Rx Item-Eraxis 50Mg Vial By Pfizer Pharma

ERAXIS- anidulafungin injection, powder, lyophilized, for solution
Roerig

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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing
Candidemia and other Candida infections (intra-abdominal abscess, and peritonitis)

The recommended dose is a single 200 mg loading dose of ERAXIS on Day 1, followed by 100 mg daily dose thereafter. Duration of treatment should be based on the patient�s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.

RX ITEM-Eraxis 50Mg Vial By Pfizer Pharm
NDC 00049-0114-28 UPC/GTIN No.3-00490-11428-8 Mfg.Part No.11428

Eraxis 50Mg Vial By Pfizer Pharma
BRAND: ERAXIS NDC: 00049-0114-28,49011428 UPC: 3-00490-11428-8,300490114288 Pfizer Pharmaceutical

ANIDULAFUNGIN INTRAVEN VI
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