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Ferumoxytol

In Iron Deficiency Anaemia in Adults With Chronic Kidney Disease

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Abstract

Ferumoxytol is an intravenously administered iron preparation indicated in the EU and the US for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).

It consists of superparamagnetic iron oxide nanoparticles coated with a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution that can be administered at relatively high dose by rapid intravenous injection.

In phase III, randomized, controlled trials, two doses of ferumoxytol (510 mg iron/dose) given 2–8 days apart increased mean haemoglobin levels from baseline to week 5 significantly more than oral iron (200 mg/day for 21 days) in adult patients with iron deficiency anaemia and CKD stages 1–5. Ferumoxytol was more effective than oral iron both in patients with non-dialysis-dependent CKD and in those with haemodialysis-dependent CKD.

Ferumoxytol was generally well tolerated in randomized controlled clinical trials. Most adverse events were mild or moderate in intensity; serious hypersensitivity or hypotensive reactions were uncommon. Local injection-site reactions were the most common system/organ-class adverse events in a pooled analysis of clinical studies and post-marketing experience.

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References

  1. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis 2006 May; 47 (5 Suppl. 3): S11–145

    Google Scholar 

  2. Macdougall IC. Iron supplementation in the non-dialysis chronic kidney disease (ND-CKD) patient: oral or intravenous? Curr Med Res Opin 2010 Feb; 26 (2): 473–82

    Article  PubMed  CAS  Google Scholar 

  3. Locatelli F, Aljama P, Barany P, et al. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004 May; 19 Suppl. 2: ii1–47

    Article  PubMed  Google Scholar 

  4. National Institute for Health and Clinical Excellence (NICE). Anaemia management in people with chronic kidney disease [online]. Available from URL: http://www.guideline.gov [Accessed 2012 Aug 22]

  5. KDOQI clinical practice guideline and clinical practice recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis 2007 Sep; 50 (3): 471–530

  6. Amgen Inc. Epogen® (epoetin alfa): US prescribing information [online]. Available from URL: http://pi.amgen.com/united_states/epogen/epogen_pi_hcp_english.pdf [Accessed 2012 Aug 22]

  7. Amgen Inc. Aranesp® (darbepoetin alfa): US prescribing information [online]. Available from URL: http://pi.amgen.com/united_states/aranesp/ckd/aranesp_pi_hcp_english.pdf [Accessed 2012 Aug 22]

  8. Gotloib L, Silverberg D, Fudin R, et al. Iron deficiency is a common cause of anemia in chronic kidney disease and can often be corrected with intravenous iron. J Nephrol 2006 Mar–Apr; 19 (2): 161–7

    PubMed  CAS  Google Scholar 

  9. Coppol E, Shelly J, Cheng S. A comparative look at the safety profiles of intravenous iron products used in the hemodialysis population. Ann Pharmacother 2011 Feb; 45: 241–7

    CAS  Google Scholar 

  10. Geisser P, Burckhardt S. The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceutics 2011 Jan 4; 3 (1): 12–33

    Article  CAS  Google Scholar 

  11. Sanofi-Aventis. Ferrlecit® (sodium ferric gluconate complex in sucrose, injection): US prescribing information [online]. Available from URL: http://products.sanofi.us/ferrlecit/ferrlecit.html [Accessed 2012 Aug 22]

  12. Pharmacosmos UK. CosmoFer (low molecular weight iron dextran) 50 mg/mL solution for infusion and injection: summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk [Accessed 2012 Aug 22]

  13. Vifor Pharma UK. Venofer (iron sucrose): summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk)/ [Accessed 2012 Aug 22]

  14. Vifor Pharma UK. Ferinject (ferric carboxymaltose): summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/ [Accessed 2012 Aug 22]

  15. Scottish Medicines Consortium. Iron isomaltoside 1000, 100 mg/mL solution for injection/infusion (Monofer®) [online]. Available from URL: http://www.scottishmedicines.org.uk/files/advice/iron_isomaltoside_Monofer_FINAL_APRIL_2011_amended_030511_for_website.pdf [Accessed 2012 Aug 22]

  16. Watson Pharma Inc. INFeD® (iron dextran injection USP): US prescribing information [online]. Available from URL: http://pi.watson.com [Accessed 2012 Aug 22]

  17. US FDA. Dexferrum® (iron dextran injection, USP): US prescribing information [online]. Available from URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/040024s022lbl.pdf [Accessed 2012 Aug 22]

  18. Takeda Pharmaceutical Company Limited, AMAG Pharmaceuticals Inc. Rienso® (ferumoxytol) receives European marketing authorisation for the treatment of iron deficiency anaemia in adult chronic kidney disease patients [media release]. 2012 Jun 25 [online]. Available from URL: http://www.takeda.com [Accessed 2012 Aug 22]

  19. AMAG Pharmaceuticals Inc. Feraheme (ferumoxytol injection): US prescribing information [online]. Available from URL: http://www.feraheme.com [Accessed 2012 Aug 22]

  20. Rienso (ferumoxytol): summary of product characteristics. London: Takeda Global Research and Development Centre (Europe) Ltd, 2012 Jun

  21. Spinowitz BS, Schwenk MH, Jacobs PM, et al. The safety and efficacy of ferumoxytol therapy in anemic chronic kidney disease patients. Kidney Int 2005 Oct; 68 (4): 1801–7

    Article  PubMed  CAS  Google Scholar 

  22. Provenzano R, Schiller B, Rao M, et al. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol 2009 Feb; 4 (2): 386–93

    Article  PubMed  CAS  Google Scholar 

  23. Balakrishnan VS, Rao M, Kausz AT, et al. Physicochemical properties of ferumoxytol, a new intravenous iron preparation. Eur J Clin Invest 2009 June; 39 (6): 489–96

    Article  PubMed  CAS  Google Scholar 

  24. Landry R, Jacobs PM, Davis R, et al. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol 2005 Jul–Aug; 25 (4): 400–10

    Article  PubMed  CAS  Google Scholar 

  25. Pai AB, Nielsen JC, Kausz A, et al. Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects. Clin Pharmacol Ther 2010 Aug; 88 (2): 237–42

    Article  PubMed  CAS  Google Scholar 

  26. Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol 2008 Aug; 19(8): 1599–605

    Article  PubMed  CAS  Google Scholar 

  27. Sharma A, Bhat P, Schiller B, et al. Efficacy of Feraheme® (ferumoxytol) administration on target hemoglobin levels and other iron parameters across 3 dialysis chains [abstract no. FR-PO1603 plus poster]. American Society of Nephrology Kidney Week 2011; 2011 Nov 8–13; Philadelphia (PA)

  28. Singh A, Patel T, Hertel J, et al. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis 2008 Nov; 52 (5): 907–15

    Article  PubMed  CAS  Google Scholar 

  29. Schiller B, Bhat P, Sharma A, et al. Safety of Feraheme® (ferumoxytol) in hemodialysis patients at 3 dialysis chains over a 1-year period [abstract no. FR-PO1573 plus poster]. American Society of Nephrology Kidney Week 2011; 2011 Nov 8–13; Philadelphia (PA)

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Acknowledgements and Disclosures

The manuscript was reviewed by D.W. Coyne, Department of Medicine, Washington University School of Medicine, St Louis, MO, USA; B.S. Spinowitz, Nephrology, New York Hospital, Queens, New York, NY, USA.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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Correspondence to Paul L. McCormack.

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McCormack, P.L. Ferumoxytol. Drugs 72, 2013–2022 (2012). https://doi.org/10.2165/11209880-000000000-00000

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