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ERAXIS® (anidulafungin) Indications and Usage

1 INDICATIONS AND USAGE

ERAXIS is indicated for use in adults for the treatment of the following fungal infections listed below. Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies known. However, once these results become available, antifungal therapy should be adjusted accordingly.

1.1 Candidemia and Other Forms of Candida Infections (Intra-abdominal Abscess and Peritonitis)

ERAXIS is indicated for the treatment of candidemia and the following Candida infections: intra-abdominal abscess and peritonitis [see Clinical Studies (14.1) and Clinical Pharmacology, Microbiology (12.4)].

1.2 Esophageal Candidiasis

ERAXIS is indicated for the treatment of esophageal candidiasis [see Clinical Studies (14.2), Table 10 for higher relapse rates off ERAXIS therapy].

1.3 Limitation of Use

ERAXIS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida, and has not been studied in sufficient numbers of neutropenic patients to determine efficacy in this group.

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