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 candidaemia/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 candidaemia and other deep tissue Candida infections. In these three studies [invasive candidiasis/candidaemia (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.
The following table 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 2.)
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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, anaemia, hyperuricaemia, hypocalcaemia, hyponatraemia, hypoalbuminaemia, hypophosphataemia, anxiety, delirium, confusional state, hallucination auditory, dizziness, paraesthesia, central pontine myelinolysis, dysgeusia, Guillain-Barre syndrome, tremor, altered visual depth perception, deafness unilateral, phlebitis, thrombophlebitis superficial, hypotension, lymphangitis, dyspepsia, dry mouth, oesophageal ulcer, hepatic necrosis, angioneurotic edema, hyperhidrosis, myalgia, monoarthritis, renal failure, haematuria, pyrexia, chills, oedema peripheral, injection site reaction, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, lymphocyte count decreased.