Bivalirudin

ANGIOMAX

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Bivalirudin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Bivalirudin ballicule

What it isA bivalent direct thrombin inhibitor, used principally as procedural anticoagulation in PCI and in HIT.

Why this oneIts short half-life and largely enzymatic clearance make it a predictable, quickly reversible-by-time infusion in the cath lab.

What limits itNo antidote exists, and renal impairment prolongs its effect despite the enzymatic clearance.

FDA label

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FDA dosing	Population	Start	Target	Max
Percutaneous coronary intervention (PCI); used with aspirin	Adults	0.75 mg/kg IV bolus, then 1.75 mg/kg/h IV infusion for duration of procedure	1.75 mg/kg/h IV infusion for procedure duration	Additional 0.3 mg/kg IV bolus if needed (per ACT at 5 min); extend infusion up to 4 h post-PCI in STEMI

Renal CrCl <30 mL/min: reduce infusion to 1 mg/kg/h; on hemodialysis: reduce to 0.25 mg/kg/h; no bolus reduction; monitor anticoagulant status/ACT

Hepatic Undefined

Extend infusion up to 4 hours post-procedure in STEMI patients undergoing primary PCI

Instructions

IV bolus injection followed by continuous infusion after reconstitution and dilution
Reconstitute each 250 mg vial with 5 mL Sterile Water for Injection; dilute to 5 mg/mL in D5W or 0.9% NaCl
Perform ACT 5 min after bolus; give additional 0.3 mg/kg bolus if needed
Do not administer in same IV line with alteplase, amiodarone, amphotericin B, chlorpromazine, diazepam, dobutamine, prochlorperazine, reteplase, streptokinase, or vancomycin

Available strengths

inj 250 mg

Contraindications

Active major bleeding

Cautions

Increases risk of bleeding; unexplained fall in BP or hematocrit should prompt consideration of hemorrhage and cessation
Acute stent thrombosis (<4 h) in STEMI patients undergoing primary PCI; monitor ≥24 h post-PCI
Increased thrombotic risk (including fatal) with coronary artery gamma brachytherapy; maintain meticulous catheter technique

Adverse reactions

Bleeding (>2%), including major bleeding events (3.7% in BAT trials: intracranial, retroperitoneal, overt bleed)
Post-marketing: fatal bleeding, hypersensitivity/anaphylaxis, thrombus formation during PCI, pulmonary hemorrhage, cardiac tamponade, INR increased

Pregnancy No available human data; animal reproduction studies (rats/rabbits SC up to 1.6×/3.2× MRHD) revealed no evidence of fetal harm.

Lactation Unknown whether present in human milk; no data on effects on breastfed child or milk production.

Cost

Bivalirudin (ANGIOMAX)

Strength		#/mo	generic $/unit	CostPlus
250 mg	inj	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Bivalirudin is administered under clinical supervision and dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

NO BOXED WARNINGS

Principal riskBleeding; acute stent thrombosis in primary PCI for STEMI

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Sedation liability0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

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