Drug updated on 9/4/2024
Dosage Form | Injection (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 Class | Erythropoiesis-stimulating agents |
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.
Latest News
Summary
- Epogen (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, for the treatment of anemia due to zidovudine in patients with HIV infection, for the treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy with a minimum of two additional months of planned chemotherapy, and for the reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Preventing Blood Transfusions: Epoetin alfa may reduce the need for blood transfusions compared to placebo (OR 0.28, 95% CI 0.13 to 0.61; low certainty evidence). However, the comparative effects between different ESAs and epoetin alfa remain uncertain (low to very low certainty evidence).
- Hemoglobin Levels: Roxadustat increases hemoglobin levels more effectively than ESAs (epoetin alfa or darbepoetin alfa) and placebo (WMD: 0.82 g/dL; 95% CI: 0.43-1.21), with significant improvements observed in NDD-CKD patients when compared to both placebo (SMD 1.57, 95% CI 1.17-1.98) and epoetin alfa (SMD 0.47, 95% CI 0.02-0.93).
- Iron Metabolism: Roxadustat improves iron metabolism markers, including increasing transferrin and TIBC levels while reducing hepcidin, ferritin, and TSAT levels in NDD-CKD patients; 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).
- Roxadustat was associated with an increased incidence of serious treatment-emergent adverse events (TEAEs) in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients (OR: 1.15; 95% CI: 1.02-1.29) and a higher incidence of adverse events compared to epoetin alfa (RR: 1.25, 95% CI 1.01-1.54; low-quality evidence).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Epogen (epoetin alfa) Prescribing Information. | 2018 | Amgen Inc., Thousand Oaks, CA |