Micafungin Use in the Treatment of Pediatric Fungal Infections
Micafungin Use in the Treatment of Pediatric Fungal Infections
The safety profile of micafungin has been evaluated by the manufacturer in 479 pediatric patients (3 days-16 years of age) enrolled in one of 11 clinical trials. Adverse effects resulted in the discontinuation of micafungin in 4–7% of children in randomized, double-blind trials. The most common adverse reactions reported included vomiting (in 31% of patients), diarrhea (22%), nausea (19%), or abdominal pain and distension (9–16%), pyrexia (22%), rash, urticaria or pruritus (5–12%), thrombocytopenia, neutropenia, anemia (13–15%), tachycardia (10%), epistaxis (9%), anxiety (7%), decreased urine output or hematuria (4%). Infusion-related reactions were reported in 5%. Similar results have been reported by other investigators.
Preliminary safety data with micafungin doses up to 15 mg/kg in premature infants have found no greater incidence of adverse effects than in previous reports in older children and adults. In the 2011 study by Benjamin and colleagues, only three of the 13 patients treated with a daily micafungin dose of 7 or 10 mg/kg had an adverse reaction considered to be potentially drug-related. These reactions included increased alkaline phosphatase, hypokalemia, fever, and infusion site phlebitis. There were no reports of renal toxicity or hematologic changes.
Adverse Effects
The safety profile of micafungin has been evaluated by the manufacturer in 479 pediatric patients (3 days-16 years of age) enrolled in one of 11 clinical trials. Adverse effects resulted in the discontinuation of micafungin in 4–7% of children in randomized, double-blind trials. The most common adverse reactions reported included vomiting (in 31% of patients), diarrhea (22%), nausea (19%), or abdominal pain and distension (9–16%), pyrexia (22%), rash, urticaria or pruritus (5–12%), thrombocytopenia, neutropenia, anemia (13–15%), tachycardia (10%), epistaxis (9%), anxiety (7%), decreased urine output or hematuria (4%). Infusion-related reactions were reported in 5%. Similar results have been reported by other investigators.
Preliminary safety data with micafungin doses up to 15 mg/kg in premature infants have found no greater incidence of adverse effects than in previous reports in older children and adults. In the 2011 study by Benjamin and colleagues, only three of the 13 patients treated with a daily micafungin dose of 7 or 10 mg/kg had an adverse reaction considered to be potentially drug-related. These reactions included increased alkaline phosphatase, hypokalemia, fever, and infusion site phlebitis. There were no reports of renal toxicity or hematologic changes.
