The Food and Drug Administration (FDA) has expanded the approval of Injectafer® (ferric carboxymaltose injection) to include patients 1 year of age and older with iron deficiency anemia (IDA) who have either intolerance to oral iron or an unsatisfactory response to oral iron. Previously, the treatment was approved only in adults.
The safety of Injectafer in pediatric patients was evaluated in study 1VIT17044 (ClinicalTrials.gov Identifier: NCT03523117), a randomized, active-controlled study in which 40 patients (1 to 12 years of age: 10 patients, 12 to 17 years of age: 30 patients) received Injectafer 15mg/kg intravenously to a maximum single dose of 750mg (whichever was smaller) on days 0 and 7 for a maximum total dose of 1500mg. In the active comparator arm, 38 patients received an age-dependent formulation of oral ferrous sulfate for 28 days.
The most common adverse reactions (incidence 4% or greater) reported with Injectafer in pediatric patients were hypophosphatemia, injection site reactions, rash, headache, and vomiting.
“We are pleased to build on the effective and proven treatment of Injectafer for adult IDA patients with the approval of this new pediatric use,” said Linda Mundy, Chief Medical Officer at American Regent, Inc. “Pediatric healthcare providers now have an option for pediatric patients as young as 1 year of age with IDA who are intolerant to oral iron or who have had an unsatisfactory response to oral iron.”
Injectafer is also indicated for the treatment of IDA in adults with nondialysis dependent chronic kidney disease. The product is supplied in 15mL and 20mL single-dose vials containing 50mg/mL of iron as ferric carboxymaltose.
- Injectafer® (ferric carboxymaltose injection) receives FDA approval for the treatment of pediatric patients with iron deficiency anemia. News release. American Regent, Inc. Accessed December 16, 2021. https://www.prnewswire.com/news-releases/injectafer-ferric-carboxymaltose-injection-receives-fda-approval-for-the-treatment-of-pediatric-patients-with-iron-deficiency-anemia-301446495.html.
- Injectafer. Package insert. American Regent, Inc.; 2021. Accessed December 16, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203565Orig1s016_CORRECTED_lbl.pdf.