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Epoetin Alfa

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https://www.readbyqxmd.com/read/29211140/pharmacotherapeutic-profile-of-users-and-expenditure-on-high-cost-drugs-in-s%C3%A3-o-leopoldo-rio-grande-do-sul-state-brazil-2014
#1
Mariani Sopelsa, Fabiane Raquel Motter, Nêmora Tregnago Barcellos, Heloísa Marquardt Leite, Vera Maria Vieira Paniz
OBJECTIVE: to describe the pharmacotherapeutic profile of users of the Specialized Program for Pharmaceutical Assistance, and to measure the expenditure on the most prevalent and the most expensive medications. METHODS: descriptive study conducted in São Leopoldo-RS, Brazil, with secondary data regarding information about requests accepted in 2014, through administrative proceedings; delivery notes of the State Health Department/RS were used to assess the costs...
October 2017: Epidemiologia e Servicos de Saude: Revista do Sistema Unico de Saude do Brasil
https://www.readbyqxmd.com/read/29172979/pharmacovigilance-of-biologics-in-a-multisource-environment
#2
Sreedhar Sagi, Hillel P Cohen, Gillian R Woollett
It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29138535/comparable-pharmacokinetics-and-pharmacodynamics-of-two-epoetin-alfa-formulations-eporon-%C3%A2-and-eprex-%C3%A2-following-a-single-subcutaneous-administration-in-healthy-male-volunteers
#3
Sumin Yoon, Su-Jin Rhee, Sun Ju Heo, Tae Young Oh, Seo Hyun Yoon, Joo-Youn Cho, SeungHwan Lee, Kyung-Sang Yu
Purpose: This study aimed to assess and compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties following a single subcutaneous injection of epoetin alfa (Eporon(®)) with those of the comparator (Eprex(®)) in healthy male subjects. Subjects and methods: A randomized, double-blind, two-sequence, crossover study was conducted. Subjects were randomly assigned to receive a single dose, that is, 4,000 IU, of the test or comparator epoetin alfa. After 4 weeks, all subjects received the alternative formulation...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29098093/epoetin-alfa-a-cause-of-coronary-artery-thrombosis
#4
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
https://www.readbyqxmd.com/read/29097481/efficacy-and-long-term-safety-of-c-e-r-a-maintenance-in-pediatric-hemodialysis-patients-with-anemia-of-ckd
#5
Michel Fischbach, Elke Wühl, Sylvie C Meyer Reigner, Zoe Morgan, Franz Schaefer
BACKGROUND AND OBJECTIVES: The study was conducted to identify a conversion factor for switching from previous erythropoiesis-stimulating agents (ESAs) to continuous erythropoietin receptor activator-methoxy polyethylene glycol-epoetin beta (C.E.R.A.) and to document the efficacy and long-term safety of C.E.R.A. in pediatric patients with anemia of CKD undergoing hemodialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this open-label, multicenter study, patients aged 6-17 years, with stable chronic anemia of CKD, undergoing hemodialysis received C...
November 2, 2017: Clinical Journal of the American Society of Nephrology: CJASN
https://www.readbyqxmd.com/read/29084409/a-comparison-of-the-safety-and-efficacy-of-hx575-epoetin-alfa-proposed-biosimilar-with-epoetin-alfa-in-patients-with-end-stage-renal-disease
#6
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
https://www.readbyqxmd.com/read/29020866/cause-and-timing-of-death-and-sub-group-differential-effects-of-erythropoietin-in-the-epo-tbi-study
#7
Markus Benedict Skrifvars, Craig French, Michael Bailey, Jeffrey Presneill, Alistair Nichol, Lorraine Little, Jacques Duranteau, Olivier Huet, Samir Haddad, Yaseen Arabi, Colin McArthur, D James Cooper, Rinaldo Bellomo
The EPO-TBI study randomised 606 patients with moderate or severe traumatic brain injury (TBI) to be treated with weekly epoetin alfa (EPO) or placebo. Six-month mortality was lower in EPO treated patients in an analysis adjusting for TBI severity. Knowledge of possible differential effects by TBI injury subtype and acute neurosurgical treatment as well as timing and cause of death (COD) will facilitate the design of future interventional TBI trials. We defined COD as cerebral (brain death, cerebral death with withdrawal or death during maximal care) and non-cerebral (death following withdrawal or during maximal care due to a non-cerebral cause)...
October 12, 2017: Journal of Neurotrauma
https://www.readbyqxmd.com/read/28974331/major-publications-in-the-critical-care-pharmacotherapy-literature-january-december-2016
#8
REVIEW
Deanna Horner, Diana Altshuler, Chris Droege, Joel Feih, Kevin Ferguson, Mallory Fiorenza, Kasey Greathouse, Leslie Hamilton, Caitlin Pfaff, Lauren Roller, Joanna Stollings, Adrian Wong
PURPOSE: To summarize select critical care pharmacotherapy guidelines and studies published in 2016. SUMMARY: The Critical Care Pharmacotherapy Literature Update (CCPLU) Group screened 31 journals monthly for relevant pharmacotherapy articles and selected 107 articles for review over the course of 2016. Of those included in the monthly CCPLU, three guidelines and seven primary literature studies are reviewed here. The guideline updates included are as follows: hospital-acquired pneumonia and ventilator-associated pneumonia management, sustained neuromuscular blocking agent use, and reversal of antithrombotics in intracranial hemorrhage (ICH)...
September 22, 2017: Journal of Critical Care
https://www.readbyqxmd.com/read/28947525/successful-treatment-of-chronic-hepatitis-c-virus-infection-in-a-patient-receiving-daily-peritoneal-dialysis
#9
Jennifer E Stark, Jennifer Cole
PURPOSE: Successful use of a 4-drug oral fixed-dose combination therapy to treat chronic hepatitis C in a patient receiving peritoneal dialysis (PD) is reported. SUMMARY: New highly effective treatments for chronic hepatitis C virus (HCV) infection are now available, but safety and efficacy data on the use of anti-HCV therapies in patients with renal failure, particularly those requiring PD, remain limited. A 73-year-old black man with chronic HCV genotype 1a infection and stage 5 chronic renal disease requiring daily automated PD was referred for HCV treatment prior to renal transplantation...
October 1, 2017: American Journal of Health-system Pharmacy: AJHP
https://www.readbyqxmd.com/read/28898593/biosimilars-implications-for-clinical-practice
#10
Robert M Rifkin, Susan R Peck
In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent...
September 2017: Journal of Oncology Practice
https://www.readbyqxmd.com/read/28782299/continuous-erythropoiesis-receptor-activator-cera-for-the-anaemia-of-chronic-kidney-disease
#11
REVIEW
Valeria M Saglimbene, Suetonia C Palmer, Marinella Ruospo, Patrizia Natale, Jonathan C Craig, Giovanni Fm Strippoli
BACKGROUND: Continuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD). OBJECTIVES: To assess benefits and harms of CERA compared with other epoetins (darbepoetin alfa and epoetin alfa or beta) or placebo/no treatment or CERA with differing strategy of administration for anaemia in individuals with CKD...
August 7, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28766493/evaluation-of-the-safety-and-immunogenicity-of-subcutaneous-hx575-epoetin-alfa-in-the-treatment-of-anemia-associated-with-chronic-kidney-disease-in-predialysis-and-dialysis-patients%C3%A2
#12
Nicole Casadevall, Vladimir Dobronravov, Kai-Uwe Eckardt, Sehsuvar Ertürk, Liliya Martynyuk, Susanne Schmitt, Gregor Schaffar, Anita Rudy, Andriy Krendyukov, Marité Ode
AIM: To assess the safety and immunogenicity of subcutaneous (SC) HX575 (epoetin-α) in dialysis- and nondialysis-dependent adult patients with chronic kidney disease (CKD). METHODS: Open-label, single-arm, multicenter study in patients (n = 416) from Germany, Italy, Poland, Romania, Russia, Turkey, and Ukraine. RESULTS: Mean (standard deviation (SD)) age was 52.3 (15.8) years, all patients were Caucasian, and similar proportions were male/female...
October 2017: Clinical Nephrology
https://www.readbyqxmd.com/read/28717516/costs-associated-with-intravenous-darbepoetin-versus-epoetin-therapy-in-hemodialysis-patients-a-randomized-controlled-trial
#13
Andrea L Woodland, Sean W Murphy, Bryan M Curtis, Brendan J Barrett
BACKGROUND: Anemia of chronic kidney disease is associated with adverse outcomes and a reduced quality of life. Erythropoiesis-stimulating agents (ESAs) have improved anemia management, and 2 agents are available in Canada, epoetin alfa (EPO) and darbepoetin alfa (DA). EPO and DA are considered equally effective in achieving target hemoglobin (Hb), but it is not clear whether there is a cost difference. There have been few head-to-head comparisons; most published studies are observational switch studies...
2017: Canadian Journal of Kidney Health and Disease
https://www.readbyqxmd.com/read/28642700/pricing-and-reimbursement-of-biosimilars-in-central-and-eastern-european-countries
#14
Paweł Kawalec, Ewa Stawowczyk, Tomas Tesar, Jana Skoupa, Adina Turcu-Stiolica, Maria Dimitrova, Guenka I Petrova, Zinta Rugaja, Agnes Männik, Andras Harsanyi, Pero Draganic
Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28465779/is-a-biologic-produced-15-years-ago-a-biosimilar-of-itself-today
#15
Stanton R Mehr, Marj P Zimmerman
Much of the testing required for the regulatory approval of a biosimilar is focused on proving that the new drug is sufficiently similar to the reference biologic in structure, pharmacokinetics or pharmacodynamics, clinical efficacy, and safety. However, the reference drug may itself have gone through some changes in the years since its approval, including those caused by alterations in the manufacturing process. Do these changes increase the risk that the reference drug may cause unexpected outcomes? It is up to the US Food and Drug Administration to decide whether the changes merit the need for additional studies to confirm that the drug meets the structural or clinical outcomes standard for the reference agent...
December 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/28438754/smad1-5-is-required-for-erythropoietin-mediated-suppression-of-hepcidin-in-mice
#16
Chia-Yu Wang, Amanda B Core, Susanna Canali, Kimberly B Zumbrennen-Bullough, Sinan Ozer, Lieve Umans, An Zwijsen, Jodie L Babitt
Anemia suppresses liver hepcidin expression to supply adequate iron for erythropoiesis. Erythroferrone mediates hepcidin suppression by anemia, but its mechanism of action remains uncertain. The bone morphogenetic protein (BMP)-SMAD signaling pathway has a central role in hepcidin transcriptional regulation. Here, we explored the contribution of individual receptor-activated SMADs in hepcidin regulation and their involvement in erythroferrone suppression of hepcidin. In Hep3B cells, SMAD5 or SMAD1 but not SMAD8, knockdown inhibited hepcidin (HAMP) messenger RNA (mRNA) expression...
July 6, 2017: Blood
https://www.readbyqxmd.com/read/28371815/phase-2-studies-of-oral-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitor-fg-4592-for-treatment-of-anemia-in-china
#17
Nan Chen, Jiaqi Qian, Jianghua Chen, Xueqing Yu, Changlin Mei, Chuanming Hao, Gengru Jiang, Hongli Lin, Xinzhou Zhang, Li Zuo, Qiang He, Ping Fu, Xuemei Li, Dalvin Ni, Stefan Hemmerich, Cameron Liu, Lynda Szczech, Anatole Besarab, Thomas B Neff, Kin-Hung Peony Yu, Frank H Valone
Background: FG-4592 (roxadustat) is an oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (HIF-PHI) promoting coordinated erythropoiesis through the transcription factor HIF. Two Phase 2 studies were conducted in China to explore the safety and efficacy of FG-4592 (USAN name: roxadustat, CDAN name: ), a HIF-PHI, in patients with anemia of chronic kidney disease (CKD), both patients who were dialysis-dependent (DD) and patients who were not dialysis-dependent (NDD). Methods: In the NDD study, 91 participants were randomized to low (1...
August 1, 2017: Nephrology, Dialysis, Transplantation
https://www.readbyqxmd.com/read/28344481/stability-of-erythropoietin-repackaging-in-polypropylene-syringes-for-clinical-use
#18
Angela Marsili, Giorgia Puorro, Chiara Pane, Anna de Rosa, Giovanni Defazio, Carlo Casali, Antonio Cittadini, Giuseppe de Michele, Brunello Ettore Florio, Alessandro Filla, Francesco Saccà
Introduction: Epoetin alfa (Eprex®) is a subcutaneous, injectable formulation of short half-life recombinant human erythropoietin (rHuEPO). To current knowledge there are no published studies regarding the stability of rHuEPO once repackaging occurs (r-EPO) for clinical trial purposes. Materials and methods: We assessed EPO concentration in Eprex® and r-EPO syringes at 0, 60, 90, and 120 days after repackaging in polypropylene syringes. R-EPO was administered to 56 patients taking part in a clinical trial in Friedreich Ataxia...
February 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/28255868/biosimilar-epoetin-alfa-increases-haemoglobin-levels-and-brings-cognitive-and-socio-relational-benefits-to-elderly-transfusion-dependent-multiple-myeloma-patients-results-from-a-pilot-study
#19
Roberto Castelli, Simona Sciara, Giorgio Lambertenghi Deliliers, Giuseppe Pantaleo
Anaemia is a complication reported in up to 70% of the multiple myeloma patients (MM), with remarkable clinical, cognitive and socio-relational consequences. Anaemia relates to the course of MM, normalizing in patients during remission and reappearing in relapsing/non-responding patients. In a pilot study with 31 patients with MM and transfusion-dependent anaemia, we evaluated the effects of Binocrit (biosimilar epoetin alfa) on transfusions, haemoglobin levels, mental status (mini-mental state evaluation) and the patients' social-relational functioning and quality of life (QoL)...
May 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28249030/low-versus-high-dose-erythropoiesis-stimulating-agents-in-hemodialysis-patients-with-anemia-a-randomized-clinical-trial
#20
RANDOMIZED CONTROLLED TRIAL
Valeria Saglimbene, Suetonia C Palmer, Jonathan C Craig, Marinella Ruospo, Antonio Nicolucci, Marcello Tonelli, David Johnson, Giuseppe Lucisano, Gabrielle Williams, Miriam Valentini, Daniela D'Alonzo, Fabio Pellegrini, Paolo Strippoli, Mario Salomone, Antonio Santoro, Stefano Maffei, Jörgen Hegbrant, Gianni Tognoni, Giovanni F M Strippoli
The increased risks of death and adverse events with erythropoiesis-stimulating agent (ESA) therapy targeting a higher hemoglobin level are established. It is uncertain whether the adverse effects of ESA therapy are related to dose and are mitigated when a fixed low ESA dose is used. We conducted a multicenter, prospective randomized open-label, blinded-endpoint (PROBE) trial to evaluate fixed low versus high dose ESA therapy on patient outcomes. We intended to recruit 2104 hemodialysis patients >18 years with anemia or receiving ESA treated at dialysis clinics in Italy...
2017: PloS One
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