Eraxis Adverse Reactions

Fifteen hundred and sixty-five (1565) patients received intravenous anidulafungin in clinical trials (1308 in Phase 2/3 studies and 257 in Phase I studies).
The safety profile of anidulafungin is based on 840 patients with candidemia/invasive candidiasis receiving the recommended daily dose of 100 mg in 9 studies. Three studies (one comparative vs. fluconazole, 2 non-comparative) assessed the efficacy of anidulafungin (100 mg) in patients with candidemia and other deep tissue Candida infections. In these three studies, [invasive candidiasis/candidemia (ICC) database] a total of 204 patients received anidulafungin, 119 for ≥14 days. In six additional studies (two comparative vs. caspofungin and four non-comparative), 636 patients including 53 neutropenic patients and 131 patients with deep tissue infection were studied; the mean durations of intravenous treatment in neutropenic patients and patients with deep tissue infection in these studies were 10.0 (range, 1 to 42 days) and 14.0 (range, 1 to 42 days) days, respectively. Adverse events were typically mild to moderate and seldom led to discontinuation.
Table 3 includes the all-causality adverse events (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin.
Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnea, bronchospasm and hypotension (see Precautions). (See Table 3.)

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In the safety assessment of the Phase 2/3 patient population (N = 669), the following additional adverse events were of note: neutropenia, leukopenia, anemia, hyperuricemia, hypocalcemia, hyponatremia, hypoalbuminemia, hypophosphatemia, anxiety, delirium, confusional state, hallucination auditory, dizziness, paresthesia, central pontine myelinolysis, dysgeusia, Guillain-Barré syndrome, tremor, altered visual depth perception, deafness unilateral, phlebitis, thrombophlebitis superficial, hypotension, lymphangitis, dyspepsia, dry mouth, esophageal ulcer, hepatic necrosis, angioneurotic edema, hyperhidrosis, myalgia, monoarthritis, renal failure, hematuria, pyrexia, chills, edema peripheral, injection site reaction, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, lymphocyte count decreased.
Pediatric population: The safety of anidulafungin was investigated in 68 pediatric subjects (1 month to <18 years) with invasive candidiasis, including candidemia (ICC) in a prospective, open-label, non-comparative pediatric study (see Pharmacology: Pharmacodynamics under Actions). The adverse event profile of these 68 pediatric subjects was similar to that observed in adults with ICC but hepatobiliary adverse events, in particular Alanine aminotransferase (ALT) increased and Aspartate aminotransferase (AST) increased appeared at a higher frequency in these pediatric patients than has been observed in adults. Although chance or differences in underlying disease severity may have contributed, it cannot be excluded that hepatobiliary adverse reactions occur more frequently in pediatric patients compared to adults.