Pharmacokinetics, safety and tolerability of intravenous ferric carboxymaltose: a dose-escalation study in volunteers with mild iron-deficiency anaemia

Arzneimittel-Forschung
Peter Geisser, José Banké-Bochita

Abstract

Iron-deficiency anaemia (IDA) represents a major burden to public health worldwide. The therapeutic aim for patients with IDA is to return iron stores and haemoglobin (Hb) levels to within the normal range using supplemental iron therapy and erythropoiesis-stimulating agents. Oral and previous intravenous (i.v.) iron formulations have a number of disadvantages, including immunogenic reactions, oxidative stress, low dosages, long administration times and the requirement for a test dose. Ferric carboxymaltose (FCM, Ferinject) is a novel, next-generation i.v. iron formulation with the potential to overcome these limitations. In this single-centre, randomized, double-blind, placebo-controlled study, the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of single, escalating doses of FCM were investigated. Four ascending doses were investigated in a total of 24 patients with mild IDA (defined as serum ferritin < 20 microg/l and transferrin saturation [TfS] < 16%): 100 mg iron as FCM given as an i.v. bolus injection, and 500, 800 and 1000 mg iron as FCM given as an i.v. infusion over 15 min. At each dose level six patients received FCM and two received placebo. The decision to escalate to the next dose was based o...Continue Reading

Citations

Mar 2, 2010·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Adrian Covic, Gabriel Mircescu
Mar 15, 2012·Expert Opinion on Pharmacotherapy·Manuel Muñoz, Elisa Martín-Montañez
Jan 15, 2014·Hospital Pharmacy·Dennis J CadaDanial E Baker
Sep 7, 2018·Journal of Applied Physiology·Nicole Karina BartPeter A Robbins

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