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Muhammad Umer Siddiqui, Yelena Galumyan, James Klein, Zunaira Naeem, Aron Schwarcz
Introduction: Epoetin alfa is an erythrocyte-stimulating factor. We here present a case of an anemic patient, who was given epogen before a coronary artery bypass (CABG) surgery and developed periprocedural myocardial infarction. To our knowledge, there has been no previous case reported of epogen causing myocardial infarction. Case Presentation: 66-year-old female presented with substernal chest pain. EKG showed ST segment elevations in aVf and L-III. Patient underwent left heart catheterization (LHC) and had triple vessel disease...
2017: Case Reports in Cardiology
Matthew R Weir, Pablo E Pergola, Rajiv Agarwal, Jeffrey C Fink, Nelson P Kopyt, Ajay K Singh, Jayant Kumar, Susanne Schmitt, Gregor Schaffar, Anita Rudy, Jim P McKay, Radmila Kanceva
BACKGROUND: HX575 (biosimilar epoetin alfa) was approved in Europe in 2007 for the treatment of chronic kidney disease (CKD)-related anemia. This study assessed the clinical equivalence of HX575 with the US-licensed reference epoetin alfa (Epogen®/Procrit®, Amgen/Janssen) following subcutaneous (SC) administration in dialysis patients with CKD-related anemia. METHODS: This randomized, double-blind, parallel-group, multicenter study (NCT01693029) was conducted at 49 US clinical sites...
2017: American Journal of Nephrology
Heba S Abed, Medhat A Al-Ghobashy, Faten A Fathalla, Maissa Y Salem
Recombinant human erythropoietin (rhEPO) is a commonly used biopharmaceutical for the treatment of anemia-associated disorders. Epogen; glycosylated erythropoietin (G-EPO) has short half-life and poor stability. Pegylated Epogen (Peg-G-EPO) was introduced to the market to overcome these limitations. The combined effects of pegylation and glycosylation on the stability of Peg-G-EPO was studied. Determination of Peg-G-EPO in the presence of its degradation products was achieved using SE-HPLC. The assay was validated according to ICH guidelines over concentration range of 50...
November 2017: Biologicals: Journal of the International Association of Biological Standardization
Kamyar Kalantar-Zadeh
BACKGROUND: Exogenous replacement of erythropoietin (EPO) by recombinant human EPO has been considered a standard of care for the treatment of anemia in patients with chronic kidney disease for more than 20 years. Genetically engineered biologic proteins derived from human, animal, or microorganism sources are a major area of growth in modern medical care, accounting for one-third of new drug approvals in the past decade. Despite benefit to patients, the use of biologics comes at a significant cost, representing one of the fastest growing segments of strained healthcare budgets around the world...
2017: American Journal of Nephrology
Dennis Stalker, Susan Reid, Atulkumar Ramaiya, Wayne A Wisemandle, Nancy E Martin
PURPOSE: The purpose of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of single 100 U/kg subcutaneous doses of Epoetin Hospira and Epogen in healthy male subjects as part of an overall program to demonstrate biosimilarity of Epoetin Hospira to the reference product Epogen. METHODS: This single-center, open-label, randomized, 2-period, crossover study was conducted in 81 healthy male subjects. Subjects were randomized to Sequence 1, in which they received 100 U/kg of Epoetin Hospira or to sequence 2, in which they received 100 U/kg Epogen subcutaneously in the first study period and the alternative treatment in the second study period...
August 2016: Clinical Therapeutics
Dennis Stalker, Atulkumar Ramaiya, Seema Kumbhat, Jeffrey Zhang, Susan Reid, Nancy Martin
PURPOSE: The purpose of this study was to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) equivalences of multiple doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen(⁎), when each is administered three times per week over 28 days to healthy male subjects METHODS: This single center, open-label, randomized, parallel group study was conducted in 129 healthy male subjects. Subjects were randomized to receive 100 U/kg Epoetin Hospira or 100 U/kg Epogen, each administered subcutaneously 3 times per week over 28 days...
2016: Clinical Therapeutics
William R Strohl
The purpose of making a "biobetter" biologic is to improve on the salient characteristics of a known biologic for which there is, minimally, clinical proof of concept or, maximally, marketed product data. There already are several examples in which second-generation or biobetter biologics have been generated by improving the pharmacokinetic properties of an innovative drug, including Neulasta(®) [a PEGylated, longer-half-life version of Neupogen(®) (filgrastim)] and Aranesp(®) [a longer-half-life version of Epogen(®) (epoetin-α)]...
August 2015: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
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
Liem Andhyk Halim, Vera Brinks, Wim Jiskoot, Stefan Romeijn, Kearkiat Praditpornsilpa, Anunchai Assawamakin, Huub Schellekens
PURPOSE: The high prevalence of pure red cell aplasia in Thailand has been associated with the sharp increase in number of recombinant human erythropoietin (rhEPO) copy products, based on a classical generic regulatory pathway, which have entered the market. This study aims to assess the quality of rhEPO copy products being used in Thailand. METHODS: Twelve rhEPO copy products were purchased from pharmacies in Thailand, shipped under controlled cold chain conditions to the Netherlands and characterized using (1) high performance size-exclusion chromatography, (2) asymmetrical flow field-flow fractionation, (3) sodium dodecyl sulfate polyacrylamide gel electrophoresis in combination with (4) Western blotting and additionally tested for (5) host cell protein impurities as well as (6) endotoxin contamination...
May 2014: Pharmaceutical Research
Kathleen E Rodgers, Theresa B Espinoza, Norma Roda, Christopher J Meeks, Gere S diZerega
PURPOSE: Angiotensin (1-7) [A(1-7)] is a bioactive peptide of the renin angiotensin system that stimulates the number of bone marrow progenitors and hematopoietic recovery after myelosuppression. We evaluated the combination of A(1-7) with colony-stimulating factors, Neupogen and Epogen, on bone marrow progenitors and the recovery of circulating formed elements following chemotherapy. METHODS: Mice were injected with gemcitabine followed 2 days later with A(1-7)...
December 2013: Cancer Chemotherapy and Pharmacology
Chadi Saifan, Mark Samarneh, Norbert Shtaynberg, Rabih Nasr, Elie El-Charabaty, Suzanne El-Sayegh
BACKGROUND: Vitamin B12 deficiency may have deleterious effects on end stage renal disease (ESRD) patients on maintenance hemodialysis, and may increase erythropoietin stimulating agent (ESA) resistance, yet little is known about its prevalence in this population. METHODS: Serum vitamin B12 and methylmalonic acid (MMA) levels were drawn from ESRD patients prior to hemodialysis. All patients with MMA levels greater than 800 nmol/L had peripheral smears evaluated for B12 deficiency...
2013: International Journal of Nephrology and Renovascular Disease
Lawrence A Delasotta, Ashwin V Rangavajjula, Michael L Frank, Jamie L Blair, Fabio R Orozco, Alvin C Ong
Introduction. To evaluate the efficacy of epoetin-α prior to revision total knee arthroplasty, we hypothesized that epoetin-α will reduce blood transfusion. Methods. Eighty-one patients were compared in this retrospective review; twenty-eight patients received our dosing regimen. All patients were mildly anemic. Epoetin-α to control (1 : 2) patient matching occurred so that one of two attending surgeons, gender, BMI, complexity of surgery, ASA score, and age were similar between groups. The clinical triggers for blood transfusion during or after the procedure were determined based on peri- and postoperative hemoglobin levels, ASA score, and/or clinical symptoms consistent with anemia...
2012: Advances in Orthopedics
Michael Lissy, Marité Ode, Karsten Roth
BACKGROUND: HX575, licensed under the brand names Binocrit®, Epoetin Alfa Hexal®, and Abseamed®, was approved in 2007 as the first biosimilar recombinant human erythropoietin alfa (epoetin alfa) in the EU using Erypo®/Eprex® as reference product. OBJECTIVES: The aim of this study was to investigate the bioequivalence and potency of registered epoetin alfa products that have not been compared before in a randomized controlled clinical study. METHODS: The study was conducted in two parts: part A compared the European-marketed HX575 and the US-marketed Epogen®; part B compared the European-marketed Erypo®/Eprex® and HX575 manufactured at two different drug substance production sites (HX575-TT denoting the already-approved technology-transfer product from an additional manufacturing site)...
2011: Drugs in R&D
Aaditya Singhal, Ashokkumar B Jain, Monika Burke, Martin Black
OBJECTIVES: There are different approaches for treating recurrent hepatitis C viral infection after a liver transplant. However, sustained virologic response is achieved in < 40% of infected allografts. We examined sustained virologic response improvement using a prolonged course of peginterferon and aggressive use of ribavirin. PATIENTS AND METHODS: From October 1998 to May 2008, 24 patients (13 male, 11 female; mean age at transplant, 49.4 +/- 7.7 years) received a prolonged course of peginterferon and ribavirin (range, 48-180 weeks)...
September 2010: Experimental and Clinical Transplantation
Shaffeeulah Bacchus, Neeta O'Mara, Harold Manley, Steven Fishbane
OBJECTIVE: To evaluate chronic kidney disease (CKD)-associated anemia management challenges and limitations and discuss strategies to improve treatment rates and patient response to therapy, monitoring of patient response to therapy, and education of prescribing providers and patients. DATA SOURCES: Multiple MEDLINE searches were performed using a comprehensive search term list to identify studies for inclusion, including, but not limited to, anemia, erythropoiesis-stimulating agent (ESA), epoetin, darbepoetin, CERA, hemoglobin, CKD, dialysis, end-stage renal disease, quality of life, and pharmacist...
November 2009: Annals of Pharmacotherapy
Leah Balsam, Abdel-Moneim Attia, Nandini P Sharma
The primary cause of anemia in HIV-infected patients with ESRD is diminished production of erythropoietin. Although most patients respond to recombinant erythropoietin, the response may be blunted in patients with ESRD and concomitant viral or bacterial infections. Previous studies demonstrated a response to erythropoietin by HIV-infected ESRD patients, but hematocrit levels on average were only 27-29%. We were interested in determining if KDOQI guidelines could be met in these patients. Hematocrits and epogen doses of all HIV-positive patients who were undergoing hemodialysis at the Nassau University Medical Center Dialysis Unit between September 2002 and March 2003 were compared to matched controls in our hemodialysis unit...
2009: Renal Failure
Randee Breiterman-White, Jacci Reznicek
Holding doses of epoetin alfa (Epogen) alters the balance between red blood cell production and death rates, and leads to a decrease in hemoglobin (Hb) levels. Although clinical circumstances sometimes require that epoetin alfa doses be held, this can be minimized by monitoring longitudinal trends, predicting the probable future course of Hb, and intervening to proactively adjust epoetin alfa doses before holding is required.
November 2008: Nephrology Nursing Journal: Journal of the American Nephrology Nurses' Association
Daniel T Mytych, Stephon La, Troy Barger, John Ferbas, Steven J Swanson
A surface plasmon resonance (SPR)-based biosensor immunoassay was developed and validated using the Biacore 3000 instrument to detect, semi-quantitate, and characterize serum antibodies against darbepoetin alfa (Aranesp) and epoetin alfa (EPOGEN). In this sensitive, dual-flow cell assay, epoetin alfa and darbepoetin alfa are covalently immobilized onto consecutive flow cells of a carboxymethyl dextran-coated sensor chip. Diluted human serum samples are injected sequentially over both surfaces. The binding of serum antibodies to the immobilized proteins are detected and recorded in real time based on the principles of SPR...
February 20, 2009: Journal of Pharmaceutical and Biomedical Analysis
Andrew J Vickers
Quality of life is an important focus of integrative oncology research. Choice of an appropriate way to measure quality of life is therefore a key concern. A common error of researchers has been to focus on whether a quality of life measure has been "validated". This may be a necessary condition for choice of endpoint, but it is certainly not sufficient. It is easily shown that interventions that undoubtedly improve quality of life, such as Epogen for chemotherapy anemia, will not have an important impact on items in some validated quality of life scales (e...
2006: Journal of the Society for Integrative Oncology
Sungae S Park, Jihea Park, Jason Ko, Louise Chen, David Meriage, Jill Crouse-Zeineddini, Wendy Wong, Bruce A Kerwin
We compared the physical and chemical properties of purported copies of recombinant human erythropoietin (rHuEPO) purchased from Korea, China, and India with the innovator product, Epoetin alfa, manufactured by Amgen Inc. The products were characterized for similarity in the types of glycoforms present, the relative degree of unfolding, in vitro potency, presence of covalent aggregates, and presence of cleavage products using established analytical methods. All products were different from Epoetin alfa (Epogen)...
May 2009: Journal of Pharmaceutical Sciences
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