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Epoetin alfa

(Epogen®)

Epogen®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous/subcutaneous; 2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, and 10,000 Units/mL in a single dose vial, 20,000 Units/2mL [10,000 Units/mL] and 20,000 Units/mL in multiple-dose vials containing benzyl alcohol)
Drug ClassErythropoiesis-stimulating agents (ESA)
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis
  • Indicated for the treatment of anemia due to zidovudine in patients with HIV-infection
  • Indicated for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
  • Indicated for the reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Epoetin alfa may reduce the need for blood transfusions with an odds ratio of 0.28 (95% confidence interval (CI) 0.13 to 0.61), although its effects on mortality remain uncertain (odds ratio (OR) 0.79, 95% CI 0.51 to 1.22; low certainty evidence).
  • Roxadustat significantly increased hemoglobin levels compared to both erythropoiesis-stimulating agents (ESAs) and placebo, with a weighted mean difference (WMD) of 0.82 g/dL (95% CI 0.43-1.21), showing increases of 1.99 g/dL in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients compared to placebo and 0.52 g/dL in dialysis-dependent chronic kidney disease (DD-CKD) patients compared to epoetin alfa.
  • Roxadustat improved iron metabolism markers, including transferrin and total iron binding capacity (TIBC) levels, and reduced hepcidin, ferritin, and transferrin saturation (TSAT) levels in NDD-CKD patients, while these effects were not observed in DD-CKD patients.
  • Epoetin alfa may increase the odds of hypertension compared to placebo (OR 2.10, 95% CI 1.22 to 3.59; very low certainty evidence). Minor adverse effects observed in normonemic adults include nausea, pyrexia, headache, generalized weakness, and superficial phlebitis.
  • Roxadustat was associated with a higher incidence of serious treatment-emergent adverse events in non-dialysis-dependent CKD patients (OR 1.15; 95% CI 1.02-1.29) and a higher overall incidence of adverse events compared to epoetin alfa (relative risk (RR) 1.25; 95% CI 1.01-1.54; low-quality evidence), although no significant association with serious adverse events was observed across NDD and DD patients.
  • Studies addressed chronic kidney disease (CKD) populations, distinguishing between non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients, with roxadustat showing improved hemoglobin response and lowered ferritin and TSAT levels in NDD-CKD patients but not in DD-CKD patients; increased serious treatment-emergent adverse events were observed in NDD-CKD patients treated with roxadustat compared to DD patients. Additionally, normonemic adults receiving EPO for neuroprotection experienced adverse effects such as thrombosis concerns, nausea, and headache.