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Context, anatomy, and key evidence

← Peptide library

thrombin inhibitor peptide

Bivalirudin

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

Bivalirudin is described as a 20-residue peptide with thrombin-inhibitory activity. Bivalirudin directly inhibits thrombin. During bivalirudin encounters, thrombotic progression or new thrombosis occurred in 17.6% of encounters, and 18 encounters had both thrombosis and bleeding. As an anticoagulant, bivalirudin for injection is associated with an increased bleeding risk per warning statement.

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

Identity

The active ingredient is bivalirudin in the trifluoroacetate salt form, characterized as a specific, reversible direct thrombin inhibitor and a synthetic peptide of 20 amino acids.

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin Injection contains bivalirudin trifluoroacetate, which is a specific and reversible direct thrombin inhibitor. Bivalirudin trifluoroacetate is a synthetic, 20 amino acid peptide salt
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin Injection contains bivalirudin trifluoroacetate, which is a specific and reversible direct thrombin inhibitor. Bivalirudin trifluoroacetate is a synthetic, 20 amino acid peptide salt”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 11 DESCRIPTION

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

Identity

Bivalirudin is administered intravenously and inhibits thrombin directly.

Sources[6]pubmedSafety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience.Bivalirudin, an IV direct thrombin inhibitor,[6]pubmedSafety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience.Bivalirudin, an IV direct thrombin inhibitor
Source records
2
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin, an IV direct thrombin inhibitor,”

    Safety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience. · OBJECTIVES

    pubmed:42635486:019448016dfc:019448016dfc
  2. supports · Source-backed record
    “Bivalirudin, an IV direct thrombin inhibitor”

    Safety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience. · OBJECTIVES

    pubmed:42635486:019448016dfc:019448016dfc

Identity

Bivalirudin is used as an anticoagulant and is described here as an alternative to heparin.

Sources[5]pubmedAssessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants.Bivalirudin is an alternative anticoagulant to heparin
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin is an alternative anticoagulant to heparin”

    Assessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants. · INTRODUCTION

    pubmed:42604760:c2ef06c7ad19:c2ef06c7ad19

Identity

Bivalirudin is described as a 20-residue peptide with thrombin-inhibitory activity.

Sources[3]pubmedMacromolecular design of a bivalirudin peptide-loaded Carbopol 940 hydrogel for local thrombin inhibition and prevention of neointimal hyperplasia.Bivalirudin is a 20-amino-acid thrombin-inhibiting peptide
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin is a 20-amino-acid thrombin-inhibiting peptide”

    Macromolecular design of a bivalirudin peptide-loaded Carbopol 940 hydrogel for local thrombin inhibition and prevention of neointimal hyperplasia. · Abstract

    pubmed:42385809:7ab2d93d58bc:7ab2d93d58bc

How does it work?

Target, response, and disposition.

Mechanism

The methods describe laboratory monitoring performed on specimens from pediatric ECLS patients receiving bivalirudin, including thrombin generation and coagulation assays.

Sources[5]pubmedAssessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants.TGA, aPTT, aPTT with hepzyme, dTT, INR were measured in 30 specimens from 12 pediatric ECLS patients anticoagulated with bivalirudin.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “TGA, aPTT, aPTT with hepzyme, dTT, INR were measured in 30 specimens from 12 pediatric ECLS patients anticoagulated with bivalirudin.”

    Assessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants. · METHODS

    pubmed:42604760:c2ef06c7ad19:c2ef06c7ad19

Mechanism

The source lists coagulation assays used to monitor bivalirudin’s anticoagulant effect, including aPTT and the more specific dTT.

Sources[5]pubmedAssessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants.Its activity is monitored using activated partial thromboplastin time (aPTT) and/or more specific tests such as plasma-diluted thrombin time (dTT).
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Its activity is monitored using activated partial thromboplastin time (aPTT) and/or more specific tests such as plasma-diluted thrombin time (dTT).”

    Assessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants. · INTRODUCTION

    pubmed:42604760:c2ef06c7ad19:c2ef06c7ad19

Mechanism

Bivalirudin can inhibit thrombin without relying on antithrombin.

Sources[4]pubmedBivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions.Bivalirudin, a direct thrombin inhibitor, inhibits thrombin without needing antithrombin.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin, a direct thrombin inhibitor, inhibits thrombin without needing antithrombin.”

    Bivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions. · Abstract

    pubmed:42602128:5c3942bcf086:5c3942bcf086

Mechanism

Carbopol 940 is identified as a crosslinked polyacrylic acid whose properties (viscosity, pH-responsive swelling, and biocompatibility) motivated its selection as a macromolecular carrier.

Sources[3]pubmedMacromolecular design of a bivalirudin peptide-loaded Carbopol 940 hydrogel for local thrombin inhibition and prevention of neointimal hyperplasia.Carbopol 940, a crosslinked polyacrylic acid, was selected for its high viscosity, pH-sensitive swelling, and established biocompatibility as a macromolecular carrier.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Carbopol 940, a crosslinked polyacrylic acid, was selected for its high viscosity, pH-sensitive swelling, and established biocompatibility as a macromolecular carrier.”

    Macromolecular design of a bivalirudin peptide-loaded Carbopol 940 hydrogel for local thrombin inhibition and prevention of neointimal hyperplasia. · Abstract

    pubmed:42385809:7ab2d93d58bc:7ab2d93d58bc

Mechanism

Bivalirudin directly inhibits thrombin.

Sources[4]pubmedBivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions.Bivalirudin, a direct thrombin inhibitor, inhibits thrombin without needing antithrombin.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin, a direct thrombin inhibitor, inhibits thrombin without needing antithrombin.”

    Bivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions. · Abstract

    pubmed:42602128:5c3942bcf086:5c3942bcf086

Pharmacokinetics

The elimination half-life reported for bivalirudin in PTCA patients with normal renal function is 25 minutes.

Sources[2]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin has a half-life of 25 minutes in PTCA patients with normal renal function.
Reported result
25 minutes
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin has a half-life of 25 minutes in PTCA patients with normal renal function.”

    These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000 · 12.3 Pharmacokinetics

    dailymed:c20969cb-72d4-469b-9bd8-332250d896c3:50c91b7062fc:50c91b7062fc

Pharmacokinetics

In the studied PTCA population with normal renal function, elimination is characterized by a short half-life (25 minutes) and weight-normalized clearance (3.4 mL/min/kg).

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin has a half-life of 25 minutes in PTCA patients with normal renal function. The total body clearance of bivalirudin in PTCA patients with normal renal function is 3.4 mL/min/kg.
Reported result
Half-life: 25 minutes; total body clearance: 3.4 mL/min/kg
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin has a half-life of 25 minutes in PTCA patients with normal renal function. The total body clearance of bivalirudin in PTCA patients with normal renal function is 3.4 mL/min/kg.”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 12.3 Pharmacokinetics

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

What has been studied?

What the evidence says.

Comparative evidence

Unfractionated heparin is still the standard anticoagulant for pediatric cardiac procedures.

Sources[4]pubmedBivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions.Unfractionated heparin remains the standard anticoagulant for pediatric cardiac procedures, but its drawbacks in children are hard to ignore.
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Unfractionated heparin remains the standard anticoagulant for pediatric cardiac procedures, but its drawbacks in children are hard to ignore.”

    Bivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions. · Abstract

    pubmed:42602128:5c3942bcf086:5c3942bcf086

Study findings

The most common reason for bivalirudin use was treatment of venous thrombosis (133 encounters, 51%).

Sources[6]pubmedSafety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience.The most common indication was treatment of venous thrombosis (n = 133, 51%).
Reported result
n = 133 (51%)
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The most common indication was treatment of venous thrombosis (n = 133, 51%).”

    Safety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience. · MEASUREMENTS AND MAIN RESULTS

    pubmed:42635486:019448016dfc:019448016dfc

Study findings

During bivalirudin encounters, thrombotic progression or new thrombosis occurred in 17.6% of encounters, and 18 encounters had both thrombosis and bleeding.

Sources[6]pubmedSafety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience.Thrombotic progression or development of new thrombi occurred in 46 of 261 (17.6%) encounters (37/229; 16% patients) with 18 of 261 experiencing both bleeding and thrombotic events.
Reported result
46/261 encounters (17.6%); 37/229 patients (16%); both events: 18/261 encounters
Source records
1
Independent studies
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Thrombotic progression or development of new thrombi occurred in 46 of 261 (17.6%) encounters (37/229; 16% patients) with 18 of 261 experiencing both bleeding and thrombotic events.”

    Safety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience. · MEASUREMENTS AND MAIN RESULTS

    pubmed:42635486:019448016dfc:019448016dfc

Risks and interactions

Risks, organized for scanning.

Safety findings

As an anticoagulant, bivalirudin is associated with an increased risk of bleeding events.

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin increases the risk of bleeding
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin increases the risk of bleeding”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 5.1 Bleeding Events

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

Safety findings

As an anticoagulant, bivalirudin for injection is associated with an increased bleeding risk per warning statement.

Sources[2]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin for injection increases the risk of bleeding
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin for injection increases the risk of bleeding”

    These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000 · 5.1 Bleeding Events

    dailymed:c20969cb-72d4-469b-9bd8-332250d896c3:50c91b7062fc:50c91b7062fc

Products and regulatory status

Same ingredient. Different records.

Regulatory status

Bivalirudin Injection has an approved indication for anticoagulation during percutaneous coronary intervention, including in patients with heparin-induced thrombocytopenia or HIT with thrombosis syndrome.

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin Injection is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 1 INDICATIONS AND USAGE

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

Administration context

The practical clinical context.

Administration

The product is formulated as a sterile, ready-to-administer IV solution and is restricted to intravenous administration.

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin Injection is a ready-to-use sterile solution for intravenous use only.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin Injection is a ready-to-use sterile solution for intravenous use only.”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 2.3 Instructions for Administration

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

Administration

The administration route and method are IV bolus plus continuous infusion, and preparation requires reconstitution and dilution.

Sources[2]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000Bivalirudin for injection is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “Bivalirudin for injection is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution.”

    These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000 · 2.3 Instructions for Preparation and Administration

    dailymed:c20969cb-72d4-469b-9bd8-332250d896c3:50c91b7062fc:50c91b7062fc

Dose records

In severe renal impairment defined by Cockcroft-Gault creatinine clearance <30 mL/min, the labeled maintenance infusion rate is reduced.

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000In patients with creatinine clearance less than 30 mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “In patients with creatinine clearance less than 30 mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h.”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 2.2 Dose Adjustment in Renal Impairment

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

Dose records

The labeled regimen specifies a weight-based IV bolus followed by continuous IV infusion at a higher weight-normalized hourly rate for the procedural duration.

Sources[1]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000The recommended dose of Bivalirudin Injection is an intravenous bolus dose of 0.75 mg/kg, followed immediately by a maintenance infusion of 1.75 mg/kg/h for the duration of the procedure.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “The recommended dose of Bivalirudin Injection is an intravenous bolus dose of 0.75 mg/kg, followed immediately by a maintenance infusion of 1.75 mg/kg/h for the duration of the procedure.”

    These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 · 2.1 Recommended Dosage

    dailymed:91cf9d00-29e0-4357-a184-f70026c47edb:6d761b58f00d:6d761b58f00d

Dose records

Dialysis-dependent patients require a substantially reduced bivalirudin infusion rate.

Sources[2]dailymedThese highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h”

    These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000 · 2.2 Dose Adjustment in Renal Impairment

    dailymed:c20969cb-72d4-469b-9bd8-332250d896c3:50c91b7062fc:50c91b7062fc

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: contraindication, interaction
  • 156 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (83), assurance_score_below_0.72 (67), current_regulatory_source_required (31), extraction_ambiguity (109), extraction_confidence_not_high (4), high_risk_requires_regulatory_or_two_independent_sources (69), no_direct_support (148), proposal_not_staged (4)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. These highlights do not include all the information needed to use BIVALIRUDIN INJECTION, safely and effectively. See full prescribing information for BIVALIRUDIN INJECTION.BIVALIRUDIN injection, for intravenous useInitial U.S. Approval: 2000 ↗

    dailymed · published 2024-03-01 · retrieved 2026-09-04T19:11:37Z

  2. These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.BIVALIRUDIN for injection, for intravenous useInitial U.S. Approval: 2000 ↗

    dailymed · published 2024-08-15 · retrieved 2026-09-04T19:11:33Z

  3. Macromolecular design of a bivalirudin peptide-loaded Carbopol 940 hydrogel for local thrombin inhibition and prevention of neointimal hyperplasia. ↗

    pubmed · published 2026-09-01 · retrieved 2026-08-25T22:58:23Z

  4. Bivalirudin as an Alternative to Heparin in Pediatric Cardiac Procedures: Evidence, Challenges, and Future Directions. ↗

    pubmed · published 2026-01-01 · retrieved 2026-08-25T22:58:23Z

  5. Assessment of Thrombin Generation in Pediatric Patients on Extracorporeal Life Support: Impact of Bivalirudin and Other Anticoagulants. ↗

    pubmed · published 2026-08-16 · retrieved 2026-08-25T22:58:23Z

  6. Safety of Bivalirudin Use in Critically Ill Children: A Single-Center Experience. ↗

    pubmed · published 2026-08-24 · retrieved 2026-08-25T22:58:23Z

Publication history and provenance

Version 5 · Automated assessment · 2026-09-04T19:11:37Z

88429eae9a5e053ce17ba89f43e4af78d1d47973b9ae5935288ef9aed36de285