Table 2: Current FDA-approved intravenous iron preparations [8, 10, 2736].

Trade nameDexferrum (iron dextran injection, USP)INFeD (iron dextran injection, USP)Ferrlecit (sodium ferric gluconate complex in sucrose injection)Venofer (iron sucrose injection, USP)Feraheme (ferumoxytol)Injectafer (ferric carboxymaltose injection)

ManufacturerAmerican Regent, Inc.Actavis Pharma, Inc.Sanofi-AventisAmerican Regent, Inc.AMAG PharmaceuticalsAmerican Regent, Inc.

Test doseYesYesNoNoNoNo

Black box warningYesYesNo NoYesNo

FDA-approved indicationsIron deficiency where oral iron administration is unsatisfactory or impossibleIron deficiency where oral iron administration is unsatisfactory or impossibleIron deficiency anemia in adult and pediatric CKD patients receiving hemodialysis and receiving ESAsIDA in adult and pediatric patients with non-dialysis-dependent, hemodialysis dependent, and peritoneal dialysis-dependent CKDIDA in adult patients with CKDIDA in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or adult patients with non-dialysis-dependent CKD

Total cumulative doseDependent on patient’s total iron requirementDependent on patient’s total iron requirement1000 mg1000 mg1020 mg1500 mg

CKD = chronic kidney disease; ESA = erythropoiesis-stimulating agent; IDA = iron deficiency anemia.
American Regent, Inc., is the human drug division of Luitpold Pharmaceuticals, Inc., Shirley, NY.