ERAXIS® Highlights

(anidulafungin)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ERAXIS safely and effectively. See full prescribing information for ERAXIS.

ERAXIS (anidulafungin) for injection, for intravenous use
Initial U.S. Approval: 2006

INDICATIONS AND USAGE

ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections:

•
Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) (1.1)
•
Esophageal candidiasis in adults (1.2)

Limitations of use

•
ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. (1.3, 5.3, 8.4)
•
ERAXIS is associated with high relapse rates in esophageal candidiasis. (1.3, 14.2)

DOSAGE AND ADMINISTRATION

AdultsPediatric Patients 1 Month of Age and Older

Candidemia and other forms of Candida infections

200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture (2.1)

3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture (2.2)

Esophageal candidiasis

100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms (2.1)

Not Approved

Rate of Infusion for Adults and Pediatric Patients

The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions] (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

For injection: 50 mg, and 100 mg as a lyophilized powder in a single-dose vial for reconstitution (3)

CONTRAINDICATIONS

•
Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins (4, 5.2)
•
Known or suspected Hereditary Fructose Intolerance (HFI) (4, 5.4)

WARNINGS AND PRECAUTIONS

•
Hepatic Effects: Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy. (5.1, 13.2)
•
Hypersensitivity: Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute. (2.4, 5.2)
•
Risk of Neonatal Toxicity Associated with Polysorbates: ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. ERAXIS is not approved in pediatric patients younger than 1 month of age. (5.3, 8.4)
•
Hereditary Fructose Intolerance (HFI): ERAXIS contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before ERAXIS administration. (5.4, 8.4)

ADVERSE REACTIONS

Adults

•
Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension. (6.1)
•
Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia. (6.1)

Pediatric Patients (1 month and older)

Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. Inform pregnant woman of the risk to the fetus. (8.1)
•
Pediatric Use: The safety and effectiveness in patients younger than 1 month of age has not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ERAXIS safely and effectively. See full prescribing information for ERAXIS.

ERAXIS (anidulafungin) for injection, for intravenous use
Initial U.S. Approval: 2006

INDICATIONS AND USAGE

ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections:

•
Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) (1.1)
•
Esophageal candidiasis in adults (1.2)

Limitations of use

•
ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. (1.3, 5.3, 8.4)
•
ERAXIS is associated with high relapse rates in esophageal candidiasis. (1.3, 14.2)

DOSAGE AND ADMINISTRATION

AdultsPediatric Patients 1 Month of Age and Older

Candidemia and other forms of Candida infections

200 mg loading dose on Day 1, followed by 100 mg once daily maintenance dose thereafter for at least 14 days after the last positive culture (2.1)

3 mg/kg (not to exceed 200 mg) loading dose on Day 1, followed by 1.5 mg/kg (not to exceed 100 mg) once daily maintenance dose thereafter for at least 14 days after the last positive culture (2.2)

Esophageal candidiasis

100 mg loading dose on Day 1, followed by 50 mg once daily maintenance dose thereafter for a minimum of 14 days and for at least 7 days following resolution of symptoms (2.1)

Not Approved

Rate of Infusion for Adults and Pediatric Patients

The rate of infusion should not exceed 1.1 mg/minute [equivalent to 1.4 mL/minute or 84 mL/hour when reconstituted and diluted per instructions] (2.3, 2.4)

DOSAGE FORMS AND STRENGTHS

For injection: 50 mg, and 100 mg as a lyophilized powder in a single-dose vial for reconstitution (3)

CONTRAINDICATIONS

•
Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins (4, 5.2)
•
Known or suspected Hereditary Fructose Intolerance (HFI) (4, 5.4)

WARNINGS AND PRECAUTIONS

•
Hepatic Effects: Risk of abnormal liver tests, hepatitis, hepatic failure; monitor hepatic function during therapy. (5.1, 13.2)
•
Hypersensitivity: Anaphylaxis, including shock has been reported. Risk of infusion-related adverse reactions, possibly histamine-mediated, including rash, urticaria, flushing, pruritus, bronchospasm, dyspnea, and hypotension; to reduce occurrence, do not exceed a rate of infusion of 1.1 mg/minute. (2.4, 5.2)
•
Risk of Neonatal Toxicity Associated with Polysorbates: ERAXIS contains polysorbate 80, an inactive ingredient. Thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension and metabolic acidosis haves been reported in low-birth weight infants receiving high doses of polysorbate. ERAXIS is not approved in pediatric patients younger than 1 month of age. (5.3, 8.4)
•
Hereditary Fructose Intolerance (HFI): ERAXIS contains fructose. Risk of metabolic crisis with life-threatening hypoglycemia, hypophosphatemia, lactic acidosis, and hepatic failure. Obtain history of HFI symptoms in pediatric patients before ERAXIS administration. (5.4, 8.4)

ADVERSE REACTIONS

Adults

•
Candidemia and other forms of Candida infections: Most common adverse reactions (≥15%) are hypokalemia, nausea, diarrhea, vomiting, pyrexia, insomnia, hypotension. (6.1)
•
Esophageal candidiasis: Most common adverse reactions (≥5%) are diarrhea, pyrexia, anemia, headache, vomiting, nausea, dyspepsia, oral candidiasis, and hypokalemia. (6.1)

Pediatric Patients (1 month and older)

Candidemia and other forms of Candida infections: Most common adverse reactions (≥ 5%): diarrhea, vomiting, pyrexia, abdominal pain, anemia, thrombocytopenia, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) increased, hypoglycemia, epistaxis, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Based on findings from animal studies, ERAXIS can cause fetal harm when administered to a pregnant woman. Inform pregnant woman of the risk to the fetus. (8.1)
•
Pediatric Use: The safety and effectiveness in patients younger than 1 month of age has not been established. (8.4)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2023
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