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ERAXIS®(anidulafungin)
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Our medical information is accurate, up to date, and scientifically balanced.
ERAXIS® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Candidemia and Other Forms of Candida Infections (Intra-abdominal Abscess and Peritonitis)
ERAXIS is...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage in Adults
Candidemia and other...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: 50 mg, and 100 mg of anidulafungin as a white to off-white sterile lyophilized powder in a single-dose vial for reconstitution.
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hepatic Adverse Reactions
Laboratory abnormalities in liver tests have been seen in healthy volunteers and pediatric patients treated...
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Adverse Reactions
6 ADVERSE REACTIONS
The following most serious adverse reactions are described elsewhere in other labeling sections:
- •
- Hepatic Adverse Reactions [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Cyclosporine
Administration of multiple doses of anidulafungin and cyclosporine to healthy subjects resulted in no significant alteration in...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings from...
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Overdosage
10 OVERDOSAGE
During clinical trials a single 400 mg dose of ERAXIS was inadvertently administered as a loading dose. No clinical adverse events were reported. In a study of 10 healthy subjects administered a loading dose of...
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Description
11 DESCRIPTION
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...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Anidulafungin is an anti-fungal drug [see Microbiology (12.4)]....
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal carcinogenicity studies of anidulafungin have not been conducted...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis)
...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
ERAXIS (anidulafungin) for Injection is supplied in a single-dose vial of sterile, lyophilized, preservative-...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Hepatic Adverse Reactions
Inform patients about the risk of developing abnormal liver function tests...
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Other
This product's prescribing information may have been updated. For current full prescribing information, please visit www.pfizer.com.
...
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