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Lesley J Scott
Intravenous ferric carboxymaltose (Ferinject® ; Injectafer® ) is a colloidal solution of nanoparticles which consist of a polynuclear iron (III)-(oxyhydr)oxide core stabilized by carboxymaltose and may be given as a single high-dose, 15-min infusion. This article reviews the clinical use of ferric carboxymaltose in various patient populations with iron deficiency (ID) [± anaemia] and briefly summarizes its pharmacological properties. Based on extensive experience in the clinical trial and real-world settings, ferric carboxymaltose is an effective and generally well tolerated treatment for rapidly replenishing iron stores and correcting anaemia in patients with ID (± anaemia) of various aetiologies, including patients with chronic heart failure (CHF), chronic kidney disease, inflammatory bowel disease or perioperative anaemia, and women with ID during pregnancy, postpartum or associated with heavy uterine bleeding...
March 2018: Drugs
Iain C Macdougall
Current recommendations for the use of intravenous iron therapy in the management of anaemia in patients with chronic kidney disease (CKD) are based on limited clinical evidence. Since the publication of the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Anaemia in Chronic Kidney Disease in 2012, a number of randomized clinical trials [notably, the Ferinject Assessment in Patients with Iron Deficiency Anaemia (FIND-CKD) and Randomized Trial to Evaluate IV and Oral Iron in Chronic Kidney Disease (REVOKE) trials] and observational studies have been completed, and a further large clinical trial-Proactive IV Iron Therapy in Dialysis Patients (PIVOTAL)-is currently underway...
December 2017: Clinical Kidney Journal
Tee Joo Yeo, Poh Shuan Daniel Yeo, Farid Abdul Hadi, Timothy Cushway, Kim Yee Lee, Bee Choo Tai, Carolyn S P Lam
AIMS: Iron deficiency (ID) is highly prevalent in patients with heart failure (HF) worldwide regardless of haemoglobin levels. Results from therapeutic trials of intermittently dosed intravenous (i.v.) iron are promising in the ambulatory Caucasian population with HF with reduced left ventricular ejection fraction, although evidence is scarce in Asia. The Pilot Randomized Controlled Trial to Assess the Role of Intravenous Ferric Carboxymaltose in Asian Patients with Heart Failure aims to assess the effect of single-dose i...
June 2016: ESC Heart Failure
B Myers, O Myers, J Moore
BACKGROUND: Iron-deficiency anaemia is common in pregnancy, with well-described maternal morbidities. When oral iron therapy has failed, intravenous (IV) preparations are considered. Ferric carboxymaltose (ferinject) is a new IV preparation which can be given quickly. There are no published data on Ferinject use in pregnancy. This study analyses historical data from women given Cosmofer, compared with those given Ferinject in pregnancy, to assess comparative efficacy and safety. METHODS: Pregnant women treated with Cosmofer and Ferinject, were identified from pharmacy records...
September 2012: Obstetric Medicine
Sunil Bhandari
The National Service Framework advocates correction of anaemia in patients with chronic kidney disease (CKD). Oral iron is insufficient, while intravenous (IV) supplementation replenishes and maintains iron stores. Previously, effective delivery of iron therapy using available parenteral preparations has been hampered by dosing schedules and the need in some cases of a test dose. The introduction in Europe of newer iron preparations, including iron isomaltoside 1000 (Monofer) and iron carboxymaltose (Ferinject), now offers a potentially safe, effective and time-efficient method of outpatient iron repletion...
June 2011: NDT Plus
Erik Philipp, Michaela Braitsch, Tobias Bichsel, Stefan Mühlebach
OBJECTIVES: This study was designed to assess the physicochemical stability of colloidal ferric carboxymaltose solution (Ferinject) when diluted and stored in polypropylene (PP) bottles and bags for infusion. METHODS: Two batches of ferric carboxymaltose solution (Ferinject) were diluted (500 mg, 200 mg and 100 mg iron in 100 mL saline) in PP bottles or bags under aseptic conditions. The diluted solutions were stored at 30°C and 75%±5% relative humidity (rH) for 72 h, and samples were withdrawn aseptically at preparation and after 24 h, 48 h and 72 h...
January 2016: European Journal of Hospital Pharmacy. Science and Practice
Matthias Bach, Tabea Geisel, Julia Martin, Bettina Schulze, Roland Schaefer, Garth Virgin, Juergen Stein
Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA)...
2015: Anemia
Richard Češka
Anaemia is one of the most common diseases. Worldwide affects up to 25% of the population. Anaemia with iron deficiency (Fe) is the leading one. It is not surprising that iron deficiency mainly affects women. Generally, anaemia is one of the major problems in every department of internal medicine. There is no ambition to provide a comprehensive review of the diagnosis and treatment of anaemia. The aim is to point out the common (but sometimes neglected) facts from daily practice in internal department and on the other hand, to highlight the news in the treatment focusing on parenteral Fe...
December 2014: Vnitr̆ní Lékar̆ství
Josep Comín-Colet, Darío Rubio-Rodríguez, Carlos Rubio-Terrés, Cristina Enjuanes-Grau, Florian S Gutzwiller, Stefan D Anker, Piotr Ponikowski
INTRODUCTION AND OBJECTIVES: Treatment with ferric carboxymaltose improves symptoms, functional capacity, and quality of life in patients with chronic heart failure and iron deficiency. The aim of this study was to assess the cost-effectiveness of ferric carboxymaltose treatment vs no treatment in these patients. METHODS: We used an economic model based on the Spanish National Health System, with a time horizon of 24 weeks. Patient characteristics and ferric carboxymaltose effectiveness (quality-adjusted life years) were taken from the Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure trial...
October 2015: Revista Española de Cardiología
Gillian M Keating
Ferric carboxymaltose (Ferinject(®), Injectafer(®)) is an intravenous iron preparation approved in numerous countries for the treatment of iron deficiency. A single high dose of ferric carboxymaltose (up to 750 mg of iron in the US and 1,000 mg of iron in the EU) can be infused in a short time frame (15 min). Consequently, fewer doses of ferric carboxymaltose may be needed to replenish iron stores compared with some other intravenous iron preparations (e.g. iron sucrose). Ferric carboxymaltose improved self-reported patient global assessment, New York Heart Association functional class and exercise capacity in patients with chronic heart failure and iron deficiency in two randomized, placebo-controlled trials (FAIR-HF and CONFIRM-HF)...
January 2015: Drugs
Gabriele Röhrig, Tilmann Steinmetz, Jürgen Stein, Tabea Geisel, Garth Virgin, Roland Schaefer, Matthias Bach, Ralf-Joachim Schulz
BACKGROUND: Anemia in the elderly is a common clinical finding. Prevalence in hospitalized geriatric patients approximates up to 40% presenting as iron deficiency anemia associated with absolute iron deficiency, anemia of chronic disease associated with functional iron deficiency or unexplained anemia. In patients with functional iron deficiency oral iron substitution is ineffective due to elevated hepcidin levels, such as in renal anemia. In these patients intravenous iron substitution represents a cornerstone...
July 24, 2014: MMW Fortschritte der Medizin
Eun-A Lim, Hyun-Soon Sohn, Haeyoung Lee, Sang-Eun Choi
BACKGROUND: Iron-deficiency anemia (IDA) is prevalent in patients with advanced chronic heart failure (CHF). It affects the patients' overall physical condition and is suggested as a strong outcome predictor in CHF. Recent clinical trials suggested that intravenous iron supplementation improves CHF functional status and quality of life. The aim of this study was to assess the cost-effectiveness of ferric carboxymaltose(FCM) in CHF patients with IDA. METHODS: Ferric carboxymaltose, an intravenous iron preparation, was compared with placebo...
2014: Cost Effectiveness and Resource Allocation: C/E
B D Keeler, J A Simpson, S Ng, C Tselepis, T Iqbal, M J Brookes, A G Acheson
AIM: The study aimed to analyse the feasibility and efficacy of administration of a single intravenous iron infusion (IVI) in the preoperative optimization of colorectal cancer patients with anaemia. METHOD: Twenty patients were recruited at least 14 days before the planned date of surgery. A single 1000 mg dose of ferric carboxymaltose (Ferinject) was administered as an outpatient procedure. Blood samples were taken at recruitment prior to drug administration (REC), on the day of surgery prior to any intervention (DOS) and on the first postoperative day...
October 2014: Colorectal Disease: the Official Journal of the Association of Coloproctology of Great Britain and Ireland
Iain C Macdougall, Andreas H Bock, Fernando Carrera, Kai-Uwe Eckardt, Carlo Gaillard, David Van Wyck, Bernard Roubert, Jacqueline G Nolen, Simon D Roger
BACKGROUND: The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown. METHODS: Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400-600 µg/L) or lower (100-200 µg/L) ferritin or oral iron therapy...
November 2014: Nephrology, Dialysis, Transplantation
R Herfs, L Fleitmann, I Kocsis
In this multi-centre, prospective, non-interventional study, the effectiveness and tolerance of ferric carboxymaltose (ferinject®; FCM) was tested through use in standard gynaecological practice. In total, data from 273 patients was evaluated. 193 of these patients displayed iron deficiency anaemia (IDA), and 68 had iron deficiency without anaemia (ID). The reasons for the ID/IDA were hypermenorrhoea (HyM) (n = 170), post-partum condition (PP) (n = 53) or another indication (n = 53). The average age of the patients was 40 years old, with 8 % of them being vegetarians...
January 2014: Geburtshilfe und Frauenheilkunde
Daniel Reim, Young-Woo Kim, Byung Ho Nam, Mi-Jung Kim, Jeong Hwan Yook, Young Kyu Park, Sung Hoon Roh, Wan Sik Yu, Jae Moon Bae
BACKGROUND: Isovolemic anemia (decrease in hemoglobin concentration with normal or even increased blood volume) after gastric cancer surgery may negatively influence short- and long-term outcomes. Therefore correction of isovolemic postoperative anemia is supposed to be beneficial. This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by 2 g/dl at 12 weeks after randomization...
April 5, 2014: Trials
S Fütterer, I Andrusenko, U Kolb, W Hofmeister, P Langguth
Drug products containing iron oxide and hydroxide nanoparticles (INPs) are important for the treatment of iron deficiency anaemia. Pharmaceuticals prepared by the complexation of different kinds of INPs and carbohydrates have different physicochemical and biopharmaceutic characteristics. The increasing number of parenteral non-biological complex drugs (NBCD) containing iron requires physicochemical methods for characterization and enabling of cross comparisons. In this context the structure and the level of crystallinity of the iron phases may be connected to the in vitro and in vivo dissolution rates, which etiologically determine the therapeutic and toxic effects...
December 2013: Journal of Pharmaceutical and Biomedical Analysis
Laura A Garvican, Philo U Saunders, Tanusha Cardoso, Iain C Macdougall, Louisa M Lobigs, Ruth Fazakerley, Kieran E Fallon, Bev Anderson, Judith M Anson, Kevin G Thompson, Christopher J Gore
PURPOSE: Iron deficiency is prevalent in distance runners and may impair endurance performance. The current practice of oral supplementation is slow and often not well tolerated. The aim of this study was to assess the efficacy of intravenous (IV) iron supplementation (ferric carboxymaltose) compared with oral supplementation (ferrous sulfate) on iron status, hemoglobin mass (Hbmass), and physiological indices of running performance in distance runners. METHODS: Twenty-seven highly trained distance runners with low (LOW) (ferritin <35 μg·L(-1) and transferrin saturation <20%, or ferritin <15 μg·L(-1)) or suboptimal (SUB) iron status (ferritin <65 μg·L(-1)) were supplemented with either IV iron (Ferinject®) or oral (ORAL) supplements (Ferrogradumet) for 6 wk...
February 2014: Medicine and Science in Sports and Exercise
Luke S G E Howard, Geoffrey M J Watson, John Wharton, Christopher J Rhodes, Kakit Chan, Rajeshree Khengar, Peter A Robbins, David G Kiely, Robin Condliffe, Charlie A Elliott, Joanna Pepke-Zaba, Karen Sheares, Nicholas W Morrell, Rachel Davies, Deborah Ashby, J Simon R Gibbs, Martin R Wilkins
Our aim is to assess the safety and potential clinical benefit of intravenous iron (Ferinject) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension (IPAH). Iron deficiency in the absence of anemia (1) is common in patients with IPAH; (2) is associated with inappropriately raised levels of hepcidin, the key regulator of iron homeostasis; and (3) correlates with disease severity and worse clinical outcomes. Oral iron absorption may be impeded by reduced absorption due to elevated hepcidin levels...
January 2013: Pulmonary Circulation
Vassilis Fragoulakis, Georgia Kourlaba, Dimitris Goumenos, Manousos Konstantoulakis, Nikolaos Maniadakis
PURPOSE: To conduct an economic evaluation comparing Ferinject(®) (ferric carboxymaltose [FCM]) with Venofer(®) (iron sucrose [IS]) and CosmoFer(®) (low-molecular-weight iron dextran [LMWID]) in the management of iron deficiency anemia in Greece. PATIENTS AND METHODS: A cost-minimization analysis was conducted since there are no clear data indicating that one of these regimens is superior to the others in terms of efficacy. Main data inputs were based on bibliography and validated by clinicians...
2012: ClinicoEconomics and Outcomes Research: CEOR
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