 5 minutes after bolus dose

May administer additional 0.3 mg/kg bolus if necessary

May continue infusion following PCI beyond 4 hours (optional post PCI, at discretion of treating health care provider) initiated at rate of 0.2 mg/kg/hr for up to 20 hours PRN

Unstable Angina/Non-ST-Elevation MI (Off-label)

0.1 mg/kg IV bolus followed by 0.25 mg/kg/hr  

Give additional bolus of 0.5 mg/kg/hr; increase infusion rate to 1.75 mg/kg/hr if PCI is necessary

May discontinue at end of procedure or continue for up to 4 hr postprocedure if necessary

Discontinue bivalirudin 3 hr before surgery if cardiac surgery deemed necessary

STEMI Undergoing Primary PCI (Off-label)

Initial: 0.75 mg/kg IV bolus; increase to 1.75 mg/kg/hr for the duration of procedure  

Postprocedure: Continue at reduced dose if necessary

Heparin-induced Thrombocytopenia

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

Dosing Considerations

Infusion may be continued following PCI/PTCA for up to 4 hours post-procedure at discretion of treating physician

In patients with ST segment elevation myocardial infarction (STEMI) continuation of therapy infusion at a rate of 1.75 mg/kg/h following PCI/PTCA for up to 4 hr post-procedure should be considered to mitigate risk of stent thrombosis

Renal Impairment

PCI Use

  • CrCl > 30 mL/min: Dose adjustment not necessary
  • CrCl 10-29 mL/min: Infusion rate should be reduced to 1 mg/kg/hr

Heparin-induced thrombocytopenia use

  • CrCl >60 mL/min: 0.13 mg/kg/hr
  • CrCl 30-60 mL/min: 0.08-0.1 mg/kg/hr
  • CrCl <30 mL/min: 0.04-0.05 mg/kg/hr

Hepatic Impairment

Dose adjustment not necessary

Anticoagulation & Risk of HIT (Orphan)

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

Orphan indication sponsor

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

Not recommended

Anticoagulant in Patients Undergoing PTCA/PCI or PCI with HITS/HITTS

Intended for use with aspirin (300 to 325 mg daily)

0.75 mg/kg IV bolus, initially, followed by continuous infusion at rate of 1.75 mg/kg/hr for duration of procedure  

Perform activated clotting time (ACT) 5 minutes after bolus dose

May administer additional 0.3 mg/kg bolus if necessary

May continue infusion following PCI beyond 4 hours (optional post PCI, at discretion of treating health care provider) initiated at rate of 0.2 mg/kg/hr for up to 20 hours PRN

Unstable Angina/Non-ST-Elevation MI (Off-label)

0.1 mg/kg IV bolus followed by 0.25 mg/kg/hr  

Give additional bolus of 0.5 mg/kg/hr IV; increase infusion rate to 1.75 mg/kg/hr if PCI is necessary

May discontinue at end of procedure or continue for up to 4 hr postprocedure if necessary

Discontinue bivalirudin 3 hr before surgery if cardiac surgery deemed necessary

STEMI Undergoing Primary PCI (Off-label)

Initial: 0.75 mg/kg IV bolus; increase to 1.75 mg/kg/hr for the duration of procedure  

Postprocedure: Continue at reduced dose if necessary

Heparin-induced Thrombocytopenia

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

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Interactions

Interaction Checker

bivalirudin and

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%)

            Urinary retention (4%)

            Hemorrhage, major (2.3%)

            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

            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 Category: B

            Lactation: Excretion in milk unknown; use with caution

            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

            Metabolism: Blood proteases

            Excretion: 20% (urine)

            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, prochlorperazine, reteplase, streptokinase, vancomycin

            IV Compatibilities

            Solution: D5W, NS

            Y-site: abciximab, alfentanil, ampicillin, ampicillin/sulbactam, azithromycin, ciprofloxacin, diphenhydramine, dobutamine, 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

            IV Administration

            Initial bolus injection followed by cont infusion

            Storage

            Refrigerate, do not freeze

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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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