ERAXIS SUMMARY
ERAXIS™ (anidulafungin) FOR INJECTION
ERAXIS for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains anidulafungin. ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesized from a fermentation product of Aspergillus nidulans. Anidulafungin is an echinocandin, a class of antifungal drugs that inhibits the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls. ERAXIS (anidulafungin) is 1-[(4R,5R)-4,5-Dihydroxy-N2-[[4"-(pentyloxy)[1,1':4',1"-terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B . Anidulafungin is a white to off-white powder that is practically insoluble in water and slightly soluble in ethanol.
ERAXIS is indicated for use in the treatment of the following fungal infections:
Candidemia and other forms of Candida infections (intra-abdominal abscess, and peritonitis) (see CLINICAL STUDIES and MICROBIOLOGY).
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.
Esophageal candidiasis (see CLINICAL STUDIES, Table 7 for higher relapse rates off ERAXIS therapy).
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 are known. However, once these results become available, antifungal therapy should be adjusted accordingly.
|
