Erythropoiesis-Stimulating Agent (ESA) Explained
[Glossary · Compound types]

Erythropoiesis-stimulating agent

Also called ESA, epoetin alfa, EPO · Reviewed

Definition: An erythropoiesis-stimulating agent (ESA) is a drug that tells the bone marrow to make more red blood cells. Epoetin alfa (Epogen) is an ESA approved to treat certain kinds of anemia, including anemia from chronic kidney disease. ESAs carry a boxed warning about death, heart attack, stroke and blood clots.

What the label approves

The Epogen label approves it for anemia from chronic kidney disease (on or off dialysis), anemia from zidovudine in people with HIV, and anemia from chemotherapy that suppresses the bone marrow. Procrit and Retacrit have separate labels.

The boxed warning

The Epogen boxed warning says:

  • in chronic kidney disease trials, aiming for a hemoglobin above 11 g/dL raised the risks of death, serious heart and blood vessel events and stroke;
  • no hemoglobin target, dose or dosing plan has been found that avoids these risks;
  • the lowest dose that reduces the need for transfusions is used;
  • in several cancers, ESAs shortened survival or raised the risk of tumor growth or return.

Why it matters for your log

ESAs raise red cells, which shows up as higher hemoglobin and hematocrit. In dialysis trials on the label, high blood pressure was reported in 27.7% on Epogen vs 12.5% on placebo. Logging doses next to your lab results helps your care team see the trend the label asks them to watch. Epoetin is a biologic, so copies are biosimilars.

Read more on Dose Track: Epogen side effects · Side effects from FDA labels

General education drawn from labels and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your product are the final word.

Frequently asked questions

Does Epogen have a boxed warning?+
Yes. ESAs including Epogen increase the risk of death, heart attack, stroke, blood clots, clotting of dialysis access, and tumor growth or return in some cancers.
Why does the Epogen label mention 11 g/dL?+
In kidney disease trials, aiming for a hemoglobin above 11 g/dL with ESAs raised the risks of death, serious heart events and stroke.