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FDA approves IV antifungal drug for infants
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The FDA has approved a supplemental new drug application for the use of micafungin sodium for certain Candida infections in patients as young as 4 months, according to a press release.
Micafungin sodium (Mycamine, Astellas) is now indicated for injection by IV infusion for the treatment of 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 transplants (HSCT).
For the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, the dosage is 2 mg/kg with (maximum daily dose 100 mg) for children ages 4 months and older.
For prophylaxis of Candida infections in HSCT recipients, children ages 4 months and older should be given 1 mg/kg, up to 50 mg.
Patients weighing 30 kg or less should receive 3 mg/kg for the treatment of esophageal candidiasis; patients weighing more than 30 kg should be given 2.5 mg/kg (maximum daily dose 150 mg), according to the manufacturer.
The overall safety of micafungin sodium was assessed in 479 patients, aged 3 days to 16 years, who received at least one dose of micafungin sodium in 11 separate clinical trials. The mean treatment duration was 24.8 days. In all pediatric studies with micafungin sodium, 439 of 479 (92%) patients experienced at least one treatment-emergent adverse reaction.
The most common (at least 15%) treatment-emergent adverse reactions observed in all children aged 4 months and older treated with micafungin sodium included: vomiting (31%), diarrhea (22%), pyrexia (22%), nausea (19%), abdominal pain (16%) and thrombocytopenia (15%), according to the manufacturer.
Click here to read the FDA approval letter.