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Laura A Garvican-Lewis, Victor L Vuong, Andrew D Govus, Peter Peeling, Grace Jung, Elizabeta Nemeth, David Hughes, Greg Lovell, Daniel Eichner, Christopher J Gore
PURPOSE: Iron is integral for erythropoietic adaptation to hypoxia, yet the importance of supplementary iron compared to existing stores is poorly understood. The aim of the present study was to compare the magnitude of the haemoglobin mass (Hbmass) response to altitude in athletes supplemented with intravenous (IV), oral or placebo iron supplementation. METHODS: Thirty-four, non-anaemic, endurance-trained athletes completed 3 weeks of simulated altitude (3000 m, 14h...
March 12, 2018: Medicine and Science in Sports and Exercise
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
Amina Delpeuch, Marc Ruivard, Armand Abergel, Olivier Aumaitre, Stéphane Boisgard, Sandrine Bagel, Valérie Sautou
Background Intravenous (IV) iron preparations bypass the difficulties (malabsorption and side effects) associated with oral iron for the treatment of iron deficiency anaemia (IDA). Ferric carboxymaltose (FCM) can be administered as a single infusion over short periods of time but is more expensive than iron sucrose (IS) when the patients are hospitalized. Objectives To evaluate the appropriateness of FCM prescriptions and to establish the economic impact of this management (including disease coding) compared to the use of IV IS...
March 8, 2018: International Journal of Clinical Pharmacy
Christine E Gilmartin, Thu Hoang, Briony A Cutts, Laura Leung
OBJECTIVE: To examine the adverse drug reactions (ADRs) and the efficacy of intravenous iron polymaltose and ferric carboxymaltose (FCM) among gynecology/obstetric patients with anemia. METHODS: The present retrospective observational study examined data from anemic obstetrics and gynecology patients who received either iron polymaltose or FCM between January 1, 2011, and April 30, 2015, at The Royal Women's Hospital, Victoria, Australia. Patient demographic data, dosage, ADR documentation, and hemoglobin levels were collected from medical records and compared...
March 2, 2018: International Journal of Gynaecology and Obstetrics
Mikael Kangaspunta, Johanna Haapamäki, Martti Färkkilä, Perttu Arkkila
OBJECTIVES: The main objective of our study was to determinate the effectiveness of intravenous iron treatment with ferric carboxymaltose in inflammatory bowel disease (IBD) patients. Our other objectives were to study parameters that would predict a good response to the treatment and to chart out possible side-effects of the treatment. MATERIALS AND METHODS: In our retrospective chart review study we collected clinical data and laboratory results related to IBD from medical records of 87 IBD patients who were treated with ferric carboxymaltose in Helsinki University Hospital between 2014 and 2016...
February 22, 2018: Scandinavian Journal of Gastroenterology
Yong Won Cho, Richard P Allen, Christopher J Earley
INTRODUCTION: There have been four randomized, placebo-controlled, double-blinded studies of intravenous (IV) iron in Restless Legs Syndrome (RLS), all of which delivered a final total dose of 1000 mg of iron. The purpose of this study was to evaluate effects of a lesser total dose (500 mg of iron). METHODS: Subjects with idiopathic RLS were enrolled in a randomized, double-blinded, placebo-controlled study. Subjects received either 500 mg ferric carboxymaltose (FCM) or placebo as a single infusion (Phase I)...
February 2018: Sleep Medicine
Julia Schnorr, Sören Fütterer, Karsten Spicher, Maria Catarinolo, Christoph Schlösser, Harald Enzmann, Peter Langguth
Although parenteral iron products have been established to medicinal use decades before, their structure and pharmacokinetic properties are not fully characterized yet. With its' second reflection paper on intravenous iron-based nano-colloidal products (EMA/CHMP/SWP/620008/2012) the European Medicine Agency provided an extensive catalogue of methods for quality, non-clinical and pharmacokinetic studies for the comparison of nano-sized iron products to an originator (EMA, 2015). For iron distribution studies, the reflection paper assumed the use of rodents...
February 15, 2018: Regulatory Toxicology and Pharmacology: RTP
Richard P Allen, Daniel L Picchietti, Michael Auerbach, Yong Won Cho, James R Connor, Christopher J Earley, Diego Garcia-Borreguero, Suresh Kotagal, Mauro Manconi, William Ondo, Jan Ulfberg, John W Winkelman
BACKGROUND: Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children...
January 2018: Sleep Medicine
N Franklin Adkinson, William E Strauss, Iain C Macdougall, Kristine E Bernard, Michael Auerbach, Robert F Kaper, Glenn M Chertow, Julie S Krop
Few trials have examined rates of hypersensitivity reactions (HSRs) with intravenous iron formulations used to treat iron deficiency anemia. This randomized, multicenter, double-blind clinical trial compared the safety and efficacy of ferumoxytol versus ferric carboxymaltose (FCM), focusing on rates of HSRs and hypotension as the primary end point. Patients with iron deficiency anemia of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol (n = 997) or FCM (n = 1000) intravenously over ≥15 minutes on days 1 and 8 or 9 for total respective doses of 1...
February 8, 2018: American Journal of Hematology
Katsuya Ikuta, Asami Shimura, Masaru Terauchi, Kazuyoshi Yoshii, Yoshihiro Kawabata
Iron-deficiency anemia (IDA) is the most common form of anemia. Iron replacement therapy is an effective treatment, but oral and previously available intravenous (IV) formulations in Japan have disadvantages such as side effects, immunogenic reactions, low dose per tablet/vial, and the need for continuous administration. Ferric carboxymaltose (FCM), which overcomes these limitations, is widely used as an IV iron preparation outside of Japan. In this single-center, open-label, single-dose escalation study, we investigated the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of FCM in Japanese subjects...
January 22, 2018: International Journal of Hematology
Tee Joo Yeo, Poh Shuan Daniel Yeo, Farid Abdul Hadi, Timothy Cushway, Kim Yee Lee, Fang Fang Yin, Anne Ching, Ruili Li, Seet Yoong Loh, Shir Lynn Lim, Raymond Ching-Chiew Wong, Bee Choo Tai, Arthur Mark Richards, Carolyn S P Lam
AIMS: Iron deficiency is highly prevalent in Southeast Asians with heart failure (HF) and associated with worse outcomes. This trial aimed to assess the effect of intravenous iron in Southeast Asians hospitalized with decompensated HF. METHODS AND RESULTS: Fifty patients hospitalized for acute decompensated HF, regardless of ejection fraction, with iron deficiency (defined as serum ferritin <300 ng/mL if transferrin saturation is <20%) were randomized to receive either one dose of intravenous ferric carboxymaltose (FCM) 1000 mg or placebo (0...
January 18, 2018: ESC Heart Failure
Filip C Castberg, Lasse Maretty, Trine Staalsoe, Casper Hempel, Erik Clasen-Linde, Lars Hviid, Jørgen A L Kurtzhals
BACKGROUND: Iron deficiency is the most widespread nutrient deficiency and an important cause of developmental impairment in children. However, some studies have indicated that iron deficiency can also protect against malaria, which is a leading cause of childhood morbidity and mortality in large parts of the world. This has rendered interventions against iron deficiency in malaria-endemic areas controversial. METHODS: The effect of nutritional iron deficiency on the clinical outcome of Plasmodium chabaudi AS infection in A/J mice and the impact of intravenous iron supplementation with ferric carboxymaltose were studied before and after parasite infection...
January 16, 2018: Malaria Journal
Amreen Naqash, Rifat Ara, Ghulam N Bader
BACKGROUND: Iron deficiency anemia (IDA) is a significant problem worldwide particularly in women. The aim of the study was to evaluate the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in comparison to iron sucrose (IS) in women with IDA. METHOD: Two hundred patients at Department of Obstetrics and Gynaecology, Sher-i-Kashmir Institute of Medical Sciences Medical College and Hospital, Jammu & Kashmir, India identified with IDA were enrolled for the study...
January 5, 2018: BMC Women's Health
Klara Klein, Shonda Asaad, Michael Econs, Janet E Rubin
Ferric carboxymaltose (FCM) is a novel iron formulation increasingly prescribed due to its effectiveness and fast infusion time. FCM administration can cause an asymptomatic hypophosphataemia secondary to fibroblast growth factor 23 (FGF23) dysregulation. In patients with chronic iron needs, however, a severe, long-lasting hypophosphataemia can lead to osteomalacia with associated bone pain. Lack of awareness of this complication results in delayed time to diagnosis and significant morbidity. We report a case of a patient with Crohn's disease and chronic iron-deficiency anaemia receiving multiple doses of FCM who developed severe hypophosphataemic osteomalacia with urinary phosphate loss and increased FGF23...
January 3, 2018: BMJ Case Reports
Eonwoo Shin, Minyoung Oh, Changhwan Sung, Ki-Hun Kim, Jin-Sook Ryu
We report a case with altered biodistribution of99m Tc-dicarboxypropane diphosphonate (99m Tc-DPD) on whole body bone scan after intravenous iron supplement therapy. A 47-year-old male patient who had recently been detected with a hepatic mass suggestive of hepatocellular carcinoma underwent bone scan as staging work-up before surgery. Bone scan images at 3 h after injection of99m Tc-DPD demonstrated unusually increased blood pool activities in the heart, liver, and spleen with usual skeletal uptakes. The patient had been treated for severe anemia from hemorrhoid with two intravenous administration of ferric hydroxide carboxymaltose complex at approximately 22 h and 2 h prior to the99m Tc-DPD injection, which we consider as the most probable cause of altered biodistribution of99m Tc-DPD...
December 2017: Nuclear Medicine and Molecular Imaging
Jorge E Toblli, Gabriel Cao, Luis Rico, Margarita Angerosa
Background: Ferric carboxymaltose (FCM) is a stable, non-dextran-based intravenous iron complex used to treat iron deficiency of various etiologies. As FCM is a nonbiological complex drug and cannot be fully characterized by physicochemical analyses, it is important to demonstrate in nonclinical models that FCM similars (FCMS) have similar biodistribution. Materials and methods: A total of 30 nonanemic rats were treated weekly with 40 mg iron/kg body weight intravenous FCM, FCMS, or isotonic saline (controls) for 4 weeks...
2017: Drug Design, Development and Therapy
Jamshed Dalal, Vijay Katekhaye, Rishi Jain
INTRODUCTION: Iron administration especially intravenous iron therapy is associated with improvements in exercise capacity and quality of life in patients with chronic heart failure (CHF). Our aim was to assess effect of ferric carboxymaltose (FCM) on hospitalization and mortality outcomes in CHF. MATERIALS AND METHODS: A literature search across PUBMED, Google Scholar and trials database was conducted to search for randomized controlled trials (till August 2016) comparing FCM to placebo in CHF with or without anaemia...
November 2017: Indian Heart Journal
Louis L Huang, Darren Lee, Stefanie M Troster, Annette B Kent, Matthew A Roberts, Iain C Macdougall, Lawrence P McMahon
Background: Intravenous (IV) iron can modulate fibroblast growth factor 23 (FGF23) concentrations and cause transient but significant hypophosphataemia. However, it is unknown what other markers might be involved, especially in different patient groups. This study aimed to determine changes in bone and haematinic biomarkers following IV ferric carboxymaltose (FCM) and to identify risk factors for hypophosphataemia in pregnant subjects and those with chronic kidney disease (CKD). Methods: Changes in bone [serum FGF23, fractional excretion of phosphate urinary fractional excretion of phosphate (FEPi), serum phosphate and serum vitamin D derivatives] and haematinic [plasma hepcidin, serum ferritin and transferrin saturation (TSAT)] biomarkers after 1 g of IV FCM were followed in iron-deficient pregnant and CKD patients and compared with controls (estimated glomerular filtration rate > 60 mL/min/1...
November 17, 2017: Nephrology, Dialysis, Transplantation
Chad S Boomershine, Todd A Koch, David Morris
INTRODUCTION: This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia. METHODS: This blinded, placebo-controlled, phase 2 study randomized adults with fibromyalgia and Revised Fibromyalgia Impact Questionnaire (FIQR) scores ≥ 60, ferritin levels < 0.05 µg/ml, and transferrin saturation < 20% (1:1) to receive ferric carboxymaltose [15 mg/kg (up to 750 mg)], or placebo (15 cc normal saline) intravenously on study days 0 and 5...
November 17, 2017: Rheumatology and Therapy
Christoph Schindler, Andreas L Birkenfeld, Markolf Hanefeld, Ulrike Schatz, Carsta Köhler, Martin Grüneberg, Diethelm Tschöpe, Matthias Blüher, Christoph Hasslacher, Stefan R Bornstein
INTRODUCTION: HbA1c is the gold standard for glycemic control in pre-diabetes and diabetes. However, its validity has been questioned, especially in the presence of imbalanced iron homeostasis. The CLEVER trial aims to evaluate the relationship between iron deficiency and HbA1c (a biomarker for the diagnosis and therapeutic monitoring of type 2 diabetes) in a randomized, placebo-controlled, multicenter clinical trial. METHODS: The CLEVER (intravenous ferric CarboxymaLtosE for improVement of mEtabolic parameters in type 2 diabetes patients with iRon deficiency) trial is a randomized, single-blind, proof-of-concept study with two treatment arms...
November 13, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
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