ERAXIS

General Pharmacokinetic Characteristics The pharmacokinetics of anidulafungin following intravenous (IV) administration of ERAXIS have been characterized in healthy subjects, special populations and patients. Systemic exposures of anidulafungin are dose-proportional and have low inter-subject variability (coefficient of variation <25%) as shown in Table 5. The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose) and the estimated plasma accumulation ...

14.1 Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis) Adults Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis) Trial The safety and efficacy of ERAXIS were evaluated in a Phase 3, randomized, double-blind study of patients with candidemia and/or other forms of invasive candidiasis. Patients were randomized to receive once daily IV ERAXIS (200 mg loading dose followed by 100 mg maintenance dose) or IV fluconazole (800 mg loading dose followed by 400 mg maintenance dose). Patients were stratified by APACHE II score (≤20 and >20) an...

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 diarrh...

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 su...

• 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 Polyso...

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 ...