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Prescribing Information
ERAXIS™ (anidulafungin) FOR INJECTION
Indications and Usage
Return to the ERAXIS Product Center

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.


ERAXIS Safety Information
 

Important Safety Information

Abnormalities in LFTs have been observed with ERAXIS. Clinically significant hepatic abnormalities have occurred in some patients with serious underlying medical conditions who were receiving multiple medications concomitantly with ERAXIS. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported, but a causal relationship with ERAXIS has not been established. Patients who develop abnormal LFTs during ERAXIS therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing ERAXIS therapy.

Possible histamine-mediated symptoms have been reported with ERAXIS, including rash, urticaria, flushing, pruritus, dyspnea, and hypotension. These events are infrequent when the rate of infusion does not exceed 1.1 mg/min.

In the treatment of candidemia, the most common treatment-related AEs included diarrhea (3.1%), hypokalemia (3.1%), and elevated ALT (2.3%).

 

Please see full prescribing information.

Eraxis (anidulafungin) for injection

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