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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...
May 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
G A Heavner, T Arakawa, J S Philo, M A Calmann, S Labrenz
In the biotechnology area, the issue of comparability with an innovator product is complex. Ideally, a side-by-side comparison of physical properties would be part of the demonstration of comparability. However, biogeneric companies do not have access to the bulk drug substance from the innovator company for biophysical comparison, and isolation of protein from marketed product cannot be guaranteed to produce material that is identical to the bulk drug substance from which it was prepared. In a recently published study, protein was isolated from marketed product and comparative studies performed...
December 2007: Journal of Pharmaceutical Sciences
Pradeep Arora, Reem A Mustafa, Jyotheen Karam, Patricia Khalil, Greg Wilding, Rajiv Ranjan, James Lohr
BACKGROUND: Providing optimal care to the growing number of chronic kidney disease (CKD) patients remains a significant problem in the United States. There is little known about the care of elderly CKD patients by primary care physicians as well as nephrologists. METHODS: We performed a retrospective study of 377 elderly male CKD (serum creatinine >1.4 mg/dl on 2 separate occasions 3 months apart) patients referred to the Nephrology Clinic at the Buffalo Veterans Administration Medical Center between 1999 and 2002 to see if the pattern of care changed during this time...
2006: International Urology and Nephrology
Songpon Deechongkit, Kenneth H Aoki, Sungae S Park, Bruce A Kerwin
This study focuses on the development and application of biophysical methodology to characterize conformations of Epogen and Eprex, the injectable formulations of recombinant human Epoetin alfa produced by different manufacturers and commonly used for the treatment of renal anemia. In these studies Eprex, from prefilled syringes, and Epogen bulk product formulated in a buffer similar to the Eprex formulation, were purified by anion-exchange chromatography. Analytical ultracentrifugation studies of the purified main peak from each sample demonstrated that Epogen contains a single component with an s value of 2...
September 2006: Journal of Pharmaceutical Sciences
Adrienne P Williams, Andrew Gettinger
PURPOSE OF REVIEW: Transfusion therapy in the intensive care unit is an ever-growing field, with new understanding of potential complications, new drug therapies to reduce the need for transfusion, and new additions in component therapy. In addition to the risks of sepsis, ABO blood group mismatch, and other complications associated with transfusion, the intensivist needs to be familiar with alternative therapies to minimize transfusion. RECENT FINDINGS: Transfusion-related acute lung injury and immunosuppression are two newly recognized complications in transfusion...
April 2006: Current Opinion in Anaesthesiology
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