English
Français
Deutsch
Español
Italiano
Português
日本語
한국어
Русский
Home
Aug 07, 2023
FDA OKs Mircera for CKD
by Ian Ingram, Deputy Managing
by Ian Ingram, Deputy Managing Editor, MedPage Today June 7, 2018
This article is a collaboration between MedPage Today and:
WASHINGTON -- The FDA on Thursday approved methoxy polyethylene glycol-epoetin beta (Mircera), an erythropoietin stimulating agent (ESA), for the treatment of children and teens on hemodialysis who are switching from another ESA following hemoglobin stabilization.
The open-label, multicenter study that led to the approval included 64 patients with chronic kidney disease (CKD) ages 5 to 17. All patients were on hemodialysis at study entry, had stable hemoglobin (Hb) levels following prior ESA treatment with epoetin alfa/beta or darbepoetin alfa, and were treated with intravenous methoxy polyethylene glycol-epoetin beta every 4 weeks for 20 weeks.
The drug was dosed every 4 weeks based on the total weekly dose of prior ESA therapy at the time of conversion. Dose adjustments were allowed to maintain target Hb levels.
Of 48 patients who received the drug with the recommended dosage, nine patients withdrew for kidney transplant, one patient died, one patient refused treatment, and two withdrew for administrative reasons (one of whom had already entered the evaluation portion of the study). Of the 36 evaluable patients, the mean change in Hb concentration from baseline was -0.15 g/dL (95% CI -0.49 to 0.2).
Safety in pediatric patients was consistent with previous studies in adult populations. Common adverse events (AEs) include blood pressure changes, constipation, cough, diarrhea, headache, injection site reactions, muscle aches or spasms, nausea, pain in the back or extremities, stuffy nose, sore throat, urinary tract infections, and vomiting.
Serious AEs include the increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
Mircera is not indicated nor is it recommended for treating cancer patients with chemotherapy-related anemia. Full prescribing and safety information is available from the FDA.