Abstract
Iron deficiency anemia is a common clinical consequence for people who suffer from chronic kidney disease, especially those requiring dialysis. Intravenous (IV) iron therapy is a widely accepted safe and efficacious treatment for iron deficiency anemia. Numerous IV iron drugs have been approved by U.S. Food and Drug Administration (FDA), including a single generic product, sodium ferric gluconate complex in sucrose. In this study, we compared the cellular iron uptake profiles of the brand (Ferrlecit®) and generic sodium ferric gluconate (SFG) products. We used a colorimetric assay to examine the amount of iron uptake by three human macrophage cell lines. This is the first published study to provide a parallel evaluation of the cellular uptake of a brand and a generic IV iron drug in a mononuclear phagocyte system. The results showed no difference in iron uptake across all cell lines, tested doses, and time points. The matching iron uptake profiles of Ferrlecit® and its generic product support the FDA’s present position detailed in the draft guidance on development of SFG complex products that bioequivalence can be based on qualitative (Q1) and quantitative (Q2) formulation sameness, similar physiochemical characterization, and pharmacokinetic bioequivalence studies.
Highlights
Iron deficiency anemia is a common complication in people who suffer from advanced stages of chronic kidney disease, especially those requiring dialysis
Available lots of Ferrlecit® and generic sodium ferric gluconate (SFG) compliant with Food and Drug Administration (FDA)-approved specifications were purchased from a retail pharmacy
The iron uptake comparison between Ferrlecit® and the generic SFG was performed in three different human macrophage cell lines: THP-1, HL60, and U937
Summary
Iron deficiency anemia is a common complication in people who suffer from advanced stages of chronic kidney disease, especially those requiring dialysis. Oral iron therapy is generally recommended for patients with non-dialysis chronic kidney disease (CKD). Intravenous (IV) administration iron supplementation is the preferable treatment for CKD patients undergoing hemodialysis and/or receiving erythropoiesis-stimulating agents (ESA) that increase iron requirements. Research findings have consistently supported the benefits of IV iron over oral iron in treating CKD patients with moderate to severe iron deficiency anemia: rapid repletion of iron stores, significant increase of hemoglobin levels, and a low rate of treatment-related adverse events [2,3,4,5,6]. Patients with hemodialysis are often concurrently prescribed ESA therapy and IV iron that can readily increase iron availability and facilitate erythropoiesis.
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