Epoetin alfa

verifiedfields	changed
verifiedrevid	476993050
tradename	Epogen
medlineplus	a692034
dailymedid	Epoetin alfa
routes of administration	Intravenous, subcutaneous
atc prefix	B03
atc suffix	XA01
biosimilars	epoetin alfa-epbx, Abseamed,‡R1R‡ Binocrit, Epoetin Alfa Hexal, Retacrit‡R2R‡‡R3R‡
legal au	S4
legal us	Rx-only
legal us comment	‡R4R‡
legal eu	Rx-only
cas number	11096-26-7
drugbank	DB00016
chemspiderid	none
unii	64FS3BFH5W
kegg	D03231
chembl	1201565
c	815
h	1317
n	233
o	241
s	5

Epoetin alfa, sold under the brand name Epogen among others, is a human erythropoietin produced in cell culture using recombinant DNA technology.[4][5] Epoetin alfa is an erythropoiesis-stimulating agent.[4] It stimulates erythropoiesis (increasing red blood cell levels) and is used to treat anemia, commonly associated with chronic kidney failure and cancer chemotherapy. Epoetin alfa is developed by Amgen.[4]

It is on the World Health Organization's List of Essential Medicines.[6] It was approved for medical use in the European Union in August 2007,

Medical uses

Adverse effects

Epoetin alfa is generally well tolerated. Common side effects include high blood pressure, headache, disabling cluster migraine (resistant to remedies), joint pain, and clotting at the injection site. Rare cases of stinging at the injection site, skin rash, and flu-like symptoms (joint and muscle pain) have occurred within a few hours following administration. More serious side effects, including allergic reactions, seizures and thrombotic events (e.g., heart attacks, strokes, and pulmonary embolism) rarely occur. Chronic self-administration of the drug has been shown to cause increases in blood hemoglobin and hematocrit to abnormally high levels, resulting in dyspnea and abdominal pain.[11]

Erythropoietin is associated with an increased risk of adverse cardiovascular complications in patients with kidney disease if it is used to target an increase of hemoglobin levels above 13.0 g/dl.[12]

Early treatment (before an infant is 8 days old) with erythropoietin correlated with an increase in the risk of retinopathy of prematurity in premature and anemic infants, raising concern that the angiogenic actions of erythropoietin may exacerbate retinopathy. Since anemia itself increases the risk of retinopathy, the correlation with erythropoietin treatment may be incidental.[13]

Safety advisories in anemic cancer patients

Amgen advised the U.S. Food and Drug Administration (FDA) regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco-regional cancer control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01).[14]

In response to these advisories, the FDA released a Public Health Advisory[15] on 9 March 2007, and a clinical alert[16] for doctors in February 2007, about the use of erythropoiesis-stimulating agents (ESAs) such as epogen and darbepoetin. The advisory recommended caution in using these agents in cancer patients receiving chemotherapy or off chemotherapy, and indicated a lack of clinical evidence to support improvements in quality of life or transfusion requirements in these settings.

Several publications and FDA communications have increased the level of concern related to adverse effects of ESA therapy in selected groups. In a revised black box warning, the FDA notes significant risks, advising that ESAs should be used only in patients with cancer when treating anemia specifically caused by chemotherapy, and not for other causes of anemia.

References

Abseamed Union Register of medicinal products, retrieved 14 January 2021^

Retacrit- epoetin alfa-epbx injection, solution DailyMed, 29 January 2020^

Retacrit- epoetin alfa-epbx injection, solution DailyMed, 26 June 2024, retrieved 25 July 2024^

Epogen- epoetin alfa solution DailyMed, 25 July 2018^

Directory of approved biopharmaceutical products CRC Press, 2005^

The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023) World Health Organization, 2023^

A randomized controlled study of iron supplementation in patients treated with erythropoietin Kidney International, November 1996^

Erythropoiesis Stimulating Agents (ESAs) for Severe Anaemia Tanya's Feline CKD Website, 14 November 2020, retrieved 17 September 2023^

Erythropoietin (Epogen®, Procrit®) for Dogs and Cats PetPlace, 6 August 2015, retrieved 17 September 2023^

Efficacy and safety of epoetin alfa in critically ill patients The New England Journal of Medicine, September 2007^

Randall Clint Baselt. Disposition of Toxic Drugs and Chemicals in Man Biomedical Publications, 2008^

Normalization of hemoglobin level in patients with chronic kidney disease and anemia The New England Journal of Medicine, November 2006^

Early Erythropoietin Administration does not Increase the Risk of Retinopathy in Preterm Infants Pediatrics and Neonatology, February 2017^

Flexible dosing with Darbepoetin alfa for the treatment of chemotherapy-induced anemia Therapeutics and Clinical Risk Management, June 2006^

FDA Public Health Advisory: Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) Food and Drug Administration, retrieved 5 June 2007^

Information for Healthcare Professionals: Erythropoiesis Stimulating Agents (ESA) Food and Drug Administration, retrieved 5 June 2007^

Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) MedWatch - 2007 Safety Information Alerts, U.S. Food and Drug Administration, 3 January 2008, retrieved 9 April 2009^

Procrit (Epoetin alfa) for injection U.S. Food and Drug Administration, 11 August 2007, retrieved 9 April 2009^

Aranesp (darbepoetin alfa) for Injection U.S. Food and Drug Administration, 8 November 2007, retrieved 9 April 2009^

Information on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp) U.S. Food and Drug Administration, 26 January 2009, retrieved 9 April 2009^

Renin-angiotensin system inhibitors linked to anemia: a systematic review and meta-analysis QJM, November 2015^

Secret ties to industry and conflicting interests in cancer research American Journal of Industrial Medicine, March 2007^

Whistleblower's story: New book reviewed Center for Medical Consumers, 5 October 2011, retrieved 12 February 2012^

Drug Rep in $3B Procrit Case: "80% of My Sales Were Medicare Fraud"; Carried $400K in "Cash" CBS news, 17 August 2009, retrieved 12 February 2012^

Balancing innovation, access, and profits--market exclusivity for biologics The New England Journal of Medicine, November 2009^

Testimony Before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives.] Medicare. Information on Highest-Expenditure Part B Drugs. United States Government Accountability Office (GAO), 28 June 2013, retrieved 29 June 2015^

Capitol Health Call: High-Cost Drugs Account for Most of Medicare Part B Spending JAMA, 14 August 2013^

Binocrit EPAR European Medicines Agency (EMA), 17 September 2018, retrieved 2 April 2020^

Epoetin Alfa Hexal EPAR European Medicines Agency (EMA), 17 September 2018, retrieved 2 April 2020^

Abseamed EPAR European Medicines Agency (EMA), 17 September 2018, retrieved 2 April 2020^

Erythropoietin: a candidate compound for neuroprotection in schizophrenia Molecular Psychiatry, January 2004^

Can erythropoietin be used to prevent brain damage in cerebral malaria? Trends in Parasitology, January 2009^

Plasmodium berghei ANKA: erythropoietin activates neural stem cells in an experimental cerebral malaria model Experimental Parasitology, February 2011^

Kidney drug could save children from malaria brain damage The Guardian, 17 February 2008^

Passage of erythropoietic agents across the blood-brain barrier: a comparison of human and murine erythropoietin and the analog darbepoetin alfa European Journal of Pharmacology, November 2004^

The effect of erythropoietin on cognition in affective disorders - Associations with baseline deficits and change in subjective cognitive complaints European Neuropsychopharmacology, August 2016^

Early erythropoiesis-stimulating agents in preterm or low birth weight infants The Cochrane Database of Systematic Reviews, February 2020^

Early versus late erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants The Cochrane Database of Systematic Reviews, February 2020^

Epoetin alfa

Medical uses

Anemia caused by kidney disease

Anemia in critically ill people

Adverse effects

Safety advisories in anemic cancer patients

Interactions

Society and culture

Economics

Biosimilars

Research

Neurological diseases

Preterm infants

References