The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Injectafer® (ferric carboxymaltose injection) to include a new single dosage regimen for the treatment of iron deficiency anemia (IDA) in adults who have intolerance or insufficient response to oral iron, or have non-dialysis-dependent chronic kidney disease (CKD).
For patients weighing at least 50kg, Injectafer may now be administered as a single dose treatment course of 15mg/kg body weight up to a maximum of 1000mg intravenously (IV). The approval is supported by data from 2 randomized, open-label, controlled clinical trials that evaluated the safety and tolerability of Injectafer as a single dose treatment course administered as 15mg/kg to a maximum of 1000mg in patients weighing at least 50kg.
The new dosing option is in addition to the approved dosage of 750mg IV in 2 doses separated by at least 7 days in patients weighing at least 50kg for a total cumulative dose of 1500mg. For patients weighing less than 50kg, the recommended dosage is 15mg/kg body weight IV in 2 doses separated by at least 7 days per course.
“We are pleased to build on the proven, mainstay Injectafer 1500mg 2-dose course of treatment with the approval of this new 1000mg single dose option,” said Linda Mundy, Chief Medical Officer at American Regent, Inc. “More than 1.7 million patients have been treated with Injectafer in the US and healthcare providers now have an additional dosing option for adult patients with IDA who may not be appropriate for oral iron or who have non-dialysis dependent CKD.”
The single 1000mg dose option of Injectafer is expected to be available in the coming weeks.
- Injectafer® (ferric carboxymaltose injection) receives FDA approval for Single dose option for the treatment of adult patients with iron deficiency anemia. [press release]. Basking Ridge, NJ and Shirley, NY: Daiichi Sankyo, Inc. and American Regent, Inc.; May 6, 2021.
- Injectafer [package insert]. Shirley, NY: American Regent, Inc.; 2021.