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, ERAXIS
was generally well tolerated; 3 of the 10 subjects experienced transient, asymptomatic
transaminase elevations (≤3 x ULN).
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
comparison.
ANIMAL PHARMACOLOGY AND TOXICOLOGY
In 3 month studies, liver toxicity, including single cell hepatocellular necrosis,
hepatocellular hypertrophy and increased liver weights were observed in monkeys
and rats at doses equivalent to 5–6 times human exposure. For both species, hepatocellular
hypertrophy was still noted one month after the end of dosing.