Erythropoietin
Regulatory sources consulted
- openfda-label-325d5d88-413d-28a2-e063-6394a90a3948
- ema-epar-EMEA/H/C/000872
- aemps-cima-07410002
- PubMed PMID:36066514 ↗
- PubMed PMID:36411551 ↗
- PubMed PMID:36927204 ↗
- PubMed PMID:38695361 ↗
- PubMed PMID:37866852 ↗
- OpenFDA · B03XA01
Approved indications
- Treatment of symptomatic anemia associated with chronic renal failure (CRF) in adult and pediatric patients.
- Treatment of anemia in adult patients with non-myeloid malignancies receiving chemotherapy.
- Treatment of anemia due to zidovudine in patients with HIV infection.
- To increase the yield of autologous blood from patients in a pre-donation program.
- Treatment of anemia in lower-risk myelodysplastic syndromes (MDS) to reduce transfusion requirements. · off-label
Contraindications
Absolute
- Uncontrolled hypertension.
- Pure red cell aplasia (PRCA) that begins after treatment with erythropoietin.
- Serious allergic reactions to the product.
- Multiple-dose vials containing benzyl alcohol are contraindicated in neonates, infants, pregnant women, and lactating women.
Clinical warnings
- Boxed warning · ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. — FDA
- Boxed warning · In cancer patients, ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence. Use only for anemia from myelosuppressive chemotherapy and not in patients where the anticipated outcome is cure. — FDA
- Major warning · Increased risk of hypertension, which can be severe and require treatment or dose adjustment. Monitor blood pressure. — FDA
Adverse events
Common (≥1%)
hypertension · arthralgia · pyrexia · nausea · vomiting · headache · cough · injection site pain · muscle spasm
Rare but serious
myocardial infarction · stroke · venous thromboembolism · tumor progression · pure red cell aplasia (PRCA) · seizures · severe cutaneous reactions
Pregnancy and lactation
Multiple-dose vials containing benzyl alcohol are contraindicated in pregnant women. When therapy is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial).
Recent literature (PubMed)
Revisión sobre síndromes mielodisplásicos (SMD) que destaca el uso de agentes estimulantes de la eritropoyesis (AEE) como tratamiento para la anemia en pacientes con SMD de bajo riesgo, mejorando la anemia en un 15-40% de los pacientes durante una mediana de 8 a 23 meses.
Revisión sobre la anemia neonatal, incluyendo la anemia de la prematuridad. Se discuten las opciones de tratamiento, incluido el uso de agentes estimulantes de la eritropoyesis, transfusiones de glóbulos rojos y suplementos de hierro.
Este artículo revisa el impacto de la anemia y la deficiencia de hierro en el cerebro en desarrollo. Se analizan ensayos aleatorizados sobre agentes estimulantes de la eritropoyesis y umbrales de transfusión en el neurodesarrollo de lactantes prematuros.
Revisión sobre la eritrocitosis secundaria (aumento de glóbulos rojos), que es el resultado de estímulos externos a la médula ósea. Es relevante para el diagnóstico diferencial de trastornos hematológicos y la comprensión de la regulación de la eritropoyetina.
Describe el enfoque diagnóstico para la eritrocitosis. La medición del nivel de eritropoyetina es un primer paso clave: un nivel bajo sugiere una causa primaria (p. ej., policitemia vera), mientras que un nivel normal o elevado indica una etiología secundaria.