Bivalirudin indications and usage

Bivalirudin
ANGIOMAX® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Bivalirudin
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

Indications and Usage

1.1 Percutaneous Transluminal Coronary Angioplasty (PTCA)

Angiomax® (bivalirudin) is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

1.2 Percutaneous Coronary Intervention (PCI)

Angiomax with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as listed in the REPLACE-2 trial [see Clinical Studies (14.1)] is indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI).

Angiomax is indicated for patients with, or at risk of, heparin induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI.

1.3 Use with Aspirin

Angiomax in these indications is intended for use with aspirin and has been studied only in patients receiving concomitant aspirin [see Dosage and Administration (2.1) and Clinical Studies (14.1)].

1.4 Limitation of Use

The safety and effectiveness of Angiomax have not been established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.

References

Adapted from the FDA Package Insert.