Doping with testosterone (T) and erythropoietin (EPO) in low doses (micro‐doping) is a challenge to detect. Here, we have investigated the ability to detect micro‐doping of recombinant human (rhEPO) and testosterone (T) after administration of a single dose of subcutaneous Eporatio (15 IU/kg) and transdermal Testogel (100 mg) to healthy males. For rhEPO detection in urine, MAIIA EPO purification kits 3F6 (#1410) and 7D3 (#1460) were used for ITP and CP analyses, respectively, whereas kit 3F6 (#1430) was used for dried blood spots (Tasso). The sensitivity to detect rhEPO in Tasso was investigated and compared with previous detection results for Capitainer and Mitra. For T detection, the urinary and capillary serum steroid profile and IRMS analysis were performed. It was possible to detect administration of 15 IU/kg Eporatio with high sensitivity with our ITP method up to 72 h after administration, and the CP findings supported the ITP findings. Tasso provides less sensitivity in detecting Eporatio than Mitra and Capitainer. With IRMS, 100% of the samples analyzed were positive, also when not associated with elevated urinary T/E or 5αAdiol/E ratios. As an alternative, high systemic T levels aligned with positive IRMS results, highlighting the value of serum T as a complementary biomarker. Overall, the World Anti‐Doping Agency ITP and CP methods employed today show good sensitivity towards detection of micro‐dosing of rhEPO and T.

01 Nov 2024·Drug testing and analysis

Evaluation of a single Eporatio® micro‐dose in urine and dried blood spots

Article

Author: Heiland, Carmel E. ; Börjesson, Annica ; Lehtihet, Mikael ; Ekström, Lena

Abstract:

Recombinant human erythropoietin (rhEPO) has been abused as a performance enhancer in sports for several years, but with advancements in detection methods, even micro‐doses can be detected in dried blood spot (DBS) samples. Here, we present the results from an Eporatio® (epoetin theta) micro‐dose administration study to detect rhEPO in DBS samples. Five healthy male volunteers received a 15 IU/kg subcutaneous dose of Eporatio®. Urine and DBS samples (Mitra® VAMS and Capitainer® B50) were collected 1, 10, 24, 36, 48 and 72 h after drug administration. After 1 h, all urine samples were negative for rhEPO, whereas 40% of DBS samples were considered suspicious. All samples between 10 and 48 h were suspicious for the presence of Eporatio®, except one urine sample that was negative at 48 h. After 72 h, 40% of urine samples and 60% of DBS samples were suspicious and would have proceeded to a confirmation analysis. DBS is an efficient complementary matrix to urine for detection of rhEPO micro‐doses.

01 Feb 2016·Clinical therapeuticsQ4 · MEDICINE

Cardiovascular Morbidity and Pure Red Cell Aplasia Associated With Epoetin Theta Therapy in Patients With Chronic Kidney Disease: A Prospective, Noninterventional, Multicenter Cohort Study

Q4 · MEDICINE

Article

Author: Bias, Peter ; Balcke, Peter ; Wiesholzer, Martin ; Mangold, Simone ; Lammerich, Andreas

PURPOSE:

The European Medicines Agency recommends limiting the hemoglobin (Hb) concentration to 10 to 12 g/dL in adults with chronic kidney disease (CKD) receiving erythropoiesis-stimulating agents such as epoetin theta. This postauthorization study assessed the incidence and intensity of cardiovascular events, including ischemic stroke, in patients receiving epoetin theta for anemia associated with CKD. A secondary end point was adverse drug reactions, including pure red cell aplasia.

METHODS:

In this prospective, noninterventional, multinational cohort study, consecutive patients with advanced or end-stage renal disease and receiving epoetin theta were followed up for 6 months. Data on reportable adverse events (RAEs) (cardiac disorders, cardiac failure, myocardial infarction, and ischemic stroke and respective subterms), epoetin theta dosage, and Hb concentrations were collected. A post hoc exploratory analysis assessed the incidences of RAEs according to tertiles for individual mean Hb concentration (≤10.7, >10.7-11.47, and >11.47 g/dL for low, intermediate, and high, respectively) and mean weekly epoetin theta dosage (≤62, >62-125, and >125 IU/kg/wk for low, intermediate, and high).

FINDINGS:

Data from 1039 patients were included (577 men, 462 women; mean age, 68.7 years). A total of 101 RAEs were documented in 89 patients (8.6%), for an event rate of 0.1985/person-year. Sixty-four patients (6.1%) died; none of the deaths was considered related to epoetin theta use. The incidence of RAEs was lowest at intermediate Hb concentrations (6.2%) compared with low (11.3%) and high (7.8%) Hb concentrations. The incidence of ischemic stroke was 1.5% at high Hb concentrations versus 0.6% at both the low and intermediate Hb concentrations. The incidence of any RAE was greater in the high-dose group (10.1%) than in the intermediate-dose (8.0%) and low-dose (7.6%) groups. The risk for any cardiovascular RAE or ischemic stroke was greatest in the high-dose/high-Hb group (13.3%), followed by high dose/low Hb (12.6%) and low dose/low Hb (12.1%). The risks for RAEs were lowest at high dose/intermediate Hb (3.8%) and low dose/intermediate Hb (5.3%). The event rate of adverse drug reactions other than the predefined RAEs was 0.0161/person-year. No cases of pure red cell aplasia were reported.

IMPLICATIONS:

The findings from the present study suggest that, for maintaining the optimal target Hb concentration (10-12 g/dL according to the current summary of product characteristics for epoetin theta; 10-11.5 g/dL according to the current guideline from Kidney Disease Improving Global Outcomes) in anemic adults with CKD, the lowest approved, effective dose epoetin theta should be used.

News (Medical) associated with Epoetin theta

13 Feb 2024

·www.businesswire.com

Injectable Hematology Growth Factors Report 2024 - Evolution in Therapeutic Care - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. This report is a comprehensive evaluation and analysis of the technology, products, and participants providing the driving force behind this evolving segment of the healthcare sector. The study is designed to provide drug company decision-makers, drug delivery developers, device designers, healthcare marketers, and supply chain participants with a detailed understanding of the economics, technologies, and opportunities for injection devices designed for patient self-administration. Provider organization business managers, healthcare administrators, and investors will also benefit from this study. Evolution in Therapeutic Care Several recombinant hematologic growth factors or agonists for their receptors have been produced that are useful in treating anemia, neutropenia, and thrombocytopenia, particularly in patients with end-stage renal disease or aplastic anemia or who have received cancer chemotherapy or a hematopoietic cell transplant. The shift in as-supplied packaging from single and multi-use vials to prefilled injection devices will accelerate over the next five years as drug developers move to empower an increasing number of chronically ill patients. The powerful physiological effects of antibodies, hormones, and other biological drugs also increase the need for safety and compliance. What You Will Learn Provides detailed analysis of injectable hematology growth factors delivery and device strategies, and product development factors. Assesses key markets, market dynamics, and market demographics. Analyzes therapeutic demand drivers and evaluates injectable drug products in a number of key therapeutic segments. Provides market data and forecasts. Profiles market sector participants, their product development activities, business strategies, and corporate alliances and affiliations Assesses the importance of alliances and partnerships on drug product commercialization. Evaluates the impact of economic, technology, and regulatory factors Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit https://www.researchandmarkets.com/r/bktosb About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ASH

09 Feb 2024

·www.prnewswire.com

Injectable Hematology Growth Factors Report: Shift in As-Supplied Packaging from Single and Multi-use Vials to Prefilled Injection Devices will Accelerate over the Next Five Years

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Injectable Hematology Growth Factors Report" has been added to ResearchAndMarkets.com's offering. Understanding the rapidly advancing sector of injectable hematology growth factors is crucial for stakeholders in the healthcare industry. The latest comprehensive report evaluates the intersection of technology, products, and key players that are shaping this dynamic segment, with particular emphasis on devices designed for patient self-administration. The study presents an in-depth examination of the evolving therapeutic care landscape, highlighting significant developments in the treatment of conditions such as anemia, neutropenia, and thrombocytopenia. It analyzes the shift from traditional vials to prefilled injection devices, a trend that is likely to gain momentum over the following five years, emphasizing the market forces driving this change. Key Highlights from the Report: An in-depth analysis of device strategies and product development factors influencing the injectable hematology growth factors delivery systems. Insight into market dynamics and demographics, underpinning industry growth. An evaluation of therapeutic demand drivers across pivotal segments in healthcare. Comprehensive market data and forecast trends to inform strategic decisions. Profiles of sector participants including business strategies and corporate associations. An assessment of how alliances and partnerships affect the commercialization of drug products. Insights into the economic, technological, and regulatory factors impacting the market. Healthcare administrators, investors, and other stakeholders will benefit from this study's findings that not only chart current market conditions but also project future industry directions. It serves as a critical resource for decision-makers aiming to understand and capitalize on the opportunities presented within this segment. The report's findings are pivotal for a broad spectrum of healthcare professionals, including pharmaceutical decision-makers, device developers, healthcare marketers, and supply chain entities. It is particularly geared towards empowering chronically ill patients and enhancing safety protocols through revolutionary drug delivery methods. Stakeholders are poised to gain substantial insights into the strategies propelling the adoption of injectable hematologic treatments, facilitating informed decisions that align with the compelling trends of self-administered therapeutic care. Discover the Future of Injectable Hematology Treatments As the healthcare industry continues its inexorable march towards more patient-centric and self-managed treatment options, understanding the nuances and intricacies of injectable hematology growth factor treatments becomes ever more critical. The recent report provides these vital insights, demarking a clear view of the path forward. Stay informed on the latest in healthcare advancements and market opportunities. For further information and to explore the depth of this report, interested parties are encouraged to delve into the comprehensive analysis that awaits them. Key Topics Covered: Hematology Market Dynamics Competitive Factors Proliferation of Biological Drugs Product Manufacturers Hematology Growth Factors Devices for Administering Injectable Growth Factors Device Selection - Stability and Material Issues Competitive Landscape Prefilled Syringes Pen Injectors Dual Chamber Pens Emerging Devices Injectable Hematology Growth Factors - Product Assessment Abseamed Accofil Aranesp Binocrit Biograstim Biopoin Epoetin Alfa Hexal Eporatio Filgrastim Hexal Fulphila Granix Grastofil Mircera NeoRecormon Neulasta Neupogen Nivestim Ratiograstim Retacrit Rolvedon Silapo Tevagrastim Udenyca (Coherus BioSciences) Zarzio Ziextenzo Market Assessment Anemia Hematopoietic Stem Cell Transplant Advanced Kidney Disease Neutropenia Predonation of Autologous Blood Company Profiles Companies Mentioned AbZ-Pharma Accord Healthcare Amgen Genentech Hexal AG Medice Arzneimittel Mylan International Novartis Pfizer Ratiopharm Rentscler Biotechnologie Roche Sandoz Stada Arzneimittel AG Teva Pharmaceuticals For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

ASH

100 Deals associated with Epoetin theta

External Link

KEGG	Wiki	ATC	Drug Bank
D10846	-	B03XA01	DB00016

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anemia	European Union	Teva GmbH	23 Oct 2009
Anemia	Iceland	Teva GmbH	23 Oct 2009
Anemia	Liechtenstein	Teva GmbH	23 Oct 2009
Anemia	Norway	Teva GmbH	23 Oct 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PIVOINE (EHA2017)	Not Applicable	Anemia	1,379	Epoetin theta	zpedpcbcfa(yurlcorgox) = only 27 patients (2%) experienced treatment-related adverse events, 2 of them (0.1%) presenting with a serious one (non fatal pulmonary embolism) fcaoalikgo (anhzmepybs )	Positive	18 May 2017

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