Safety Of Intravenous Ferric Carboxymaltose Research Articles

Randomized Controlled Trial of Intravenous Ferric Carboxymaltose vs Oral Iron to Treat Iron Deficiency Anemia After Variceal Bleed in Patients With Cirrhosis.

Limited evidence exists on the optimal strategy to correct iron deficiency anemia after variceal bleeding (VB) in cirrhosis. This trial compared the efficacy and safety of intravenous ferric carboxymaltose (IV-FCM) with those of oral iron therapy in this cohort. In this open-label, single-center, randomized controlled trial, eligible patients with hemoglobin <10 g/dL and iron deficiency (ferritin <100 ng/mL) after VB received either IV-FCM (1,500-2,000 mg) divided into 2 doses (n = 48) or oral carbonyl iron (100 mg elemental iron/day) (n = 44) for 3 months. The primary outcome was change in hemoglobin at 3 months. Secondary outcomes included improvement in anemia (last hemoglobin >12 g/dL), normalization of iron stores (ferritin >100 ng/mL), liver-related adverse events, adverse drug reactions, and changes in quality of life (CLDQOL questionnaire). Baseline characteristics, including median Child-Turcotte-Pugh score 7 (interquartile range [IQR] 6-9), Model for End-Stage Liver Disease score 12 (IQR 10-17), blood hemoglobin (8.25 ± 1.06 g/dL), and ferritin (30.00 ng/mL [15.00-66.50]), were comparable in both arms. The median increase in hemoglobin at 3 months in the IV and oral arms was 3.65 g/dL (IQR 2.55-5.25) and 1.10 g/dL (IQR 0.05-2.90 g/dL) ( P < 0.001), respectively. Iron stores normalized in 84.6% and 21% of the IV and oral arms, respectively ( P < 0.001). Anemia improved in 50% and 21.9% in the IV and oral arms, respectively ( P < 0.009). Patients in the IV arm showed a significant improvement in all domains of CLDQOL. Liver-related adverse events were comparable in both arms. Transient mild/moderate hypophosphatemia developed in 43% of patients receiving IV-FCM. Intravenous iron replacement is efficacious and safe to treat iron deficiency anemia after VB in patients with cirrhosis.

Clinical efficacy and safety of intravenous ferric carboxymaltose for treatment of restless legs syndrome: a multicenter, randomized, placebo-controlled clinical trial.

Iron therapy is associated with improvements in restless legs syndrome (RLS). This multicenter, randomized, double-blind study evaluated the effect of intravenous ferric carboxymaltose (FCM) on RLS. A total of 209 adult patients with a baseline International RLS (IRLS) score ≥ 15 were randomized (1:1) to FCM (750 mg/15 mL) or placebo on study days 0 and 5. Ongoing RLS medication was tapered starting on Day 5, with the goal of discontinuing treatment or achieving the lowest effective dose. Co-primary efficacy endpoints were changed from baseline in IRLS total score and the proportion of patients rated as much/very much improved on the Clinical Global Impression (CGI)-investigator (CGI-I) scale at day 42 in the "As-Treated" population. The "As-Treated" population comprised 107 FCM and 101 placebo recipients; 88 (82.2%) and 68 (67.3%), respectively, completed the day 42 assessment. The IRLS score reduction was significantly greater with FCM versus placebo: least-squares mean (95% confidence interval [CI]) -8.0 (-9.5, -6.4) versus -4.8 (-6.4, -3.1); p = .0036. No significant difference was observed in the proportion of FCM (35.5%) and placebo (28.7%) recipients with a CGI-I response (odds ratio 1.37 [95% CI: 0.76, 2.47]; p = .2987). Fewer patients treated with FCM (32.7%) than placebo (59.4%) received RLS interventions between day 5 and study end (p = .0002). FCM was well tolerated. The IRLS score improved with intravenous FCM versus placebo, although the combination of both co-primary endpoints was not met. Potential methodological problems in the study design are discussed.

A comparative study of ferric carboxymaltose and iron sucrose as a parenteral iron treatment in iron deficiency anemia during pregnancy in a tertiary care hospital

Background: Anemia from the Greek word (anhaima) meaning “without blood” is the deficiency of red blood cell and/or hemoglobin which result in reduced oxygen-carrying capacity of blood causing tissue hypoxia. Aims and Objectives: To study the efficacy and safety of intravenous ferric carboxymaltose (FCM) versus iron sucrose in the management of iron deficiency anemia in pregnancy. Materials and Methods: A prospective, single-center, comparative interventional randomized study was carried among 180 antenatal mother admitted to antenatal ward in the Department of Obstetrics and Gynaecology of Burdwan Medical College and Hospital, from July 1st, 2020, to December 30th, 2021. Results: A total of 180 patients, 90 patients in each FCM and iron sucrose group, were included in the study. There was significant (P=0.001) mean change in hemoglobin (Hb) level in both the groups from pre-treatment to 3 and 6-week post-treatment. There was also a significant (P=0.001) mean change in ferritin level in both the groups from pre-treatment to 3 and 6-week post-treatment. The mean change in Hb level and ferritin level was higher among patients of FCM compared to iron sucrose. The adverse reactions were lower among patients of FCM than iron sucrose. Conclusions: This study found that FCM is safer than iron sucrose. Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly high rise of Hb and ferritin levels over a 6-week period with lesser adverse effects.

Efficacy, tolerability, and safety of intravenous ferric carboxymaltose compared with oral ferrous sulfate for the treatment of iron deficiency anemia during the antepartum period

Efficacy, tolerability, and safety of intravenous ferric carboxymaltose compared with oral ferrous sulfate for the treatment of iron deficiency anemia during the antepartum period

Safety, pharmacokinetics, and pharmacodynamics of intravenous ferric carboxymaltose in children with iron deficiency anemia

BackgroundIron deficiency is the primary cause of anemia in children. Intravenous (IV) iron formulations circumvent malabsorption and rapidly restore hemoglobin.MethodsThis Phase 2, non-randomized, multicenter study characterized the safety profile and determined appropriate dosing of ferric carboxymaltose (FCM) in children with iron deficiency anemia. Patients aged 1–17 years with hemoglobin <11 g/dL and transferrin saturation <20% received single IV doses of undiluted FCM 7.5 mg/kg (n = 16) or 15 mg/kg (n = 19).ResultsThe most common drug-related treatment-emergent adverse event was urticaria (in three recipients of FCM 15 mg/kg). Systemic exposure to iron increased in a dose-proportional manner with approximate doubling of mean baseline-corrected maximum serum iron concentration (157 µg/mL with FCM 7.5 mg/kg; and 310 µg/mL with FCM 15 mg/kg) and area under the serum concentration–time curve (1901 and 4851 h·µg/mL, respectively). Baseline hemoglobin was 9.2 and 9.5 g/dL in the FCM 7.5 and 15 mg/kg groups, respectively, with mean maximum changes in hemoglobin of 2.2 and 3.0 g/dL, respectively.ConclusionsIn conclusion, FCM was well tolerated by pediatric patients. Improvements in hemoglobin were greater with the higher dose, supporting use of the FCM 15 mg/kg dose in pediatric patients (Clinicaltrials.gov NCT02410213).ImpactThis study provided information on the pharmacokinetics and safety of intravenous ferric carboxymaltose for treatment of iron deficiency anemia in children and adolescents.In children aged 1–17 years with iron deficiency anemia, single intravenous doses of ferric carboxymaltose 7.5 or 15 mg/kg increased systemic exposure to iron in a dose-proportional manner, with clinically meaningful increases in hemoglobin.The most common drug-related treatment-emergent adverse event was urticaria.The findings suggest that iron deficiency anemia in children can be corrected with a single intravenous dose of ferric carboxymaltose and support use of a 15 mg/kg dose.

Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial

BackgroundAnaemia in pregnancy is highly prevalent in African countries. High-dose oral iron is the current recommended treatment for pregnancy-related iron deficiency anaemia (IDA) in Nigeria and other African countries. This oral regimen is often poorly tolerated and has several side effects. Parenteral iron preparations are now available for the treatment of IDA in pregnancy but not widely used in Africa.The IVON trial is investigating the comparative effectiveness and safety of intravenous ferric carboxymaltose versus oral ferrous sulphate standard-of-care for pregnancy-related IDA in Nigeria. We will also measure the implementation outcomes of acceptability, feasibility, fidelity, and cost-effectiveness for intravenous ferric carboxymaltose.MethodsThis is an open-label randomised controlled trial with a hybrid type 1 effectiveness-implementation design, conducted at 10 health facilities in Kano (Northern) and Lagos (Southern) states in Nigeria. A total of 1056 pregnant women at 20–32 weeks’ gestational age with moderate or severe anaemia (Hb < 10g/dl) will be randomised 1:1 into two groups. The interventional treatment is one 1000-mg dose of intravenous ferric carboxymaltose at enrolment; the control treatment is thrice daily oral ferrous sulphate (195 mg elemental iron daily), from enrolment till 6 weeks postpartum.Primary outcome measures are (1) the prevalence of maternal anaemia at 36 weeks and (2) infant preterm birth (<37 weeks’ gestation) and will be analysed by intention-to-treat. Maternal full blood count and iron panel will be assayed at 4 weeks post-enrolment, 36 weeks’ gestation, delivery, and 6 weeks postpartum. Implementation outcomes of acceptability, feasibility, fidelity, and cost will be assessed with structured questionnaires, key informant interviews, and focus group discussions.DiscussionThe IVON trial could provide both effectiveness and implementation evidence to guide policy for integration and uptake of intravenous iron for treating anaemia in pregnancy in Nigeria and similar resource-limited, high-burden settings. If found effective, further studies exploring different intravenous iron doses are planned.Trial registration ISRCTN registry ISRCTN63484804. Registered on 10 December 2020Clinicaltrials.govNCT04976179. Registered on 26 July 2021The current protocol version is version 2.1 (080/080/2021).

Intravenous ferric carboxymaltose versus iron sucrose in iron deficiency anemia of pregnancy

Iron deficiency is the most common nutritional deficiency worldwide. Anemia, defined by the World Health Organization as hemoglobin &amp;#60; 11 g/dl, is frequently seen in the antenatal period and affects 4-48% of women who give birth and severe anemia, with hemoglobin levels &amp;#60;9 g/dl .This study is to evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.: A comparative, interventional, prospective study was carried out in 100 antenatal patients with Anemia (hemoglobin level between 5 to 9.5 gm/dl) in the department of obstetrics and gynecology, Government Medical College, Baroda, Gujarat, India from September 2017 to August 2018. The subjects were randomized in two groups. First group receiving 1000 mg of intravenous iron sucrose divided in five doses on alternate days (200 mg each) and Second group receiving 1000 mg of intravenous ferric carboxymaltose.: Maximum number of patients in our study were belonged to low socioeconomic group, significantly higher number of women achieved rise of hemoglobin &amp;#62;2gm/dl in FCM group, which was highly significant (p value &amp;#60;0.001). Mean rise of hemoglobin was 1.9 g/dl for FCM group and 1.66gm/dl for iron sucrose group, which was also significant. Serum ferritin level in ferric carboxymaltose group was rises more as compared to iron sucrose group. Unpaired‘t’ test was used to test the significance of rise and compare the rise between two groups.Ferric carboxymaltose is an efficient and better alternative to Iron Sucrose in treating iron deficiency anemia of pregnancy. It has an added advantage of single dose regime with lower side effects.

Efficacy and safety of intravenous ferric carboxymaltose in moderate to severe postpartum iron deficiency anemia

Efficacy and safety of intravenous ferric carboxymaltose in moderate to severe postpartum iron deficiency anemia

MO985EFFICACY AND SAFETY OF FERRIC CARBOXYMALTOSE IN THE MANAGEMENT OF EARLY POST-RENAL TRANSPLANT ANEMIA

Abstract Background and Aims The efficacy and safety of intravenous ferric carboxymaltose (FeCarb) has been demonstrated both in patients with chronic kidney disease and dialysis, but its effects have not been evaluated in kidney transplant (KT) recipients. Method Retrospective study (2016-2018) of KT recipients who received FeCarb during the first 30 days after kidney transplantation (KT). Early efficacy was analyzed by evaluating the first determination of ferrokinetics and hemoglobin levels after administration and late efficacy with the determination &amp;gt;90 days post-administration. Safety parameters were also analyzed. Results Out of 283 KT performed, 77 recipients received one dose of FeCarb (52 received a 500mg dose and 25 a 1000mg dose) after a median of 6 days after the KT (IQR 3.5-9 days). 24 patients required transfusion after administration, 7 of them in the setting of concomitant event and 17 for non-response to FeCarb. Among the non-responders (n=17) there was a higher percentage of women, the initial hemoglobin was lower and they received a higher dose of FeCarb (Table). Responders (n=53) improved early and late ferrokinetic and anemia parameters (Figure). In the multivariate analysis adjusted by gender, controlled infection at the time of FeCarb administration, dose of FeCarb administered, immunosuppression, and previous treatment with erythropoietin, hemoglobin levels below 8 g/dL were associated with increased risk of transfusion after FeCarb administration (HR 11.30 [3.03-42.2]). Tolerability was excellent, with no immediate adverse reactions after FeCarb administration. 17 responders had a controlled infection at the time of FeCarb administration (median days under antibiotic treatment: 3, IQR 1-5). The infection did not worsen the response to FeCarb and no clinical impairment after FeCarb administration was observed. Conclusion: FeCarb administration in early post-transplant anemia is effective in patients with hemoglobin higher than 8g/dl and is not associated with increased risk of infection deterioration.

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.

Introduction:Iron deficiency anemia (IDA) is common among obstetric and gynecologic patients. This systematic review aimed to assess the comparative efficacy and safety of commonly used intravenous (IV) iron formulations, ferric carboxymaltose (FCM), and iron sucrose (IS) in the treatment of IDA in obstetric and gynecologic patients.Methods:We systematically searched PubMed, EMBASE, Cochrane CENTRAL, and Google Scholar for eligible randomized controlled trials (RCTs) comparing IV iron replacement using FCM and IS up to October 2019. The primary outcome was to compare the efficacy of FCM and IS, assessed by measuring serum hemoglobin (Hb) and ferritin levels before and after iron replacement. The secondary outcome was to compare the safety of FCM and IS, assessed by the incidence of adverse events during iron replacement. The meta-analysis was performed using RevMan 5.3.Results:We identified 9 RCTs with 910 patients (FCM group, n = 456; IS group, n = 454). Before iron replacement, FCM and IS group patients had similar baseline Hb (mean difference [MD], 0.04 g/dL; 95% confidence interval [CI], −0.07 to 015; I2 = 0%; P = 0.48) and ferritin levels (MD, −0.42 ng/mL; 95% CI, −1.61 to 0.78; I2 = 45%; P = 0.49). Following iron replacement, patients who received FCM had higher Hb (MD, 0.67; 95% CI, 0.25–1.08; I2 = 92%; P = 0.002) and ferritin levels (MD, 24.41; 95% CI, 12.06–36.76; I2 = 75%; P = 0.0001) than patients who received IS. FCM group showed a lower incidence of adverse events following iron replacement than IS group (risk ratio, 0.53; 95% CI, 0.35–0.80; I2 = 0%; P = 0.003). Serious adverse events were not reported in any group.Conclusion:FCM group showed better efficacy in increasing Hb and ferritin levels and a favorable safety profile with fewer adverse events compared with IS group for IDA treatment among obstetric and gynecologic patients. However, this meta-analysis was limited by the small number of RCTs and high heterogeneity.Trial registration:The review was prospectively registered with the International Prospective Registry of Systematic Reviews (https://www.crd.york.ac.uk/prospero/, registration number CRD42019148905).

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Patients with Postoperative Anemia Following Same-Day Bilateral Total Knee Arthroplasty: A Randomized Controlled Trial.

(1) Background: The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) to treat acute postoperative anemia following same-day bilateral total knee arthroplasty (TKA). (2) Methods: A total of 118 patients who underwent same-day bilateral TKA were randomly assigned to two groups: an FCM group (FCM infusion, 58 patients) and a Control group (placebo with normal saline, 60 patients). The primary endpoint was the number of responders with a Hb increase of two or more points by the second postoperative week. The secondary endpoints were Hb level, iron metabolism variables and blood transfusion rate at 2, 6 and 12 weeks after surgery. (3) Results: The FCM group had more Hb responders than the Control group (62.1% vs. 31.6%, p < 0.001). The Hb level was significantly higher in the FCM group during 12 weeks after surgery (all p < 0.05). Ferritin, iron and transferrin saturation levels were significantly higher in the FCM group from 2 to 12 weeks postoperatively (all p < 0.05). There was no difference in transfusion rate after surgery (p > 0.05). (4) Conclusion: In patients with postoperative anemia after same-day bilateral TKA, IV FCM infusion significantly improved Hb response two weeks after surgery without severe adverse events compared to placebo. In contrast, transfusion rate and various parameters of quality of life assessment up to 12 weeks did not vary between these groups. Level of evidence: Level I.

Efficacy and safety of intravenous ferric carboxymaltose in iron deficiency anemia; Real-life data from Turkey, a single center experience

Efficacy and safety of intravenous ferric carboxymaltose in iron deficiency anemia; Real-life data from Turkey, a single center experience

Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial

Iron deficiency anaemia is of major concern in low-income settings, especially for women of childbearing age. Oral iron substitution efficacy is limited by poor compliance and iron depletion severity. We aimed to assess the efficacy and safety of intravenous ferric carboxymaltose versus oral iron substitution following childbirth in women with iron deficiency anaemia in Tanzania. This parallel-group, open-label, randomised controlled phase 3 trial was done at Bagamoyo District Hospital and Mwananyamala Hospital, Tanzania. Eligible participants were close to delivery and had iron deficiency anaemia defined as a haemoglobin concentration of less than 110 g/L and a ferritin concentration of less than 50 μg/L measured within 14 days before childbirth. Participants were randomly assigned 1:1 to receive intravenous ferric carboxymaltose or oral iron, stratified by haemoglobin concentration and site. Intravenous ferric carboxymaltose was administered at a dose determined by the haemoglobin concentration and bodyweight (bodyweight 35 kg to <70 kg and haemoglobin ≥100 g/L: 1000 mg in one dose; bodyweight 35 kg to <70 kg and haemoglobin <100 g/L, or bodyweight ≥70 kg and haemoglobin ≥100 g/L: 1500 mg in two doses at least 7 days apart; bodyweight ≥70 kg and haemoglobin <100 g/L: 2000 mg in two doses at least 7 days apart). Oral iron treatment consisted of three dried ferrous sulphate tablets of 200 mg containing 60 mg of elementary iron and 5 mg of folic acid every morning. Oral treatment was to be taken for 3 months after haemoglobin normalisation. The primary outcome was haemoglobin normalisation (>115 g/L) at 6 weeks. Follow-up visits were at 6 weeks, and 3, 6, and 12 months. Analyses were done in the modified intention-to-treat population of participants who had a 6-week haemoglobin concentration result, using logistic and linear regression models for binary and continuous outcomes, adjusted for baseline haemoglobin concentration and site. This trial is registered with ClinicalTrials.gov, NCT02541708. Between Oct 8, 2015, and March 14, 2017, 533 individuals were screened and 230 were enrolled and randomly assigned to a study group (114 to intravenous iron, 116 to oral iron). At 6 weeks, 94 (82%) participants in the intravenous iron group and 92 (79%) in the oral iron group were assessed for the primary outcome. 75 (80%) participants in the intravenous iron group and 47 (51%) in the oral iron group had normalised haemoglobin (odds ratio 4·65, 95% CI 2·33-9·27). There were two mild to moderate infusion-related adverse events; and five serious adverse events (three in the intravenous iron group, two in the oral iron group), unrelated to the study medication. Intravenous iron substitution with ferric carboxymaltose was safe and yielded a better haemoglobin response than oral iron. To our knowledge, this is the first study to provide evidence of the benefits and safety of intravenous iron substitution in a low-income setting. Vifor Pharma, R Geigy-Stiftung, Freiwillige Akademische Gesellschaft, and Swiss Tropical and Public Health Institute.

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044

Treatment of anemia in cancer patients undergoing chemotherapy with intravenous ferric carboxymaltose without erythropoiesis-stimulating agents.

Background:Anemia is commonly encountered in cancer patients receiving active chemotherapy. Due to adverse events and presumed negative effects on disease-progression and survival, erythropoiesis-stimulating agents are not frequently used. In this study, we assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) to treat cancer-induced anemia (CIA).Patients and Methods:We recruited adult cancer patients on active chemotherapy with a hemoglobin (Hb) level ⩽11.0 g/dL. Based on serum ferritin (sFr) and transferrin saturation (TSAT), patients were divided into 3 groups: group I (absolute iron deficiency, n = 26) with sFr < 30 ng/mL and TSAT < 20%; group II (functional iron deficiency, n = 24) with sFr 30–800 ng/mL and TSAT < 20%; and patients with TSAT ⩾ 20% were placed in group III as “others” (n = 34). All patients were treated with intravenous FCM. Serum hepcidin and C-reactive protein were used as biomarkers to predict response.Results:A total of 84 patients with a median age (SD) of 53.8 (10.6) were recruited. Baseline median Hb level was 10.2 (range: 8.3–11.0) gm/dL. At week 12, there was a significant increment in Hb level for patients in groups I and II (median increment: 2.35 and 1.5 gm/dL, respectively), with limited response observed in group III, and most of the increment noted as early as week 3 (⩾1.0 g/dL). Responders tended to have lower levels of hepcidin. No clinically significant adverse events were reported; however, asymptomatic hypophosphatemia was observed in 39 (46.4%) patients.Conclusions:Intravenous FCM is a safe and effective treatment option for the management of a subgroup of patients with CIA.The study was registered at ClinicalTrials.gov [Identifier: NCT04246021]

1814P - The use of intravenous ferric carboxymaltose without erythropoiesis-stimulating agents in the treatment of anemia in cancer patients undergoing chemotherapy with or without radiotherapy

BackgroundAnemia in cancer patients undergoing chemotherapy is commonly encountered and may worsen their quality of life. Because of recent concerns about their negative effect on overall survival and serious adverse events, erythropoiesis-stimulating agents (ESA) are not commonly prescribed. This study will assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) therapy in such patients. MethodsAdult patients with non-myeloid malignancies on chemotherapy with Hemoglobin (Hb)≤ 11.0g/dL and a life expectancy >24 weeks were recruited. Based on serum ferritin (sFr) level and transferrin saturation (TSAT), patients were categorized into three Groups: Group-I (Absolute Iron Deficiency: AIDA) with sFr <30ng/mL and TSAT <20%. Group-II (Functional Iron Deficiency Anemia: FIDA) with sFr 30-800ng/mL and TSAT <20%. Patients with TSAT >20% were placed in group-III as “others”. Based on Hb level and body weight, patients were given FCM in one or two short intravenous infusions. ResultsA total of 84 patients; 70 (83.3%) females were recruited. Median age [standard deviation] was 53.8 [10.6] years. Chemotherapy varied according to the primary cancer and many had it as a second-line or beyond. The median Hb level at baseline was 10.2 (range: 8.3-11.0 ) gm/dL. At week-12, patients with AIDA (26,31.0%) and FIDA (24, 28.6%) had a significant increment in Hb (median increment: 2.35 and 1.5gm/dL, respectively). Patients in Group-III (34, 40.5%) had limited response. Most of the increment (≥1.0g/dL) occurred as early as week-3. No immediate infusion-related adverse events were reported. However, asymptomatic hypophosphatemia was observed in 39 (46.4%) patients (table).Table1814PTableVariablesAbsolute iron deficiency (n=26)Functional iron deficiency (n=24)Others (n=34)P-valueFerritin Level (week 12, mg/mL) Mean (SD) Median (range)589 (509) 442 (177-2794)838 (875) 577 (168-4184)956 (667) 802 (166-2687)0.0247Phophorus level (week 2, mg/dL) Mean (SD) Median (range)1.8 (0.7) 1.5 (1.1-3.4)2.5 (1.0) 3.3 (1.0-5.4)2.2 (0.9) 3.3 (1.0-4.1)0.0124Hypophophatemia Number Percentage17 65.4%6 25.0%16 47.1% ConclusionsIntravenous FCM, without ESA, is safe and effective in the treatment of anemia in cancer patients undergoing active treatment with chemotherapy. Legal entity responsible for the studyThe authors. FundingKing Hussein Cancer Center. DisclosureAll authors have declared no conflicts of interest.

Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding.

SummaryBackgroundAcute gastrointestinal bleeding is prevalent condition and iron deficiency anaemia is a common comorbidity, yet anaemia treatment guidelines for affected patients are lacking.AimTo compare efficacy and safety of intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf) in patients with anaemia secondary to non‐variceal gastrointestinal bleedingMethodsA prospective 42‐day study randomised 61 patients with haemoglobin <10 g/dL upon discharge (Day 0) to receive FCM (n = 29; Day 0: 1000 mg, Day 7: 500 or 1000 mg; per label) or FeSulf (n = 32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42. The primary outcome was complete response (haemoglobin ≥12 g/dL [women], ≥13 g/dL [men]) after 6 weeks.ResultsA higher proportion of complete response was observed in the FCM vs the FeSulf group at Days 21 (85.7% vs 45.2%; P = 0.001) and 42 (100% vs 61.3%; P < 0.001). Additionally, the percentage of patients with partial response (haemoglobin increment ≥2 g/dL from baseline) was significantly higher in the FCM vs the FeSulf group (Day 21:100% vs 67.7%; P = 0.001, Day 42:100% vs 74.2%; P = 0.003). At Day 42, normalisation of transferrin saturation to 25% or greater was observed in 76.9% of FCM vs 24.1% of FeSulf‐treated patients (P < 0.001). No patient in the FCM group reported any adverse event vs 10 patients in the FeSulf group.ConclusionFCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non‐variceal acute gastrointestinal bleeding.

PB2045 EFFICACY &amp; SAFETY OF INTRAVENOUS FERRIC CARBOXYMALTOSE IN IRON DEFICIENCY ANEMIA: A PROSPECTIVE STUDY

Background:Iron deficiency anemia (IDA) is the most common nutritional anemia globally. Goal of iron replacement therapy are correction of anemia and repletion of body iron stores. Oral iron replacement is the preferred route in general. However, response to oral iron replacement therapy is often suboptimal due to poor compliance to treatment resulting from gastrointestinal intolerance and prolonged duration of oral iron therapy. Ferric carboxymaltose is a relatively recently approved parenteral iron formulation which can be administered in large doses of upto 1000 mg in a single infusion.Aims:The present study describes the efficacy &amp; safety of intravenous ferric carboxymaltose for treatment of iron deficiency anemia in a tertiary institution in India.Methods:This non‐randomised prospective study included 77 patients of age ≥ 12 years with confirmed diagnosis of iron deficiency anemia between January 2018 &amp; January 2019. Detailed history was taken &amp; examination performed for signs &amp; etiology of IDA. The cut‐off serum ferritin level for IDA diagnosis was &lt; 15 ng/ml. Pregnant females and patients with concurrent vitamin B12 deficiency were excluded. All patients were treated with Injection Ferric Carboxymaltose (FCM) by I.V. infusion over 30 minutes in day care. Total dose of parenteral iron was calculated according to Ganzoni Formula: Total iron deficit (mg) = 2.4 x body weight (kg) x [target haemoglobin – actual haemoglobin (g/dl)] + 500 mg (depot iron). The maximum dose of FCM administered in a single infusion was 1000 mg. Patients with total iron dose &gt; 1000 mg received two divided doses one week apart. Patients also received oral folic acid at 5 mg/day dose for at least 3 weeks. Appropriate workup for etiology of IDA was performed in all patients. Therapeutic response was assessed after 3 weeks of first FCM dose &amp; was defined as hemoglobin increase of ≥ 2 g/dl from baseline.Results:The median age of patients was 33 years (range 16 ‐ 75 years) and majority (78%) were females. The median baseline hemoglobin was 5 g/dl (range 2.0 ‐ 8.6 g/dl). Therapeutic response was achieved in 100% patients. Mean increase in haemoglobin at 3 weeks was 4.2 g/dl (range 2.8 ‐ 5.5 g/dl). One patient had mild headache during FCM infusion. There was no infusion‐related toxicity or any other adverse event.Summary/Conclusion:In our study, intravenous ferric carboxymaltose was found to be highly effective &amp; safe alternative to oral iron for treatment of iron deficiency anemia, with excellent patient compliance. It is ideally suited for patients who require rapid replenishment of iron stores.

Comparison of ferric Carboxymaltose and iron sucrose complex for treatment of iron deficiency anemia in pregnancy- randomised controlled trial

BackgroundTo evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.MethodsA randomized clinical trial was conducted from (January 2016–August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome.ResultsMean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group.ConclusionTreatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting.Clinical trial registration (www.ctri.nic.in)CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).

Clinical experience with ferric carboxymaltose in the management of anemia in acute gastrointestinal bleeding.

ObjectiveThe aim of this study was to assess the efficacy and safety of intravenous ferric carboxymaltose (FCM) following hospitalization for acute gastrointestinal bleeding (AGIB) in the context of a restrictive transfusion strategy.Patients and methodsA retrospective single-center study analyzed patients with AGIB (excluding AGIB secondary to portal hypertension) administered a single FCM dose with or without blood transfusion.ResultsEighty-six episodes in 84 patients were analyzed. Seventy-nine patients had upper AGIB. Nineteen episodes were associated with hemodynamic instability. FCM was administered during hospitalization as a single dose of 1000 mg iron in 84/86 episodes and as a single dose of 500 mg iron in two episodes, with blood transfusion in 60/86 (69.8%) episodes. The mean hemoglobin (Hb) was 9.0 g/dl at admission, 7.6 g/dl at the lowest in-hospital value, 9.4 g/dl at discharge, and 12.7 g/dl at follow-up (mean: 55 days postdischarge) (P<0.001 for follow-up vs. all other timepoints). The lowest mean in-hospital Hb value was 7.2 and 8.8 g/dl, respectively, in patients with transfusion+FCM versus FCM alone; the mean Hb was 12.4 versus 13.7 g/dl at follow-up. In patients administered FCM alone, the mean Hb at follow-up in the subpopulations aged older than or equal to 75 years (n=33), Charlson comorbidity index of at least 3 (n=48), and Hb of up to 10 g/dl at admission (n=47) were 12.6, 13.1, and 13.3 g/dl, respectively. No adverse effects were detected.ConclusionTreatment with FCM for AGIB is associated with a good erythropoietic response and anemia correction after hospitalization, even in severe episodes or when transfusion is needed. FCM is safe and well tolerated, and may support a restrictive transfusion policy.