Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose for the treatment of iron deficiency anemia: Rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions

Journal of Blood Medicine

Volumn 8, Issue , 2017, Pages 155-163

  Adkinson, N Franklin ^a   Strauss, William E ^b   Bernard, Kristine ^b   Kaper, Robert F ^b   Macdougall, Iain C ^c   Krop, Julie S ^b  

^a JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b AMAG PHARMACEUTICALS INC   (United States)

^c KING S COLLEGE HOSPITAL   (United Kingdom)

Author keywords

Anaphylaxis; Ferric carboxymaltose; Ferumoxytol; Hypersensitivity; Hypotension; Iron deficiency anemia

Indexed keywords

25 HYDROXYVITAMIN D; CALCITRIOL; FERRIC CARBOXYMALTOSE; FERUMOXYTOL; FIBROBLAST GROWTH FACTOR 23; HEMOGLOBIN; IRON; PARATHYROID HORMONE; PHOSPHATE;

ADULT; ALLERGIC REACTION; ANAPHYLAXIS; ARTICLE; CARDIOVASCULAR DISEASE; COMPARATIVE STUDY; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; FEMALE; HUMAN; HYPOPHOSPHATEMIA; HYPOTENSION; INCIDENCE; IRON DEFICIENCY ANEMIA; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; URINARY EXCRETION;

EID: 85031284867     PISSN: None     EISSN: 11792736     Source Type: Journal    
DOI: 10.2147/JBM.S142236     Document Type: Article

References (34)

1. WHO/CDC. Worldwide Prevalence of Anemia 1993-2005: WHO Global Database on Anemia. Geneva, Switzerland: WHO Press; 2008.
2. Miller JL. Iron deficiency anemia: a common and curable disease. Cold Spring Harb Perspect Med. 2013;3(7):a011866.
3. Ford DC, Dahl NV, Strauss WE, et al. Ferumoxytol versus placebo in iron deficiency anemia: efficacy, safety, and quality of life in patients with gastrointestinal disorders. Clin Exp Gastroenterol. 2016;9:151-162.
4. Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl. 2012;2(4):280-335.
5. Macdougall IC, Bircher AJ, Eckardt KU, et al. Iron management in chronic kidney disease: conclusions from a “Kidney Disease: Improving Global Outcomes” (KDIGO) controversies conference. Kidney Int. 2016;89(1):28-39.
6. Macdougall IC, Vernon K. Complement activation-related pseudoallergy: a fresh look at hypersensitivity reactions to intravenous iron. Am J Nephrol. 2017;45(1):60-62.
7. Sampson HA, Munoz-Furlong A, Campbell RL, et al. Second symposium on the definition and management of anaphylaxis: summary report - Second National Institute of Allergy and Infectious Disease/ Food Allergy and Anaphylaxis Network Symposium. J Allergy Clin Immunol. 2006;117(2):391-397.
8. Johansson SG, Bieber T, Dahl R, et al. Revised nomenclature for allergy for global use: Report of the Nomenclature Review Committee of the World Allergy Organization, October 2003. J Allergy Clin Immunol. 2004;113(5):832-836.
9. Lieberman P, Kemp SF, Oppenheimer J, Lang DM, Bernstein IL, Nicklas RA. The diagnosis and management of anaphylaxis: an updated practice parameter. J Allergy Clin Immunol. 2005;115(3 suppl 2):S483-S523.
10. Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis - a practice parameter update 2015. Ann Allergy Asthma Immunol. 2015;115(5): 341-384.
11. Hempel JC, Poppelaars F, Gaya da Costa M, et al. Distinct in vitro complement activation by various intravenous iron preparations. Am J Nephrol. 2017;45(1):49-59.
12. Szebeni J. Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity. Toxicology. 2005;216(2-3): 106-121.
13. Bircher AJ, Auerbach M. Hypersensitivity from intravenous iron products. Immunol Allergy Clin North Am. 2014;34(3):707-723.
14. Blazevic A, Hunze J, Boots JM. Severe hypophosphataemia after intravenous iron administration. Neth J Med. 2014;72(1):49-53.
15. Mani LY, Nseir G, Venetz JP, Pascual M. Severe hypophosphatemia after intravenous administration of iron carboxymaltose in a stable renal transplant recipient. Transplantation. 2010;90(7):804-805.
16. Sato K, Nohtomi K, Demura H, et al. Saccharated ferric oxide (SFO)- induced osteomalacia: in vitro inhibition by SFO of bone formation and 1,25-dihydroxy-vitamin D production in renal tubules. Bone. 1997;21(1):57-64.
17. Sato K, Shiraki M. Saccharated ferric oxide-induced osteomalacia in Japan: iron-induced osteopathy due to nephropathy. Endocr J. 1998;45(4): 431-439.
18. Schouten BJ, Doogue MP, Soule SG, Hunt PJ. Iron polymaltose-induced FGF23 elevation complicated by hypophosphataemic osteomalacia. Ann Clin Biochem. 2009;46(pt 2):167-169.
19. Van Wyck DB, Mangione A, Morrison J, Hadley PE, Jehle JA, Goodnough LT. Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion. 2009;49(12):2719-2728.
20. Onken JE, Bregman DB, Harrington RA, et al. A multicenter, randomized, active-controlled study to investigate the efficacy and safety of intravenous ferric carboxymaltose in patients with iron deficiency anemia. Transfusion. 2014;54(2):306-315.
21. Schaefer B, Wurtinger P, Finkenstedt A, et al. Choice of high-dose intravenous iron preparation determines hypophosphatemia risk. PLoS One. 2016;11(12):e0167146.
22. Mannheim J [webpage on the Internet]. Hypophosphatemia; 2014. Available from: https://medlineplus.gov/ency/article/000307.htm. Accessed March 11, 2017.
23. Anand G, Schmid C. Severe hypophosphataemia after intravenous iron administration. BMJ Case Rep. 2017;2017.
24. Schouten BJ, Hunt PJ, Livesey JH, Frampton CM, Soule SG. FGF23 elevation and hypophosphatemia after intravenous iron polymaltose: a prospective study. J Clin Endocrinol Metab. 2009;94(7):2332-2337.
25. Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013;28(8):1793-1803.
26. Ganguli A, Kohli HS, Jha V, Gupta KL, Sakhuja V. The comparative safety of various intravenous iron preparations in chronic kidney disease patients. Ren Fail. 2008;30(6):629-638.
27. Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014;89(6): 646-650.
28. Kosch M, Bahner U, Bettger H, Matzkies F, Teschner M, Schaefer RM. A randomized, controlled parallel-group trial on efficacy and safety of iron sucrose (Venofer) vs iron gluconate (Ferrlecit) in haemodialysis patients treated with rHuEpo. Nephrol Dial Transplant. 2001;16(6):1239-1244.
29. Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014;9(4):705-712.
30. Sav T, Tokgoz B, Sipahioglu MH, et al. Is there a difference between the allergic potencies of the iron sucrose and low molecular weight iron dextran? Ren Fail. 2007;29(4):423-426.
31. Sheashaa H, El-Husseini A, Sabry A, et al. Parenteral iron therapy in treatment of anemia in end-stage renal disease patients: a comparative study between iron saccharate and gluconate. Nephron Clin Pract. 2005;99(4):c97-c101.
32. Airy M, Mandayam S, Mitani AA, et al. Comparative outcomes of predominant facility-level use of ferumoxytol versus other intravenous iron formulations in incident hemodialysis patients. Nephrol Dial Transplant. 2015;30(12):2068-2075.
33. Wang C, Graham DJ, Kane RC, et al. Comparative risk of anaphylactic reactions associated with intravenous iron products. JAMA. 2015;314(19):2062-2068.
34. Wetmore JB, Weinhandl ED, Zhou J, Gilbertson DT. Relative incidence of acute adverse events with ferumoxytol compared to other intravenous iron compounds: a matched cohort study. PLoS One. 2017;12(1):e0171098.