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ERAXIS®Highlights (anidulafungin)

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

Dosage and Administration (2)5/2020

INDICATIONS AND USAGE

Anidulafungin is an echinocandin antifungal indicated in adults for the treatment of:

  • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) (1.1)
  • Esophageal candidiasis (1.2)

Limitations of use: has not been studied in endocarditis, osteomyelitis and meningitis due to Candida or in sufficient numbers of neutropenic patients (1.3)

DOSAGE AND ADMINISTRATION

  • Candidemia and other forms of Candida infections: 200 mg loading dose on Day 1, followed by 100 mg daily dose thereafter for at least 14 days after the last positive culture (2.1)
  • Esophageal candidiasis: 100 mg loading dose on Day 1, followed by 50 mg daily dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms (2.1)
  • 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, 5.2)

DOSAGE FORMS AND STRENGTHS

  • Lyophilized powder for injection: 50 mg per vial (3)
  • Lyophilized powder for injection: 100 mg per vial (3)

CONTRAINDICATIONS

  • Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins (4)

WARNINGS AND PRECAUTIONS

  • Hepatic Effects: Risk of abnormal liver function tests, hepatitis, hepatic failure; monitor hepatic function during therapy (5.1)
  • Hypersensitivity: Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute (2.3,5.2)

ADVERSE REACTIONS

  • Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia (6.2)
  • Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea and dyspepsia (6.3)

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

  • Pregnancy: Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. Inform pregnant woman of risk to the fetus (8.1)
  • Pediatrics: The safety and effectiveness in patients ≤16 years has not been established (8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2020

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Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch