scholarly journals A Systematic Literature Review and Meta-Analysis of the Incidence of Serious or Severe Hypersensitivity Reactions after Administration of Ferric Derisomaltose and Ferric Carboxymaltose

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4157-4157
Author(s):  
Patrick Biggar ◽  
Nicholas Kennedy ◽  
Johannes Pöhlmann ◽  
Richard F Pollock-Wilkins
Keyword(s):  
Iron Deficiency ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Meta Analysis ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Hypersensitivity Reactions ◽  
Active Comparator ◽  
Number Of Patients ◽  
Iv Iron

Abstract Background and Aims Intravenous (IV) iron is the preferred treatment for patients with iron deficiency (ID) and iron deficiency anemia (IDA) in a variety of clinical situations. Although uncommon, administration of modern IV iron formulations can result in hypersensitivity reactions and, very rarely, anaphylactic reactions. The objective of the present study was to systematically review the literature to identify and analyze data on the incidence of serious or severe hypersensitivity reactions (HSRs) after administration of different IV iron formulations. Methods A prospectively-registered systematic literature review (SLR) was conducted to identify prospective, active comparator randomized controlled trials (RCTs) comparing ferric derisomaltose (FDI) (also known as iron isomaltoside 1000) or ferric carboxymaltose (FCM) with other IV iron formulations or oral iron. The primary endpoint was the incidence of serious or severe hypersensitivity reactions occurring on the day or day after dosing of IV iron, based on pre-specified terms (MedDRA classification). Results Data were obtained from ten prospective, active comparator RCTs of FDI (N=3,474) and seven prospective, active comparator RCTs of FCM (N=2,683), two of which were head-to-head comparisons of FDI and FCM. The trials enrolled a total of 10,467 patients, of whom 6,157 were treated with either FDI or FCM. The number of patients experiencing any serious or severe hypersensitivity reactions was 5/3474 with FDI (0.14%) versus 29/2683 (1.08%) with FCM; Bayesian inference of proportions showed the reaction rates to be significantly lower with FDI relative to FCM (Figure). Conclusions To our knowledge, the present analysis represents the first SLR and meta-analysis of the incidence of serious or severe HSRs after administration of FDI vs FCM based on pre-specified MedDRA terms. The SLR conducted for the present meta-analysis, identified 15 prospective, head-to-head RCTs including 10,467 patients, of whom 3,474 and 2,683 were treated with FDI and FCM, respectively. The analysis demonstrated that serious or severe hypersensitivity reactions were uncommon with the newer high-dose IV iron formulations; and showed a significantly lower incidence of serious or severe hypersensitivity reactions with FDI compared to FCM. Figure 1 Figure 1. Disclosures Biggar: Vifor-Fresenius: Consultancy; Pharmacosmos: Consultancy; Medice: Consultancy. Pöhlmann: Pharmacosmos A/S: Consultancy. Pollock-Wilkins: Pharmacosmos A/S: Consultancy.

Observational study of ferric carboxymaltose in France (OncoFer; interim analysis).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20654-e20654 ◽  
Author(s):  
Alain Toledano ◽  
Elisabeth Luporsi ◽  
Florian Scotté ◽  
Jean F. Morere ◽  
Philippe Huot-Marchand ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Solid Tumors ◽  
Hematological Malignancies ◽  
Red Blood Cell Transfusion ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Post Intervention ◽  
Serious Adverse Events ◽  
Number Of Patients ◽  
Iv Iron

e20654 Background: Iron deficiency with anemia is a frequent complication in cancer.Ferric carboxymaltose (FCM) is approved for the correction of iron deficiency in France since the beginning of 2011. This observational multicenter study has recruited 2 cohorts of patients to describe FCM use in daily practice for patients with hematological malignancies or solid tumors. Methods: Cohort 1 (retrospective): 450 patients treated in 2010 with any intravenous (IV) iron or red blood cell transfusion (BT); Cohort 2 (prospective): 450 patients treated with FCM after July 1, 2011. Patient characteristics are collected for 3 months pre and post intervention. Recruitment of the 810 patients has been completed. Results: Outcomes of the first 100 patients are described below. The majority of patients receiving FCM had metastatic solid tumors and received just under 1000 mg iron. Hematological malignancies were only included in BT cohort. Results are detailed below. Number of patients at baseline with serum ferritin (SF) level and TSAT are 10 and 7 respectively in cohort 1 and 28 and 26 respectively in cohort 2, therefore the reason for initiating FCM appeared to be based predominately on Hb level. Functional iron deficiency was present in 85% where TSAT and ferritin were measured. No related serious adverse events were reported for the IV iron preparations. Conclusions: FCM was well tolerated and seemed effective in treating iron deficiency anemia. Administration was usually delivered at home with fewer infusions required for FCM compared to iron sucrose. These interim results need to be confirmed in the final analysis. [Table: see text]

scholarly journals Management of postpartum iron deficiency anemia: review of literature

2018 ◽  
Vol 8 (1) ◽  
pp. 338
Author(s):  
Mohamed Saber ◽  
Mohamed Khalaf ◽  
Ahmed M. Abbas ◽  
Sayed A. Abdullah
Keyword(s):  
Iron Deficiency ◽  
Blood Transfusion ◽  
Iron Deficiency Anemia ◽  
Iron Sucrose ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Allogenic Blood Transfusion ◽  
Iron Dextran ◽  
Peripheral Tissues ◽  
Iv Iron

Anemia is a condition in which either the number of circulating red blood cells or their hemoglobin concentration is decreased. As a result, there is decreased transport of oxygen from the lungs to peripheral tissues. The standard approach to treatment of postpartum iron deficiency anemia is oral iron supplementation, with blood transfusion reserved for more server or symptomatic cases. There are a number of hazards of allogenic blood transfusion including transfusion of the wrong blood, infection, anaphylaxis and lung injury, any of which will be devastating for a young mother. These hazards, together with the national shortage of blood products, mean that transfusion should be viewed as a last resort in otherwise young and healthy women. Currently, there are many iron preparations available containing different types of iron salts, including ferrous sulfate, ferrous fumarate, ferrous ascorbate but common adverse drug reactions found with these preparations are mainly gastrointestinal intolerance like nausea, vomiting, constipation, diarrhoea, abdominal pain, while ferrous bis-glycinate (fully reacted chelated amino acid form of iron) rarely make complication. Two types of intravenous (IV) preparations available are IV iron sucrose and IV ferric carboxymaltose. IV iron sucrose is safe, effective and economical. Reported incidence of adverse reactions with IV iron sucrose is less as compared to older iron preparations (Iron dextran, iron sorbitol), but it requires multiple doses and prolonged infusion time. Intramuscular iron sucrose complex is particularly contraindicated because of poor absorption. It was also stated that when iron dextran is given intravenously up to 30% of patients suffer from adverse effects which include arthritis, fever, urticaria and anaphylaxis.

VP151 Endovenous Iron Deficiency Anemia Treatment In Inflammatory Bowel Disease: Hospital-based Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 219-220
Author(s):  
Jovana Stojanovic ◽  
Flavia Kheiraoui ◽  
Enrica Maria Proli ◽  
Franco Scaldaferri ◽  
Massimo Volpe ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Iron Deficiency ◽  
Technology Assessment ◽  
Bowel Disease ◽  
Health Technology ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Efficacy And Safety ◽  
Iv Iron ◽  
Inflammatory Bowel

INTRODUCTION:Iron Deficiency Anemia (IDA), a common cause of anemia in the world, is a frequently neglected disease that represents the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD) (1). The release of new intravenous (IV) iron compounds represents a great opportunity for both physicians and patients, but the higher costs might hold back their optimal diffusion. A Health Technology Assessment (HTA) approach was used to provide insights on the sustainability of the IV iron formulations in a hospital setting, with a special focus on ferric carboxymaltose.METHODS:Epidemiology of IBD, as well as IDA associated with these conditions, was assessed with a systematic appraisal of the published literature. Data on efficacy and safety of IV iron formulations currently used in Italy were retrieved from the available medical electronic databases. A hospital based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed.RESULTS:The reported prevalence of anemia in patients with IBD varies markedly from 10 to 73 percent for Crohn's Disease and from 9 to 67 percent for Ulcerative Colitis. Although there are no studies on direct comparison of different IV iron preparations, the literature indicates good efficacy and safety profiles of these formulations. However, ferric carboxymaltose seemed to provide a better and faster correction of hemoglobin and serum ferritin levels in iron-deficient patients (2,3). Our analyses indicated that ferric carboxymaltose, in spite of a greater price, would have positive benefits for the hospital, in terms of reduced costs related to individual patient management, and for the patients themselves, by reducing the number of infusions and accesses to health facilities.CONCLUSIONS:This hospital-based HTA reports an overall positive organizational, economic and ethical evaluation for the sustainable introduction of ferric carboxymaltose in the Italian outpatient setting.

Treatment of Iron Deficiency Anemia in Pregnancy with Intravenous versus Oral Iron: Systematic Review and Meta-Analysis

2018 ◽  
Vol 36 (04) ◽  
pp. 366-376 ◽  
Author(s):  
Richard Burwick ◽  
Shravya Govindappagari
Keyword(s):  
Systematic Review ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Meta Analysis ◽  
Oral Iron ◽  
Sensitivity Analyses ◽  
Deficiency Anemia ◽  
Iv Iron ◽  
Anemia In Pregnancy ◽  
In Pregnancy

Objective To perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the benefits of intravenous (IV) iron in pregnancy. Study Design Systematic review was registered with PROSPERO and performed using PRISMA guidelines. PubMed, MEDLINE, Web of Science, ClinicalTrials.gov, Cochrane Library, and Google Scholar were searched. Eleven RCTs, comparing IV to oral iron for treatment of iron-deficiency anemia in pregnancy, were included. Meta-analyses were performed with Stata software (College Station, TX), utilizing random effects model and method of DerSimonian and Laird. Outcomes were assessed by pooled odds ratios (OR) or pooled weighted mean difference (WMD). Sensitivity analyses were performed for heterogeneity. Results We found that pregnant women receiving IV iron, compared with oral iron, had the following benefits: (1) Achieved target hemoglobin more often, pooled OR 2.66 (95% confidence interval [CI]: 1.71–4.15), p < 0.001; (2) Increased hemoglobin level after 4 weeks, pooled WMD 0.84 g/dL (95% CI: 0.59–1.09), p < 0.001; (3) Decreased adverse reactions, pooled OR 0.35 (95% CI: 0.18–0.67), p = 0.001. Results were unchanged following sensitivity analyses. Conclusion In this meta-analysis, IV iron is superior to oral iron for treatment of iron-deficiency anemia in pregnancy. Women receiving IV iron more often achieve desired hemoglobin targets, faster and with fewer side effects.

scholarly journals Hypophosphatemia Associated with Intravenous Iron Therapies for Iron Deficiency Anemia: A Systematic Literature Review

2020 ◽  
Vol Volume 16 ◽  
pp. 245-259 ◽  
Author(s):  
John A Glaspy ◽  
Michelle Z Lim-Watson ◽  
Michael A Libre ◽  
Swagata S Karkare ◽  
Nandini Hadker ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Literature Review ◽  
Iron Deficiency Anemia ◽  
Systematic Literature Review ◽  
Intravenous Iron ◽  
Deficiency Anemia

scholarly journals Hypersensitivity reactions to intravenous ferric carboxymaltose in a patient with iron deficiency anemia: a rare case report

2018 ◽  
Vol 7 (5) ◽  
pp. 1036
Author(s):  
Shadma H. Quazi ◽  
Sushil K. Varma ◽  
Sharjeel H. Khan ◽  
Sonali S. Kirde ◽  
Harshada Arun Bhoware
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Iron Deficiency ◽  
Iron Deficiency Anemia ◽  
Poor Response ◽  
The United States ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Hypersensitivity Reactions ◽  
Rare Case Report

Ferric carboxymaltose (FCM) is a non-dextran iron preparation recently approved in the United States for intravenous treatment of iron deficiency anemia (IDA) in adult patients with intolerance or poor response to oral iron therapy. Acute hypersensitivity reactions (HSRs) during iron infusions are very rare but can be life-threatening. Adverse events, including immune system disorders (0% in FCM) and skin disorders (7.3% in FCM), are less frequently observed with FCM. On treatment with FCM, the change in hemoglobin from baseline to the highest observed level is about 2.8g/dL. Treatment of IDA with FCM resulted in fewer hypersensitivity reactions. Here, authors report a case of a 23 years old female diagnosed for IDA presented with the picture of adverse drug reaction due to injection FCM given by the physician. The patient was managed with Antibiotics, Corticosteroids and Intravenous fluids and recovered well within 12 hours of admission from this adverse drug reaction. Since such cases have been rarely reported, authors are intended to notify about this potentially dangerous drug reaction due to FCM which is used extensively in the treatment of IDA. Hence management of iron infusions requires very careful and precise observation, and, in the event of an adverse reaction, prompt recognition and severity-related interventions by well-trained medical and nursing staff.

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

Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-5
Author(s):  
Saleema Wani ◽  
Mariyam Noushad ◽  
Shabana Ashiq
Keyword(s):  
Retrospective Study ◽  
Iron Deficiency ◽  
Pregnant Women ◽  
Iron Deficiency Anemia ◽  
Oral Iron ◽  
Deficiency Anemia ◽  
Ferric Carboxymaltose ◽  
Blood Hemoglobin ◽  
Iv Iron ◽  
In Pregnancy

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.

Iron Deficiency Anemia and Chronic Renal Insufficiency In An Oncology Population

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5152-5152
Author(s):  
Ralph Boccia ◽  
Betsy Lahue ◽  
Robert Hauser ◽  
Jessica Dioguardi
Keyword(s):  
Iron Deficiency ◽  
Renal Insufficiency ◽  
Iron Deficiency Anemia ◽  
Patient Population ◽  
Deficiency Anemia ◽  
Oncology Patients ◽  
Iron Treatment ◽  
Number Of Patients ◽  
Anemia Management ◽  
Iv Iron

Abstract Abstract 5152 Anemia in oncology patients is common and may negatively impact cancer treatment outcomes. Iron deficiency is a major contributor to anemia, which can be exacerbated by both underlying conditions and chemotherapeutic agents. Additionally, many oncology patients may have concomitant renal insufficiency or chronic kidney disease (CKD), increasing their susceptibility to iron deficiency. Therefore, recognizing renal insufficiency as well as iron deficiency may improve anemia management in oncology patients. To determine the proportion of oncology patients with iron deficiency anemia (IDA), potential renal insufficiency and the current utilization of IV iron treatment in these populations, a large electronic medical records database was examined. All patients treated with chemotherapy in a physician services oncology network from January 1, 2008 to August 1, 2010 were selected in order to determine the prevalence of an iron deficiency anemia (IDA) diagnosis (expressed as an ICD-9-CM 280.1-.9), and a diagnosis of CKD (expressed as either from a diagnosis code of CKD (585.1-.6) or estimated GFR <60 mL/min). Overall, 83,219 patients receiving a chemotherapeutic agent were selected. Of these patients, 36% (30,298) were diagnosed with IDA, 34% of whom were receiving IV iron treatment (9,971/30,298). These patients represented approximately 85% (9971/11,776) of the total IV iron treated population in the dataset. While only 8% (2,482/30,298) of patients with a diagnosis of IDA also had a diagnosis of CKD. Of the patients that did present with a GFR level, 49% of patients had a GFR level <60 mL/min. However, the true prevalence of CKD in this population was difficult to determine because a significant percentage of patients did not present with a GFR level available in their records. In this oncology patient population IDA is relatively common, with greater than 30% of patients diagnosed. While only one third of these patients were receiving IV iron treatment in the IDA patient population, it is unknown whether patients are not being treated for their iron deficiency or are being managed on oral iron therapy alone. Given recent controversies around ESA use, guidelines suggest that iron indices should be checked, and IV iron supplementation should be considered in patients receiving ESA therapy. Additionally, only a fraction of patients diagnosed with IDA are also diagnosed with CKD, even though analysis of GFR values suggests that a significant number of patients may have renal insufficiency. These data suggest that identification of patients with renal insufficiency may be suboptimal and that further treatment of IDA in this patient population may be warranted in order to optimize anemia management. Disclosures: Boccia: AMAG: Consultancy, Honoraria, Speakers Bureau. Lahue:AMAG: Employment. Hauser:AMAG: Research Funding. Dioguardi:AMAG: Employment.

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