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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
NeoplasmsD009369C8013145739
Chronic kidney failureD007676EFO_0003884N18.637145534
Myelodysplastic syndromesD009190D461147223
Hiv infectionsD015658EFO_0000764B20124815
LymphomaD008223C85.91271112
Breast neoplasmsD001943EFO_0003869C501618
Drug therapyD0043582136
FatigueD005221HP_0012378R53.8321126
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C9537111
Plasma cell neoplasmsD0542192518
Cerebral palsyD002547G8012137
Brain hypoxia-ischemiaD020925EFO_1000846P91.64337
Blood transfusionD0018034517
Orthopedic proceduresD019637467
Traumatic brain injuriesD000070642S063416
Renal insufficiencyD051437HP_0000083N191315
Precancerous conditionsD011230224
Lymphoproliferative disordersD008232Orphanet_2442D47.9224
Show 57 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients113214
Acquired immunodeficiency syndromeD000163EFO_0000765B2055
Reperfusion injuryD0154271113
Congenital heart defectsD006330HP_0001627Q24.91213
Retinopathy of prematurityD012178EFO_1001158H35.11112
Sickle cell anemiaD000755EFO_0000697D57212
Moyamoya diseaseD009072EFO_0004250I67.51112
Amyotrophic lateral sclerosisD000690EFO_0000253G12.21122
Replacement arthroplasty kneeD019645112
Chronic diseaseD002908112
Show 32 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F13112
Pulmonary hypertensionD006976EFO_0001361I27.2011
Autoimmune hepatitisD019693K75.411
Parkinson diseaseD010300EFO_0002508G2011
Alveolar bone lossD01630111
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Developmental disabilitiesD002658EFO_0003852F8911
Iron metabolism disordersD019189E83.111
Cerebrovascular disordersD002561EFO_0003763I60-I6911
Uterine diseasesD014591N85.911
Heart diseasesD006331EFO_0003777I51.911
Myocardial reperfusion injuryD015428EFO_000268711
HemiarthroplastyD06278511
FibrosisD00535511
Crohn diseaseD003424EFO_0000384K5011
Insulin resistanceD007333EFO_000261411
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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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