scholarly journals Treatment of iron deficiency and iron deficiency anemia with intravenous ferric carboxymaltose in pregnancy

2018 ◽  
Vol 298 (1) ◽  
pp. 75-82 ◽  
Author(s):  
Bernd Froessler ◽  
Tijana Gajic ◽  
Gustaaf Dekker ◽  
Nicolette A. Hodyl
2018 ◽  
Vol 298 (6) ◽  
pp. 1231-1232 ◽  
Author(s):  
Ibrahim A. Abdelazim ◽  
Bassam Nusair ◽  
Shikanova Svetlana ◽  
Gulmira Zhurabekova

Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Saleema Wani ◽  
Mariyam Noushad ◽  
Shabana Ashiq

Iron deficiency anemia (IDA) during pregnancy arises because of preexisting inadequate stores or complex physiological changes and can lead to serious maternal and fetal complications. Oral iron, either as iron sulfate or fumarate, with or without folic acid, is the most commonly used treatment for IDA in pregnancy. Intravenous (IV) iron has a role in the treatment of IDA in pregnancy, particularly in women who present late, display severe anemia (Hb ≤ 9 g/dL), or risk factors, and are intolerant/noncompliant of oral iron. Previously, administration of IV iron was minimal, owing to potentially serious anaphylactic reactions. Recently, new IV iron products have been developed, offering better compliance, tolerability, efficacy, and a good safety profile. Our study aimed to assess the effectiveness, safety, and tolerability of IV ferric carboxymaltose (FCM) in the treatment of IDA in pregnant women in the UAE. Data from 1001 pregnant women who received at least one administration of FCM (500, 1000, or 1500 mg) during their second or third trimester of pregnancy (2 years backward from study initiation) were collected retrospectively from electronic medical records at Corniche Hospital, Abu Dhabi, UAE. Results showed that 41.4% of the women were able to achieve an increase of ≥2 g/dL in blood hemoglobin overall. A change of ≥2 g/dL was achieved by 27.5% of women administered a dose of 500 mg, 39.2% of women administered a dose of 1000 mg, and 63.9% of women administered a dose of 1500 mg of IV FCM. This indicates a directly proportional relationship between increasing IV FCM dose and the increase of ≥2 g/dL in blood hemoglobin. A total of 7 (0.7%) women reported mild, nonserious adverse events during the study. Within the limits of this retrospective study, IV FCM therapy was safe and effective in increasing the mean hemoglobin of pregnant women with IDA.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2121-2121
Author(s):  
Pooja Mehra ◽  
Surabhi Palkimas ◽  
Laura Parsons ◽  
Theresa Libby ◽  
Leslie Ward ◽  
...  

Background: Anemia in pregnancy increases the need for blood transfusion during and after delivery and is associated with an increased risk of maternal and fetal mortality, therefore preventing maternal anemia may improve outcomes. Iron deficiency is the most common pathologic cause of anemia in pregnancy and is estimated to affect about 30% of pregnant women in the third trimester in the US. The baseline peripartum blood transfusion rate at our institution is 3.2%. Historically, patients who may have benefited from intravenous (IV) iron were continued on oral iron and subsequently delivered with persistent iron deficiency anemia. If identified to need IV iron, these patients were usually referred to a hematologist. However, in the absence of a structured protocol, referral was provider-dependent. Objective: We formed a multidisciplinary work group consisting of members from the departments of Hematology, Obstetrics, Pharmacy, Nursing, and Blood Bank to reduce peripartum blood transfusions by developing a process to manage pregnant patients with iron deficiency anemia. The treatment algorithm utilized at our institution was adapted from "How I treat anemia in pregnancy: iron, cobalamin, and folate" (Achebe & Gafter-Gvili, 2017), which recommends IV iron for hemoglobin less than 11 g/dL and ferritin less than 30 µg/dL in the third trimester and for hemoglobin less than 10.5 g/dL and ferritin less than 30 µg/dL in the second trimester along with recommendations for iron repletion in the first trimester. The primary endpoint was the utilization of blood transfusion. Secondary endpoints included an increase in maternal hemoglobin after treatment and evaluating the safety of IV ferric carboxymaltose as measured by side effects and frequency of hypophosphatemia. Five months after initiation of the IV iron recommendations, we performed an audit to assess its use. Methods: A retrospective IRB-approved chart review of anemic, iron-deficient pregnant women who received IV ferric carboxymaltose from 1/30/19 - 6/30/19 was performed. Thirty-six patients were identified and their charts were reviewed to determine the hemoglobin and ferritin levels prior to IV iron, the number of IV iron infusions received with any side effects, phosphorus levels on days of IV iron, hemoglobin level after IV iron, and need for peripartum blood transfusion. Results: Of the 36 patients who received IV iron for anemia in pregnancy, post-IV iron hemoglobin and blood transfusion information was only available for 26 patients. The remaining 10 patients had not delivered as yet or had delivered at another institution so data were not available. Of these 26 patients, the median age was 26.0 years and all received IV iron during their third trimester. No patients required a blood transfusion peripartum. The average hemoglobin prior to IV iron was 9.3 g/dL and the average hemoglobin after 1-2 IV iron infusions was 11.3 g/dL, an increase of 2.0 g/dL across the total group (Figure 1) (p<0.0001). Of these 26 patients, 7 patients received 1 dose of IV iron and 2 patients experienced heartburn or nausea during or soon after the IV iron infusion. Phosphorus levels were checked in 24 patients and 6 experienced hypophosphatemia with no attributable side effects. No patient experienced a serious adverse effect or reaction requiring discontinuation of IV iron therapy. Conclusion: Results from the first 5 months of this project suggest using a standardized iron deficiency anemia treatment protocol including IV iron to reduce the need for peripartum blood transfusion and increase hemoglobin levels. Additionally, our data suggest IV ferric carboxymaltose is well-tolerated in these patients. These results also support using multi-professional teams to improve the quality of healthcare delivery to pregnant patients with iron deficiency anemia. We have created an IRB-approved database to study more patient-centered postpartum outcomes such as quality of life among IV iron recipients as well as lactation rates and fetal outcomes. We plan to expand this strategy to other patients who have a predictable and likely preventable need for intermittent blood transfusion, such as patients with chronic gynecologic blood loss. Reference: Achebe, M. M., & Gafter-Gvili, A. (2017). How I treat anemia in pregnancy: iron, cobalamin, and folate. Blood, 129(8), 940-949. https://doi.org/10.1182/blood-2016-08-672246. Disclosures Davidson: ABIM: Other: American Board of Internal Medicine.


Author(s):  
Reema Kumar Bhatt ◽  
P. S. Rao ◽  
Sanjay Sharma ◽  
Chetan Yadav

Background: Iron deficiency is a common cause of anaemia in pregnancy which influences the health of mother and developing fetus. Intravenous (IV) iron preparations are considered, when oral iron therapy is ineffective or intolerant. Ferric carboxymaltose is an IV preparation that can be given with ease of administration and better tolerated. The aim of this study was to assess the efficacy and safety of IV ferric carboxymaltose in pregnant mother with all grades of anemia in the second and third trimester.Methods: This is a prospective observational study where 44 pregnant women with iron deficiency anemia [IDA] received ferric carboxymaltose up to 15mg/kg in second and third trimester. The parameters that were taken into account, to assess the effectiveness of the treatment was repeat haemoglobin [Hb] measurements and the subjective sense of wellbeing in the patient. The safety of the drug was analysed by continuous fetal heart rate [FHR] monitoring during the infusion and observation of any adverse reactions.Results: Ferric carboxymaltose intravenous infusion significantly increased Hb levels above baseline values in all women. The Increase in Hb levels were observed at 3- and 6-weeks post infusion therapy. FHR monitoring did not show any drug related unfavourable effect on the fetus. Of the 44 women interviewed, 33 (75%) women reported sense of well-being, 7 (15.9%) women could not feel any difference after the infusion and 4 (9.1%) patients could not comment. No serious adverse effects were noticed but minor side effects occurred in 3 (6.8%) patients.Conclusions: This prospective study showed safety and efficacy of ferric carboxymaltose in pregnancy with IDA which is consistent with available observational data.


Author(s):  
Stefanie Howaldt ◽  
Eugeni Domènech ◽  
Nicholas Martinez ◽  
Carsten Schmidt ◽  
Bernd Bokemeyer

Abstract Background Iron-deficiency anemia is common in inflammatory bowel disease, requiring oral or intravenous iron replacement therapy. Treatment with standard oral irons is limited by poor absorption and gastrointestinal toxicity. Ferric maltol is an oral iron designed for improved absorption and tolerability. Methods In this open-label, phase 3b trial (EudraCT 2015-002496-26 and NCT02680756), adults with nonseverely active inflammatory bowel disease and iron-deficiency anemia (hemoglobin, 8.0-11.0/12.0 g/dL [women/men]; ferritin, &lt;30 ng/mL/&lt;100 ng/mL with transferrin saturation &lt;20%) were randomized to oral ferric maltol 30 mg twice daily or intravenous ferric carboxymaltose given according to each center’s standard practice. The primary endpoint was a hemoglobin responder rate (≥2 g/dL increase or normalization) at week 12, with a 20% noninferiority limit in the intent-to-treat and per-protocol populations. Results For the intent-to-treat (ferric maltol, n = 125/ferric carboxymaltose, n = 125) and per-protocol (n = 78/88) analyses, week 12 responder rates were 67% and 68%, respectively, for ferric maltol vs 84% and 85%, respectively, for ferric carboxymaltose. As the confidence intervals crossed the noninferiority margin, the primary endpoint was not met. Mean hemoglobin increases at weeks 12, 24, and 52 were 2.5 vs 3.0 g/dL, 2.9 vs 2.8 g/dL, and 2.7 vs 2.8 g/dL with ferric maltol vs ferric carboxymaltose. Treatment-emergent adverse events occurred in 59% and 36% of patients, respectively, and resulted in treatment discontinuation in 10% and 3% of patients, respectively. Conclusions Ferric maltol achieved clinically relevant increases in hemoglobin but did not show noninferiority vs ferric carboxymaltose at week 12. Both treatments had comparable long-term effectiveness for hemoglobin and ferritin over 52 weeks and were well tolerated.


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