Safety Of Ferric Carboxymaltose Research Articles

Safety and Efficacy of FCM in the Management of Iron Deficiency Anaemia: a Multi-centre Cohort-based Study

This study investigated the efficacy and safety of ferric carboxymaltose (FCM) in the treatment of iron deficiency anaemia (IDA) in a cohort of 100 patients across four locations in West Bengal, India. The results demonstrated significant improvements in various hematological parameters, including a substantial increase in haemoglobin levels, following FCM administration. The study also highlighted the absence of adverse events, showcasing a favorable safety profile of FCM in this population. The use of FCM, a third-generation parenteral iron formulation, proved effective in addressing moderate-to-severe IDA, aligning with existing evidence supporting its efficacy and safety. The rapid and substantial improvement in haemoglobin levels observed within four weeks of FCM administration emphasizes its efficiency in iron repletion, particularly in cases where oral preparations may be insufficient. The absence of adverse effects further supports the tolerability of FCM, a crucial factor in its consideration for widespread use. The study contributes valuable real-world data, especially in the context of the high prevalence of anaemia in India. The findings underscore the potential of FCM as a cornerstone in the treatment of severe anaemia, advocating for its inclusion in targeted interventions and public health initiatives. Overall, this study adds to the growing body of evidence supporting FCM as a promising option in the management of iron deficiency anaemia.

Seven-Year Single-Center Experience of the Efficacy and Safety of Ferric Carboxymaltose in Cancer Patients with Iron-Deficiency Anemia.

Anemia remains an essential concern affecting the quality of life and the survival of cancer patients. Although there are different approaches to treating anemia in cancer patients, the number of studies reporting the efficacy of iron replacement in cancer patients is limited. In this study, the efficacy and safety of iron carboxymaltose, a parenteral iron treatment option, in the treatment of anemia, were examined retrospectively. A total of 1102 adult patients who received IV ferric carboxymaltose treatment at Hacettepe Oncology Hospital between 2014 and 2020 were included. The mean hemoglobin change observed at the end of the 12th week was 1.8 g/dL, and the rate of patients with an increase in hemoglobin of 1 g/dL or more was 72.1%. It was observed that the treatment demonstrated effectiveness in patients receiving active cancer treatment in all tumor types. The treatment was generally safe, and no grade 3-5 side effects were observed in the patients included in the study. According to one of the most extensive series published in the literature, iron carboxymaltose is an efficient and safe alternative for cancer patients with iron-deficiency anemia.

Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial

Prior clinical trials have investigated intravenous iron in patients with heart failure (HF) and iron deficiency, but the safety and efficacy of this therapy remains unclear. We report the baseline demographics and clinical characteristics of patients enrolled in the HEART-FID study and compare HEART-FID participants with patients within other contemporary clinical trials of patients with HF with reduced ejection fraction (HFrEF), including other intravenous iron trials. In the 3,065 participants randomized in HEART-FID, median (IQR) age was 69.7 (62.0-76.5) years, 1,037 (33.8%) were female, 322 (10.5%) were Black, median ejection fraction was 32% (25%-37%), 1,837 (60.0%) had ischemic etiology, and baseline median NT-proBNP was 1,462 (721-2,966) pg/mL. Median baseline hemoglobin was 12.6 (11.6-13.6) g/dL, and median 6-minute walk test distance was 272 (196-350) m, similar to prior intravenous iron HFrEF trials. Common comorbidities included atrial fibrillation/flutter (43.7%), and type 2 diabetes (45.2%). Compared with several recent HFrEF trials, patients enrolled in HEART-FID had similar baseline demographics and clinical characteristics, though a greater proportion of women and Black participants were recruited in HEART-FID. In HEART-FID, HFrEF therapy included a beta-blocker in 92.5%, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitors (ARNI) in 86.1% (with 29.7% ARNI), and a mineralocorticoid antagonist (MRA) in 55.6%. Patients enrolled in HEART-FID were similar to those enrolled in other contemporary HFrEF trials and registries, including trials of intravenous iron in HFrEF. However, the HEART-FID cohort is substantially larger and more racially diverse than prior trials of intravenous iron in HFrEF. ClinicalTrials.gov (NCT03037931).

Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnancy: A Subgroup Analysis of a Multicenter Real-World Study Involving 1191 Pregnant Women.

Real-world evidence of the efficacy and safety of ferric carboxymaltose (FCM) infusion in Indian pregnant women with iron deficiency anemia (IDA) is lacking. To assess the efficacy and safety of intravenous (IV) FCM in Indian pregnant women with IDA in 4 weeks in a real-life scenario. This is a subgroup analysis of our previously conducted retrospective, multicenter, observational, real-world PROMISE study. Data on demographic and hematological parameters, patient-reported adverse events, and physicians' clinical impressions of efficacy and safety were analysed at 4 ± 1 week. This subgroup analysis included 1191 pregnant women in whom IV FCM resulted in a significant increase in hemoglobin (Hb) by 2.8 g/dL and serum ferritin by 30.03 μg/L at 4 weeks (P < 0.001 for both). In 103 pregnant women with severe IDA, there was a significant increase in Hb by 3.6 g/dL (P < 0.001), and serum ferritin by 16.96 μg/L (P=0.12). In 978 pregnant women with moderate IDA, significant improvement in Hb by 2.74 g/dL and serum ferritin by 33 μg/L (P < 0.001 for both) was noted. Similarly, there was a significant increase in red blood cell count, hematocrit, mean corpuscular volume, and mean corpuscular hemoglobin (P < 0.001 for all). In pregnant women with mild IDA (n = 26), Hb increased significantly by 1.99 g/dL (P < 0.001). Adverse effects were reported in 8.6% of pregnant women. No new safety signals or serious adverse effects were observed. Based on physicians' global assessment, good to very good efficacy and safety of IV FCM was noted in 99.2% and 98.6% of pregnant women, respectively. IV FCM rapidly corrected anemia in a short period of 4 weeks with favorable safety in the second and third trimester of pregnancy with all severities of IDA (severe, moderate, and mild). The physicians' favorable global assessment of FCM's efficacy and safety in pregnant women with IDA supports its use in daily clinical practice. This trial is registered with CTRI/2021/12/039065.

Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India.

BackgroundParenteral iron preparations, like ferric carboxymaltose (FCM), are commonly used to manage moderate-to-severe iron deficiency anemia (IDA). Real-world data on efficacy and safety of FCM is limited in India.MethodsA retrospective, observational and real-world study was conducted to assess the efficacy and safety of FCM in adolescents and adults with IDA across 269 centers in India. Data was retrieved from medical records of patients who received FCM for management of IDA. Physicians’ clinical assessment of efficacy and safety of FCM was also assessed. Data were analyzed for hematological parameters at baseline and at 4 ± 1 week for study population, and for severity of anemia.ResultsIn 1800 patients with IDA, intravenous FCM resulted in a significant increase in hemoglobin (Hb) of 2.76 g/dL, serum ferritin of 35.85 µg/L, red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (P < 0.001 for all) at 4 ± 1 week as compared to baseline. In subjects with severe IDA, an increase in Hb was of 3.31 g/dL, serum ferritin increased of 35.84 µg/L, RBC count, hematocrit and MCH improved significantly (P < 0.001 for all). In subjects with moderate IDA, Hb (increase of 2.63 g/dL), serum ferritin (increase of 35.92 µg/L), RBC count, hematocrit, MCV, and MCH improved significantly (P < 0.001 for all). In subjects with mild IDA, only the mean Hb values at 4 weeks were significantly higher (P < 0.001; increased by 1.89 g/dL). Physicians rated efficacy of FCM as very good to good in 97.5% of patients. Similarly, safety of FCM was rated very good to good in 97.2% subjects.ConclusionFCM efficiently, safely and quickly corrects moderate-to-severe anemia in Indian patients in a short span of 4 weeks. Physicians’ positive clinical impression of efficacy and safety supports clinical usage of FCM in real-world scenario.

MO526: Renal Function in Patients With Non-Dialysis Kidney Disease Treated With Ferric Carboxymaltose

Abstract BACKGROUND AND AIMS Iron deficiency anemia occurs in most patients with non-dialysis chronic kidney disease (ND-CKD). Several studies have suggested the efficacy and safety of ferric carboxymaltose (FCM) in this group of patients, but none have shown a positive impact on renal function. The aim our study was to investigate the impact of FCM on renal function in ND-CKD patients. METHOD Prospective observational study of ND-CKD stages 3 to 5 patients, with anemia and iron deficiency [ferritin level &amp;lt;100 µg/L or &amp;lt;200 µg/L with transferrin saturation (TSAT) &amp;lt;20%], treated with FCM from 01 January 2019 to 31 June 2021. FCM was administrated as a single IV infusion. Patients were categorized into two cohorts according to the dose of FCM received: 500 mg or 1000 mg. Clinical and analytical data were compared among groups at baseline and 24 weeks after infusion. Renal function was assessed using estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI formula. Statistical analysis was executed using SPSS (Version 23 for Mac OSX). RESULTS The mean age of 140 patients was 77.31 ± 9.68 years, 62 (44.3%) were male, 86 (61.4%) were diabetic, 84 (60%) had congestive heart failure and 121 (86.4%) had hypertension. Thirty-five (25%) patients had CKD stage 3, 74 (52.9%) had stage 4 and 31 (22.1%) had stage 5. Seventy-eight (55.7%) patients were treated with 1000 mg of FCM. There were no gender, comorbidity, CKD etiology or stage differences among groups. Patients treated with 1000 mg were younger (74.36 ± 13.59 versus 78.44 ± 9.28 years, P = .046). At baseline, mean Hb was 10.4 ± 1.35, 10.27 ± 1.47 and 10.54 ± 1.2 g/dL and mean eGFR was 26.18 ± 17.167, 23.55 ± 4.17 and 28.71 ± 19.43 mL/min/1.73 m2 for the whole group, 1000 mg and 500 mg cohorts. At 24 weeks, Hb showed an increase of 1.24 ± 1.78 (P = .001), 1.54 ± 1.99 (P = .001) and 0.86 ± 1.4 g/dL (P = .001), and eGFR an increase of 1.13 ± 6.49 (P = .041) and 1.55 ± 6.87 mL/min/1.73 m2 (P = .049) for the whole group and 1000 mg cohort, but not 500 mg cohort. A Pearson correlation was performed and revealed a positive correlation between the variation of Hb and eGFR during the study follow-up period (r = .283, P = .001 and r = .310, P = .008) in the same groups. CONCLUSION In addition to the effectiveness in correcting iron deficiency anemia in patients with ND-CKD, our results suggest a positive impact on renal function of higher doses of FCM after 6 months of administration.

Ferric carboxymaltose for treatment of iron deficiency and iron deficiency anemia caused by abnormal uterine bleeding.

Heavy menstrual bleeding leads to depletion of iron stores, with subsequent iron deficiency (ID) and iron deficiency anemia (IDA). To evaluate the efficacy and safety of ferric carboxymaltose (FCM) in treatment of ID/IDA caused by abnormal uterine bleeding (AUB). One hundred and twenty women ≥ 40 years old with chronic AUB and ID/IDA were included in this study for correction of ID/IDA. Participants received FCM infusion for correction of ID/IDA. The pre-treatment ferritin, hemoglobin (Hb), red blood cell (RBC) mean corpuscular volume (MCV), and RBC mean corpuscular hemoglobin (MCH) values were compared with the 6- and 12-week post-treatment values. The pre-treatment ferritin and Hb levels significantly increased from 13.2 ±7.4 µg/l and 8.8 ±0.8 g/dl, respectively, to 111.5 ±5.6 µg/l and 13.9 ±0.6 g/dl, respectively, 6 weeks after FCM (p = 0.001 and 0.0009; respectively), and to 98.7 ±6.1 µg/l and 12.9 ±0.65 g/dl, respectively, 12 weeks after FCM (p = 0.01 and 0.01; respectively). In addition, the pre-treatment RBC MCV and RBC MCH values significantly increased from 74.3 ±2.3 fl and 26.6 ±5.3 pg, respectively, to 88.7 ±1.9 fl and 29.6 ±4.5 pg, respectively, 6 weeks after FCM (p = 0.01 and 0.03, respectively), and to 93.3 ±1.75 fl and 30.3 ±3.8 pg, respectively, 12 weeks after FCM (p = 0.001 and 0.0001, respectively). FCM was safe and effective for correction of ID/IDA caused by chronic AUB within 6 weeks. The serum ferritin, Hb, and RBC indices remained significantly high compared to the pre-treatment values 12 weeks after FCM infusion.

Letter to “Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real‐life experience”

Journal of Obstetrics and Gynaecology ResearchVolume 48, Issue 2 p. 515-515 Letter to the Editor Letter to “Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real-life experience” Sanjay A. Gupte, Corresponding Author Sanjay A. Gupte guptehospital@gmail.com Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorGayatri Venkataraman, Gayatri Venkataraman Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorAarti S. Shah, Aarti S. Shah Department of Reproductive Medicine, Pulse Clinic, Ahmedabad, IndiaSearch for more papers by this author Sanjay A. Gupte, Corresponding Author Sanjay A. Gupte guptehospital@gmail.com Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorGayatri Venkataraman, Gayatri Venkataraman Department of Obstetrics and Gynecology, Gupte Hospital and Centre for Research in Reproduction, Pune, IndiaSearch for more papers by this authorAarti S. Shah, Aarti S. Shah Department of Reproductive Medicine, Pulse Clinic, Ahmedabad, IndiaSearch for more papers by this author First published: 21 November 2021 https://doi.org/10.1111/jog.15106Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume48, Issue2February 2022Pages 515-515 RelatedInformation

Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real-life experience.

There is limited clinical evidence of ferric carboxymaltose injection (FCM) usage in Indian pregnant women. We assessed the efficacy and safety of FCM in Indian pregnant women with moderate-to-severe anemia. Single-center, retrospective, observational data collection was conducted at a tertiary care research institute. Data of pregnant women with anemia who received FCM in their second and third trimester was retrieved and analyzed for hematological parameters at baseline and at 4 ± 2 weeks. Neonatal outcomes were also assessed. Adverse events and other safety parameters were noted. Data of 271 patients was retrieved and analyzed for safety and data for 168 patients analyzed for efficacy. A significant increase in hemoglobin was noted with FCM in 4 weeks (1.25 g/dL; p < 0.001). Patients with severe anemia reported an increase in hemoglobin of 4.23 g/dL (p=0.01). Patients receiving FCM in the second trimester noted a significant increase in hemoglobin of 1.74 g/dL (p < 0.001). A significant increase in hemoglobin was noted as early as 20 days (p < 0.001) and also in patients receiving FCM after 34 weeks (p=0.002). No adverse fetal or neonatal outcomes were observed. Adverse events noted in 4% of patients with itching and rash being most common. Continuous monitoring of blood pressure, heart rate, and oxygen saturation for 40 min during and after FCM administration reported no deterioration or negative safety signal. FCM corrects anemia in all subsets of Indian pregnant women and supports evidence of efficacy and safety. Continuous monitoring of vital parameters during FCM infusions supports its excellent safety.

Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials.

ImportancePerioperative anemia is a common comorbid condition associated with increased risk of morbidity and mortality in patients undergoing elective surgical procedures.ObjectiveWe conducted a systematic literature review (SLR) to determine the efficacy and safety of the use of intravenous ferric carboxymaltose (FCM) for the treatment of perioperative anemia in preoperative, intraoperative, and postoperative elective surgical care.Evidence ReviewStudies meeting inclusion criteria for the SLR reported on treatment efficacy in an adult study population randomly allocated to FCM for the treatment of perioperative anemia during the perioperative period. After screening, 10 of 181 identified studies from searches in MEDLINE and EMBASE databases were identified for inclusion in this review.FindingsPreoperative treatment was reported in six studies, intraoperative treatment in one study, postoperative treatment in two studies, and both pre- and postoperative treatment in one study. Together, 1975 patients were studied, of whom 943 were randomized to FCM, of whom 914 received FCM treatment. The 10 studies reported elective surgical populations for colorectal, gastric, orthopedic, abdominal, urologic, plastic, neck, gynecologic, and otolaryngologic procedures. Given the clinical and methodological heterogeneity of the studies, the analyses were limited to qualitative assessments without meta-analyses. All 10 studies reported statistically greater changes in hemoglobin concentration, serum ferritin, and/or transferrin saturation with FCM treatment compared with comparators (placebo, oral iron, standard care, or a combination of these). Two studies reported statistically significant differences in transfusion rate and 2 studies reported significant differences in length of hospital stay between FCM and its comparator(s).Conclusions and RelevanceThis SLR adds to existing data that administration of FCM in preoperative and postoperative settings improves hematologic parameters. Several studies in the review supported the beneficial effects of FCM in reducing transfusion rate and length of stay. Larger, well-designed, longer-term studies may be needed to further establish the efficacy and safety of FCM in elective surgery patients with perioperative anemia.

The newest information for iron metabolism: ferric carboxymaltose, a recently available treatment option for iron-deficiency anemia

Iron-deficiency anemia (IDA) is the most common form of anemia. It is treated through iron replacement therapy, with oral iron administration as the recommended first-line treatment. However, intravenous (IV) iron formulation is at timed used owing to adverse effects of oral iron administration such as gastrointestinal symptoms. Although saccharated ferric iron oxide had been the only available IV iron formulation in Japan for a long time, ferric carboxymaltose (FCM) has recently been approved. In this review, the characteristics, efficacy, and safety of FCM will be discussed mainly by introducing the results of three clinical trials for FCM conducted in Japan. More effective treatment for patients with IDA might be achieved through the introduction of FCM administration in clinical settings.

Efficacy and safety of ferric carboxymaltose in anemia in pregnancy

Objectives: To study the role, safety and efficacy of ferric carboxymaltose in antenatal women. Methodology: This will be a prospective interventional study conducted in Obstetrics and Gynaecology department of AMC MET medical college. Study group of 40 antenatal women between 20 weeks to 32 weeks of gestation will be followed through. Haemoglobin level before infusion of FCM and after 2 weeks of infusion will be estimated. The efficacy of ferric carboxymaltose will be analysed in study group. The evaluation of safety and tolerance to mother will also be monitored. Inclusion criteria: Gestational age > 20 weeks and < 32 weeks, Haemoglobin concentration of > 6 gm% and < 8 gm%. Exclusion criteria: Hypersensitivity reaction to any iron preparation, History of blood transfusion, History of iron overload diseases, Concomitant medical or surgical diseases. Results: A total of 40 antenatal patients were included in our study. It’s observed that the incidence of anaemia was higher among the reproductive age group especially in pregnant women of 21 to 30 years of age, than so in age group less than 20 and more than 30. Out of which 35% were primigravida and 65% were multigravida. Among 40 patients who received Inj. Ferric carboxylate maltose, 3 patients developed drug reactions. The mean rise in haemoglobin was found to be 0.9gm/dl at the end of 15 days from treatment. Correspondingly the MCV and RDW values were up by 11fL and 4.3% respectively. Conclusion: Ferric carboxymaltose is a safe and effective treatment option for iron deficiency anaemia in antenatal patients.

Pharmacokinetic, Pharmacodynamic, and Safety Profiles of Ferric Carboxymaltose in Chinese Patients with Iron-deficiency Anemia

PurposeIron deficiency (ID) is one of the most commonly known nutritional deficiencies and is considered the primary cause of anemia (iron-deficiency anemia). Ferric carboxymaltose (FCM), an intravenous iron preparation, has been widely used for >10 years for iron-deficiency anemia treatment worldwide because of its many advantages. MethodsThis single-center, open-label, single dose escalation study in Chinese subjects was designed to assess the pharmacokinetic/pharmacodynamic parameters and safety of FCM in this population. The first 12 subjects received a 500-mg dose; after assessing safety data from the first 6 subjects in this cohort, another 12 subjects were assigned to the 1000-mg dose cohort. FindingsAfter an infusion of FCM over 15 min, a rapid dose-dependent increase in total serum iron levels was observed with a median Tmax of 30 min following the start of the infusion for both cohorts. The Cmax and AUC for the 1000-mg dose were ~1.8-fold (p = 0.2929) and 2.3-fold (p = 0.0318) those associated with the 500-mg dose, respectively. Mean terminal t1/2 values were 12.3 and 10.5 h for the 2 cohorts. The renal elimination of FCM was negligible (<0.1%). Increase in mean serum iron levels and ferritin concentrations showed dose dependency. Iron-binding capacity was transiently well utilized after dosing, as indicated by transferrin saturation >88% with 500-mg FCM and >90% with 1000-mg FCM. Hemoglobin levels did not show significant changes during the 7-day observation period, whereas mean reticulocyte counts significantly increased in both cohorts, suggesting activation of the hematopoietic system. FCM was well tolerated in these Chinese subjects. No new or unexpected treatment-emergent adverse events were attributable to FCM. ImplicationsThe pharmacokinetic/pharmacodynamic and safety profiles in Chinese subjects seemed comparable to those in white and Japanese populations. ChinaDrugTrials.org.cn identifier: CTR20160863

Effectiveness and safety of ferric carboxymaltose therapy in peritoneal dialysis patients: an observational study.

BackgroundThe efficacy of intravenous (IV) ferric carboxymaltose (FCM) has been demonstrated in haemodialysis and non-dialysis studies, but evidence is lacking in patients undergoing peritoneal dialysis (PD).MethodsThis multicentre, retrospective study evaluated the effectiveness and safety of FCM in patients on PD over 12 months. We retrospectively reviewed the electronic medical records of PD patients who initiated FCM treatment between 2014 and 2017 across seven Spanish centres.ResultsNinety-one patients were included in the safety population (mean ± SD age 57.7 ± 15.0 years) and 70 in the efficacy population (mean age 50.9 ± 14.5 years). No hypersensitivity reaction, FCM discontinuation or dose adjustment due to a serious adverse event (SAE) was registered in the safety population. The most common non-SAEs reported were headache (four events), mild hypotension (three events) and hypertension (two events), among others. In the efficacy population (n = 70), 68.6% of patients achieved ferritin levels of 200–800 ng/mL, 78.4% achieved transferrin saturation (TSAT) >20%, and 62.8% achieved TSAT >20% and ferritin >200 ng/mL after 12 months of FCM initiation (P < 0.01). Haemoglobin (Hb) levels were maintained at >11 g/dL with a lower dose of darbepoetin throughout the follow-up. The sub-analysis of patients naïve to IV iron and with absolute or relative iron deficiency (n = 51) showed that 76.5% reached ferritin >200 ng/mL, 80.4% TSAT >20% and Hb increased (1.2 g/dL) after 4 months of FCM treatment (P < 0.01).ConclusionIn this multicentre, retrospective, real-world study conducted in the PD population, FCM was effective, safe and easy to administer during routine clinical visits.

REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women.

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.

Treatment with ferric carboxymaltose in stable patients with severe iron deficiency anemia in the emergency department.

The AABB Choosing Wisely Campaign recommends "don't transfuse for iron deficiency without hemodynamic instability". However, the management of iron deficiency anemia (IDA) in the emergency department (ED) is heterogeneous and patients are often over-transfused. Intravenous iron is effective in correcting anemia and new formulations, including ferric carboxymaltose (FCM), allow the administration of high doses with low immunogenicity. The aim of this retrospective study was to analyze the management of hemodynamically stable patients aged 18-55years with severe IDA (hemoglobin < 8g/dL), who presented to the ED from January 2014 to July 2018. Patients who received FCM (FCM1) and those who did not receive FCM (FCM0) were compared. Efficacy and safety of FCM at follow-up were evaluated. Seventy-one subjects fulfilled the inclusion criteria (FCM0 n = 48; FCM1 n = 23). The mean Hb at admission was 6.6g/dL. 40% in the FCM0 and 13% in FCM1 were transfused (p = 0.02). 21% of FCM0 patients were admitted to the ward, while all FCM1 were discharged (p = 0.02). Within 2 weeks, the Hb increase was 2.8 ± 1g/dL in the FCM1 group. Sixteen FCM1 patients were evaluated at 52 ± 28days (median 42, range 27-122): the average Hb increase was 5.3 ± 1.4g/dL. In summary, we showed that FCM administration in the ED in hemodynamically stable patients was associated with fewer transfusions and hospital admissions compared to the FCM0 group; moreover, it succeeded in safely, effectively and rapidly increasing Hb levels after discharge from the ED. Further studies are needed to develop recommendations for IDA in the ED and to identify transfusion thresholds for non-hospitalized patients.

Effectiveness and safety of ferric carboxymaltose to treat iron deficiency anemia in cancer patients.

e23153 Background: Most cancer patients are faced with anemia during the disease course. Iron deficiency (ID) is one of the major causes of anemia in cancer patients.Bleeding, malabsorption and organ dysfunction may cause iron deficiency in cancer patients. Anemia may result in a decrease in the patient's performance and delayed chemotherapy. Administration of intravenous (IV) iron is a therapeutic option in cancer patients with iron-deficiency related anemia. In this study we analyzed effectiveness and tolerability of ferric carboxymaltose in cancer patients with iron deficiency anemia Methods: This is a retrospective analysis of 603 cancer patients who were treated with ferric carboxymaltose for anemia and iron-deficiency between October 2014 and April 2017 in a tertiary cancer clinic. Demographic data, cancer diagnoses, pre- and post-treatment hemoglobin levels, pre-treatment ferritin, serum iron, and transferrin saturation (TSA) levels were recorded. Results: The median age of the population was 55 (22-90) years, and 52% were male. Of 603 patients, 47.9% (n = 289) had gastrointestinal malignancies and 17% (n = 103) had breast cancer. A total of 331 patients (55%) received cytotoxic chemotherapy and 272 patients (45%) were not on anti-cancer treatment. Median dose of the ferric carboxymaltose is 1000 mg (500-2000). The median baseline hemoglobin, ferritin and TSA were 10.7 (7-13) g/dl, 28 (2.9-2200) ng/ml and 9.3 (1-19) %, respectively. The median hemoglobin level at the 12th week of treatment was 12.7 g/dl. The median increase in hemoglobin was 2.9 (-0.10-6.9) g/dl in patients whom received cytotoxic chemotherapy. Only 2 patients had allergic reaction during IV ferric carboxymaltose administration and treatment was discontinued. Conclusions: Intravenous-iron improved hemoglobin levels both in actively treated and not-actively treated cancer patients. The effect has been shown in the first 3 months after injection. This approach is safe and tolerable. However, the impact of tumor progression on IV iron replacement is unclear, further studies are required.

Efficacy and Safety of Ferric Carboxymaltose Therapy in Continuous Flow LVAD Patients

Purpose Iron deficiency (ID) is common in heart failure patients and is associated with reduced exercise capacity, fatigue, worsening heart failure and increased rate of heart failure hospitalization. Intravenous iron therapy allows restoration of iron deficiency, increasing hemoglobin levels and ameliorates functional capacity. In this study, we aimed to determine the efficacy and safety of ferric carboxymaltose (FCM) treatment in continuous flow LVAD patients Methods In the study, we retrospectively analysed 29 patients treated with 1000 mg IV iron (FCM) due to ID between June 2018 and October 2018. We evaluated the effect of therapy on functional capacity, six-minute walking distance(6MWD), and laboratory findings. Results Mean age of the population was 51.6 ± 13.4 years, and 69% of the patients were male. Mean body mass index(BMI) was 26.8 ± 5.47kg/m2. The mean follow-up period after FCM infusion was 97.8 ± 21.2 days. NYHA functional class decreased from 1.83 ± 0.46 to 1.39 ± 0.49. 6MWD increased from 371 ± 75 meters to 395 ± 60 meters, mean change was 13.7 ± 35 meters. Hematological parameters (hemoglobin, hematocrit, blood iron level, ferritin, TSAT) improved. Mean NT pro-BNP value decreased from 1520 ± 1429 pg/ml to 1513 ± 1817 pg/ml, mean change was 6.7 pg/ml. The number of thrombocytes decreased (276 ± 97 to 220 ± 49.8, mean change 56.1 ± 87.7), mean platelet volume increased (10.25 ± 1.01 to 10.43 ± 0.92, mean change 0.188±0.55) and platecrit decreased (0.28 ± 0.071 to 0.23 ± 0.047, mean change -0.048 ± 0.074) In the follow up period four patients developed pump thrombosis (PT) and treated with iv thrombolytic therapy. When we compare the iron treated patients with the ones who were not treated there was an increase in the rate of pump thrombosis although it did not reach significance (PT rates were respetively, 13.7% - 6.3%, p=0.239). The variables associated with pump thrombosis were BMI (PT:50.7 ± 13.7 kg/m2- nonPT:57.25 ± 10.6 kg/m2 p=0.001), increase in mean platelet volume (PT: 10.3 ± 0.94 fl - nonPT: 11.15 ± 0.17 fl, p=0.001) and increase in platecrit (PT: 0.225 ± 0.039 % - nonPT:0.282 ± 0.063%, p= 0.023) after therapy. Conclusion FCM therapy increased functional class and 6MWD in LVAD patients with ID. Natriuretic peptid levels decreased after therapy. However there was a trend in pump thrombosis after therapy. Further studies are needed to establish the safety of FCM therapy in this population.

Ferric carboxymaltose in the treatment of iron deficiency in pediatric inflammatory bowel disease.

Iron deficiency (ID) with or without anemia is a common complication of pediatric inflammatory bowel disease (IBD), causing significant morbidity. Despite this, ID remains prevalent and undertreated, related in part to questions surrounding optimal formulation and route of administration. Ferric carboxymaltose (FCM) is a recent formulation of intravenous iron, allowing higher doses and rapid infusion times. This study aims to demonstrate the efficacy and safety of FCM in paediatric patients with IBD, and explore the differences between patients with active and quiescent disease. Paediatric patients 6-18 years with IBD with iron deficiency (ID) or iron deficiency anemia (IDA) were treated prospectively with FCM at the Queensland Children's Hospital in Brisbane. Patients received FCM as a single dose of 15 mg/kg up to 1,000 mg over 15-20 min. Biochemical parameters measured prior to and approximately 8 weeks after the infusion were: hemoglobin (Hb), mean corpuscular volume (MCV), ferritin, and transferrin saturation (TS). C-reactive protein (CRP) was measured as a marker of co-existing inflammation. Resolution of anemia or ID was assessed following treatment, with adverse events captured. A total of 101 patients received infusions of FCM during the study period and were analysed, median age 14 (IQR 14-16) years. A total of 44% of patients underwent treatment for IDA, while 56% were for ID without anemia. Following FCM infusion, 64% of patients with IDA had resolution of anemia, with 81% showing resolution for ID without anemia. Elevation of CRP throughout the study period had no influence on resolution of IDA with FCM (P=0.68), but in patients with ID, patients with quiescent disease activity were more likely to have resolution of ID [odds ratios (ORs) 5.1; P=0.03]. Rapid, high dose FCM in children aged 6 and over is safe, well tolerated and efficacious for correction of ID. Replenishing iron in IBD is important and FCM improves our ability to meet this need.

A prospective study on the efficacy and safety of ferric carboxymaltose in correcting anaemia in patients with heavy menstrual bleeding

A prospective study on the efficacy and safety of ferric carboxymaltose in correcting anaemia in patients with heavy menstrual bleeding