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Epogen (EPOETIN ALFA)

Epogen (generic name: EPOETIN ALFA) is a Erythropoiesis-stimulating Agent Recombinant protein drug developed by Amgen. It is currently FDA-approved (first approved 1989) for Anemia due to chemotherapy, Anemia in chronic kidney disease.

Epogen works by binding to the erythropoietin receptor, triggering a cascade of signals that stimulate the production of red blood cells.

Epogen (EPOETIN ALFA) is a recombinant erythropoietin analogue developed by AMGEN, targeting the erythropoietin receptor to stimulate erythropoiesis. It is an erythropoiesis-stimulating agent approved by the FDA in 1989 for treating anemia due to chemotherapy and chronic kidney disease. Epogen is a proprietary product owned by AMGEN, with no generic manufacturers listed. Key safety considerations include the risk of thromboembolic events and tumor progression. As a patented product, Epogen remains under AMGEN's commercial control.

At a glance

Mechanism of action

Think of Epogen like a key that unlocks a process in your body called erythropoiesis, which is the production of red blood cells. When Epogen binds to its receptor, it sends a signal that tells your bone marrow to make more red blood cells, which helps to increase your red blood cell count and alleviate anemia.

Approved indications

• Anemia due to chemotherapy
• Anemia in chronic kidney disease

Boxed warnings

• WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients with chronic kidney disease (CKD) experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL [see Warnings and Precautions ( 5.1 )] . No trial has identified a hemoglobin target level, E SA dose, or dosing strategy that does not increase these risks [see Dosage and Administration ( 2.2 )] . Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions [see Warnings and Precautions ( 5.1 )] . Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers [see Warnings and Precautions ( 5.2 )] . To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions [see Dosage and Administration ( 2.4 )] . Use ESAs only for anemia from myelosuppressive chemotherapy [see Indications and Usage ( 1.3 )] . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure [see Indications and Usage ( 1.5 )] . Discontinue following the completion of a chemotherapy course [see Dosage and Administration ( 2.4 )] . Perisurgery: Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.1 )] . WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete boxed warning. Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL ( 5.1 ). No trial has identified a hemoglobin target level, E SA dose, or dosing strategy that does not increase these risks ( 2.2 ) . Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions ( 5.1 ). Cancer : ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers ( 5.2 ). Use the lowest dose to avoid RBC transfusions ( 2.4 ). Use ESAs only for anemia from myelosuppressive chemotherapy ( 1.3 ) . ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). Discontinue following the completion of a chemotherapy course ( 2.4 ). Perisurgery : Due to increased risk of deep venous thrombosis ( DVT ) , DVT prophylaxis is recommended ( 5.1 ).

Common side effects

• Product storage error
• Aplasia pure red cell
• Haemoglobin decreased
• Nephrogenic systemic fibrosis
• Therapeutic response decreased
• Anaemia
• Anti-erythropoietin antibody positive
• Haemoglobin abnormal
• Skin induration
• Peritonitis bacterial
• Intercepted product administration error
• Skin hypertrophy

Key clinical trials

• A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Treatment Trial) (PHASE2)
• MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
• Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia (PHASE3)
• ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions (PHASE3)
• Vafseo Outcomes In-Center Experience (PHASE3)
• A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions (PHASE3)
• Choices About Genetic Testing And Learning Your Risk With Smart Technology (NA)
• Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being Ineligible to ESA (PHASE1,PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Epogen CI brief — competitive landscape report
• Epogen updates RSS · CI watch RSS
• Amgen portfolio CI

Frequently asked questions about Epogen

Related

• Drug class: All Erythropoiesis-stimulating Agent drugs
• Target: All drugs targeting Erythropoietin receptor
• Manufacturer: Amgen — full pipeline
• Therapeutic area: All drugs in Metabolic
• Indication: Drugs for Anemia due to chemotherapy
• Indication: Drugs for Anemia in chronic kidney disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing