Anidulafungin (1 brand name, 2 dosage forms, 2 routes)
Available dosage forms: POWDER, INJECTABLE.
Routes of administration: INTRAVENOUS, INJECTION.
Brand Names
- ERAXIS
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)]
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)]
Mechanism of Action
Anidulafungin is an anti-fungal drug [see Microbiology (12.4)].
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 260 mg followed by 130 mg daily; 3 of the 10 subjects experienced transient, asymptomatic transaminase elevations (≤3 × ULN) [see Warnings and Precautions (5.1)]. Anidulafungin is not dialyzable. The maximum non-lethal dose of anidulafungin in rats was 50 mg/kg, a dose which is equivalent to 10 times the recommended daily dose for esophageal candidiasis (50 mg/day) or equivalent to 5 times the recommended daily dose for candidemia and other Candida infections (100 mg/day), based on relative body surface area comparisons.