Retacrit (epoetin alfa-epbx) / Stada, Norbitec, Pfizer - LARVOL DELTA

Vadadustat (Vafseo) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2024 ➔ Oct 2025

Combination therapy • Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CDC25C • GNRP • PTPRC • STAT5

Daprodustat (Jesduvroq) for anemia of chronic kidney disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Confined Lewis Pairs: Investigation of the X-→Si20 Interaction in Halogen-Encapsulating Silafulleranes. (PubMed, Angew Chem Int Ed Engl) - "First, we evaluated the structure-determining template effect of Cl- in a systematic series of concave silapolyquinane model systems...Third, 35Cl NMR spectroscopy proved to be highly diagnostic for an experimental assessment of the Cl- →Si20 interaction as the paramagnetic shielding and, in turn, δ(35Cl) of the endohedral Cl- ion correlate inversely with Eint. Finally, we disclose the synthesis of [PPN][Cl@Si20Y20] (Y = Me, Et, Br) and provide a thorough characterization of these new silafulleranes."

Journal

Management of Epoetin Alfa-Epbx in Anemia Due to Chronic Kidney Disease (CKD): Pre- and Post-Pharmacist Evaluation Consult (ASHP 2023) - No abstract available

Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Anemia Management in Non-Dialysis CKD Patients (KIDNEY WEEK 2023) - "Nurse Practitioner clinic was utilized to provide frequent follow-up for patients on home ESA, with a specific Retacrit protocol created for them... Our study highlights the inadequate management of anemia in CKD patients, leading to avoidable healthcare utilization and compromising the chances of successful transplantation. Improved anemia management is urgently needed to address these concerns and optimize patient outcomes."

Clinical • Anemia • Hematological Disorders • Nephrology • Transplantation

NCI-2009-01173: Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (clinicaltrials.gov) - P3 | N=247 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2023 ➔ Sep 2024

Combination therapy • Trial completion date • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

The Painful Problem of Biosimilars in the Clinic (Cancer Network) - "Co-editor-in-Chief Howard S. Hochster, MD, discusses persistent obstacles to the effective use of biosimilars in clinical practice."

Media quote

Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study. (PubMed, Clin Nephrol) - "The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern."

Journal • Anemia • Cardiovascular • Hematological Disorders

Pharmacist-driven epoetin alfa-epbx dosing for hospitalized patients. (PubMed, Am J Health Syst Pharm) - "Pharmacist-driven ESA dosing was associated with significant decreases in ESA average acquisition cost and average total dose per patient."

Journal • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

CLINICAL OUTCOMES AND HEALTHCARE RESOURCE UTILIZATION (HCRU) IN PATIENTS WITH LR-MDS REINITIATING ESAS FOLLOWING PREVIOUS ESA TREATMENT (EHA 2022) - "The most used ESA was darbepoetin alfa (60%), followed by epoetin alfa (38%) and epoetin alfa-epbx (2%). In these patients, poor clinical outcomes and frequent health system visits were observed. This study highlights the need to consider alternative treatment options for patients with LR-MDS."

Clinical • Clinical data • HEOR • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Obesity • Oncology

Clinical outcomes and healthcare resource utilization (HCRU) in patients (pts) with lower-risk myelodysplastic syndromes (LR-MDS) reinitiating erythropoiesis-stimulating agents (ESAs) following previous ESA treatment. (ASCO 2022) - "The most used ESA was darbepoetin alfa (60%), followed by epoetin alfa (38%) and epoetin alfa-epbx (2%). In this real-world study of community practice in the USA, reinitiation of ESA treatment after prior discontinuation in LR-MDS was prevalent. In these pts, poor clinical outcomes and frequent health system visits were observed. This study highlights the need to consider alternative treatment options for pts with LR-MDS."

Clinical • Clinical data • HEOR • Acute Myelogenous Leukemia • Anemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Obesity • Oncology

Retacrit®, Biosimilar of Epoetin alfa, in Chemotherapy-Induced Anemia in Routine Practice: Impact of Iron Supplementation. (PubMed, Oncology) - "Epoetin alpha biosimilar was effective and well tolerated for treating chemotherapy-induced anemia. Patients in subgroup with iron supplementation had lower TSAT at inclusion compared to subgroup without supplementation. Comparable mean Hb levels were achieved in both subgroups. The rate of patients with iron supplementation through the intravenous route was however insufficient."

Journal • Anemia • Cardiovascular • Chemotherapy-Induced Anemia • Hematological Disorders • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology • Solid Tumor

Assessing a Pharmacist's Impact on Initial Epoetin Alfa-epbx Dosing (ASHP 2021) - No abstract available

Variation in health plan coverage of ESAs for anemia due to chronic kidney disease. (PubMed, J Manag Care Spec Pharm) - "The following drugs were indicated for anemia due to CKD: darbepoetin alfa, methoxy polyethylene glycol-epoetin beta, epoetin alfa (available as two brands), and epoetin alfa-epbx. Margaretos, Panzer, and Chambers are employed by Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health. Lai was with Tufts Medical Center, Institute for Clinical Research and Health Policy Studies, Center for the Evaluation of Value and Risk in Health at the time of this study."

HEOR • Journal • Anemia • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS (Streetinsider.com) - "Biosimilars, which grew 79% operationally to $530 million, primarily driven by recent oncology monoclonal antibody biosimilar launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab) globally, as well as continued growth from Retacrit (epoetin) in the U.S."

Sales • Anemia • Immunology • Oncology

[VIRTUAL] Biosimilar cost versus reimbursement comparison in oncology practice (ASHP 2020) - " When comparing Avastin with MVASI, comprehensively for Medicare, Medicaid, and private insurance it was better to use Avastin over MVASI. The same can be said for Procrit and Retacrit...The biosimilar Avsola gave the best reimbursement for Medicare, and Inflectra had the worst reimbursements across the board. Neulasta’s biosimilars provided better reimbursements over Neulasta itself. Herceptin, when compared with the biosimilar Kanjinti, gave better reimbursements for Medicare and private insurance. Biosimilars can be feasible depending on the patient’s insurance provider and the type of biosimilar being used."

Reimbursement • Oncology

Data from a microdosed rhEPO administration study applying the new biotinylated clone AE7A5 antibody and a further optimized SAR-PAGE protocol. (PubMed, Drug Test Anal) - "Microdoses of Retacrit (epoetin zeta), an EPO biosimilar, were administered intravenously and subcutaneously to human males and females...Previous studies applying different electrophoretic techniques and the not further optimized SAR-PAGE protocol revealed considerably shorter detection windows for rhEPO-microdoses. Since the new biotinylated antibody performed significantly more sensitive than the non-biotinylated version, the new protocol will improve the sensitivity and hence detectability of recombinant EPO in doping control."

Clinical • Journal • EPO

[VIRTUAL] Pharmacy driven conversion of darbepoetin to epoetin alfa-epbx in an outpatient hemodialysis clinic: an evaluation of potential costs and outcomes (ASHP 2020) - "Darbepoetin (Aranesp) has commonly been preferred for the treatment of these patients due to its once-weekly dosing. Key secondary endpoints will include mean changes of ESA dosing per month, mean weekly cost of ESA therapy, and incidence of blood transfusions. Patients will retrospectively be reviewed five months before Retacrit implementation and will be continued to be reviewed for five months following implementation."

Clinical • Hematological Disorders • EPO

[VIRTUAL] Fatal outcome of pulmonary embolism in a non-critically ill COVID-19 patient on erythropoiesis-stimulating agent (ESA): a case report (ASHP 2020) - "The COVID-19 treatment for this patient included a 10-day course of dexamethasone and two units of convalescent plasma. Remdesivir was not initiated due to the patient meeting exclusion criteria per institutional protocol of creatinine clearance < 30 mL/min...Outpatient dosing of epoetin alfa-epbx (Retacrit) 10,000 units (128 units/kg) three times weekly was continued inpatient...If an ESA is to be utilized in COVID-19 positive dialysis population, considering a more conservative Hgb goal might be appropriate and closer monitoring is warranted. Further randomized controlled studies are also much needed to shed light onto optimal thromboprophylaxis for non-critical care population.References available upon request"

Clinical • Cardiovascular • Chronic Kidney Disease • Coronary Artery Disease • Critical care • Diabetes • Diabetic Nephropathy • Hematological Disorders • Infectious Disease • Metabolic Disorders • Nephrology • Novel Coronavirus Disease • Pneumonia • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Thrombocytopenia • Type 2 Diabetes Mellitus • PCR

[VIRTUAL] Medication use evaluation of erythropoietin stimulating agent in end-stage renal disease (ASHP 2020) - "Purpose: The purpose of this medication use evaluation of epoetin alfa-pbx (Retacrit) was to evaluate the current prescribing practices in the hospital setting as well as the appropriateness. Overall use at the site was found to be appropriate. However, some situations require clinical judgment as Retacrit dosing is based on patient specific clinical circumstances. The majority of the Retacrit usage is monitored by Nephrologists and their associates."

Chronic Kidney Disease • Hematological Disorders • Immunology • Inflammation • Nephrology • Renal Disease • EPO

[VIRTUAL] Evaluating use, conversion eligibility, and cost of epoetin alfa-epbx once-weekly conversion to three times weekly. (ASHP 2020) - "The goal sample size for this study is 100 patients. Descriptive statistics will be presented for data collected."

Hematological Disorders

Epoetin alfa-epbx: a new entrant into a crowded market. a historical review of the role of erythropoietin stimulating agents and the development of the first epoetin biosimilar in the United States. (PubMed, Expert Rev Clin Pharmacol) - "With many biologic therapies nearing patent expiration, biosimilars will become increasingly common in clinical practice. Ensuring patient safety with these products will require increased post-marketing surveillance and awareness from prescribers."

Journal • Review • Hematological Disorders • EPO

Glycan analysis of erythropoiesis-stimulating agents. (PubMed, J Pharm Biomed Anal) - "In this study, a combination of chromatography and mass spectrometry analysis has been used to characterise and compare the glycosylation profiles of five ESA products; Eprex® (epoetin alfa), NeoRecormon® (epoetin beta), Binocrit® (epoetin alfa biosimilar), Silapo (epoetin alfa biosimilar) and Aranesp® (darbepoetin alfa). The products exhibit notable differences in N- and O-glycosylation, including attributes such as sialic acid occupation, O-acetylation, N-acetyllactosamine extended antennae and sulphated/penta-sialylated N-glycans, which have the potential to cause divergence of therapeutic potencies. The study highlights the need for continued monitoring of ESA product glycosylation, ideally allied to pharmacological data, in order to ensure consistency and therapeutic equivalence between products and enhance our understanding of ESA structure-activity-relationships."

Journal • Chronic Kidney Disease • Hematological Disorders • Nephrology • Renal Disease

Pfizer's Biosimilar Revenues Soar 80% (Center for Biosimilars) - "Biosimilar revenues climbed to $424 million (up 80%), driven mainly by the recent launches of biosimilars for rituximab (Ruxience), bevacizumab (Zirabev), and trastuzumab (Trazimera) products in the United States and elsewhere...The company also cited ongoing growth in revenues from its epoetin zeta biosimilar (Retacrit), mainly in the United States. Pfizer said sales declined 21% overall for its reference product Enbrel (etanercept) owing to competition in Europe, Japan, and Brazil, where biosimilars of this drug are available."

Sales • Immunology • Oncology