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Hepatic Effects

Laboratory abnormalities in liver function tests have been seen in healthy volunteers and patients treated with ERAXIS (anidulafungin) . In some patients with serious underlying medical conditions who were receiving multiple concomitant medications along with ERAXIS (anidulafungin) , clinically significant hepatic abnormalities have occurred. Isolated cases of significant hepatic dysfunction, hepatitis, or hepatic failure have been reported in patients; a causal relationship to ERAXIS (anidulafungin) has not been established. Patients who develop abnormal liver function tests during ERAXIS (anidulafungin) therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing ERAXIS (anidulafungin) therapy.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal carcinogenicity studies of anidulafungin have not been conducted.

Anidulafungin was not genotoxic in the following in vitro studies: bacterial reverse mutation assays, a chromosome aberration assay with Chinese hamster ovary cells, and a forward gene mutation assay with mouse lymphoma cells. Anidulafungin was not genotoxic in mice using the in vivo micronucleus assay.

Anidulafungin produced no adverse effects on fertility in male or female rats at intravenous doses of 20 mg/kg/day (equivalent to 2 times the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area).

Pregnancy

Pregnancy Category C

Embryo-fetal development studies were conducted with doses up to 20 mg/kg/day in rats and rabbits (equivalent to 2 and 4 times, respectively, the proposed therapeutic maintenance dose of 100 mg/day on the basis of relative body surface area). Anidulafungin administration resulted in skeletal changes in rat fetuses including incomplete ossification of various bones and wavy, misaligned or misshapen ribs. These changes were not dose-related and were within the range of the laboratory's historical control database. Developmental effects observed in rabbits (slightly reduced fetal weights) occurred in the high dose group, a dose that also produced maternal toxicity. Anidulafungin crossed the placental barrier in rats and was detected in fetal plasma.

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ERAXIS (anidulafungin) should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nursing Mothers

ERAXIS (anidulafungin) should be administered to nursing mothers only if the potential benefit justifies the risk. Anidulafungin was found in the milk of lactating rats. It is not known whether anidulafungin is excreted in human milk.

Pediatric Use

Safety and effectiveness of anidulafungin in pediatric patients has not been established (see CLINICAL PHARMACOLOGY - Special Populations/Pediatric).

Last reviewed on RxList: 12/9/2010
This monograph has been modified to include the generic and brand name in many instances.