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Josefien Knoeff, Beat Flühmann, Stefan Mühlebach
Introduction: This study investigates the drug selection and dispensing behaviour of hospital pharmacists of intravenous iron products including iron sucrose and iron sucrose similar, with special emphasis on substitution and interchangeability in France and Spain. Iron-carbohydrate complex drugs represent different available intravenous iron drugs and are part of the non-biological complex drug (NBCD) class, an expanding drug class with up to 30 brands available in intravenous pharmacotherapy and over 50 in clinical development...
March 2018: European Journal of Hospital Pharmacy. Science and Practice
Kimberley Span, Ebel H E Pieters, Wim E Hennink, Annette van der Toorn, Vera Brinks, Rick M Dijkhuizen, Geralda A F van Tilborg
PURPOSE: The aim of this study was to determine the potential of magnetic resonance imaging to evaluate the biodistribution of exogenous iron within 24 h after one single injection of Venofer® (iron sucrose). METHODS: Venofer® was evaluated in vitro for its ability to generate contrast in MR images. Subsequently, iron disposition was assessed in rats with MRI, in vivo up to 3 h and post mortem at 24 h after injection of Venofer®, at doses of 10- and 40 mg/kg body weight (n = 2 × 4), or saline (n = 4)...
March 8, 2018: Pharmaceutical Research
Susana Pastor, Elisabeth Coll, Lara Rodríguez-Ribera, Elitsa Stoyanova, Zuray F Corredor, Ricard Marcos
End-stage renal disease (ESRD) patients present high levels of phosphorus and calcium products in serum, which contribute to the development of vascular calcification and cardiovascular disease, and to low iron stores and carnitine deficiency. For these reasons, ESRD patients are generally supplemented with different medicines. Some of the most common treatments include the use of Carnicor, Venofer, and Sevelamer drugs. Carnicor is used as a source of L-carnitine, acting as antioxidant and neuroprotector. Venofer is used to reduce the deficit of iron...
May 2018: Environmental and Molecular Mutagenesis
Kimberley Span, Ebel H E Pieters, Vera Brinks, Wim E Hennink, Huub Schellekens
The aim of the study was to examine the reproducibility of a rat model to assess the preclinical similarity in safety profiles and tissue accumulation of iron products. Accordingly, the effect of several doses of intravenously administered Venofer® and of Ferrlecit® on blood parameters, and on kidney and particularly liver toxicity were examined in non-anemic Sprague Dawley rats. The different analysis showed neither a clear treatment nor a dose effect after multiple injections. The parameters measured in this rat strain showed some iron induced adverse effects, but these could not be correlated to treatment specific differences...
December 24, 2017: Journal of Pharmacological and Toxicological Methods
U Altanerova, M Babincova, P Babinec, K Benejova, J Jakubechova, V Altanerova, M Zduriencikova, V Repiska, C Altaner
Magnetic hyperthermia, or the heating of tissues using magnetic materials, is a promising approach for treating cancer. We found that human mesenchymal stem cells (MSCs) isolated from various tissues and MSCs expressing the yeast cytosine deaminase∷uracil phosphoribosyl transferase suicide fusion gene ( yCD∷UPRT ) can be labeled with Venofer, an iron oxide carbohydrate nanoparticle. Venofer labeling did not affect cell proliferation or the ability to home to tumors. All Venofer-labeled MSCs released exosomes that contained iron oxide...
2017: International Journal of Nanomedicine
Amy Barton Pai
Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug...
November 2017: Annals of the New York Academy of Sciences
Niloufar Zadeh Saraji, Maryam Hami, Reza Boostani, Mohammad Javad Mojahedi
Introduction: Restless leg syndrome (RLS) is a sensory motor disorder. Patients with this syndrome have serious and uncontrollable desire to move their legs, which is mostly due to an uncomfortable feeling intensified when they are motionless. It may be a genetic disorder or secondary to iron deficiency, neurodegenerations, pregnancy, some drugs and severe kidney diseases. Objectives: This study was designed to find out the prevalence and its risk factors of RLS in hemodialysis patients. Patients and Methods: This multicenter cross-sectional study was done on 260 hemodialysis patients...
2017: Journal of Renal Injury Prevention
Heshmatolah Shahbazian, Ali Ghorbani, Azita Zafar-Mohtashami, Abdolreza Balali, Armaghan AleAli, Gholam Reza Lashkarara
Introduction: One of the most important causes of erythropoietin-resistant anemia in end-stage renal disease (ESRD) patients is increased levels of inflammatory cytokines. Objectives: In this study pentoxifylline, an anti-inflammatory and anti-cytokine drug, with no significant side effects was used to manage anemia in ESRD patients. Patients and Methods: Thirty-nine ESRD patients with erythropoietin-resistant anemia were assigned to two groups, the treatment and the control groups. In treatment group, 19 patients received erythropoietin, venofer and pentoxifylline for 6 months...
2017: Journal of Renal Injury Prevention
Rafael Bielza Galindo, Jesús Llorente Gutiérrez, José Luis Pérez González, Asunción Mora Casado, David Blanco Díaz, Javier Escalera Alonso, Adoración Morales Fernández, Cristina Molano Ortiz, Beredys Esmirla García López, Nazaret Del Amo Del Arco, Juan Pablo Barro Ordovas, Estefanía Arias Muñana, Marta Neira Álvarez, David Sanz Rosa, Jorge Fco Gómez Cerezo
INTRODUCTION: There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). MATERIAL AND METHODS: A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system...
January 2018: Revista Española de Geriatría y Gerontología
U Altanerova, K Benejova, V Altanerova, S Tyciakova, B Rychly, P Szomolanyi, F Ciampor, M Cihova, V Repiska, K Ondicova, B Mravec, C Altaner
We report on a simple iron oxide (Venofer) labeling procedure of dental pulp mesenchymal stem cells (DP-MSCs) and DP-MSCs transduced with yeast cytosinedeaminase::uracilphosphoribosyltransferase (yCD::UPRT-DP-MSCs). Venofer is a drug approved for intravenous application to treat iron deficiency anemia in patients. Venofer labeling did not affect DP-MSCs or yCD::UPRT-DP-MSCs viability and growth kinetics. Electron microscopy of labeled cells showed internalized Venofer nanoparticles in endosomes. MRI relativity measurement of Venofer labeled DP-MSCs in a phantom arrangement revealed that 100 cells per 0...
2016: Neoplasma
Yu S Milovanov, N A Mukhin, L V Kozlovskaya, S Yu Milovanova, M M Markina
AIM: To investigate the impact of anemia correction with erythropoiesis stimulants on the serum level of the circulating morphogenetic protein α-Klotho in patients with Stages 3B--4 chronic kidney disease (CKD). SUBJECTS AND METHODS: 64 patients aged 42±8 years with Stages 3B--4 nondiabetic CKD were examined and divided into 2 groups: 1) 32 patients with anemia (the target hemoglobin levels could be achieved and kept with erythropoietin and iron saccharate in 20 patients (Group A) and those could not be done in 12 patients (Group 1B)...
2016: Terapevticheskiĭ Arkhiv
Mohammad Reza Abassi, Amin Safavi, Masoumeh Haghverdi, Babak Saedi
Kidney failure affects different aspects of normal life. Among different manifestations, sleep problem can be considered as a common complaint of ESRD (End Stage Renal Disease) patients. In this study, we aimed to investigate the interrelationship between sleep disorders in ESRD patients and their characteristics. Through a cross-sectional study (2010-2011), 88 ESRD patients undergoing maintenance hemodialysis thrice weekly were recruited to enter the study. We used a self-administered questionnaire into which the data were reflected...
March 2016: Acta Medica Iranica
Martha L Louzada, Cyrus C Hsia, Fatimah Al-Ani, Fiona Ralley, Anargyros Xenocostas, Janet Martin, Sarah E Connelly, Ian H Chin-Yee, Leonard Minuk, Alejandro Lazo-Langner
BACKGROUND: Intravenous iron therapy is a treatment option for iron deficient patients who are intolerant to oral iron or where oral iron is ineffective, but with possible adverse effects. Currently, prospective studies comparing different intravenous iron formulations are needed to determine safety and efficacy of these agents. METHODS: We conducted a prospective, double-blind, randomized controlled trial (RCT) to assess the feasibility of a trial comparing the safety of high molecular weight intravenous iron dextran, Infufer®, with intravenous iron sucrose, Venofer®, in non-hemodialysis adult outpatients...
2016: BMC Hematology
Nikolaos Papadimitriou, Susann Li, Helena Barreto Henriksson
For evaluation of cell therapy applications, it is of interest to be able to trace and observe cellular distribution of the transplanted cells. The aim with the study was to examine viability, traceability, and multilineage capability of iron sucrose-labeled mesenchymal stem cells (MSCs) after transplantation into lapine intervertebral discs (IVDs). MSCs were collected from three human donors, age 31-50 years, and IVDs from 12 rabbits, age 3 months. MSCs were isolated from the bone marrow and cultured using standard protocols...
October 15, 2015: Stem Cells and Development
Sunil Bhandari, Philip A Kalra, Jatin Kothari, Patrice M Ambühl, Jeppe H Christensen, Ashot M Essaian, Lars L Thomsen, Iain C Macdougall, Daniel W Coyne
BACKGROUND: Iron deficiency anaemia is common in patients with chronic kidney disease, and intravenous iron is the preferred treatment for those on haemodialysis. The aim of this trial was to compare the efficacy and safety of iron isomaltoside 1000 (Monofer®) with iron sucrose (Venofer®) in haemodialysis patients. METHODS: This was an open-label, randomized, multicentre, non-inferiority trial conducted in 351 haemodialysis subjects randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sucrose (Group B)...
September 2015: Nephrology, Dialysis, Transplantation
Nikolaos Papadimitriou, Anna Thorfve, Camilla Brantsing, Katarina Junevik, Adad Baranto, Helena Barreto Henriksson
For evaluation of cell therapy strategies using human mesenchymal stem cells (hMSCs), it is important to be able to trace transplanted cells and their distribution in tissues, for example, cartilage, over time. The aim of the study was to determine effects on cell viability, traceability, and chondrogenic differentiation of hMSCs after iron labeling with iron sucrose. hMSCs were collected (seven donors, 13-57 years) from patients undergoing spinal surgery. Two subsets of experiments were performed. (1) Iron labeling of hMSCs: 1 mg/mL of Venofer(®) (iron sucrose) was added (16 h) to cultures...
November 1, 2014: Stem Cells and Development
Anila Thomas, Leif E Peterson
BACKGROUND: Ferric citrate is a novel phosphate binder which has the potential to reduce usage of erythropoietin-stimulating agents (ESAs) and intravenous (IV) iron used for anemia management during hemodialysis (HD) among patients with end-stage renal disease (ESRD). Currently, the potential health care cost savings on a national scale due to the use of ferric citrate in ESRD are undetermined. METHODS: Per-patient-per-year costs of ESAs (Epogen(®) and Aranesp(®) [Amgen Inc...
2014: International Journal of Nephrology and Renovascular Disease
Iain C Macdougall, William E Strauss, Justin McLaughlin, Zhu Li, Frank Dellanna, Joachim Hertel
BACKGROUND AND OBJECTIVES: Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1...
April 2014: Clinical Journal of the American Society of Nephrology: CJASN
Monika Praschberger, Carolin Cornelius, Markus Schitegg, Hans Goldenberg, Barbara Scheiber-Mojdehkar, Brigitte Sturm
CONTEXT: Severe iron deficiency requires intravenous iron supplementation to replenish iron stores. Intravenous iron sucrose has been used for decades for the treatment of anemia. New generic iron sucrose products are now marketed for the use in several countries and there is an ongoing discussion about the safety and efficacy of iron sucrose similars. OBJECTIVE: In this study, we compared the iron sucrose originator Venofer® and the generic iron sucrose AZAD (ISA) regarding bioavailability, toxicity and stability in human THP-1 cells and HepG2 cells...
March 2015: Pharmaceutical Development and Technology
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
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