Effectiveness of Single-dose Ferric Carboxymaltose in Enhancing Hemoglobin Levels in Pregnant Women with Moderate-to-Severe Iron-deficiency Anemia
Rekha Wadhwani, Poorva Badkur, Juhi Agarwal, Bharti Lodhi, Farheen Fathima
Keywords :
Anemia, Ferric carboxymaltose, FCM, Hemoglobin, Iron deficiency, Pregnancy
Citation Information :
Wadhwani R, Badkur P, Agarwal J, Lodhi B, Fathima F. Effectiveness of Single-dose Ferric Carboxymaltose in Enhancing Hemoglobin Levels in Pregnant Women with Moderate-to-Severe Iron-deficiency Anemia. J South Asian Feder Obs Gynae 2023; 15 (4):424-427.
Background: Anemia contributes to increased pregnancy-associated morbidity and mortality; hence warranting rapid correction. Parenteral ferric carboxymaltose (FCM) has FDA and DCGI approval for use in pregnancy-linked iron-deficiency anemia, with minimal and nonserious side effects. Ferric carboxymaltose is given as a single-dose administration, requiring lesser hospital visits and costs. FCM has been accepted for clinical use in the Indian population. However, there is limited evidence about its use for moderate or severe anemia among antenatal women. This study aims to analyze the efficacy and safety of single-dose intravenous ferric carboxy maltose among anemic pregnant females.
Methods: Prospective observational study comprising 150 iron-deficiency anemic pregnant women between 16 and 32 weeks of gestation with hemoglobin between 5 and 9 gm/dL. Single dose of FCM (dose calculated by Ganzoni's formula) was administered and treatment effectiveness was assessed by serial hemoglobin measurement at 2 weeks and 6 weeks after administration of FCM and then at the time of delivery. Safety was determined by analysis of adverse drug reactions and biochemical tests at the aforesaid time intervals.
Results: The mean rise in hemoglobin at 2 weeks was 1.35 gm/dL, at 6 weeks was 3.08 gm/dL and at delivery was 4.80 gm/dL (p < 0.001). No serious adverse effects were found.
Conclusions: The present study bolsters clinical use of intravenous FCM in anemic pregnant females in view of its efficacy and safety. Low-risk single dose dispensation and subsequent upsurge in hemoglobin levels should place FCM as a preferred alternative in moderate-to-severe anemia management during pregnancy.
World Health Organization. 2011. Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. Accessed August 4, 2017. http://www.who.int/vmnis/indicators/haemoglobin.pdf.
Daru J, Zamora J, Fernández-Félix BM, et al. Risk of maternal mortality in women with severe anaemia during pregnancy and post-partum: a multilevel analysis. LancetGlobHealth 2018; 6(5):e548–e554. DOI: 10.1016/S2214-109X(18)30078-0.
Schreir SL, 2018. Approach to the Adult Patient with Anemia. W.C. Mentzer Ed. Waltham, MA: UpToDate Inc https://www.passeidireto.com/arquivo/40983230/357938333-approach-to-the-adult-patient-with-anemia-up-to-date.
Bloor SR, Schutte R, Hobson AR. Oral iron supplementation—gastrointestinal side effects and the impact on the gut microbiota. Microbiol Res 2021;12:491–502. DOI: 10.3390/microbiolres12020033.
Jose A, Mahey R, Sharma JB, et al. Comparison of ferric carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy-randomised controlled trial. BMC Pregnancy Childbirth 2019;19(1):54. DOI: 10.1186/s12884-019-2200-3.
Dave CV, Brittenham GM, Carson JL, et al. Risks for anaphylaxis with intravenous iron formulations: A retrospective cohort study. Ann Intern Med 2022;175(5):656–664. DOI: 10.7326/M21-4009.
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. Available from: https://www.researchgate.net/publication/284820750_The_pharmacology_and_safety_profile_of_ferric_carboxymaltose_FerinjectR_structurereactivity_relationships_of_iron_preparations.
Gupte SA, Venkataraman G, Shah AS, et al. Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real‐life experience. J Obstet Gynaecol Res 2021;47:3464–3470. DOI: 10.1111/jog.14956.
DelRosso LM, Picchietti DL, Ferri R. Comparison between oral ferrous sulfate and intravenous ferric carboxymaltose in children with restless sleep disorder. Sleep 2021;44(2):zsaa155. DOI: 10.1093/sleep/zsaa155.
Cirillo L, Somma C, Allinovi M, et al. Ferric carboxymaltose vs. ferrous sulfate for the treatment of anemia in advanced chronic kidney disease: an observational retrospective study and cost analysis. Sci Rep 2021;11(1):7463. DOI: 10.1038/s41598-021-86769-z.
Shin HW, Go DY, Lee SW, et al. Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for iron deficiency anemia in obstetric and gynecologic patients: A systematic review and meta-analysis. Medicine (Baltimore). 2021;100(20):e24571. DOI: 10.1097/MD.0000000000024571.
Kant S, Kaur R, Ahamed F, et al. Effectiveness of intravenous ferric carboxymaltose in improving hemoglobin level among postpartum women with moderate-to-severe anemia at a secondary care hospital in Faridabad, Haryana – an interventional study. Indian J Public Health 2020;64(2):168–172. DOI: 10.4103/ijph.IJPH_85_19.
Harsoor V, Chikkagowdra S, Aniruddha RH, et al. Safety and efficacy of ferric carboxy maltose in pregnant women- a pilot study. Int J Reprod Contracept Obstet Gynecol 2021;10:647–652. DOI: 10.18203/2320-1770.ijrcog20210321.
Yadav UK, Ghimire P, Amatya A, et al. “Factors associated with anemia among pregnant women of underprivileged ethnic groups attending antenatal care at Provincial Level Hospital of Province 2, Nepal”, Anemia 2021;2021:8847472. DOI: 10.1155/2021/8847472.
Garg R, Singh S, Singh S, et al. A comparative study to evaluate the efficacy and safety of single dose intravenous iron carboxymaltose vs multidose iron sucrose in postpartum cases of severe iron deficiency anemia. J South Asian Feder Obs Gynae 2015;7(1):18–21. DOI: 10.5005/jp-journals-10006-1314.
Mahapatra P, Gupte S, Gopinath P, et al. Ferric carboxymaltose for the treatment of anemia during antenatal and postpartum period: expert opinion. J South Asian Feder Obs Gynae 2022;14(3):292–301. DOI: 10.5005/jp-journals-10006-2026.