Bivalirudin


Concise Prescribing Info
Indications/Uses
As an anticoagulant in percutaneous coronary intervention.
Dosage/Direction for Use
Adult : IV Initial: 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.
Dosage Details
Intravenous
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.
Special Patient Group
Patients w/ ACS: Initially, 0.1 mg/kg IV bolus followed by 0.25 mg/kg/hr IV infusion. Medically managed patients may continue infusion for up to 72 hr. If will proceed to PCI: Additional IV inj of 0.5 mg/kg before the procedure then increased to 1.75 mg/kg/hr for the duration of the procedure. After PCI: Infusion may continue at 0.25 mg/kg/hr for a further 4-12 hr if necessary. If will proceed to CABG: Stop infusion 1 hr pre-op and patient should be treated w/ unfractionated heparin.
Renal Impairment
CrCl Dosage
<30 Contraindicated.
30-59 Reduced infusion to 1.4 mg/kg/hr.
Dialysis Contraindicated.
Hepatic Impairment
No dosage adjustment needed.
Reconstitution
Dilute a 250 mg vial w/ 5 mL of sterile water for inj. Further dilute the reconstituted soln w/ 50 mL of dextrose 5% or NaCl 0.9% inj to produce a final concentration of 5 mg/mL.
Incompatibility
Amiodarone, alteplase, diazepam, prochlorperazine, amphotericin B, vancomycin, chlorpromazine, reteplase, streptokinase. Concentration-dependent incompatibility w/ dobutamine, famotidine, haloperidol, labetalol, lorazepam and promethazine.
Contraindications
Active major bleeding. CrCl <30 mL/min and dialysis-dependent patients. Severe uncontrolled HTN; subacute bacterial endocarditis.
Special 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.
Adverse Reactions
Acute stent thrombosis, bleeding, ecchymosis, hypotension, HTN, headache, nausea, dyspepsia, insomnia, nervousness, anxiety, pelvic and abdominal pain, urinary retention, anaemia, thrombocytopaenia, inj site pain; rarely, thrombosis, tachycardia, bradycardia, vomiting, back pain, dyspnoea, fever.
Potentially Fatal: Anaphylaxis including anaphylactic shock.
Overdosage
Symptoms: Bleeding. Management: Discontinue treatment w/ bivalirudin. Bivalirudin is haemodialysable.
Drug Interactions
May increase risk of bleeding when used w/ thrombolytics, oral anticoagulants or drugs that affect platelet function.
Food Interaction
Avoid alfalfa, anise, bilberry as it may enhance the adverse/toxic effect of anticoagulants.
Action
Description: 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.
Pharmacokinetics:
Distribution: Does not bind to plasma proteins. Volume of distribution: 200 mL/kg.
Metabolism: Partly metabolised by the kidneys.
Excretion: Via urine (approx 20%) and proteolytic cleavage. Elimination half-life (normal renal function): Approx 25 min.
Storage
Unopened vial: Store between 15-30°C. Reconstituted soln: Store between 2-8°C for up to 24 hr.
Disclaimer: This information is independently developed by MIMS based on Bivalirudin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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