Epogen
Epoetin alfa
Manufacturer: Amgen, Inc.
Black Box Warning (Boxed Warning)
A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.
FDA-Approved Indications (5)
Treatment of anemia associated with chronic renal failure, including patients on dialysis (end stage renal disesae) and patients not on dialysis
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 …
Population: patients with non-myeloid malignancies receiving concomitant myelosuppressive chemotherapy
Treatment of anemia due to zidovudine in patients with Human Immunodeficiency Virus (HIV) infection
Population: patients with HIV infection receiving zidovudine ≤ 4200 mg/week with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL
Treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
Population: patients on dialysis and not on dialysis
Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery
Population: patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery
Indications & Usage
1 INDICATIONS AND USAGE Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ). - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.3 ). Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery ( 1.4 ). Limitations of Use Epogen has not been shown to improve quality of life, fatigue, or patient well-being ( 1.5 ). Epogen is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy ( 1.5 ). In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure ( 1.5 ). In patients with cancer receiving myelosuppressive chemotherapy in whom the anemia can be managed by transfusion ( 1.5 ). In patients scheduled for surgery who are willing to donate autologous blood ( 1.5 ). In patients undergoing cardiac or vascular surgery ( 1.5 ). As a substitute for RBC transfusions in patients who require immediate correction of anemia ( 1.5 ). 1.1 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. 1.2 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. 1.3 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. 1.4 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. 1.5 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 outcom
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