Bivalirudin
Indications
Bivalirudin is used for:
As an anticoagulant in percutaneous coronary intervention
Adult Dose
Intravenous
As an anticoagulant in percutaneous coronary intervention
Adult: Initially, 0.75 mg/kg inj followed by an infusion of 1.75 mg/kg/hr during procedure and up to 4 hours postprocedure. If needed, may continue infusion at 0.25 mg/kg/hr for 4-12 hours.
Hepatic impairment: No dosage adjustment needed.
Child Dose
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
30-59 Reduced infusion to 1.4 mg/kg/hr.
<30 Contraindicated.
Dialysis Contraindicated.
Administration
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
Contra Indications
Active major bleeding. CrCl <30 mL/min and dialysis-dependent patients. Severe uncontrolled HTN; subacute bacterial endocarditis.
Precautions
Increased risk of potentially fatal thrombosis during brachytherapy procedure. Patients at high risk of serious bleeding; recent major surgery or puncture of large vessels or organ biopsy. Renal impairment. Pregnancy, lactation, elderly.
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
Interactions
May increase risk of bleeding when used w/ thrombolytics, oral anticoagulants or drugs that affect platelet function.
Adverse Effects
Side effects of Bivalirudin :
>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%)
Mechanism of Action
Bivalirudin is a synthetic 20-amino acid analogue of the naturally occurring hirudin. It is a specific and reversible direct thrombin inhibitor thats works by binding to the catalytic and anionic exosite of circulating and clot-bound thrombin. It is used as an anticoagulant in percutaneous coronary intervention.