HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ERAXIS safely and effectively. See full prescribing information for ERAXIS.
ERAXIS® (anidulafungin) for injection, for intravenous use
Initial U.S. Approval: 2006
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections:
Limitations of use
DOSAGE AND ADMINISTRATION
Rate of Infusion for Adults and Pediatric Patients
The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions] (2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 50 mg, and 100 mg as a lyophilized powder in a single-dose vial for reconstitution (3)
WARNINGS AND PRECAUTIONS
Pediatric Patients (1 month and older)
Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
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