American Journal of Kidney Diseases
Volume 52, Issue 5 , Pages 907-915 , November 2008

Safety of Ferumoxytol in Patients With Anemia and CKD

  • Ajay Singh, MD

      Affiliations

    • Brigham and Women's Hospital, Boston, MA
    • Harvard Medical School, Boston, MA
  • ,
  • Tejas Patel, MD

      Affiliations

    • Brigham and Women's Hospital, Boston, MA
    • Harvard Medical School, Boston, MA
  • ,
  • Joachim Hertel, MD

      Affiliations

    • University Hospital Medical Center, Augusta, GA
  • ,
  • Marializa Bernardo, MD

      Affiliations

    • Southwest Houston Research, Houston, TX
  • ,
  • Annamaria Kausz, MD

      Affiliations

    • AMAG Pharmaceuticals Inc, Cambridge, MA
    • Tufts University School of Medicine, Boston, MA
  • ,
  • Louis Brenner, MD

      Affiliations

    • Brigham and Women's Hospital, Boston, MA
    • Harvard Medical School, Boston, MA
    • AMAG Pharmaceuticals Inc, Cambridge, MA
    • Corresponding Author InformationAddress correspondence to Louis Brenner, MD, AMAG Pharmaceuticals Inc, 61 Mooney St, Cambridge, MA 02138

Received 11 March 2007 ,Accepted 1 August 2008.

References 

  1. Astor BC, Muntner P, Levin A, Eustace JA, Coresh J. Association of kidney function with anemia: The Third National Health and Nutrition Examination Survey (1988-1994). Arch Intern Med. 2002;162:1401–1408
  2. Kazmi WH, Kausz AT, Khan S, et al. Anemia: An early complication of chronic renal insufficiency. Am J Kidney Dis. 2001;38:803–812
  3. Eschbach JW. The anemia of chronic renal failure: Pathophysiology and the effects of recombinant erythropoietin. Kidney Int. 1989;35:134–148
  4. Fishbane S, Maesaka JK. Iron management in end-stage renal disease. Am J Kidney Dis. 1997;29:319–333
  5. Silverberg DS, Blum M, Agbaria Z, et al. Intravenous iron for the treatment of predialysis anemia. Kidney Int Suppl. 1999;69:S79–S85
  6. Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008;19:1599–1605
  7. Coyne DW, Kapoian T, Suki W, et al. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: Results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. J Am Soc Nephrol. 2007;18:975–984
  8. Macdougall IC, Tucker B, Thompson J, Tomson CR, Baker LR, Raine AE. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int. 1996;50:1694–1699
  9. Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005;68:2846–2856
  10. National Kidney Foundation. Using iron agents, in KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease. Am J Kidney Dis. 2006;47(suppl 3):S58–S70
  11. American Regent Laboratories Inc. Dexferrum® [package insert]. Shirley, NY: American Regent Laboratories Inc; 2001;
  12. Watson Pharma Inc. INFeD® Prescribing Information. Morristown, NJ: Watson Pharma Inc; 2001;
  13. Watson Pharma Inc. Ferrlecit® [package insert]. Corona, CA: Watson Pharma Inc; 2006;
  14. American Regent Inc. Venofer® [package insert]. Shirley, NY: American Regent Inc; 2005;
  15. Fishbane S, Ungureanu VD, Maesaka JK, Kaupke CJ, Lim V, Wish J. The safety of intravenous iron dextran in hemodialysis patients. Am J Kidney Dis. 1996;28:529–534
  16. Bailie GR, Clark JA, Lane CE, Lane PL. Hypersensitivity reactions and deaths associated with intravenous iron preparations. Nephrol Dial Transplant. 2005;20:1443–1449
  17. Faich G, Strobos J. Sodium ferric gluconate complex in sucrose: Safer intravenous iron therapy than iron dextrans. Am J Kidney Dis. 1999;33:464–470
  18. Van Wyck DB, Cavallo G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36:88–97
  19. Auerbach M, Al Talib K. Low-molecular weight iron dextran and iron sucrose have similar comparative safety profiles in chronic kidney disease. Kidney Int. 2008;73:528–530
  20. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. On the relative safety of parenteral iron formulations. Nephrol Dial Transplant. 2004;19:1571–1575
  21. Prakash S, Walele A, Dimkovic N, Bargman J, Vas S, Oreopoulos D. Experience with a large dose (500 mg) of intravenous iron dextran and iron saccharate in peritoneal dialysis patients. Perit Dial Int. 2001;21:290–295
  22. Macdougall IC, Roche A. Administration of intravenous iron sucrose as a 2-minute push to CKD patients: A prospective evaluation of 2,297 injections. Am J Kidney Dis. 2005;46:283–289
  23. Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: A new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005;25:400–410
  24. Spinowitz BS, Schwenk MH, Jacobs PM, et al. The safety and efficacy of ferumoxytol therapy in anemic chronic kidney disease patients. Kidney Int. 2005;68:1801–1807
  25. Spinowitz B, Besarab A, Bolton WK, et al. Ferumoxytol as intravenous iron replacement therapy in chronic kidney disease (CKD) patients not on dialysis: Evaluation of safety and efficacy in two phase III Studies. J Am Soc Nephrol. 2006;17:342A;(abstr)
  26. Hedin H, Ljungstrom KG. Prevention of dextran anaphylaxis (Ten years experience with hapten dextran). Int Arch Allergy Immunol. 1997;113:358–359
  27. Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26:445–454
  28. Chandler G, Harchowal J, Macdougall IC. Intravenous iron sucrose: Establishing a safe dose. Am J Kidney Dis. 2001;38:988–991
  29. Michael B, Coyne DW, Fishbane S, et al. Sodium ferric gluconate complex in hemodialysis patients: Adverse reactions compared to placebo and iron dextran. Kidney Int. 2002;61:1830–1839
  30. St Peter WL, Lambrecht LJ, Macres M. Randomized cross-over study of adverse reactions and cost implications of intravenous push compared with infusion of iron dextran in hemodialysis patients. Am J Kidney Dis. 1996;28:523–528
  31. Van Wyck D, Anderson J, Johnson K. Labile iron in parenteral iron formulations: A quantitative and comparative study. Nephrol Dial Transplant. 2004;19:561–565
  32. Jacobs P, Lewis J, Frigo T. Bleomycin detectable iron and percent transferrin saturation in the serum of patients receiving either ferumoxytol, iron gluconate or iron sucrose. J Am Soc Nephrol. 2004;15:546A;(abstr)
  33. Lewis J, Jacobs P, Frigio T. Comparison of free iron in ferumoxytol with other iron therapeutics. J Am Soc Nephrol. 2003;14:771A;(abstr)
  34. Saadeh CE, Srkalovic G. Acute hypersensitivity reaction to ferric gluconate in a premedicated patient. Ann Pharmacother. 2005;39:2124–2127
  35. Zager RA, Johnson AC, Hanson SY. Parenteral iron therapy exacerbates experimental sepsis. Kidney Int. 2004;65:2108–2112
  36. Fishbane S. Review of issues relating to iron and infection. Am J Kidney Dis. 1999;34(suppl 2):S47–S52
  37. Bullen JJ, Rogers HJ, Spalding PB, Ward CG. Natural resistance, iron and infection: A challenge for clinical medicine. J Med Microbiol. 2006;55:251–258
  38. Auerbach M, Rodgers GM. Intravenous iron. N Engl J Med. 2007;357:93–94
  39. Charytan C, Qunibi W, Bailie GR. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100:c55–c62
  40. Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006;21:378–382

 Trial registration: www.clinicaltrials.gov; study number: NCT 00255450.

 Originally published online as doi:10.1053/j.ajkd.2008.08.001 on September 29, 2008.

PII: S0272-6386(08)01191-8

doi: 10.1053/j.ajkd.2008.08.001

American Journal of Kidney Diseases
Volume 52, Issue 5 , Pages 907-915 , November 2008