Eraxis Adverse Reactions

Fifteen hundred and sixty-five (1565) subjects received single or multiple doses of intravenous anidulafungin in clinical trials: 1308 in Phase 2/3 trials (923 patients with candidaemia/invasive candidiasis, 355 patients with oral/oesophageal candidiasis, 30 patients with invasive aspergillosis), 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. Originally, in 3 studies (one comparative vs. fluconazole, two non-comparative) 204 patients were studied; the mean duration of intravenous treatment in these patients was 13.5 days (range, 1 to 38 days) and 119 patients received ≥14 days of anidulafungin. In 6 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 neutropenics 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 reactions were typically mild to moderate and seldom led to discontinuation.
Infusion-related adverse reactions have been reported with anidulafungin in clinical studies, including flushing, hot flush, pruritus, rash, and urticaria, summarized in Table 6 (see Precautions).
The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See Table 6.)

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Paediatric population: The safety of anidulafungin was investigated in 68 paediatric subjects (1 month to <18 years) with invasive candidiasis, including candidemia (ICC) in a prospective, open-label, non-comparative paediatric study (see Pharmacology: Pharmacodynamics under Actions). The adverse event profile of these 68 paediatric 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 paediatric 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 paediatric patients compared to adults.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.