Journal Information
Vol. 42. Issue 1.
Pages 100-101 (January - March 2020)
Share
Share
Download PDF
More article options
Vol. 42. Issue 1.
Pages 100-101 (January - March 2020)
Letter to the Editor
DOI: 10.1016/j.htct.2019.01.007
Open Access
Intravenous ferric carboxymaltose for the treatment of iron deficiency anaemia – reply
Visits
...
Rodolfo Delfini Cancadoa,
Corresponding author
rdcan@uol.com.br

Corresponding author at: Hemocentro da Santa Casa de São Paulo, Rua Marquês de Itú, 579 – 3° andar, 01223-001 – São Paulo, SP, Brazil.
, João Ricardo Friedrischb
a Faculdade de Ciências Médicas da Santa Casa de São Paulo, São Paulo, SP, Brazil
b Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil
Article information
Full Text
Bibliography
Download PDF
Statistics
Tables (1)
Table 1. Estimated total iron deficit (mg elemental iron) based on hemoglobina and body weight.13
Full Text

Ferric carboxymaltose (FCM) is a new parenteral iron product and the first of the new agents approved for rapid and high-dose replenishment of depleted iron stores.1,2 FCM is an iron complex that consists of a ferric hydroxide core stabilized by a carbohydrate shell and its properties permit the administration of large doses (15mg/kg; maximum of 1000mg/infusion) in a single and rapid infusion without the requirement of a test dose.1,3–5 Moreover, FCM is a stable complex with the advantage of being non-dextran-containing and with a very low immunogenic potential and therefore the risk of anaphylatic reactions is low.1,3,4

FCM is, therefore, an effective option in the treatment of iron-deficiency anaemia (IDA) in patients for whom oral iron preparations are ineffective or cannot be administered. The goals of treatment in IDA include restoring haemoglobin (Hb) to normal levels, replenishing iron stores and normalizing red cell indices. Additional goals are to relieve anaemia-related symptoms and improve health-related quality-of-life (HR-QOL).1–4

FCM treatment results in transient elevations in serum iron, serum ferritin and transferrin saturation, and, ultimately, in the correction of Hb levels and replenishment of depleted iron store in several 6–12-week, randomized, open-label, controlled, multicentre trials in various patient populations, including those with inflammatory bowel disease, heavy uterine bleeding, postpartum IDA or perioperative anaemia, and those with chronic kidney disease.3–8 FCM also improved self-reported patient global assessment, NYHA functional class and exercise capacity in patients with heart failure and iron deficiency in the FAIR-HF and CONFIRM-HF trials.9,10

In most trials, patients received either FCM equivalent to an iron dose of ≤1000mg (or 15mg/kg in those weighing <66kg) administered over ≤15min (subsequent doses administered at 1-week intervals) or oral ferrous sulfate at a dose equivalent to 65mg iron three times daily or 100mg iron twice daily. FCM was considered to be as least as effective as ferrous sulfate with regard to changes from baseline in Hb levels or the proportion of patients achieving a haematopoietic response at various timepoints. In general, improvements in Hb levels and, particularly, the replenishment of depleted iron store were more rapid with FCM than with ferrous sulfate. Recipients of FCM demonstrated improvements from baseline in serum ferritin levels and transferrin saturation, as well as improvements from baseline in HR-QOL assessment scores.1,3–8

Ganzoni's formula captures the total body iron deficit in milligrams (body weight in kg×[target Hbactual Hb in g/dL]×0.24+500).11 However, the formula is inconvenient, prone to error, inconsistently used in clinical practice, and underestimates iron requirements.3,12 The FERGIcor trial6 compared a novel and simple scheme (Table 1) with the Ganzoni-calculated dosing in anaemic patients with IBD. The simple FCM dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated iron sucrose dose regimen. In this clinical trial setting, the simple scheme has only been used for dosing of FCM, however, in clinical practice, it is also used for dosing of other intravenous iron compounds. Limitations of this scheme include patients with Hb below 7.0g/dL, who likely need an additional 500mg. Also, the estimation of iron needs in iron deficiency without anaemia is not covered. A minimum of 500–1000mg should be considered.14,15

Table 1.

Estimated total iron deficit (mg elemental iron) based on hemoglobina and body weight.13

Degree of iron deficiency  Haemoglobin level (g/dL)  Iron deficit (mg)
    Body weight<70kg  Body weight≥70kg 
Moderate  10–12 (women)10–13 (men)  1000  1500 
Severe  7–10  1500  2000 
Critical  <7  2000  2500 

Simplified scheme for estimation of total iron requirements.13

The maximum recommended cumulative dose of Ferinject is 1000mg of iron (20mL Ferinject) per week.

This novel dosing scheme, based on many clinical trials and observational data on high dose IV iron administration with FCM and low molecular weight iron dextran, was approved and has been increasingly utilized in the US, EU, Brazil as well as in many other countries, can equally be utilized as a simple dosing guide for other patient groups and iron formulations that can be given at doses of 1000mg per administration for efficient and rapid iron replenishment.1,2

In response to IV iron administration, serum ferritin is greatly elevated for the first 8 wk after infusion. Therefore, ferritin should be monitored only after 8–12 wk, and in case of iron overload (TSAT>50%), treatment should be adjusted accordingly.1,2,6,7

Conflicts of interest

The authors declare no conflicts of interest.

References
[1]
G.M. Keating.
Ferric carboxymaltose: a review of its use in iron deficiency.
[2]
R.D. Cancado, M. Muñoz.
Rev Bras Hematol Hemoter, 33 (2011), pp. 461-469
[3]
S. Kulnigg, S. Stoinov, V. Simanenkov, L.V. Dudar, W. Karnafel, L.C. Garcia, et al.
A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial.
Am J Gastroenterol, 103 (2008), pp. 1182-1192
[4]
D.B. Van Wyck, A. Mangione, J. Morrison, P.E. Hadley, J.A. Jehle, L.T. Goodnough.
Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized controlled trial.
Transfusion, 49 (2009), pp. 2719-2728
[5]
S. Kulnigg, S. Stoinov, V. Simanenkov, L.V. Dúdar, W. Karnafel, L. Garcia, et al.
A novel intravenous iron formulation for treatment of anemia in inflammatory bowel disease: the ferric carboxymaltose (FERINJECT) randomized controlled trial.
Am J Gastroenterol, 103 (2008), pp. 1182-1192
[6]
R. Evstatiev, P. Marteau, T. Iqbal, I.L. Khalif, J. Stein, B. Bokemeyer, et al.
FERGIcor, a randomized controlled trial on ferric carboxymaltose for iron deficiency anemia in inflammatory bowel disease.
Gastroenterology, 141 (2011), pp. 846-853
[7]
J.E. Onken, D.B. Bregman, R.A. Harrington, D. Morris, P. Acs, B. Akright, C. Barish, 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 (Paris), 54 (2014), pp. 306-315
[8]
I.C. Macdougall, A.H. Bock, F. Carrera, K.U. Eckardt, C. Gaillard, D. Van Wyck, et al.
FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia.
Nephrol Dial Transplant, 29 (2014), pp. 2075-2084
[9]
S.D. Anker, J. Comin Colet, G. Filippatos, R. Willenheimer, K. Dickstein, H. Drexler, et al.
Ferric carboxymaltose in patients with heart failure and iron deficiency.
N Engl J Med, 361 (2009), pp. 2436-2448
[10]
P. Ponikowski, D.J. van Veldhuisen, J. Comin-Colet, G. Ertl, M. Komajda, V. Mareev, et al.
Rationale and design of the CONFIRM-HF study: a double blind, randomized, placebo-controlled study to assess the effects of intravenous ferric carboxymaltose on functional capacity in patients with chronic heart failure and iron deficiency.
ESC Heart Fail, 1 (2014), pp. 52-58
[11]
A.M. Ganzoni.
Intravenous iron-dextran: therapeutic and experimental possibilities.
Schweiz Med Wochenschr, 100 (1970), pp. 301-303
[12]
W. Reinisch, M. Staun, R.K. Tandon, I. Altorjay, A.V. Thillainayagam, C. Gratzer, et al.
A randomized, open-label, noninferiority study of intravenous iron isomaltoside 1,000 (Monofer) compared with oral iron for treatment of anemia in IBD (PROCEED).
Am J Gastroenterol, 108 (2013), pp. 1877-1888
[13]
J. Stein, F. Hartmann, A.U. Dignass.
Diagnosis and management of iron deficiency anemia in patients with IBD.
Nat Rev Gastroenterol Hepatol, 7 (2010), pp. 599-610
[14]
B. Favrat, K. Balck, C. Breymann, M. Hedenus, T. Keller, A. Mezzacasa, et al.
Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women – PREFER, a randomized, placebo-controlled study.
[15]
R. Evstatiev, O. Alexeeva, B. Bokemeyer, I. Chopey, M. Felder, M. Gudehus, et al.
Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease.
Clin Gastroenterol Hepatol, 11 (2013), pp. 269-277
Copyright © 2019. Associação Brasileira de Hematologia, Hemoterapia e Terapia Celular
Idiomas
Hematology, Transfusion and Cell Therapy

Subscribe to our newsletter

Article options
Tools
en pt
Cookies policy Política de cookies
To improve our services and products, we use "cookies" (own or third parties authorized) to show advertising related to client preferences through the analyses of navigation customer behavior. Continuing navigation will be considered as acceptance of this use. You can change the settings or obtain more information by clicking here. Utilizamos cookies próprios e de terceiros para melhorar nossos serviços e mostrar publicidade relacionada às suas preferências, analisando seus hábitos de navegação. Se continuar a navegar, consideramos que aceita o seu uso. Você pode alterar a configuração ou obter mais informações aqui.