Drug updated on 4/17/2024
| 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.
Summary
- Epoetin alfa (Epogen) is indicated for the treatment of anemia due to chronic kidney disease, zidovudine in HIV-infected patients, and myelosuppressive chemotherapy. It also reduces the need for allogeneic RBC transfusions in patients undergoing elective surgery.
- Six studies were reviewed which compared epoetin alfa with other erythropoiesis-stimulating agents (ESAs), including roxadustat and HIF-PHIs.
- The studies suggest that epoetin alfa may be superior to placebo in preventing blood transfusions among CKD patients, but its effects on mortality are uncertain. Compared to roxadustat or HIF-PHIs, it shows a clear benefit in reducing the need for transfusions, but unresolved safety concerns regarding cardiovascular outcomes exist.
- Roxadustat appears effective at managing anemia by increasing hemoglobin levels without significant adverse events versus ESAs or placebo, except a higher incidence of serious TEAEs was observed among non-dialysis-dependent CKD patients.
- Biosimilars of epoetin alfa demonstrate comparable efficacy and safety as the original biologics when treating chemotherapy-induced anemia, suggesting they could serve as viable alternatives within oncology supportive care settings.
- While Epogen remains a cornerstone treatment for certain types of anemias, emerging alternatives like roxadustat present new options with distinct advantages, especially among subgroups such as non-dialysis-dependent CKD patients. However, the specific safety concerns associated with each drug option must be considered.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Epogen (epoetin alfa) Prescribing Information. | 2018 | Amgen Inc., Thousand Oaks, CA |