Dosing & Uses
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 mgkg/hr IV; adjust to aPTT 1.5-2.5 times baseline value
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
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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
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
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.
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
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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Patient Handout
Formulary
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