Intravenous ferric carboxymaltose for anaemia in pregnancy

Abstract

BackgroundIron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anaemia (IDA) is associated with significant maternal, fetal and infant morbidity. Current options for treatment are limited: these include oral iron supplementation, which can be ineffective and poorly tolerated, and red blood cell transfusions, which carry an inherent risk and should be avoided. Ferric carboxymaltose is a new treatment option that may be better tolerated.The study was designed to assess the safety and efficacy of iron deficiency anaemia (IDA) correction with intravenous ferric carboxymaltose in pregnant women with mild, moderate and severe anaemia in the second and third trimester.MethodsProspective observational study; 65 anaemic pregnant women received ferric carboxymaltose up to 15 mg/kg between 24 and 40 weeks of pregnancy (median 35 weeks gestational age, SD 3.6). Treatment effectiveness was assessed by repeat haemoglobin (Hb) measurements and patient report of well-being in the postpartum period. Safety was assessed by analysis of adverse drug reactions and fetal heart rate monitoring during the infusion.ResultsIntravenous ferric carboxymaltose infusion significantly increased Hb values (p < 0.01) above baseline levels in all women. Increased Hb values were observed at 3 and 6 weeks post infusion and up to 8 weeks post-infusion. Ferritin values increased significantly after the infusion. Only 4 women had repeat ferritin values post-partum which remained above baseline levels. Fetal heart rate monitoring did not indicate a drug related negative impact on the fetus. Of the 29 (44.6%) women interviewed, 19 (65.5%) women reported an improvement in their well-being and 9 (31%) felt no different after the infusion. None of the women felt worse. No serious adverse effects were found and minor side effects occurred in 13 (20%) patients.ConclusionsOur prospective data is consistent with existing observational reports of the safe and effective use of ferric carboxymaltose in the treatment of iron deficiency anaemia in pregnancy.

Role of Intravenous Ferric Carboxy-maltose in Pregnant Women with Iron Deficiency Anaemia

“…Ferritin values also increased significantly after the infusion. 21 Earlier starting of iron supplementation in these patients, seems to be the most important strategy. 22 David et al, Evstatiev et al and Iftikhar et al [23][24][25] proved that FCM was well tolerated and had better compliance than other iron preparations.…”

Safety and efficacy of intravenous iron polymaltose, iron sucrose and ferric carboxymaltose in pregnancy: A systematic review

“…women; 41 studies ), FCM (n = 276 women; four studies 13,[52][53][54] ) and IPM (n = 164 women; three studies [55][56][57] ).…”

“…The majority of studies involved a comparison group of some kind including oral iron (n = 17; 36%), 11,14,16,19,24,26,27,29,31,32,34,35,37,39,50,56,57 IV iron (n = 4; 9%), 13 [14][15][16]18,20,24,26,28,31,[33][34][35][36][37][38][39]41,42,44,49,50,53 Only one study was identified that directly compared the administration of a full replacement dose of IV iron to a dose that was 300 mg less than the calculated full replacement dose. In comparing the two groups, administration of the full replacement dose was associated with a greater increase of 8 g/L 3-4 weeks after administration and 14 g/L at delivery.…”

“…0-4.5%) [55][56][57] was lower than FCM (5.0%; range: 0-20%) 13,[52][53][54] and IS (6.7%; range: 0-19.5%). 11,13,16,20,[22][23][24][25]27,31,32,34,36,38,40,44,49 Across all studies, the median reported prevalence of ADRs was similar among prospective (4.5%) 11,16,19,20,22,23,27,29,31,32,34,36,38,40,44,49,53,[55][56][57] and retrospective (5%) 13,52,54 studies.…”

Safety and Efficacy of Intravenous Ferric Carboxy Maltose in Iron Deficiency Anaemia During Postpartum Period

“…Ferritin values also increased significantly after the infusion. 9 David et al 10 , Evstatiev et al 11 and Iftikhar et al 12 proved that FCM was well tolerated and had better compliance than other iron preparations.The results of our study were consistent with the above mentioned trials. FCM has been shown to be an effective option in the treatment of IDA in multiple studies and it also improves the quality of life.…”