Epoetin Alfa-epbx (Retacrit) as a Treatment Option
Biosimilar Equivalence
- The American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) guideline update concluded that biosimilars of epoetin alfa show comparable effectiveness and safety to originator products, with moderate to low quality of evidence, in patients with chronic kidney disease and cancer 1, 2, 3
- Multiple studies in both cancer and chronic kidney disease populations found no significant differences in hemoglobin response, transfusion requirements, or adverse events between biosimilar and reference epoetin alfa, demonstrating biosimilar equivalence 3, 4
- Biosimilars have been available in Europe for over 10 years without major safety concerns emerging, providing long-term safety data 3, 4
Cancer-Associated Anemia: Specific Recommendations
- The American Society of Clinical Oncology (ASCO) recommends that ESAs, including biosimilars, may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to <10 g/dL, with a strength of evidence ranging from moderate to low 1, 2
- RBC transfusion remains an alternative option depending on severity and clinical circumstances, as recommended by the American Society of Clinical Oncology (ASCO) 1, 2
Critical Safety Considerations
- The American Society of Clinical Oncology (ASCO) warns that all ESAs, including biosimilars, carry significant risks, including increased mortality, myocardial infarction, stroke, and thromboembolism when targeting hemoglobin levels >11 g/dL, with a strength of evidence ranging from high to moderate 1
- The American Society of Clinical Oncology (ASCO) also warns of an increased risk of thromboembolic events, particularly in patients with a history of thromboses, surgery, prolonged immobilization, and certain disease/treatment combinations, with a strength of evidence ranging from high to moderate 1, 5, 6
Dosing Considerations
- The American Society of Clinical Oncology (ASCO) recommends that hemoglobin should be increased only to the lowest concentration needed to avoid transfusions, not to exceed 12 g/dL, with a strength of evidence ranging from high to moderate 1, 7, 2
- If hemoglobin rises >2 g/dL per 4 weeks or exceeds 12 g/dL, the dose should be reduced by 25-50%, as recommended by the European Society for Medical Oncology (ESMO) 7
Pre-Treatment Evaluation
- The American Society of Clinical Oncology (ASCO) recommends that before initiating any ESA, a thorough workup should be conducted to identify and correct alternative causes of anemia, including iron deficiency, with a strength of evidence ranging from high to moderate 3, 6, 4