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ERAXIS®(anidulafungin)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

ERAXIS® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

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

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adults

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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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4 CONTRAINDICATIONS

ERAXIS is contraindicated in:

  • Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other...
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5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Adverse Reactions

Laboratory abnormalities in liver tests have been seen...

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6 ADVERSE REACTIONS

The following most serious adverse reactions are described elsewhere in other labeling sections:

  • Hepatic Adverse Reactions [see...
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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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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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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Anidulafungin is an anti-fungal drug [see

12.3 Pharmacokinetics

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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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14 CLINICAL STUDIES

14.1 Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis)

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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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17 PATIENT COUNSELING INFORMATION

Hepatic Adverse Reactions

Inform patients about the risk of developing abnormal liver function tests and...

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This product's prescribing information may have been updated. For current full prescribing information, please visit www.pfizer.com.

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