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Muhammad Masoom Javaid, Priyanka Khatri, Srinivas Subramanian
Pure red cell aplasia is a rare condition associated with the use of recombinant human erythropoietin preparations. It has predominantly been associated with the subcutaneous use of a particular epoetin-α product, Eprex, and is rarely associated with intravenous use or with other commercially available products. Only a few cases of pure red cell aplasia secondary to epoetin-β have been reported. On account of its rarity, the condition can often be missed on initial presentation, leading to unnecessary investigations and delayed diagnosis...
December 8, 2016: Postgraduate Medical Journal
L Martin, M Ashenden, J Bejder, M Hoffmann, N Nordsborg, K Karstoft, J Morkeberg, K Sharpe, F Lasne, A Marchand
To minimize the chances of being caught after doping with recombinant human erythropoietins (rhEPO), athletes have turned to new practices using micro-doses and excess fluid ingestion to accelerate elimination and decrease the probability of detection. Our objective was to test the sensitivity of detection by validated methods (IEF: isoelectric focusing; SDS-PAGE: sodium dodecyl sulfate polyacrylamide gel electrophoresis) when such practices are used. First, after a three-week rhEPO boost period and 10 days of wash out, detection of a single 900 IU micro-dose of Eprex® was evaluated in healthy male subjects...
November 2016: Drug Testing and Analysis
Chuen Wen Tan, Wei-Chuen Tan-Koi, Jennifer Ng, Choong Meng Chan, William Ying Khee Hwang
Antibody-mediated pure red cell aplasia is a rare but serious complication in chronic kidney disease patients receiving recombinant human erythropoietin (r-HuEpo). Between April 2012 and May 2013, eight such cases were reported in our institution. Their clinical features were reviewed and their HLA alleles were compared with those of healthy controls. All patients were exposed to epoetin alfa (Eprex(®)) with polysorbate-80 as stabilizer via subcutaneous route with a mean age of 61.9 years and mean exposure of 11...
June 27, 2016: Pharmacogenomics
Amit B Agarwal, Ali McBride
The World Health Organization defines a biosimilar as "a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product." Biosimilars are biologic medical products that are very distinct from small-molecule generics, as their active substance is a biological agent derived from a living organism. Approval processes are highly regulated, with guidance issued by the European Medicines Agency and US Food and Drug Administration. Approval requires a comparability exercise consisting of extensive analytical and preclinical in vitro and in vivo studies, and confirmatory clinical studies...
August 2016: Critical Reviews in Oncology/hematology
Maj Vinberg, Pia Weikop, Niels Vidiendal Olsen, Lars Vedel Kessing, Kamilla Miskowiak
AIM: This study investigated the effect of repeated infusions of recombinant human erythropoietin (EPO) on markers of inflammation in patients with affective disorders and whether any changes in inflammatory markers were associated with improvements on verbal memory. METHODS: In total, 83 patients were recruited: 40 currently depressed patients with treatment-resistant depression (TRD) (Hamilton Depression Rating Scale-17 items (HDRS-17) score >17) (sub-study 1) and 43 patients with bipolar disorder (BD) in partial remission (HDRS-17 and Young Mania Rating Scale (YMRS)⩽14) (sub-study 2)...
October 2016: Brain, Behavior, and Immunity
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
Bahgat E Fayed, Abdulkader F Tawfik, Alaa Eldeen B Yassin
The aim of this study was to optimize the formulation of erythropoietin (EPO) using amino acids instead of human serum albumin (HSA) and to evaluate its in vivo stability in order to avoid the risk of viral contamination and antigenicity. Different EPO formulations were developed in such a way as to allow studying the effects of amino acids and surfactants on the EPO stability profile. The main techniques applied for EPO analysis were ELISA, Bradford method, and SDS gel electrophoresis. The in vivo stability was evaluated in a Balb-c mouse animal model...
March 2016: Acta Pharmaceutica
Gayathri Kumarasinghe, Ling Gao, Mark Hicks, Jeanette Villanueva, Aoife Doyle, Padmashree Rao, Min Ru Qiu, Andrew Jabbour, Arjun Iyer, Hong Chee Chew, Christopher S Hayward, Peter Macdonald
BACKGROUND: Hearts from older donors are increasingly being referred for transplantation. However, these hearts are more susceptible to ischemia-reperfusion injury (IRI), reflected in higher rates of primary graft dysfunction. We assessed a strategy of pharmacologic conditioning, supplementing Celsior (Genzyme, Naarden, The Netherlands) preservation solution with glyceryl trinitrate (GTN; Hospira Australia Pty, Ltd, Mulgrave, VIC, Australia), erythropoietin (EPO; Eprex; Janssen-Cilag, North Ryde, NSW, Australia), and zoniporide (ZON; Pfizer, Inc...
May 2016: Journal of Heart and Lung Transplantation
Liem Andhyk Halim, Vera Brinks, Wim Jiskoot, Stefan Romeijn, Rob Haselberg, Chris Burns, Meenu Wadhwa, Huub Schellekens
Comprehensive physicochemical characterization and biological assays are essential parts in assessing quality attributes of biologicals. Here, we compared the quality of different marketed recombinant human erythropoietin (epoetin) products: originators, Eprex and NeoRecormon as well as 2 biosimilars, Retacrit and Binocrit. In addition, assessment of batch-to-batch variability was included by collecting 2 or more batches of each product. Common assays which included sodium dodecyl sulfate-polyacrylamide gel electrophoresis, high-performance size-exclusion chromatography, asymmetrical flow field-flow fractionation, capillary zone electrophoresis, and potency testing were used...
February 2016: Journal of Pharmaceutical Sciences
Fatemeh Beiraghdar, Yunes Panahi, Behzad Einollahi, Eghlim Nemati, Amirhossein Sahebkar, Arash Hassanzadeh, Hamid T Khosroshahi, Sima A Azar, Javid Safa, Sadroddin R Hashemi, Jalal Etemadi, Eisa T Marzony, Hamid Noshad
BACKGROUND: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. OBJECTIVE: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin(®)) and compare it with the innovator product Eprex(®), as a standard rHuEPO. METHODS: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57)...
October 2015: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
MinKyung Oh, Jaeseung Yoon, Doo-Yeoun Cho
BACKGROUND AND OBJECTIVES: A new biosimilar human recombinant epoetin alfa product (PDA10) has been developed by PanGen Biotech Inc., Korea. This study was planned to demonstrate the pharmacokinetic and pharmacodynamic comparability of PDA10 to an existing epoetin alfa (Eprex) after a single intravenous administration to healthy adult male volunteers. METHODS: A randomized, double-blinded, single-dose, crossover study was conducted in 30 subjects. The subjects were assigned randomly to one of two sequence groups, and single doses of 100 IU/kg PDA10 or Eprex were administered intravenously on each of 2 treatment days separated by a 4-week washout period...
October 2015: Clinical Drug Investigation
Michela Guarienti, Edoardo Giacopuzzi, Alessandra Gianoncelli, Sandra Sigala, Pierfranco Spano, Sergio Pecorelli, Luca Pani, Maurizio Memo
The zebrafish (Danio rerio) is a very popular vertebrate model system, especially embryos represent a valuable tool for in vivo pharmacological assays. This is mainly due to the zebrafish advantages when compared to other animal models. Erythropoietin is a glycoprotein hormone that acts principally on erythroid progenitors, stimulating their survival, proliferation and differentiation. Recombinant human erythropoietin (rhEPO) has been widely used in medicine to treat anemia and it is one of the best-selling biotherapeutics worldwide...
December 2015: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Samantha K Barton, Annie R A McDougall, Jacqueline M Melville, Timothy J M Moss, Valerie A Zahra, Tammy Lim, Kelly J Crossley, Graeme R Polglase, Mary Tolcos
Inadvertently injurious ventilation of preterm neonates in the delivery room can cause cerebral white matter (WM) inflammation and injury. We investigated the impact of an early high dose of recombinant human erythropoietin (EPO) on ventilation-induced WM changes in preterm lambs. Injurious ventilation, targeting a V(T) of 15 ml kg(-1) with no positive end-expiratory pressure, was initiated for 15 min in preterm lambs (0.85 gestation). Conventional ventilation was continued for a further 105 min. Lambs received either 5000 IU kg(-1) of EPO (EPREX®; Vent+EPO; n = 6) or vehicle (Vent; n = 8) via an umbilical vein at 4 ± 2 min...
March 1, 2016: Journal of Physiology
Mark Timms, Rohan Steel, John Vine
The recombinant human erythropoietins epoetin alfa (Eprex®), darbepoetin (Aranesp®) and methoxy polyethylene glycol-epoetin beta (Mircera®) were administered to greyhounds for 7, 10 and 14 days respectively. Blood and urine samples were collected and analysed for erythropoietin by ELISA, LC-MS/MS and western blotting. Limits of confirmation in plasma for western blotting and LC-MS/MS methods ranged from a low of 2.5mIU/mL, and closely matched the sensitivity of ELISA screening.
February 2016: Drug Testing and Analysis
Cécile Vigneau, Sylvie Le Stum, Corinne Isnard-Bagnis, Gabriel Choukroun, Yannick Lemeur, Nassim Kamar, Emmanuel Oger
INTRODUCTION: Erythropoiesis Stimulating Agents (ESA) are largely prescribed before dialysis stage to chronic kidney disease patients. In accordance to current international guidelines, lots have been made by pharmacological companies in order to improve self management of ESAs: subcutaneaous administration, pencil devices, mutidose cartridges, low injection volume, very fine needles, once a month injections but none is currently known on the percentage of patients who actually do self administration of ESAs...
December 2014: Néphrologie & Thérapeutique
Kresimir Pucaj, Katherine Riddle, Simon R Taylor, Nuris Ledon, Gordon T Bolger
This study examined the safety, pharmacodynamic (PD), and pharmacokinetic (PK) biosimilarity of the human recombinant erythropoietin (EPO) products ior(®) EPOCIM and Eprex(®) following a 28-day repeated intravenous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology, and pathology findings for control rats dosed with vehicle and rats dosed either with 30, 300, and 600 I.U./kg of ior(®) EPOCIM or 600 I...
November 2014: Journal of Pharmaceutical Sciences
Iain C Macdougall, Nicole Casadevall, Francesco Locatelli, Christian Combe, Gerard M London, Salvatore Di Paolo, Andreas Kribben, Danilo Fliser, Hans Messner, John McNeil, Paul Stevens, Antonio Santoro, Angel L M De Francisco, Paul Percheson, Anna Potamianou, Arnaud Foucher, Daniel Fife, Véronique Mérit, Els Vercammen
BACKGROUND: Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa)...
March 2015: Nephrology, Dialysis, Transplantation
M Hasanova, Ch Asadov, Z Alimirzoyeva, T Mammadova, A Shirinova
Alpha-thalassemia is widely spread in human population and one of the most common types of α-thalassemia is hemoglobinopathy H which develops with mild microcytic hypochromic anemia, hepatosplenomegaly and jaundice. The basic method of anemia correction is blood transfusion. However this method has crucial deficiencies. As it is known recombinant erythropoetin (rEPO) contributes to erythroid proliferation and could be used for anemia treatment. The aim of the study was to qualify efficiency of administration rEPO in complex therapy of hemaglobinopathy H...
January 2014: Georgian Medical News
Mahmoud Rafieian-Kopaei, Hamid Nasri, Mehdi Nematbakhsh, Azar Baradaran, Alaleh Gheissari, Hamid Rouhi, Seyed Mohammad Ahmadi Soleimani, Milad Baradaran-Ghahfarokhi, Fatemeh Ghaed-Amini, Mohammadreza Ardalan
BACKGROUND: Investigations have attempted to modify the outcome of tubular injury by either ameliorating renal tubular damage or promoting tubular regeneration in the case of acute tubular necrosis. OBJECTIVES: We investigated the protective effect of Eprex an erythropoietin analogue on tubular injury induced by gentamicin (GM). MATERIALS AND METHODS: Forty male Wistar rats were randomly divided into four groups. In group 1,rats were served as a sham group...
July 2012: Journal of Nephropathology
Mehri Kadkhodaee
Recent publications have suggested renoprotective actions for erythropoietin in certain models of acute kidney injury. In a study by Rafieian-Kopaei et al., the effects of erythropoietin on amelioration of gentamicin-induced renal toxicity was investigated and renoprotective effect for Eprex, an analogue of erythropoietin was shown when the drug was given in combination with gentamicin. There has also been a protective effect when the drug was applied after gentamicin administration. Thus, the drug was effective even after induction of tubular damage which opens a very valuable window for its therapeutic actions...
July 2012: Journal of Nephropathology
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