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• W2000486133 abstract "Related Article, p. 907 Related Article, p. 907 Use of intravenous iron for the management of anemia in chronic kidney disease (CKD) and dialysis patients has repeatedly been shown to increase hemoglobin levels and lower the dose of erythropoiesis-stimulating agents (ESAs). Each of the currently available formulations of intravenous iron has limitations related to safety or convenience. The currently available preparations are all iron-carbohydrate complexes or colloids based on small spheroidal iron-carbohydrate particles developed to shield bioactive free iron. Each particle consists of a core made of an iron-oxyhydroxy gel surrounded by a shell of carbohydrate that stabilizes the gel, slows the release of iron, and maintains the resulting particles in colloidal suspension. The molecular weight of the iron complex reflects the size of the iron core and the surrounding carbohydrate. There are currently 2 iron-dextran formulations and 2 nondextran formulations (iron salts), as well as 2 new compounds under consideration. These compounds are described in more detail in Table 1.Table 1Intravenous Iron PreparationsCurrently Available Intravenous Iron Preparations1Watson Pharmaceuticals, Inc: INFeD Prescribing Information. Watson Pharmaceuticals, Inc, Morristown, NJ2006Google Scholar, 2American Regent, Inc: DexFerrum Prescribing Information. American Regent, Inc, Shirley, NY2001Google Scholar, 3Watson Pharmaceuticals, Inc: Ferrlecit Prescribing Information. Watson Pharmaceuticals, Inc, Morristown, NJ2004Google Scholar, 4American Regent, Inc: Venofer Prescribing Information. American Regent, Inc, Shirley, NY2005Google ScholarInvestigational Agents (not FDA approved)5Landry R. Jacobs P.M. Davis R. et al.Pharmacokinetic study of Ferumoxytol: A new iron replacement therapy in normal subjects and hemodialysis patients.Am J Nephrol. 2005; 25: 400-410Crossref PubMed Scopus (84) Google Scholar, 6Manley H.J. McClaran M.L. Determination of VIT 45 (IND#63,243 – American Regent) removal by closed loop in vitro hemodialysis system.Int J Artif Organs. 2006; 29: 1062-1066PubMed Google Scholar, 7FDA Advisory Committee Briefing Document, Drug Safety and Risk Management Committee, February 1, 2008http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-4337b1-01-FDA.pdfGoogle ScholarTrade NameDexFerrumINFeDFerrlecitVenoferFerumoxytolInjectaferManufacturerAmerican Regent, IncWatson Pharmaceuticals, IncWatson Pharmaceuticals, IncAmerican Regent, IncAMAG PharmaceuticalsAmerican Regent, IncCarbohydrateHigh-molecular-weight dextranLow-molecular-weight dextranGluconateSucrosePolyglucose sorbitol carboxymethyletherCarboxymaltoseMolecular weight measured by manufacturer (Da)265,000165,000289,000-440,00034,000-60,000750,000150,000Total-dose or >500-mg infusionYesYesNoNoYesYesPremedicationTDI onlyTDI onlyNoNoNoNoTest dose requiredYesYesNoNoNoNoIron concentration (mg/mL)505012.5205030Vial volume (mL)1-2255NANABlack box warningYesYesNoNoNANAPreservativeNoneNoneBenzyl alcoholNoneNoneNoneNote: Ferric gluconate and iron sucrose are also referred to as iron salts.Abbreviations: NA, not applicable; TDI, total-dose infusion. Open table in a new tab Note: Ferric gluconate and iron sucrose are also referred to as iron salts. Abbreviations: NA, not applicable; TDI, total-dose infusion. The usual dose for repletion of iron stores is 1,000 to 1,500 mg. While high- and low-molecular-weight preparations of iron dextran can be given as a total dose infusion (eg, 1,000 to 1,500 mg) over 60 to 90 minutes, there are concerns about anaphylactic reactions. The iron salts ferric gluconate and iron sucrose do not appear to cause anaphylaxis, but higher doses result in other acute reactions, precluding total dose infusions. In this issue of the American Journal of Kidney Diseases, Singh and colleagues8Singh A. Patel T. Hertel J. et al.Safety of Ferumoxytol in patients with anemia and CKD.Am J Kidney Dis. 2008; 52: 907-915Abstract Full Text Full Text PDF PubMed Scopus (124) Google Scholar report the safety results of ferumoxytol, an investigational form of intravenous iron, which can be given as 510 mg intravenously in less than 1 minute. This study compared adverse reactions to ferumoxytol to placebo, but not to other forms of intravenous iron, and excluded patients more likely to develop drug reactions. Before we can conclude that ferumoxytol is the perfect combination of safety and convenience, it is worth reviewing the safety of the other available intravenous irons and comparing those results to this recent ferumoxytol study. Intravenous iron in combination with ESA to reach the target hemoglobin concentration is now the standard of care for anemia in CKD. Iron dextran was the most widely used intravenous iron until the introduction of ferric gluconate, and then iron sucrose, to the US market. Shortly thereafter, the use of iron dextran in dialysis patients plummeted due to the view that iron dextran carried a greater risk of severe reactions. Newer information suggests low-molecular-weight iron dextran is much safer than high-molecular-weight iron dextran, with the latter agent accounting for an overwhelming majority of reported serious adverse events to iron dextran in a retrospective analysis by Chertow and colleagues of 50 million doses of intravenous iron.9Chertow G.M. Mason P.D. Vaage-Nilsen O. Ahlmen J. Update on adverse drug events associated with parenteral iron.Nephrol Dial Transplant. 2006; 21: 378-382Crossref PubMed Scopus (391) Google Scholar In this analysis, low-molecular-weight iron dextran had serious reaction rates of less than 1 in 200,000, similar to the iron salts. Retrospective analyses from spontaneous reporting systems lead to systematic underreporting of the actual incidence of drug reactions, but the similarity between reaction rates reported with low-molecular-weight iron dextran and the iron salts undermine the view that the newer irons are clearly safer. Further, many identified serious adverse events were unable to be classified by brand and were subsequently assigned equally between high-molecular-weight and low-molecular-weight iron dextran for the final analysis. It is therefore likely that this underestimated the toxicity of the high-molecular-weight preparation while overestimating the toxicity of low-molecular-weight iron dextran. During a brief period of time when low-molecular-weight iron dextran was unavailable, necessitating the use of high-molecular-weight iron dextran in dialysis centers in the United States, there was an 1,100% increase in serious adverse events related to intravenous iron reported to the US Food and Drug Administration (data obtained by the author through a Freedom of Information Act request).10Rodgers G.M. Auerbach M. Cella D. et al.High-molecular weight iron dextran: a wolf in sheep's clothing?.J Am Soc Nephrol. 2008; 19: 833-834Crossref PubMed Scopus (48) Google Scholar The safety of intravenous iron is not only limited by anaphylaxis and other acute reactions. In vitro and animal studies by Zager and colleagues showed the iron salts induce cellular injury while low-molecular-weight iron dextran does not at comparable to higher doses.11Zager R.A. Johnson A.C.M. Hanson S.Y. Wasse H. Parenteral iron formulations: a comparative toxicologic analysis and mechanisms of cell injury.Am J Kidney Dis. 2002; 40: 90-103Abstract Full Text Full Text PDF PubMed Scopus (188) Google Scholar, 12Zager R.A. Johnson A.C.M. Hanson S.Y. Parenteral iron nephrotoxicity: potential mechanisms and consequences.Kidney Int. 2004; 66: 144-156Abstract Full Text Full Text PDF PubMed Scopus (111) Google Scholar A beautiful series of studies in patients with CKD stages 3 and 4 have demonstrated that 100 mg of iron sucrose induces increased markers of oxidative stress and causes transient proteinuria and enzymuria.13Agarwal R.A. Vasavada N. Sachs N.G. Chase S. Oxidative stress and renal injury with intravenous iron in patients with chronic kidney disease.Kidney Int. 2004; 65: 2279-2289Abstract Full Text Full Text PDF PubMed Scopus (203) Google Scholar, 14Leehey D.J. Palubiak D.J. Chebrolu S. Agarwal R. Sodium ferric gluconate causes oxidative stress but not acute renal injury in patients with chronic kidney disease: a pilot study.Nephrol Dial Transplant. 2005; 20: 135-140Crossref PubMed Scopus (35) Google Scholar, 15Agarwal R. Rizkala A.R. Kaskas M.O. Minasian R. Trout J.R. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease.Kidney Int. 2007; 72: 638-642Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar On further analysis, the increase in proteinuria was characterized as albuminuria. Further, the albumin molecule itself was damaged, such that a ladder pattern was seen on western blots.16Agarwal R. On the nature of proteinuria with acute renal injury in patients with chronic kidney disease.Am J Physiol Renal Physiol. 2005; 288: F265-F271Crossref PubMed Scopus (25) Google Scholar This laddering of albumin was also time dependent and resolved over 24 hours. In contrast, although 250 mg of ferric gluconate increased oxidative stress, it did not significantly increase proteinuria.13Agarwal R.A. Vasavada N. Sachs N.G. Chase S. Oxidative stress and renal injury with intravenous iron in patients with chronic kidney disease.Kidney Int. 2004; 65: 2279-2289Abstract Full Text Full Text PDF PubMed Scopus (203) Google Scholar, 14Leehey D.J. Palubiak D.J. Chebrolu S. Agarwal R. Sodium ferric gluconate causes oxidative stress but not acute renal injury in patients with chronic kidney disease: a pilot study.Nephrol Dial Transplant. 2005; 20: 135-140Crossref PubMed Scopus (35) Google Scholar These data are consistent with Zager's preclinical studies and with a study by Pai et al, which showed increased non–transferrin-bound (free) iron and markers of oxidative stress after a single dose of either iron sucrose or ferric gluconate compared with iron dextran.17Pai A.B. Boyd A.V. McQuade C.R. et al.Comparison of oxidative stress markers after intravenous administration of iron dextran, sodium ferric gluconate and iron sucrose in patients undergoing hemodialysis.Pharmacotherapy. 2007; 27: 343-350Crossref PubMed Scopus (74) Google Scholar The study by Singh and colleagues evaluated the safety, efficacy, and ease of administration of ferumoxytol, 255 or 510 mg, over 17 to 60 seconds in patients with CKD stages 1 to 5 and 5D. They reported only 1 serious adverse event to ferumoxytol in 750 patients studied, suggesting a better safety profile than reported with iron dextran. This anaphylactoid reaction occurred in a patient with multiple drug allergies. In addition, the authors suggested that the high doses given over such a short period of time provides for a greater ease of administration than exists with the currently available iron salts and iron dextrans. In their discussion, Singh and colleagues state that iron dextran is associated with a 1.7% incidence of anaphylactoid reactions, referencing data published prior to the study by Chertow and colleagues9Chertow G.M. Mason P.D. Vaage-Nilsen O. Ahlmen J. Update on adverse drug events associated with parenteral iron.Nephrol Dial Transplant. 2006; 21: 378-382Crossref PubMed Scopus (391) Google Scholar and prior to the increased awareness of the toxicity differences between high- and low-molecular-weight preparations of iron dextran, though they note that “there are data to suggest that low-molecular-weight iron dextran may be better tolerated than high-molecular-weight iron dextran.” Many iron experts are more forceful, noting huge differences in toxicity between the 2 iron dextrans, and more than 15 publications that proscribe the use of the high-molecular-weight formulation.10Rodgers G.M. Auerbach M. Cella D. et al.High-molecular weight iron dextran: a wolf in sheep's clothing?.J Am Soc Nephrol. 2008; 19: 833-834Crossref PubMed Scopus (48) Google Scholar, 18Auerbach M. Al Talib K.A. Low-molecular weight iron dextran and iron sucrose have similar comparative safety profiles in chronic kidney disease.Kidney Int. 2008; 73: 528-530Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar Two recent publications urge the US Food and Drug Administration to remove high-molecular-weight iron dextran from the pharmacopoeia.10Rodgers G.M. Auerbach M. Cella D. et al.High-molecular weight iron dextran: a wolf in sheep's clothing?.J Am Soc Nephrol. 2008; 19: 833-834Crossref PubMed Scopus (48) Google Scholar, 19Auerbach M. Rodgers G.M. Intravenous iron.N Engl J Med. 2007; 357: 93-94Crossref PubMed Scopus (38) Google Scholar Although the ferumoxytol safety profile appears better than the retrospective chart review of low-molecular-weight iron dextran and comparable to the iron salts, 2 prospective comparison studies of low-molecular-weight iron dextran versus iron sucrose found no differences in efficacy or toxicity.20Monieum K.A. Bhandari S. Tolerability and efficacy of parenteral iron therapy in haemodialysis patients: a comparison of preparations.Transfusion Altern Transfusion Med. 2007; 9: 37-42Crossref Google Scholar, 21Sav T. Tokgoz B. Sipahioglu M.H. Is there a difference between allergic potencies of the iron sucrose and low molecular weight iron dextran?.Ren Fail. 2007; 29: 423-426Crossref PubMed Scopus (64) Google Scholar Lastly, the 5.2% incidence of minor infusion-related side effects seen with ferumoxytol represents a nearly 10- to 20-fold increase over such events seen with ferric gluconate, iron sucrose, and low-molecular-weight iron dextran.22Fishbane S. Ungureanu V.D. Maesake J.K. Kaupke C.J. Lim V. Wish J. The safety of intravenous iron dextran in hemodialysis patients.Am J Kidney Dis. 1996; 28: 528-534Google Scholar Ferumoxytol, with a modified dextran shell, may not be as safe as suggested by Singh et al's report, as the study excluded all patients who had an allergy to iron products or to 2 or more drugs. This greatly limits the likelihood of a drug reaction, because such patients are known to have increased sensitivity to even chemically dissimilar drugs.23Asero R. Tedeschi A. Riboldi P. Grafini S. Bonanni E. Cugno M. Coagulation cascade and fibrinolysis in patients with multiple-drug allergy syndrome.Ann Allergy Asthma Immunol. 2008; 100: 44-48Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar A large double-blind safety study of ferric gluconate found reactions to both drug and placebo were 7-fold more common among those with a history of iron dextran allergy.24Coyne D.W. Adkinson Jr, F.N. Nissenson A.R. et al.Sodium ferric gluconate complex in hemodialysis patients II. Adverse reactions in iron dextran-sensitive and dextran-tolerant patients.Kidney Int. 2003; 63: 217-224Abstract Full Text Full Text PDF PubMed Scopus (87) Google Scholar Singh et al report the anaphylactoid reaction to ferumoxytol occurred in a man with “multiple drug allergies,” which is inconsistent with the study's own exclusion criteria, but highlights the higher reaction rate among predisposed individuals. Lastly, the ferumoxytol study, unlike the ferric gluconate study trial, did not exclude patients receiving antihistamines, which can mimic, or glucocorticoids, which can mask, drug reactions.25Auerbach M. Ballard H. Glaspy J. Clinical update: intravenous iron for anaemia.Lancet. 2007; 369: 1502-1504Abstract Full Text Full Text PDF PubMed Scopus (162) Google Scholar Cumulatively, these studies call into question the wisdom of abandoning low-molecular-weight iron dextran as first-line therapy in dialysis patients.18Auerbach M. Al Talib K.A. Low-molecular weight iron dextran and iron sucrose have similar comparative safety profiles in chronic kidney disease.Kidney Int. 2008; 73: 528-530Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar Low-molecular-weight iron dextran also has the advantage of being able to be given as a single total-dose infusion of 1 g over 1 to 2 hours, while the maximal single dose of iron salts is significantly less. In my practice, in the past 15 months we have given over 150 total-dose infusions of 1,000 to 1,500 mg of low-molecular-weight iron dextran in 60 to 90 minutes to patients with iron deficiency from a wide variety of disease states, without incident. Although the efficacy, toxicity profile, and marked increased ease of administration of ferumoxytol provide an exciting new avenue for investigation for those interested in the role of intravenous iron in treating anemia across many disease states, ferumoxytol should be compared to the other iron formulations in unselected patient populations before yet another premature conclusion is drawn about safety and efficacy of intravenous iron products. In conclusion, the clinical community's larger perception of risk associated with all intravenous irons is antiquated and incorrect.10Rodgers G.M. Auerbach M. Cella D. et al.High-molecular weight iron dextran: a wolf in sheep's clothing?.J Am Soc Nephrol. 2008; 19: 833-834Crossref PubMed Scopus (48) Google Scholar While the perception of adverse event rates are driven higher by high-molecular-weight iron dextran, low-molecular-weight iron dextran, and to a lesser extent the 2 iron salts, suffer the stigma. The folklore surrounding the toxicity of intravenous iron will only end with prospective, randomized, controlled, comparative clinical trials. Financial Disclosure: None. Safety of Ferumoxytol in Patients With Anemia and CKDAmerican Journal of Kidney DiseasesVol. 52Issue 5PreviewIron deficiency anemia is a common complication in patients with chronic kidney disease (CKD). Currently available intravenous (IV) iron replacement therapies have either inconvenient regimens of administration or adverse event profiles that limit their utility in the outpatient setting. Ferumoxytol is a novel, semisynthetic, carbohydrate-coated, superparamagnetic iron oxide nanoparticle that is administered IV as an injection. The main objective of this study was to assess the safety of ferumoxytol for the treatment of patients with CKD stages 1 to 5 and 5D. Full-Text PDF ErratumAmerican Journal of Kidney DiseasesVol. 53Issue 6PreviewIn the editorial entitled “Ferumoxytol as a New, Safer, Easier-to-Administer Intravenous Iron: Yes or No?” (Auerbach, American Journal of Kidney Diseases 52:826-829, 2008), there were 2 numerical errors. In Table 1, ferumoxytol (AMAG Pharmaceuticals Inc, Cambridge, MA) is listed as having an iron concentration (mg/mL) of “50”, but should have been listed as having an iron concentration (mg/mL) of “30”. In the second full paragraph on page 827, tested doses for ferumoxytol were given as 255 mg and 510 mg; however, only the 510 mg amount was used. Full-Text PDF" @default.
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