Abstract
Intravenous iron is necessary for optimal management of anemia in patients receiving hemodialysis and is utilized in the majority of these patients in the US. The availability of nondextran formulations of intravenous iron has significantly improved the safety of its use. The nondextran iron formulation sodium ferric gluconate complex (SFGC) has been extensively studied in the hemodialysis population, with two large phase IV trials documenting its safety. SFGC is efficacious and, at recommended doses, is associated with a low incidence of adverse events. There have been few comparative studies of the nondextran intravenous iron preparations; however, they are known to have different pharmacokinetic characteristics. There is also evidence to indicate that these compounds differ in terms of their cytotoxic and proinflammatory properties, and their propensity to induce oxidative stress. This paper reviews the current literature on the safety of SFGC and examines the emerging safety issues surrounding the use of intravenous iron.
Key Points
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The nondextran iron formulation sodium ferric gluconate complex (SFGC; Ferrlecit®) was approved by FDA priority review in 1999
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Phase IV data support the safety of SFGC for management of anemia in adult and pediatric hemodialysis patients
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SFGC is associated with a reduced risk of anaphylactoid reactions compared with iron dextran formulations
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Studies of other safety issues associated with SFGC use are ongoing
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Limited data exist on the use of SFGC in patients with CKD or those receiving peritoneal dialysis
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The authors have participated in clinical research studies funded by, or hold or have held consulting agreements in which they were compensated on an occasional basis for hourly work performed, with no prescribed minimal number of hours, from Watson Pharmaceuticals, Inc, the manufacturer of sodium ferric gluconate complex.
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Michael, B., Fishbane, S., Coyne, D. et al. Drug Insight: safety of intravenous iron supplementation with sodium ferric gluconate complex. Nat Rev Nephrol 2, 92–100 (2006). https://doi.org/10.1038/ncpneph0068
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DOI: https://doi.org/10.1038/ncpneph0068