The FDA has approved the use of Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of pediatric patients aged 5 to 17 years who are converting from one erythropoiesis-stimulating agent (ESA( after their hemoglobin level was stabilized with an ESA.

Dosage and administration:

In adults, Mircera is administered by subcutaneous or intravenous injection. Dosage for initial treatment is 0.6 mcg/kg body weight administered once every 2 weeks. Dosage for conversion from another ESA is monthly or every 2 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at the time of conversion. In pediatric patients, Mircera is administered by intravenous injection only. When converting from another ESA, it is dosed once every 4 weeks based on total weekly epoetin alfa or darbepoetin alfa dose at the time of conversion.

Efficacy and safety: Approval was based on an open-label dose-finding trial of 64 patients aged 5-17 years. All had chronic kidney disease and were on hemodialysis, and had been previously treated with another ESA and achieved stable hemoglobin levels. Patients received Mircera intravenously every 4 weeks based on the total weekly dose of the previously used ESA, with dosage adjustments after the first dose as needed to maintain target hemoglobin levels. Efficacy was based partly on how well target hemoglobin levels were maintained in this trial, but also on extrapolation from results of trials in adults. The safety profile in these pediatric patients was consistent with those previously observed in adults.

Side effects/risks: The most common adverse reactions are hypertension, diarrhea, and nasopharyngitis.