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Epogen (Epoetin Alfa-Epbx)
Epoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin.
RETACRIT (epoetin alfa-epbx) is a biosimilar erythropoiesis-stimulating agent indicated for anemia due to chronic kidney disease, zidovudine in HIV infection, myelosuppressive chemotherapy, and perioperative blood loss reduction in elective noncardiac nonvascular surgery. The drug has a half-life of 4-13 hours with IV administration and achieves peak concentrations within 5-24 hours subcutaneously, with no accumulation at recommended dosing regimens. Major contraindications include uncontrolled hypertension, pure red cell aplasia following ESA treatment, and serious allergic reactions; benzyl alcohol-containing formulations are contraindicated in neonates, infants, and pregnant/lactating women. RETACRIT has not demonstrated improvements in quality of life or fatigue and carries restrictions on use in certain cancer populations and cardiac/vascular surgery patients.
At a glance
| Generic name | Epoetin Alfa-Epbx |
|---|---|
| Sponsor | Amgen |
| Drug class | Erythropoiesis-stimulating agent (ESA) |
| Target | Erythropoietin receptor |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 1989 |
| Annual revenue | 400 |
Mechanism of action
Epoetin alfa-epbx is a biosimilar erythropoietin product that stimulates red blood cell production through the same biological mechanism as the naturally occurring hormone erythropoietin. The drug binds to erythropoietin receptors on erythroid progenitor cells in bone marrow, promoting their proliferation and differentiation into mature red blood cells. This mechanism is identical to that of endogenous erythropoietin, making it effective for treating various forms of anemia.
Approved indications
- Anemia due to chemotherapy
- Anemia in chronic kidney disease
Common side effects
- Pyrexia
- Cough
- Rash
- Hypertension
- Arthralgia
- Dizziness
- Vascular Occlusion
- Medical Device Malfunction
- Muscle spasm
- Upper respiratory tract infection
Serious adverse events
- Thrombosis
- Myocardial infarction
- Erythema
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Epogen CI brief — competitive landscape report
- Epogen updates RSS · CI watch RSS
- Amgen portfolio CI