These highlights do not include all the information needed to use RETACRIT safely and effectively. See full prescribing information for RETACRIT. RETACRIT® (epoetin alfa-epbx) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2018 RETACRIT (epoetin alfa-epbx) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.Biosimilarity of RETACRIT has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to EPOGEN/PROCRIT (epoetin alfa)

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These highlights do not include all the information needed to use RETACRIT safely and effectively. See full prescribing information for RETACRIT. RETACRIT® (epoetin alfa-epbx) injection, for intravenous or subcutaneous use Initial U.S. Approval: 2018 RETACRIT (epoetin alfa-epbx) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product.Biosimilarity of RETACRIT has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to EPOGEN/PROCRIT (epoetin alfa)

Medication label

Why this: Advisory · dailymed-prescription

RETACRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion. RETACRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4,200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL. RETACRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy. RETACRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. RETACRIT is not indicated for patients who are willing to donate autologous blood pre-operatively. RETACRIT has not been shown to improve quality of life, fatigue, or patient well-being. RETACRIT is not indicated for use: •In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. •In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. •In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion. •In patients scheduled for surgery who are willing to donate autologous blood. •In patients undergoing cardiac or vascular surgery. •As a substitute for RBC transfusions in patients who require immediate correction of anemia.

generic_name: epoetin alfa-epbx
product_names: epoetin alfa-epbx
ndc: 59353-002, 59353-003, 59353-004, 59353-010, 59353-120, 59353-220, 59353-002-01, 59353-002-10, 59353-003-01, 59353-003-10, 59353-004-01, 59353-004-10, 59353-010-01, 59353-010-10, 59353-120-01, 59353-120-10, 59353-220-01, 59353-220-10
group: drugs
license: us-gov-pd
attribution: Courtesy of the National Library of Medicine
reviewed: 2026-09-18
language: en