HIGHLIGHTS OF PRESCRIBING INFORMATION
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 use
Initial U.S. Approval: 2000
INDICATIONS AND USAGE
Bivalirudin is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).(1)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose, ADD-Vantage™ vial for reconstitution.(3)
WARNINGS AND PRECAUTIONS
Most common adverse reaction (>2%) was bleeding.(6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use.(7)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
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bivalirudin for injection - ADD-VANTAGE Highlights
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