Pharmacokinetic and Pharmacodynamic Equivalence of Epoetin Hospira and Epogen After Single Subcutaneous Doses to Healthy Male Subjects.
Abstract
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 subcut...
Source: Clinical Therapeutics - July 25, 2016 Category: Drugs & Pharmacology Authors: Stalker D, Reid S, Ramaiya A, Wisemandle WA, Martin NE Tags: Clin Ther Source Type: research
Early High-Dose Erythropoietin Therapy After Out-of-Hospital Cardiac Arrest A Multicenter, Randomized Controlled Trial
ConclusionsIn patients resuscitated from an OHCA of presumed cardiac cause, early administration of erythropoietin plus standard therapy did not confer a benefit, and was associated with a higher complication rate. (High Dose of Erythropoietin Analogue After Cardiac Arrest [Epo-ACR-02]; NCT00999583) (Source: Journal of the American College of Cardiology: Cardiovascular Imaging)
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - June 27, 2016 Category: Radiology Source Type: research
Preprocedure Anemia Management Decreases Transfusion Rates in Patients Undergoing Transcatheter Aortic Valve Implantation
Conclusions Preprocedural anemia management was successful in improving hemoglobin levels in anemic patients and in decreasing transfusion rates in TAVI. (Source: Canadian Journal of Cardiology)
Source: Canadian Journal of Cardiology - May 24, 2016 Category: Cardiology Source Type: research
Sp558 * 24-month safety outcomes of biosimilar epoetin alfa in the european monitor-ckd5 pharmacoepidemiological study of anaemia in haemodialysis
(Source: Nephrology Dialysis Transplantation)
Source: Nephrology Dialysis Transplantation - May 13, 2016 Category: Urology & Nephrology Authors: Goldsmith, D., Mann, J., Dellanna, F., London, G., Combe, C., Zaoui, P., Gorray, M., Hoebel, N., Abraham, I., MacDonald, K., Turner, M. Tags: DIALYSIS. ANAEMIA Source Type: research
Sp312 * evaluation of the safety and immunogenicity of subcutaneous (sc) hx575 epoetin alfa in the treatment of anaemia associated with ckd
(Source: Nephrology Dialysis Transplantation)
Source: Nephrology Dialysis Transplantation - May 13, 2016 Category: Urology & Nephrology Authors: Casadevall, N., Dobronravov, V., Eckardt, K.-U., Erturk, S., Martynyuk, L., Schmitt, S., Ode, M., Schaffar, G., Rudy, A. Tags: CHRONIC KIDNEY DISEASE ANAEMIA Source Type: research
Pharmacodynamic and Pharmacokinetic Equivalences of Epoetin Hospira and Epogen(®) After Multiple Subcutaneous Doses to Healthy Male Subjects.
Abstract
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. Blood was collected for determination of he...
Source: Clinical Therapeutics - April 20, 2016 Category: Drugs & Pharmacology Authors: Stalker D, Ramaiya A, Kumbhat S, Zhang J, Reid S, Martin N Tags: Clin Ther Source Type: research
Long-Term Effect of Epoetin Alfa on Clinical and Biochemical Markers in Friedreich Ataxia (P5.387)
Conclusions: Although results are not in favor of an effect of Epoetin alfa in FRDA, this is the largest trial testing its effect. It is still possible that Epoetin alfa may show some symptomatic effect on upper limbs performance. This study provides Class I evidence that Erythropoietin does not ameliorate VO2max in patients with FRDA.Disclosure: Dr. Sacca has received personal compensation activities with Novartis, Almirall, Genzyme, and TEVA a speaker, editorial work, and advisory boards. Dr. Puorro has nothing to disclose. Dr. Marsili has nothing to disclose. Dr. Antenora has nothing to disclose. Dr. Pane has nothing to...
Source: Neurology - April 3, 2016 Category: Neurology Authors: Sacc, F., Puorro, G., Marsili, A., Antenora, A., Pane, C., Casali, C., Marcotulli, C., Defazio, G., Liuzzi, D., Tatillo, C., Cambriglia, D., Schiano di Cola, G., Giuliani, L., Guardasole, V., Salzano, A., Ruvolo, A., De Rosa, A., Cittadini, A., De Michele Tags: Movement Disorders: Ataxia Source Type: research
A Randomized, Open-Label, Multicenter, Phase III Study of Epoetin Alfa Versus Best Standard of Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy [Breast Cancer]
Conclusion
The primary end point, PFS based on investigator-determined PD, did not meet noninferiority criteria. As a consistency assessment with the primary finding, PFS based on independent review committee–determined PD met noninferiority criteria. Overall, this study did not achieve noninferiority objective in ruling out a 15% increased risk in PD/death. RBC transfusion should be the preferred approach for the management of anemia in this population. (Source: Journal of Clinical Oncology)
Source: Journal of Clinical Oncology - March 29, 2016 Category: Cancer & Oncology Authors: Leyland-Jones, Bondarenko, Nemsadze, Smirnov, Litvin, Kokhreidze, Abshilava, Janjalia, Li, Lakshmaiah, Samkharadze, Tarasova, Mohapatra, Sparyk, Polenkov, Vladimirov, Xiu, Zhu, Kimelblatt, Deprince, Safonov, Bowers, Vercammen Tags: Chemotherapy, Clinical Trials, Quality of Life Breast Cancer Source Type: research
Effects of Epoetin Alfa Titration Practices, Implemented After Changes to Product Labeling, on Hemoglobin Levels, Transfusion Use, and Hospitalization Rates
Conclusions Following prospective payment system implementation and labeling revisions, EPO doses declined significantly. Under the new label, facility EPO titration practices were associated with mean hemoglobin levels (but not standard deviations) and transfusion use, but not hospitalization rates. (Source: American Journal of Kidney Diseases)
Source: American Journal of Kidney Diseases - March 14, 2016 Category: Urology & Nephrology Source Type: research
Time savings of weekly versus three-times-per-week administration of erythropoiesis stimulating agents in United States dialysis patients.
CONCLUSIONS: Switching from TIW EPO to QW DPO can result in time savings due to fewer administrations and provide opportunities to redirect nurse time towards activities aimed at improving patient care.
PMID: 26583202 [PubMed - in process] (Source: Current Medical Research and Opinion)
Source: Current Medical Research and Opinion - February 18, 2016 Category: Research Tags: Curr Med Res Opin Source Type: research
Abstract P1-10-02: Usage of epoetin alfa biosimilars in the management of chemotherapy-induced anemia in patients with breast cancer: A subanalysis of the ORHEO study
IntroductionChemotherapy-induced anemia (CIA) is a frequent complication of breast cancer patients that is associated with fatigue and impaired quality of life. Biosimilars of erythropoietin-stimulating agents have now been approved to treat CIA in Europe. The ORHEO (biOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational study conducted in France to evaluate the efficacy and safety of a biosimilar epoetin alfa in an oncology setting. The large number of patients who enrolled in the study permitted indication-specific subanalyses to be undertaken. Herein we...
Source: Cancer Research - February 18, 2016 Category: Cancer & Oncology Authors: Albrand, H., Luporsi, E., Michallet, M., Soubeyran, P. Tags: Poster Session Abstracts Source Type: research
Epoetin alfa
Erythropoietin is a glycoprotein produced in the kidney that stimulates red blood cell production. Epoetin alfa, a biosynthetic form of erythropoietin, is a hematopoietic agent that principally affects erythropoiesis. The drug is prepared from cultures of genetically modified mammalian cells using recombinant DNA technology. [#] (Source: Aids Info Drugs)
Source: Aids Info Drugs - February 16, 2016 Category: Drugs & Pharmacology Source Type: research
Long‐term effect of epoetin alfa on clinical and biochemical markers in friedreich ataxia
ConclusionsAlthough results are not in favor of an effect of epoetin alfa in Friedreich ataxia, this is the largest trial testing its effect. It is still possible that epoetin alfa may show some symptomatic effect on upper‐limb performance. This study provides class I evidence that erythropoietin does not ameliorate VO2 max in patients with Friedreich ataxia. © 2016 International Parkinson and Movement Disorder Society (Source: Movement Disorders)
Source: Movement Disorders - February 16, 2016 Category: Neurology Authors: Francesco Saccà, Giorgia Puorro, Angela Marsili, Antonella Antenora, Chiara Pane, Carlo Casali, Christian Marcotulli, Giovanni Defazio, Daniele Liuzzi, Chiara Tatillo, Donata Maria Cambriglia, Giuseppe Schiano di Cola, Luigi Giuliani, Vincenzo Guardasole Tags: Research Article Source Type: research
A Randomized, Open-Label, Multicenter, Phase III Study of Epoetin Alfa Versus Best Standard of Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy.
CONCLUSION: The primary end point, PFS based on investigator-determined PD, did not meet noninferiority criteria. As a consistency assessment with the primary finding, PFS based on independent review committee-determined PD met noninferiority criteria. Overall, this study did not achieve noninferiority objective in ruling out a 15% increased risk in PD/death. RBC transfusion should be the preferred approach for the management of anemia in this population.
PMID: 26858335 [PubMed - as supplied by publisher] (Source: Clinical Breast Cancer)
Source: Clinical Breast Cancer - February 8, 2016 Category: Cancer & Oncology Authors: Leyland-Jones B, Bondarenko I, Nemsadze G, Smirnov V, Litvin I, Kokhreidze I, Abshilava L, Janjalia M, Li R, Lakshmaiah KC, Samkharadze B, Tarasova O, Mohapatra RK, Sparyk Y, Polenkov S, Vladimirov V, Xiu L, Zhu E, Kimelblatt B, Deprince K, Safonov I, Bow Tags: J Clin Oncol Source Type: research
Roxadustat (FG-4592) Versus Epoetin Alfa for Anemia in Patients Receiving Maintenance Hemodialysis: A Phase 2, Randomized, 6- to 19-Week, Open-Label, Active-Comparator, Dose-Ranging, Safety and Exploratory Efficacy Study
Conclusions In this phase 2 study of anemia therapy in patients with end-stage renal disease on maintenance hemodialysis therapy, roxadustat was well tolerated and effectively maintained Hb levels. (Source: American Journal of Kidney Diseases)
Source: American Journal of Kidney Diseases - February 2, 2016 Category: Urology & Nephrology Source Type: research
