FDA label
What is Epogen used for?
Epogen contains epoetin. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Epogen lists 4 uses: Anemia Due to Chronic Kidney Disease; Anemia Due to Zidovudine in Patients with HIV Infection; Anemia Due to Chemotherapy in Patients with Cancer; Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery.
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Indications and Usage, quoted from the label by Amgen, Inc (BLA103234). Cross-references to other label sections are left out.
Anemia Due to Chronic Kidney Disease
Epogen 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.
Anemia Due to Zidovudine in Patients with HIV Infection
Epogen is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in patients with HIV infection with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.
Anemia Due to Chemotherapy in Patients with Cancer
Epogen 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.
Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
Epogen 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. Epogen is not indicated for patients who are willing to donate autologous blood pre-operatively.
Limitations of Use
Epogen has not been shown to improve quality of life, fatigue, or patient well-being.
Epogen 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.
Source: DailyMed label, set id 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5, version 137, effective June 23, 2026. NDC 55513-126, one of 6 listings for this product.
Questions
What is Epogen used for?
The FDA label for Epogen lists 4 uses: Anemia Due to Chronic Kidney Disease; Anemia Due to Zidovudine in Patients with HIV Infection; Anemia Due to Chemotherapy in Patients with Cancer; Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery.
What drug class is Epogen?
FDA lists epoetin in the Erythropoiesis-stimulating Agent established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.