Ferinject® Product Information
Ferric carboxymaltose (Ferinject®) is a solution of nanoparticles which consists of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose. Due to the stability of the complex, it does not release ionic iron under physiological conditions and limits the toxic effects of weakly bound iron. Furthermore, it causes iron to be taken up by macrophages and deposited in the reticuloendothelial system of the liver, thus reducing the risk of large amounts of iron in the serum.40
The cumulative total dose of Ferinject® (in mg of iron) has to be calculated individually and cannot be exceeded. The cumulative total dose is calculated using the Ganzoni formula as follows:
Total iron deficiency [mg] = total cumulative dose [mg] =
body weight [kg] × (target Hb - actual Hb) [g / dl] × 2.4 + stored iron [mg]
For body weight below 35 kg:
- Target Hb = 13 g/dL
- Stored iron = 15mg/kg
For body weight 35kg and above:
- Target Hb = 15g/dL
- Stored iron = 500mg
- For body weight ≤ 66 kg , the calculated total cumulative dose should be rounded down to the nearest 100mg of iron.
- For body weight> 66 kg the calculated cumulative total dose should be rounded up to the next 100 mg of iron.
- In patients with overweight, the calculation should be performed assuming normal body weight / blood volume ratio.
- For the conversion of Hb [mM] into Hb [g / dl], Hb [mM] is multiplied by a factor of 1.61145.
Ferinject® can be administered through intravenous infusion or through intravenous bolus injection. Ferinject® must not be administered subcutaneously or intramuscularly. Ferinject® can be given in a dose of up to 1000mg of iron or 20 mg of iron per kg of body weight if less than 50 kg. The total weekly dose should however not exceed 1000 mg.
For hemodialysis patients, Ferinject® must be injected into the venous arm of the dialysis machine or through intravenous infusion in single doses of up to 4 ml (200 mg of iron) per day but not more than three times per week.
- Clénin GE. The treatment of iron deficiency without anaemia (in otherwise healthy persons). Swiss Med Wkly. 2017;147:w14434
- Musallam KM, Taher AT. Iron deficiency beyond erythropoiesis: should we be concerned? Curr Med Res Opin. 2018;34(1):81–93.
- Doom JR. Striking while the iron is hot: Understanding the biological and neurodevelopmental effects of iron deficiency to optimize intervention in early childhood. Curr Pediatr Rep. 2015;2(4):291–298
- Worldwide prevalence of anaemia 1993–2005. WHO The global prevalence of anaemia in 2011. Geneva: World Health Organization 2015
- Lopez A et al. Iron deficiency anaemia. Lancet 2016;387(10021):907–16
- Herklotz R and Huber A. Labordiagnose von Eisenstoffwechselstörungen. Schweiz Med Forum 2010;10(30–31):500–507
- Clénin et al. The treatment of iron deficiency without anaemia (in otherwise healthy persons). Swiss Med Wkly. 2017 Jun14;147:w14434
- Hercberg S, Preziosi P, Galan P. Iron deficiency in Europe. Public Health Nutr 2001; 4: 537–545
- Chrobak C et al. Iron homeostasis in inflammation: a single centre prospective observational study in medical inpatients. Swiss Med Wkly. 2017;147:w14431
- Muckenthaler MU et al. A red carpet for iron metabolism. Cell 2017;168(3):344–361
- Dignass A et al. Limitations of Serum Ferritin in Diagnosing Iron Deficiency in Inflammatory Conditions. Int J Chronic Dis. 2018 Mar 18;2018:9394060
- Crichton RR et al. Iron therapy with special emphasis on intravenous administration. UNI-MED 2008, 4th Edition, chapter 3
- Huch R and Breymann C. Anämie in Schwangerschaft und Wochenbett. UNI-MED 2005, chapt. 3, p. 35
- Hunt JR. High-, but not low-bioavailability diets enable substantial control of women’'s iron absorption in relation to body iron stores, with minimal adaptation within several weeks, The American Journal of Clinical Nutrition, Volume 78, Issue 6, 1 December 2003, Pages 1168–1177
- Hurrell R, Egli I. Iron bioavailability and dietary reference values. Am J Clin Nutr. 2010;91(5):1467S–1467S
- Crichton R et al. Iron Therapy – With Special Emphasis on Intravenous Administration, 4th edition, UNI-MED, 2008, chapt. 2, p. 19–20
- Finch CA, Bellotti V, Stray S, Lipschitz DA, Cook JD, Pippard MJ, Huebers HA. Plasma ferritin determination as a diagnostic tool. West J Med 1986;145:657–663.
- Douglas B. Kell and Etheresia Pretorius. Serum ferritin is an important inflammatory disease marker, as it is mainly a leakage product from damaged cells. Metallomics, 2014,6, 748.
- T. N. Tran, S. K. Eubanks, K. J. Schaffer, C. Y. J. Zhou and M. C. Linder, Secretion of ferritin by rat hepatoma cells and its regulation by inflammatory cytokines and iron, Blood, 1997, 90, 4979–4986.
- L. A. Cohen, L. Gutierrez, A. Weiss, Y. Leichtmann- Bardoogo, D. L. Zhang, D. R. Crooks, R. Sougrat, A. Morgenstern, B. Galy, M. W. Hentze, F. J. Lazaro, T. A. Rouault and E. G. Meyron-Holtz, Serum ferritin is derived primarily from macrophages through a nonclassical secretory pathway. Blood 2010 116:1574-1584; doi: https://doi.org/10.1182/blood-2009-11-253815
- Cappellini MD et al. Iron deficiency across chronic inflammatory conditions: international expert opinion on definition, diagnosis, and management. Am J Hematol. 2017; 92(10):1068–1078
- Martius et al. Eisenmangel ohne Anämie – ein heisses Eisen? Nicht hämatologische Auswirkungen des Eisenmangels: Welche sind belegt, wann kommen sie zum Tragen? Schweiz Med Forum 2009;9(15–16):294–299
- Verdon F et al. Iron supplementation for unexplained fatigue in non-anaemic women: double blind randomized placebo controlled trial. BMJ 2003, 326: 1124–1126
- Cornuz J et al. Fatigue: a practical approach to diagnosis in primary care. 2006, CMAJ, 174(6)
- Favrat B et al. Evaluation of a single dose of ferric carboxymaltose in fatigue, iron-deficient women–PREFER a randomized, placebo-controlled study. PLoS One 2014;9(4):e94217
- Houston BL et al. Efficacy of iron supplementation on fatigue and physical capacity in non-anaemic iron-deficient adults: a systematic review of randomized controlled trials. BMJ Open 2018 8(4):e019240
- Yokoi K et al. Iron deficiency without anaemia is a potential cause of fatigue: meta-analyses of randomized controlled trials and cross-sectional studies. Br J Nutr. 2017 117(10):1422–1431
- Murray-Kolb LE, Beard JL. Iron treatment normalizes cognitive functioning in young women. On J Clin Nutr 2007, 85: 778
- Low MS et al. Daily iron supplementation for improving anaemia, iron status and health in menstruating women. Cochrane Database Syst Rev. 2016 Apr 18;4:CD009747
- Geng F et al. Impact of fetal-neonatal iron deficiency on recognition memory at two months of age. J Pediatr. 2015; 167(6):1226–1232
- Berglund SK et al. Effects of iron supplementation of low-birth-weight infants on cognition and behavior at 7 years: a randomized controlled trial. Pediatr Res. 2018;83(1–1):111–118
- Allen RP et al. Evidence-based and consensus clinical practice guidelines for the iron treatment of restless legs syndrome/Willis-Ekbom disease in adults and children: an IRLSSG task force report. Sleep Med. 2018, 41, 27–44
- Ferric carboxymaltose in patients with restless legs syndrome and nonanemic iron deficiency: a randomized trial. Mov Disord. 2017;32(10):1478–1482
- Kantor J et al. Decreased serum ferritin is associated with alopecia in women. J Invest Dermatol 2003;121:985
- Deloche C et al. Low iron stores: a risk factor for excessive hair loss in non-menopausal women. Eur J Dermatol 2007;17:507–512
- Martines-Torres C et al. Effect of exposure to low temperature on normal and iron-deficient subjects. On J Physiol 1984, 246: R380–R383
- Scott L J. Ferric carboxymaltose: a review in iron deficiency. Drugs 2018;78(4):479–493
- Information for Healthcare professionals Ferinject®: www.swissmedicinfo.ch
- Geisser P. Safety and efficacy of iron(III)-hydroxyde polymaltose complex / a review of over 25 years experience. Arzneimittelforschung 2007;57(6A):439–52
- Geisser P. The pharmacology and safety profile of ferric carboxymaltose (Ferinject®): structure/reactivity relationships of iron preparations. Port J Nephrol Hypert 2009:23(1):11–16