ERAXIS 50 mg/15mL
anidulafungin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Roerig
ERAXIS is a injection, powder, lyophilized, for solution containing anidulafungin at 50 mg/15mL, taken intravenous. Manufactured by Roerig.
Key Facts
- Brand Name
- ERAXIS
- Generic Name
- anidulafungin
- NDC Code (Product)
0049-0114- Manufacturer
- Roerig
- Strength
- 50 mg/15mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA021632
- Drug Class
- Echinocandin Antifungal [EPC]
- Marketing Start
- 02/17/2006
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 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 ) 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 in adults and pediatric patients 1 month of age and older [see Clinical Studies (14.1) and Microbiology (12.4) ] . 1.2 Esophageal Candidiasis ERAXIS is indicated for the treatment of esophageal candidiasis in adults [see Indications a…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults Pediatric 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 ) 2.1 Recommended Dosage in Adults 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 a 100 mg once daily maintenance dose thereafter. Duration of treatment should be based on the patient…
Contraindications
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) ] • Known hypersensitivity to anidulafungin, any component of ERAXIS, or other echinocandins ( 4 , 5.2 ) • Known or suspected Hereditary Fructose Intolerance (HFI) ( 4 , 5.4 )
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 the steady state pharmacokinetics of either drug. No dosage adjustment of cyclosporine or anidulafungin is needed when the two drugs are co-administered [see Clinical Pharmacology (12.3) ] . 7.2 Voriconazole Administration of multiple doses of anidulafungin and voriconazole to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of voriconazole or anidulafungin is needed when the two drugs are co-administered [see Clinical Pharmacology (12.3) ] . 7.3 Tacrolimus Administration of multiple doses of anidulafungin and a single-dose of tacrolimus to healthy subjects resulted in no significant alteration in the steady state pharmacokinetics of either drug. No dosage adjustment of tacrolimus or anidulafungin is needed when the two drugs are co-administered [see Clinical Pharmacology (12.3) ] . 7.4 Rifampin Administration of multiple doses of anidulafungin and rifampin to patients resulted in no significant alteration in the steady state pharmacokinetic…
Adverse Reactions
6 ADVERSE REACTIONS The following most serious adverse reactions are described elsewhere in other labeling sections: • Hepatic Adverse Reactions [see Warnings and Precautions (5.1) ] • Anaphylactic and Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] 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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates obser…
Frequently Asked Questions
What is ERAXIS used for?
ERAXIS contains anidulafungin. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is ERAXIS a controlled substance?
ERAXIS is not classified as a controlled substance by the DEA.
What is the generic name for ERAXIS?
The generic name for ERAXIS is anidulafungin. There are no other listed brand versions of anidulafungin.
What is the NDC code for ERAXIS 50 mg/15mL?
The NDC (National Drug Code) for ERAXIS 50 mg/15mL is 0049-0114, listed by Roerig.
Other ERAXIS Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)