ERAXIS® Contraindications (anidulafungin) | Pfizer Medical Information - US

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4 CONTRAINDICATIONS

ERAXIS is contraindicated in:

Patients with known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins [see Warnings and Precautions (5.2)]
Patients with known or suspected Hereditary Fructose Intolerance (HFI) [see Warnings and Precautions (5.4)]

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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.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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 Microbiology (12.4)]....

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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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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.