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Micafungin (Mycamine) Approved for Pediatric Use
The FDA has approved the use of micafungin sodium (Mycamine, Astellas Pharma) for the treatment of pediatric patients aged 4 months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem-cell transplantation (HSCT).
The safety and efficacy profiles of micafungin in pediatric patients 4 months and older are based on data from studies in adult and pediatric patients and on additional pediatric pharmacokinetic and safety information.
The overall safety of micafungin was assessed in 479 patients aged 3 days through 16 years, who received at least one dose of micafungin in 11 separate clinical trials. The mean treatment duration was 24.8 days. In all pediatric studies with micafungin, 439 of 479 patients (92%) experienced at least one treatment-emergent adverse event (TEAE). The most common TEAEs observed in all micafungin-treated pediatric patients age 4 months and older included vomiting (31%), diarrhea (22%), pyrexia (22%), nausea (19%), abdominal pain (16%) and thrombocytopenia (15%).
Mycamine (micafungin) is a member of a class of antifungal agents, the echinocandins. The drug was approved in 2005 for the treatment of adult patients with esophageal candidiasis and in 2008 for use in adult patients with candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses.
Source: Astellas Pharma; June 24, 2013.