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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
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Epogen/procrit, 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)
Epoetin alfa
Tradename
Proper name
Company
Number
Date
Products
Epogen/Procritepoetin alfaAmgenN-103234 RX-
6 products
Procritepoetin alfaAmgenN-103234 RX-
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
procritBiologic Licensing Application2020-05-21
retacritBiologic Licensing Application2022-07-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
anemiaEFO_0004272D000740D64.9
Agency Specific
FDA
EMA
Expiration
Code
epoetin alfa, Epogen/Procrit, Amgen, Inc.
1997-12-31Orphan excl.
epoetin alfa, Procrit, Amgen, Inc.
1997-12-31Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B03: Antianemic preparations
— B03X: Other antianemic preparations in atc
— B03XA: Other antianemic preparations in atc
— B03XA02: Darbepoetin alfa
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
524 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740EFO_0004272D64.96681115220254
Chronic renal insufficiencyD051436N1847196844
NeoplasmsD009369C80—13145739
Chronic kidney failureD007676EFO_0003884N18.637145534
Myelodysplastic syndromesD009190D4611472—23
Hiv infectionsD015658EFO_0000764B2012—4815
LymphomaD008223C85.91271112
Breast neoplasmsD001943EFO_0003869C50—161—8
Drug therapyD004358—213—6
FatigueD005221HP_0012378R53.83—21126
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95—37—111
Plasma cell neoplasmsD054219—25—18
Cerebral palsyD002547G80121—37
Brain hypoxia-ischemiaD020925EFO_1000846P91.6433——7
Blood transfusionD001803—45—17
Orthopedic proceduresD019637—46——7
Traumatic brain injuriesD000070642S06—34—16
Renal insufficiencyD051437HP_0000083N19—13—15
Precancerous conditionsD011230—22——4
Lymphoproliferative disordersD008232Orphanet_2442D47.9—22——4
Show 57 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—113——214
Acquired immunodeficiency syndromeD000163EFO_0000765B20—5———5
Reperfusion injuryD01542711——13
Congenital heart defectsD006330HP_0001627Q24.912——13
Retinopathy of prematurityD012178EFO_1001158H35.111——12
Sickle cell anemiaD000755EFO_0000697D5721———2
Moyamoya diseaseD009072EFO_0004250I67.511——12
Amyotrophic lateral sclerosisD000690EFO_0000253G12.2112———2
Replacement arthroplasty kneeD019645—1——12
Chronic diseaseD002908—1——12
Show 32 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F131———12
Pulmonary hypertensionD006976EFO_0001361I27.201————1
Autoimmune hepatitisD019693K75.41————1
Parkinson diseaseD010300EFO_0002508G201————1
Alveolar bone lossD0163011————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Developmental disabilitiesD002658EFO_0003852F89————11
Iron metabolism disordersD019189E83.1————11
Cerebrovascular disordersD002561EFO_0003763I60-I69————11
Uterine diseasesD014591N85.9————11
Heart diseasesD006331EFO_0003777I51.9————11
Myocardial reperfusion injuryD015428EFO_0002687————11
HemiarthroplastyD062785————11
FibrosisD005355————11
Crohn diseaseD003424EFO_0000384K50————11
Insulin resistanceD007333EFO_0002614————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEPOETIN ALFA
INNepoetin alfa
Description
Erythropoietin precursor (Epoetin)
Classification
Protein
Drug classerythropoietins
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID113427-24-0
RxCUI105694
ChEMBL IDCHEMBL1201565
ChEBI ID—
PubChem CID—
DrugBankDB00016
UNII ID64FS3BFH5W (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
EPOR
EPOR
Organism
Homo sapiens
Gene name
EPOR
Gene synonyms
NCBI Gene ID
Protein name
erythropoietin receptor
Protein synonyms
truncated erythropoietin receptor
Uniprot ID
Mouse ortholog
Epor (13857)
erythropoietin receptor (P14753)
Variants
Clinical Variant
No data
Financial
Retacrit - Pfizer
$
€
£
₣
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Procrit - Johnson & Johnson
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,147 documents
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Safety
Black-box Warning
Black-box warning for: Procrit, Retacrit
Adverse Events
Top Adverse Reactions
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45,758 adverse events reported
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