Epoetin alfa
Abseamed, Binocrit, Epoetin Alfa, Epogen/Procrit, Procrit, Retacrit (epoetin alfa) is a protein pharmaceutical. Epoetin alfa was first approved as Epogen/procrit on . It is used to treat anemia in the USA. It has been approved in Europe to treat anemia, chronic kidney failure, and neoplasms. It is known to target erythropoietin receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Epogen/procrit, Retacrit
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| anemia | HP_0001903 | D000740 | D64.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
epoetin alfa, Epogen/Procrit, Amgen, Inc. | |||
| 1997-12-31 | Orphan excl. | ||
epoetin alfa, Procrit, Amgen, Inc. | |||
| 1997-12-31 | Orphan excl. | ||
Patent Expiration
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ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J0881 | Injection, darbepoetin alfa, 1 microgram (non-esrd use) |
| J0882 | Injection, darbepoetin alfa, 1 microgram (for esrd on dialysis) |
| J0885 | Injection, epoetin alfa, (for non-esrd use), 1000 units |
| Q4081 | Injection, epoetin alfa, 100 units (for esrd on dialysis) |
| Q5105 | Injection, epoetin alfa-epbx, biosimilar, (retacrit) (for esrd on dialysis), 100 units |
| Q5106 | Injection, epoetin alfa-epbx, biosimilar, (retacrit) (for non-esrd use), 1000 units |
Clinical
Clinical Trials
800 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | 14 | 116 | 149 | 78 | 73 | 420 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 8 | 45 | 49 | 22 | 35 | 156 |
| Chronic renal insufficiency | D051436 | — | N18 | 9 | 40 | 52 | 20 | 30 | 150 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.9 | 8 | 24 | 23 | 14 | 13 | 79 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 6 | 20 | 24 | 14 | 9 | 71 |
| Neoplasms | D009369 | — | C80 | 1 | 16 | 16 | 5 | 12 | 50 |
| Syndrome | D013577 | — | — | 2 | 25 | 11 | 3 | 7 | 45 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 24 | 12 | 3 | 6 | 44 |
| Preleukemia | D011289 | — | — | 2 | 23 | 12 | 3 | 5 | 42 |
| Iron deficiencies | D000090463 | — | — | 1 | 3 | 4 | 6 | 10 | 22 |
Show 72 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 16 | 3 | 1 | — | 5 | 23 |
| Leukemia | D007938 | — | C95 | — | 8 | 7 | — | 1 | 16 |
| Multiple myeloma | D009101 | — | C90.0 | — | 3 | 8 | — | 4 | 15 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 6 | 4 | — | 5 | 14 |
| Blood transfusion | D001803 | — | — | — | 4 | 5 | — | 6 | 12 |
| Plasma cell neoplasms | D054219 | — | — | — | 3 | 6 | — | 2 | 11 |
| Brain injuries | D001930 | — | S06.9 | — | 7 | 5 | — | 1 | 11 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | 5 | 4 | 5 | — | — | 11 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 5 | 4 | — | 1 | 8 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 3 | 6 | 1 | — | — | 8 |
Show 103 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | — | 3 | 5 | — | — | — | 7 |
| Cardiac surgical procedures | D006348 | — | — | 1 | 2 | — | — | 5 | 7 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | 5 | — | — | — | 6 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 1 | 5 | — | — | — | 6 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 1 | 3 | — | — | 1 | 4 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | — | 1 | 4 |
| Critical illness | D016638 | — | — | — | 3 | — | — | 1 | 4 |
| Sclerosis | D012598 | — | — | 2 | 2 | — | — | — | 3 |
| Coronary artery disease | D003324 | — | I25.1 | — | 3 | — | — | — | 3 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | 1 | — | — | 1 | 3 |
Show 65 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 2 | 3 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | 1 | — | — | — | 2 | 3 |
| Cerebral infarction | D002544 | — | I63 | 2 | — | — | — | — | 2 |
| Reticulocyte count | D017701 | — | — | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Autoimmune hepatitis | D019693 | — | — | 1 | — | — | — | — | 1 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | 1 | — | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
| Cerebral hemorrhage | D002543 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cytopenia | D000095542 | — | — | — | — | — | — | 9 | 9 |
| Pancytopenia | D010198 | HP_0001876 | D61.81 | — | — | — | — | 8 | 8 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | — | — | 2 | 2 |
| Iron metabolism disorders | D019189 | — | E83.1 | — | — | — | — | 2 | 2 |
| Hemolytic anemia | D000743 | — | D55-D59 | — | — | — | — | 2 | 2 |
| Surgical blood loss | D016063 | — | — | — | — | — | — | 2 | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | — | — | 2 | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 2 | 2 |
| Continuous ambulatory peritoneal dialysis | D010531 | — | — | — | — | — | — | 1 | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Epoetin alfa |
| INN | epoetin alfa |
| Description | Erythropoietin precursor (Epoetin) |
| Classification | Protein |
| Drug class | erythropoietins |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201565 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00016 |
| UNII ID | 64FS3BFH5W (ChemIDplus, GSRS) |
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Retacrit – Pfizer
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Procrit – Johnson & Johnson
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Estimated US medical usage
Epoetin alfa
Total medical expenditures per year (USD, in millions)
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Safety
Black-box Warning
Black-box warning for: Epogen, Mircera, Procrit, Retacrit
Adverse Events
Top Adverse Reactions
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57,927 adverse events reported
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