Abstract
Introduction
: Anemic patients may benefit from the various intravenous iron replacement options available. Ferric carboxymaltose (FCM) is a new iron formulation (150 kDa) that can be given at high doses (20 mg/kg, up to 1000 mg) over a short period (≤ 15 min), without test dosing.
Areas covered
: This paper reviews studies dealing with the efficacy and safety of FCM for treating anemia in relatively large numbers of patients, in addition to analyzing the differences regarding clinical conditions, iron doses, follow-up, comparators, and hematologic response targets.
Expert opinion
: Overall, there is substantial evidence that FCM is effective in treating iron-deficiency anemia in many acute and chronic conditions, with a favorable benefit–risk profile. The efficacy of FCM for correcting anemia is similar to that of iron sucrose, and it is superior to oral iron or placebo in replenishing iron stores. Despite higher acquisition costs (as fewer administrations are needed), treatment with FCM (as well as with iron isomaltoside 1000 or ferumoxytol) seems to be cost-effective when compared to iron sucrose, and is more convenient for patients. There are, however, some aspects (such as hypophosphatemia) and important missing information (such as use in children and pregnant women) that need to be addressed for facilitating a widespread use of FCM.
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Acknowledgements
The authors gratefully acknowledge the collaboration of JA García-Erce and J Rodríguez-García, from Hospital General San Jorge (Huesca, Spain), in the statistical data analysis and discussion.
Notes
Anker SD, Comin Colet J, Filippatos G, the FAIR-HF Trial Investigators. Stockholm, Sweden. Poster MP375. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009;361:3436-48 Bisbe E, Garcia-Erce JA, Diez-Lobo AI, Munoz M; Anaemia Working Group Espana. A multicentre comparative study on the efficacy of intravenous ferric carboxymaltose and iron sucrose for correcting preoperative anaemia in patients undergoing major elective surgery. Br J Anaesth 2011;107:477-8 Breymann C, Gliga F, Bejenariu C, Strizhova N. Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Int J Gynaecol Obstet 2008;101:67-73 Moore RA, Gaskell H, Rose P, Allen J. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data. BMC Blood Disord 2011;11:4 Evstatiev R, Marteau P, Iqbal T, FERGIcor, randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease disease. Gastroenterology 2011;141:846-53 Kulnigg S, Stoinov S, Simanenkov V, A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol 2008;103:1182-92 Qunibi WJ, Martinez C, Smith M, A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron fro treatment of iron deficiency anemia of non-dialysis-dependent chronic kidney disease. Nephrol Dial Transplant 2011;26:1599-607 Schaefer RM, Khasabov NN, Todorov NG, Evenepoel P. Intravenous ferric carboxymaltose or iron sucrose to treat iron deficiency anaemia in haemodialysis patients. Poster presented at the XLV ERA-EDTA Congress; 10 – 1 May 2008 Seid MH, Derman RJ, Baker JB, Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008;199:435-7 Van Wyck DB, Martens MG, Seid MH, Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomised controlled trial. Obstet Gynecol 2007;110:267-78 Van Wyck DB, Mangione A, Morrison J, Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion 2009;49:2719-28 Covic A, Mircescu G. The safety and efficacy of intravenous ferric carboxymaltose in anaemic patients undergoing haemodialysis: a multi-centre, open-label, clinical study. Nephrol Dial Transplant 2010;25:2722-30 Kulnigg S, Stoinov S, Simanenkov V, A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol 2008;103:1182-92 Qunibi WJ, Martinez C, Smith M, A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron fro treatment of iron deficiency anemia of non-dialysis-dependent chronic kidney disease. Nephrol Dial Transplant 2011;26:1599-607 Seid MH, Derman RJ, Baker JB, Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008;199:435-7 Van Wyck DB, Martens MG, Seid MH, Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomised controlled trial. Obstet Gynecol 2007;110:267-78 Van Wyck DB, Mangione A, Morrison J, Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion 2009;49:2719-28 Anker SD, Comin Colet J, Filippatos G, the FAIR-HF Trial Investigators. Stockholm, Sweden. Poster MP375. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009;361:3436-48 Breymann C, Gliga F, Bejenariu C, Strizhova N. Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Int J Gynaecol Obstet 2008;101:67-73 Moore RA, Gaskell H, Rose P, Allen J. Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data. BMC Blood Disord 2011;11:4 Evstatiev R, Marteau P, Iqbal T, FERGIcor, randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease disease. Gastroenterology 2011;141:846-53 Kulnigg S, Stoinov S, Simanenkov V, A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial. Am J Gastroenterol 2008;103:1182-92 Qunibi WJ, Martinez C, Smith M, A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron fro treatment of iron deficiency anemia of non-dialysis-dependent chronic kidney disease. Nephrol Dial Transplant 2011;26:1599-607 Schaefer RM, Khasabov NN, Todorov NG, Evenepoel P. Intravenous ferric carboxymaltose or iron sucrose to treat iron deficiency anaemia in haemodialysis patients. Poster presented at the XLV ERA-EDTA Congress; 10 – 1 May 2008 Seid MH, Derman RJ, Baker JB, Ferric carboxymaltose injection in the treatment of postpartum iron deficiency anemia: a randomized controlled clinical trial. Am J Obstet Gynecol 2008;199:435-7 Van Wyck DB, Martens MG, Seid MH, Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomised controlled trial. Obstet Gynecol 2007;110:267-78 Van Wyck DB, Mangione A, Morrison J, Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Transfusion 2009;49:2719-28