References

  1. Feraheme® Prescribing Information.
  2. Data on file. AMAG Pharmaceuticals, Inc.
  3. Venofer® Prescribing Information.
  4. Ferrlecit® Prescribing Information.
  5. INFeD® Prescribing Information.
  6. National Kidney Foundation KDOQI™ guidelines for anemia of chronic kidney disease. http://www.kidney.org/professionals/kdoqi/guidelines_updates/doqiupan_iii.html. Accessed: June 22, 2009.
  7. Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron [Ferrlecit] in chronic kidney disease. Am J Nephrol. 2006;26(5):445-454.
  8. Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose [Venofer®] to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-c62.
  9. Stoves J, Inglis H, Newstead CG. A randomized study of oral vs intravenous iron [Venofer®] supplementation in patients with progressive renal insufficiency treated with erythropoietin. Nephrol Dial Transplant. 2001;16(5):967-974.
  10. Van Wyck DB, Roppolo M, Martinez CO, et al. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005;68(6):2846-2856.
  11. McFarlane SI, Chen S-C, Whaley-Connell AT, et al. Prevalence and associations of anemia of CKD: Kidney Early Evaluation Program (KEEP) and National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008;51(suppl 2):S46-S55.
  12. Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJG. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008;19:1599-1605.
  13. Hörl WH, Macdougall IC, Rossert J, Schaefer RM. OPTA-therapy with iron and erythropoiesis-stimulating agents in chronic kidney disease. Nephrol Dial Transplant. 2007;22(suppl 3):iii2-iii6.
  14. Donne RL, Foley RN. Anaemia management and cardiomyopathy in renal failure. Nephrol Dial Transplant. 2002;17[suppl 1]:37-40.
  15. Astor BC, Muntner P, Levin A, Eustace J, 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.
  16. Kausz AT, Steinberg EP, Nissenson AR, Pereira BJG. Prevalence and management of anemia among patients with chronic kidney disease in a health maintenance organization. Dis Manage Health Outcomes. 2002;10(8):505-513.
  17. Hsu C-Y, McCulloch CE, Curhan GC. Epidemiology of anemia associated with chronic renal insufficiency among adults in the United States: results from the Third National Health and Nutrition Examination Survey. J Am Soc Nephrol. 2002;13(2):504-510.
  18. Hsu C-Y, McCulloch CE, Curhan GC. Iron status and hemoglobin level in chronic renal insufficiency. J Am Soc Nephrol. 2002;13(II):2783–2786.
  19. Gotloib L, Silverberg D, Fudin R, Shostak A. Iron deficiency is a common cause of anemia in chronic kidney disease and can often be corrected with intravenous iron. J Nephrol. 2006;19(2):161-167.
  20. Post JB, Wilkes BM, Michelis MF. Iron deficiency in patients with chronic kidney disease: potential role for intravenous iron therapy independent of erythropoietin. Int Urol Nephrol. 2006;38:719-723.
  21. Dowling TC. Prevalence, etiology, and consequences of anemia and clinical and economic benefits of anemia correction in patients with chronic kidney disease: an overview. Am J Health Syst Pharm. 2007;64(suppl 8):S3-S7.
  22. Nurko S. Anemia in chronic kidney disease: causes, diagnosis, treatment. Cleveland Clin J Med. 2006;73(3):289-297.
  23. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis. 2006;47(5 suppl 3):S11-S145.
  24. Silverberg DS, Blum M, Agbaria Z, et al. The effect of i.v. iron alone or in combination with low-dose erythropoietin in the rapid correction of anemia of chronic renal failure in the predialysis period. Clin Nephrol. 2001;55(3):212-219.
  25. Mircescu G, Gârneaţă L, Căpuşă C, Ursea N. Intravenous iron supplementation for the treatment of anaemia in pre-dialyzed chronic renal failure patients. Nephrol Dial Transplant. 2006;21:120-124.
  26. Besarab A, Amin N, Ahsan M, et al. Optimization of epoetin therapy with intravenous iron therapy in hemodialysis patients. J Am Soc Nephrol. 2000;11:530-538.
  27. Fishbane S, Frei GL, Maesaka J. Reduction in recombinant human erythropoietin doses by the use of chronic intravenous iron supplementation. Am J Kidney Dis. 1995;26(1):41-46.
  28. Macdougall IC, Tucker B, Thompson J, et al. A randomized controlled study of iron supplementation in patients treated with erythropoietin. Kidney Int. 1996;50(5):1694-1699.
  29. Andrews NC. Disorders of iron metabolism. N Engl J Med. 1999;341(26):1986-1995.
  30. Eschbach JW. Iron requirements in erythropoietin therapy. Best Pract Res Clin Haematol. 2005;18:347-361.
  31. Bron D, Meuleman N, Mascaux C. Biological basis of anemia. Semin Oncol. 2001;28(2 suppl 8):1-6.
  32. Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005;352(10):1011-1023.
  33. Swinkels D, Wetzels J. Hepcidin: a new tool in the management of anaemia in patients with chronic kidney disease? Nephrol Dial Transplant. 2008;23:2450-2453.
  34. Ganz, T. Hepcidin and its role in regulating systemic iron metabolism. Hematology. 2006:29-35.
  35. Wish JB. Assessing iron status: beyond serum ferritin and transferrin saturation. Clin J Am Soc Nephrol. 2006;1(suppl 1)S4-S8.
  36. Pruchnicki MC, Dasta JF. Acute renal failure in hospitalized patients: part I. Ann Pharmacother. 2002;36:1261-1267.
  37. Fishbane S. Iron management in nondialysis-dependent CKD. Am J Kidney Dis. 2007;49(6):736-743.
  38. Fishbane S, Pollack S, Feldman H, et al. Iron indices in chronic kidney disease in the National Health and Nutritional Examination Survey 1988–2004. Clin J Am Soc Nephrol. 2009;4(1):57-61.
  39. CDC. Prevalence of chronic kidney disease and associated risk factors — United States, 1999–2004. MMWR Morb Mortal Wkly Rep. 2007;56:161-165.
  40. Gilbertson DT, Liu J, Xue JL, et al. Projecting the number of patients with end-stage renal disease in the United States to the year 2015. J Am Soc Nephrol. 2005;16(12):3736-3741.
  41. National Kidney Foundation. KDOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002;39(2 suppl 1):S1-266.
  42. National Kidney Foundation. KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis. 2007;50(3):471-530.
  43. Kalantar-Zadeh K, Rodriguez RA, Humphreys MH. Association between serum ferritin and measures of inflammation, nutrition and iron in haemodialysis patients. Nephrol Dial Transplant. 2004;19(1):141-149.
  44. Kalantar-Zadeh K, Kalantar-Zadeh K, Lee GH. The fascinating but deceptive ferritin: to measure it or not to measure it in chronic kidney disease. Clin J Am Soc Nephrol. 2006;1:S9-S18.

KDOQI is a trademark of the National Kidney Foundation.

Important Safety Information
Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

Warnings and precautions

In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when personnel and therapies are readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme-treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Please see full Prescribing Information for Feraheme.