Identification

Name
Erythropoietin
Accession Number
DB00016  (BTD00103, BIOD00103, DB08923)
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Hormones
Description

Erythropoietin (EPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow [Label]. Epoetin alfa (Epoge) was developed by Amgen Inc. in 1983 as the first rhEPO commercialized in the United States, followed by other alfa and beta formulations. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein produced in cell culture using recombinant DNA technology and is used for the treatment of patients with anemia associated with various clinical conditions, such as chronic renal failure, antiviral drug therapy, chemotherapy, or a high risk for perioperative blood loss from surgical procedures [Label]. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin and has the same biological activity as the endogenous erythropoietin. Epoetin alfa biosimilar, such as Retacrit (epoetin alfa-epbx or epoetin zeta), has been formulated to allow more access to treatment options for patients in the market [5]. The biosimilar is approved by the FDA and EMA as a safe, effective and affordable biological product and displays equivalent clinical efficacy, potency, and purity to the reference product [1]. Epoetin alfa formulations can be administered intravenously or subcutaneously.

Protein structure
Db00016
Protein chemical formula
C815H1317N233O241S5
Protein average weight
18396.1 Da
Sequences
>DB00016 (Erythropoietin) sequence
APPRLICDSRVLERYLLEAKEAENITTGCAEHCSLNENITVPDTKVNFYAWKRMEVGQQA
VEVWQGLALLSEAVLRGQALLVNSSQPWEPLQLHVDKAVSGLRSLTTLLRALGAQKEAIS
PPDAASAAPLRTITADTFRKLFRVYSNFLRGKLKLYTGEACRTGDR
Download FASTA Format
Synonyms
  • E.P.O.
  • Epoetin alfa
  • Epoetin alfa rDNA
  • Epoetin alfa-epbx
  • Epoetin alfa, recombinant
  • Epoetin beta
  • Epoetin beta rDNA
  • Epoetin epsilon
  • Epoetin gamma
  • Epoetin gamma rDNA
  • Epoetin kappa
  • Epoetin omega
  • Epoetin theta
  • Epoetin zeta
  • Epoetina alfa
  • Epoetina beta
  • Epoetina dseta
  • Epoetina zeta
  • Epoétine zêta
  • Epoetinum zeta
  • Erythropoiesis stimulating factor
  • Erythropoietin (human, recombinant)
  • Erythropoietin (recombinant human)
  • ESF
  • SH-polypeptide-72
External IDs
BM 06.019
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AbseamedInjection, solution10000 IU/1.0mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution1000 IU/0.5mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution8000 IU/0.8mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution30000 IU/0.75mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution1000 IU/0.5mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution40000 IU/1.0mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution6000 IU/0.6mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution40000 IU/1.0mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution6000 IU/0.6mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
AbseamedInjection, solution5000 IU/0.5mlIntravenous; SubcutaneousMedice Arzneimittel Pütter Gmb H & Co. Kg2007-08-28Not applicableEu
International/Other Brands
Binocrit (Sandoz) / Epobel (Nobel Ilac Pazarlama ve Sanayii Ltd. STI., Turkey) / Epocept (Lupin pharma) / Epofit (Intas pharma) / Epogin (Chugai) / Eqralys (Hemofarm AD) / Nanokine (Nanogen Pharmaceutical biotechnology, Vietnam)) / Retacrit (Hospira, Inc.) / Silapo (Cell Pharm GmbH)
Categories
UNII
64FS3BFH5W
CAS number
11096-26-7

Pharmacology

Indication

Indicated in adult and paediatric patients for the:

  • treatment of anemia due to Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
  • treatment of anemia due to zidovudine in patients with HIV-infection.
  • treatment of anemia due to the effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
  • reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Associated Conditions
Associated Therapies
Pharmacodynamics

Erythropoietin and epoetin alfa are involved in the regulation of erythrocyte differentiation and the maintenance of a physiological level of circulating erythrocyte mass. It is reported to increase the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks [6]. Depending on the dose administered, the rate of hemoglobin increase may vary. In patients receiving hemodialysis, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly [6].

Epoetin alfa serves to restore erythropoietin deficiency in pathological and other clinical conditions where normal production of erythropoietin is impaired or compromised. In anemic patients with chronic renal failure (CRF), administration with epoetin alfa stimulated erythropoiesis by increasing the reticulocyte count within 10 days, followed by increases in the red cell count, hemoglobin, and hematocrit, usually within 2 to 6 weeks [Label]. Epoetin alfa was shown to be effective in increasing hematocrit in zidovudine-treated HIV-infected patients and anemic cancer patients undergoing chemotherapy [Label].

Mechanism of action

Erythropoietin or exogenous epoetin alfa binds to the erythropoietin receptor (EPO-R) and activates intracellular signal transduction pathways [3]. The affinity (Kd) of EPO for its receptor on human cells is ∼100 to 200 pM [4]. Upon binding to EPO-R on the surface of erythroid progenitor cells, a conformational change is induced which brings EPO-R-associated Janus family tyrosine protein kinase 2 (JAK2) molecules into close proximity. JAK2 molecules are subsequently activated via phosphorylation, then phosphorylate tyrosine residues in the cytoplasmic domain of the EPO-R that serve as docking sites for Src homology 2-domain-containing intracellular signaling proteins [3]. The signalling proteins include STAT5 that once phosphorylated by JAK2, dissociates from the EPO-R, dimerizes, and translocates to the nucleus where they serve as transcription factors to activate target genes involved in cell division or differentiation, including the apoptosis inhibitor Bcl-x [3]. The inhibition of apoptosis by the EPO-activated JAK2/STAT5/Bcl-x pathway is critical in erythroid differentiation. Via JAK2-mediated tyrosine phosphorylation, erythropoietin and epoetin alfa also activates other intracellular proteins involved in erythroid cell proliferation and survival, such as Shc , phosphatidylinositol 3-kinase (PI3K), and phospholipase C-γ1 [3].

TargetActionsOrganism
AErythropoietin receptor
agonist
Human
Absorption

The time to reach peak concentration is slower via the subcutaneous route than the intravenous route which ranges from 20 to 25 hours, and the peak is always well below the peak achieved using the intravenous route (5–10% of those seen with IV administration) [4]. The bioavailability of subcutaneous injectable erythropoietin is much lower than that of the intravenously administered product and is approximately 20-40% [4].

Adult and paediatric patients with CRF: Following subcutaneous administration, the peak plasma levels are achieved within 5 to 24 hours [Label].

Cancer patients receiving cyclic chemotherapy: The average time to reach peak plasma concentration was approximately 13.3 ± 12.4 hours after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing. The Cmax is expected be 3- to 7- fold higher and the Tmax is expected to be 2- to 3-fold longer in patients receiving a 40,000 Units SC weekly dosing regimen [Label].

Volume of distribution

In healthy volunteers, the volume of distribution of intravenous epoetin alfa was generally similar to the plasma volume (range of 40–63.80 mL/kg), indicating limited extravascular distribution [4, 2].

Protein binding

No information of serum protein binding available.

Metabolism

Binding of erythropoietin and epoetin alfa to EPO-R leads to cellular internalization, which involves the degradation of the ligand. Erythropoietin and epoetin alfa may also be degraded by the reticuloendothelial scavenging pathway or lymphatic system [4].

Route of elimination

Erythropoietin and epoetin alfa are cleared via uptake and degradation via the EPO-R-expressing cells, and may also involve other cellular pathways in the interstitium, probably via cells in the reticuloendothelial scavenging pathway or lymphatic system [4]. Only a small amount of unchanged epoetin alfa is found in the urine [7].

Half life

Healthy volunteers: The half life is approximately 4 hours in healthy volunteers receiving an intravenous injection [6]. A half-life of approximately 6 hours has been reported in children [6].

Adult and paediatric patients with CRF: The elimination half life following intravenous administration ranges from 4 to 13 hours, which is about 20% longer in CRF patients than that in healthy subjects. The half life is reported to be similar between adult patients receiving or not receiving dialysis [Label].

Cancer patients receiving cyclic chemotherapy: Following subcutaneous administration, the average half life is 40 hours with range of 16 to 67 hours [Label].

Clearance

*Healthy volunteers: * In male volunteers receiving intravenous epoetin alfa, the total body clearance was approximately 8.12 ± 1.00 mL/h/kg [2].

Cancer patients receiving cyclic chemotherapy: The average clearance was approximately 20.2 ± 15.9 mL/h/kg after 150 Units/kg three times per week (TIW) subcutaneous (SC) dosing [Label]. The patients receiving a 40,000 Units SC weekly dosing regimen display a lower clearance (9.2 ± 4.7 mL/h/kg) [Label].

Toxicity

Overdose from epoetin alfa include signs and symptoms associated with an excessive and/or rapid increase in hemoglobin concentration, including cardiovascular events. Patients with suspected or known overdose should be monitored closely for cardiovascular events and hematologic abnormalities. Polycythemia should be managed acutely with phlebotomy, as clinically indicated. Following resolution of the overdose, reintroduction of epoetin alfa therapy should be accompanied by close monitoring for evidence of rapid increases in hemoglobin concentration (>1 gm/dL per 14 days). In patients with an excessive hematopoietic response, reduce the dose in accordance with the recommendations described in the drug label [Label].

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
DrugInteraction
BenazeprilThe serum concentration of Erythropoietin can be decreased when it is combined with Benazepril.
BenazeprilatThe serum concentration of Erythropoietin can be decreased when it is combined with Benazeprilat.
CaptoprilThe serum concentration of Erythropoietin can be decreased when it is combined with Captopril.
CilazaprilThe serum concentration of Erythropoietin can be decreased when it is combined with Cilazapril.
CyclophosphamideThe risk or severity of pulmonary toxicity can be increased when Erythropoietin is combined with Cyclophosphamide.
DelaprilThe serum concentration of Erythropoietin can be decreased when it is combined with Delapril.
EnalaprilThe serum concentration of Erythropoietin can be decreased when it is combined with Enalapril.
EnalaprilatThe serum concentration of Erythropoietin can be decreased when it is combined with Enalaprilat.
FosinoprilThe serum concentration of Erythropoietin can be decreased when it is combined with Fosinopril.
FosinoprilatThe serum concentration of Erythropoietin can be decreased when it is combined with Fosinoprilat.
Food Interactions
Not Available

References

General References
  1. Brinks V, Hawe A, Basmeleh AH, Joachin-Rodriguez L, Haselberg R, Somsen GW, Jiskoot W, Schellekens H: Quality of original and biosimilar epoetin products. Pharm Res. 2011 Feb;28(2):386-93. doi: 10.1007/s11095-010-0288-2. Epub 2010 Oct 1. [PubMed:20886265]
  2. Halstenson CE, Macres M, Katz SA, Schnieders JR, Watanabe M, Sobota JT, Abraham PA: Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta. Clin Pharmacol Ther. 1991 Dec;50(6):702-12. [PubMed:1752115]
  3. Weiss MJ: New insights into erythropoietin and epoetin alfa: mechanisms of action, target tissues, and clinical applications. Oncologist. 2003;8 Suppl 3:18-29. [PubMed:14671225]
  4. Elliott S, Pham E, Macdougall IC: Erythropoietins: a common mechanism of action. Exp Hematol. 2008 Dec;36(12):1573-84. doi: 10.1016/j.exphem.2008.08.003. Epub 2008 Oct 14. [PubMed:18922615]
  5. FDA News Release: FDA approves first epoetin alfa biosimilar for the treatment of anemia [Link]
  6. EMA Summary of Product Characteristics: RETACRIT (epoetin alfa-epox) injection, for intravenous or subcutaneous use [File]
  7. Epoetin Alfa (Epogen®) Product Monograph [File]
External Links
UniProt
P01588
Genbank
X02158
PubChem Substance
46508122
ChEMBL
CHEMBL1201565
Therapeutic Targets Database
DAP000202
PharmGKB
PA10072
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Epoetin_alfa
ATC Codes
B03XA01 — Erythropoietin
AHFS Codes
  • 20:16.00 — Hematopoietic Agents
FDA label
Download (725 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedNot AvailableAnemias / Chronic Renal Failure (CRF)1
1CompletedBasic ScienceRenal Effects1
1CompletedBasic ScienceThere Are no Conditions Under Study. Healthy Volunteers1
1CompletedPreventionParkinson's Disease (PD)1
1CompletedTreatmentAnemias / Chronic Kidney Disease (CKD)1
1CompletedTreatmentCerebral Palsy (CP)1
1CompletedTreatmentChronic Kidney Disease (CKD) / Pulmonary Hypertension (PH) / Sickle Cell Disorders1
1CompletedTreatmentChronic Renal Failure (CRF)1
1CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
1CompletedTreatmentHypoxic-Ischaemic Encephalopathy1
1CompletedTreatmentRenal Insufficiency,Chronic1
1TerminatedSupportive CareMalignant Lymphomas / Neutropenias1
1Unknown StatusTreatmentHealthy Volunteers4
1Unknown StatusTreatmentTransplantation, Kidney1
1, 2Active Not RecruitingPreventionAortic Arch Hypoplasia or Interruption / Congenital Heart Disease (CHD) / Hypoplastic Left Heart Syndrome (HLHS) / Transposition of the Great Arteries1
1, 2Active Not RecruitingTreatmentHypoxic-Ischaemic Encephalopathy / Neonatal Asphyxia / Neonatal Encephalopathy1
1, 2CompletedTreatmentAngiogenesis / Burr Hole / Ischemic Attack / Moyamoya Disease / Stroke, Ischemic1
1, 2RecruitingTreatmentAnemias / Cardiovascular Disease (CVD)1
1, 2TerminatedTreatmentCardiac Surgery-CABG and/or Cardiac Valve Replacement1
1, 2Unknown StatusBasic ScienceHealthy Volunteers1
2Active Not RecruitingPreventionNeonatal Anemia1
2CompletedPreventionCerebral Palsy (CP) / Developmental Psychomotor Disorders / Intracranial Hemorrhages / Periventricular Leukomalacia1
2CompletedPreventionMyocardial Ischemia1
2CompletedPreventionOptic Neuritis1
2CompletedSupportive CareAnemias / Leukemias / Lymphoproliferative Disorders / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm / Precancerous Conditions / Unspecified Adult Solid Tumor, Protocol Specific2
2CompletedSupportive CareAnemias / Leukemias / Myelodysplastic Syndromes / Myelodysplastic/Myeloproliferative Neoplasms1
2CompletedSupportive CareAnemias / Tiredness / Unspecified Adult Solid Tumor, Protocol Specific2
2CompletedTreatmentAcquired Immune Deficiency Syndrome (AIDS) / Anemias4
2CompletedTreatmentAnemia in End Stage Renal Disease1
2CompletedTreatmentAnemias6
2CompletedTreatmentAnemias / Blood Transfusions / Orthopedic Procedures1
2CompletedTreatmentAnemias / Chronic Kidney Disease (CKD)1
2CompletedTreatmentAnemias / Chronic Kidney Disease (CKD) / Chronic Renal Failure (CRF)1
2CompletedTreatmentAnemias / Chronic Lymphocytic Leukaemia (CLL) / Leukemia, Lymphocytic / Malignancies / Neoplasms / Quality of Life1
2CompletedTreatmentAnemias / Chronic Renal Failure (CRF)1
2CompletedTreatmentAnemias / Critical Illness1
2CompletedTreatmentAnemias / End Stage Renal Disease (ESRD)1
2CompletedTreatmentAnemias / Kidney Diseases1
2CompletedTreatmentAnemias / Malignancies1
2CompletedTreatmentAnemias / Cancer treatment / Malignancies1
2CompletedTreatmentAnemias / Neoplasms3
2CompletedTreatmentAnemias / Renal Insufficiency,Chronic1
2CompletedTreatmentAnemias / Cancer treatment1
2CompletedTreatmentAneurysmal Subarachnoid Hemorrhage1
2CompletedTreatmentBeta-Thalassemia1
2CompletedTreatmentCerebral Palsy (CP)1
2CompletedTreatmentFriedreich's Ataxia2
2CompletedTreatmentHead and Neck Carcinoma1
2CompletedTreatmentMalignant Neoplasm of Pancreas1
2CompletedTreatmentMoods Disorders1
2CompletedTreatmentMyelodysplastic Syndrome1
2CompletedTreatmentMyelodysplastic Syndromes3
2CompletedTreatmentMyocardial Infarction1
2CompletedTreatmentPreterm, Infant1
2CompletedTreatmentRenal Failure1
2CompletedTreatmentST Elevation Acute Myocardial Infarction1
2Not Yet RecruitingTreatmentAnemia of Chronic Disease / Hip Arthropathy / Iron Deficiency Anemia (IDA) / Knee Arthropathy1
2Not Yet RecruitingTreatmentAngiogenesis / Stroke, Ischemic1
2Not Yet RecruitingTreatmentInfants, Premature1
2RecruitingHealth Services ResearchDiabetic Chronic Ulcers1
2RecruitingTreatmentAnemias1
2RecruitingTreatmentAnemias / Chronic Renal Failure (CRF) / Dialysis therapy1
2RecruitingTreatmentAnemias / Congenital Heart Disease (CHD) / Cyanosis / Cyanotic Congenital Heart Disease1
2RecruitingTreatmentBipolar Disorder (BD) / Cognitive Impairments1
2RecruitingTreatmentCognitive Impairments / Depression, Bipolar / Electroconvulsive Therapy / Unipolar Depression1
2RecruitingTreatmentErectile Dysfunction (ED) / Prostate Cancer1
2RecruitingTreatmentInfants, Premature1
2RecruitingTreatmentNon-arteritic Anterior Ischemic Optic Neuropathy (NAION)1
2TerminatedPreventionBrain Injury / Erythropoietin / Infants, Premature / Intraventricular Hemorrhage / Neurodevelopmental Outcomes / Periventricular Leukomalacia / Randomized Clinical Trial1
2TerminatedTreatmentAgeing / Anemias / Hemoglobins2
2TerminatedTreatmentAging / Anemias1
2TerminatedTreatmentAnemias2
2TerminatedTreatmentAnemias / Epoetin Alfa / Malignancies1
2TerminatedTreatmentAnemias / Human Immunodeficiency Virus (HIV)1
2TerminatedTreatmentAnemias / Malignancies / Neoplasms1
2TerminatedTreatmentAnemias / Rheumatoid Arthritis1
2TerminatedTreatmentAnemias / Surgery, Arthroscopy1
2TerminatedTreatmentAnemias / Hemodialysis-dependent chronic kidney disease (HDD-CKD)1
2TerminatedTreatmentEnd Stage Renal Disease (ESRD)1
2TerminatedTreatmentLeukemias1
2TerminatedTreatmentMyelodysplastic Syndromes1
2TerminatedTreatmentMyelodysplastic Syndromes (MDS)1
2TerminatedTreatmentStrokes1
2Unknown StatusTreatmentAcute Myocardial Infarction (AMI)1
2Unknown StatusTreatmentAnemias1
2Unknown StatusTreatmentAnemias / Myelodysplastic Syndromes1
2Unknown StatusTreatmentMultiple Sclerosis (Primary or Secondary Progressive Phase)1
2Unknown StatusTreatmentNewborn Infants1
2Unknown StatusTreatmentTrauma, Multiple1
2WithdrawnPreventionMalignancies1
2WithdrawnPreventionTraumatic Brain Injury (TBI)1
2WithdrawnTreatmentAnemias1
2WithdrawnTreatmentAnemias / Myelodysplastic Syndromes1
2WithdrawnTreatmentAnemias / Rheumatoid Arthritis1
2WithdrawnTreatmentHuman Immunodeficiency Virus (HIV) Infections / Neuropathy1
2WithdrawnTreatmentStrokes1
2, 3CompletedTreatmentAnemias / Blood Transfusions / Orthopedic Procedures1
2, 3CompletedTreatmentBlood Transfusions / Blood Transfusions, Autologous / Cardiovascular Surgical Procedures / Mammaplasty / Orthopedic Procedures1
2, 3CompletedTreatmentBlood Transfusions / Blood Transfusions, Autologous / Cardiovascular Surgical Procedures / Orthopedic Procedures1
2, 3CompletedTreatmentInfant, Low Birth Weight / Infant, Small for Gestational Age / Infants, Premature / Neonatal Anemia / Newborn Infants1
2, 3CompletedTreatmentPerinatal Asphyxia1
2, 3TerminatedTreatmentNerve Compression Syndromes1
2, 3Unknown StatusTreatmentMalaria, Cerebral1
2, 3WithdrawnTreatmentTraumatic Brain Injury (TBI)1
3Active Not RecruitingTreatmentAnemia in Incident Dialysis Patients1
3Active Not RecruitingTreatmentAnemias1
3Active Not RecruitingTreatmentAnemias / Chronic Myelomonocytic Leukemia / De Novo Myelodysplastic Syndrome / Myelodysplastic Syndrome / Previously Treated Myelodysplastic Syndromes1
3Active Not RecruitingTreatmentCKD Anemia in Stable Dialysis Patients1
3Active Not RecruitingTreatmentExtreme Prematurity1
3Active Not RecruitingTreatmentOptic Nerve Diseases1
3CompletedDiagnosticAnemias1
3CompletedPreventionAnemias / Left Ventricular Hypertrophy / Renal Failure1
3CompletedSupportive CareAcute Myelogenous Leukaemia (AML) / Leukemias / Myelodysplastic Syndrome1
3CompletedSupportive CareAdenocarcinoma of the Cervix / Adenosquamous carcinoma of the cervix / Anemias / Cervical Squamous Cell Carcinoma / Radiation Toxicity / Stage IIB Cervical Cancer / Stage III Cervical Cancer / Stage IVA Cervical Cancer / Therapeutic Agent Toxicity1
3CompletedSupportive CareAnemias / Cancer, Breast / Chronic Myeloproliferative Disorders / Drug/Agent Toxicity by Tissue/Organ / Leukemias / Lung Cancers / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm / Precancerous Conditions / Small Intestine Cancer / Unspecified Adult Solid Tumor, Protocol Specific1
3CompletedSupportive CareAnemias / Leukemias / Lymphoproliferative Disorders / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm / Precancerous Conditions / Unspecified Adult Solid Tumor, Protocol Specific1
3CompletedSupportive CareAnemias / Leukemias / Lymphoproliferative Disorders / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm / Precancerous/Nonmalignant Condition / Unspecified Adult Solid Tumor, Protocol Specific1
3CompletedSupportive CareAnemias / Leukemias / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm1
3CompletedSupportive CareAnemias / Prostate Cancer / Tiredness1
3CompletedTreatmentAnemias16
3CompletedTreatmentAnemias / Aortic Valve Stenosis1
3CompletedTreatmentAnemias / Blood Transfusions, Autologous / Orthopedic Procedures1
3CompletedTreatmentAnemias / Blood Transfusions / Orthopedic Procedures1
3CompletedTreatmentAnemias / Cancer of the Ovary / Cancer, Breast / Esophagus Cancer / Malignant Lymphomas / Multiple Myeloma (MM) / Neoplasms / Prostate Cancer / Small Cell Lung Carcinoma1
3CompletedTreatmentAnemias / Chronic Kidney Disease (CKD)1
3CompletedTreatmentAnemias / Chronic Kidney Disease (CKD) / Chronic Renal Failure (CRF)2
3CompletedTreatmentAnemias / Chronic Renal Failure (CRF)1
3CompletedTreatmentAnemias / End Stage Renal Disease (ESRD)1
3CompletedTreatmentAnemias / Head and Neck Carcinoma1
3CompletedTreatmentAnemias / Hodgkins Disease (HD) / Leukemias / Non-Hodgkin's Lymphoma (NHL)1
3CompletedTreatmentAnemias / Kidney Diseases1
3CompletedTreatmentAnemias / Malignancies / Neoplasms1
3CompletedTreatmentAnemias / Cancer treatment / Malignancies1
3CompletedTreatmentAnemias / Multiple Myeloma (MM)1
3CompletedTreatmentAnemias / Myelodysplastic Syndromes1
3CompletedTreatmentAnemias / Neoplasms1
3CompletedTreatmentAnemias / Neoplasms, Breast / Quality of Life1
3CompletedTreatmentAnemias / Thrombosis, Venous1
3CompletedTreatmentAngioplasty, Transluminal, Percutaneous Coronary / Myocardial Infarction1
3CompletedTreatmentCancer, Breast1
3CompletedTreatmentCarcinoma NOS / Prostate1
3CompletedTreatmentChronic Hepatitis C Virus (HCV) Infection2
3CompletedTreatmentChronic Kidney Disease (CKD) / Chronic Renal Failure (CRF)2
3CompletedTreatmentCongestive Heart Failure (CHF) / Renal Insufficiency,Chronic1
3CompletedTreatmentHepatitis C Viral Infection1
3CompletedTreatmentHip Fractures1
3CompletedTreatmentLung Cancers1
3CompletedTreatmentMyelodysplastic Syndromes1
3CompletedTreatmentPredialysis Patients1
3CompletedTreatmentRectal Neoplasms / Stomach Neoplasms1
3CompletedTreatmentRenal Failure1
3CompletedTreatmentTraumatic Brain Injury (TBI)1
3Not Yet RecruitingTreatmentHypoxic-Ischaemic Encephalopathy1
3RecruitingTreatmentCerebral Palsy (CP) / Infants, Premature / Intracranial Hemorrhages / Periventricular Leukomalacia1
3RecruitingTreatmentHypoxic-Ischaemic Encephalopathy1
3RecruitingTreatmentIntraventricular Hemorrhage of Prematurity1
3RecruitingTreatmentMyelodysplastic Syndromes2
3RecruitingTreatmentNeonatal Asphyxia / Neonatal Encephalopathy1
3SuspendedTreatmentSpinal Cord Injuries (SCI)1
3TerminatedTreatmentAnemias5
3TerminatedTreatmentAnemias / Chemotherapy, Adjuvant / Hemoglobins / Neoplasms, Breast / Quality of Life1
3TerminatedTreatmentAnemias / Lung Cancer Non-Small Cell Cancer (NSCLC) / Lung Cancers1
3TerminatedTreatmentAnemias / Malignancies1
3TerminatedTreatmentAnemias / Myelodysplastic Syndromes1
3TerminatedTreatmentAnemias / Neoplasms1
3TerminatedTreatmentChronic Renal Failure (CRF) / Drug Resistance1
3TerminatedTreatmentGastrointestinal Cancers / Rectal Carcinoma1
3TerminatedTreatmentHead and Neck Carcinoma1
3Unknown StatusPreventionAcute Renal Failure (ARF)1
3Unknown StatusPreventionDiabetes Mellitus (DM) / Kidney Insufficiency, Chronic1
3Unknown StatusSupportive CareAnemias / Leukemias / Malignant Lymphomas / Multiple Myeloma and Plasma Cell Neoplasm / Unspecified Adult Solid Tumor, Protocol Specific1
3Unknown StatusTreatmentCervix Cancer1
3WithdrawnTreatmentAnemias / Blood Transfusions / Orthopedic Procedures1
4CompletedNot AvailableAnemias1
4CompletedNot AvailableAnemias / Neoplasms2
4CompletedNot AvailablePure Red Cell Aplasia1
4CompletedBasic ScienceHigh Blood Pressure (Hypertension) / Thrombotic events1
4CompletedDiagnosticAnemias / Chronic Renal Failure (CRF)1
4CompletedPreventionOther and unspecified effects of high altitude1
4CompletedPreventionPatients Receiving a Kidney From a Non-Heart-Beating Donor1
4CompletedSupportive CareAnemias / Cancer, Breast / Tiredness1
4CompletedSupportive CareAnemias / Cervical Cancers1
4CompletedTreatmentAnemias9
4CompletedTreatmentAnemias / Chronic Kidney Disease (CKD)1
4CompletedTreatmentAnemias / Chronic Renal Failure (CRF)1
4CompletedTreatmentAnemias / Erythrocyte Transfusion / Renal Dialysis / Renal Insufficiency,Chronic1
4CompletedTreatmentAnemias / Human Immunodeficiency Virus (HIV) Infections1
4CompletedTreatmentAnemias / Cancer treatment / Malignancies1
4CompletedTreatmentAnemias / Neoplasms2
4CompletedTreatmentAnemias / Renal Anemia, Chronic1
4CompletedTreatmentAnemias / Cancer treatment1
4CompletedTreatmentAntineoplastic Chemotherapy Induced Anemia1
4CompletedTreatmentChronic Hepatitis C Virus (HCV) Infection1
4CompletedTreatmentChronic Renal Failure (CRF)1
4CompletedTreatmentDelayed Graft Function1
4CompletedTreatmentMyelodysplastic Syndromes1
4CompletedTreatmentOsteoarthritis (OA)1
4RecruitingPreventionAnemias / Atherosclerosis / Cardiovascular / CKD1
4RecruitingTreatmentAnemias1
4RecruitingTreatmentAnemias / Hematopoietic Stem Cell Transplantation (HSCT) / Malignant Lymphomas1
4RecruitingTreatmentAutoimmune Encephalitis1
4RecruitingTreatmentMyelodysplastic Syndromes1
4TerminatedPreventionContrast Induced Nephropathy (CIN)1
4TerminatedTreatmentAnemias6
4TerminatedTreatmentAnemias / Hepatitis C Virus (HCV) Infection / Human Immunodeficiency Virus (HIV) Infections / Neutropenias1
4TerminatedTreatmentAnemias / Kidney Diseases1
4TerminatedTreatmentAnemias / Cancer treatment / Malignancies1
4TerminatedTreatmentAnemias / Renal Failure, Chronic Renal Failure1
4TerminatedTreatmentAnemias / Renal Insufficiency,Chronic1
4TerminatedTreatmentSubarachnoid Hemorrhage1
4TerminatedTreatmentMaintenance of surgical hemostasis therapy1
4Unknown StatusPreventionDiabetic Nephropathies1
4Unknown StatusTreatmentAcute Myocardial Infarction (AMI)1
4Unknown StatusTreatmentChronic Hepatitis C Virus (HCV) Infection1
4Unknown StatusTreatmentHeart Failure, Unspecified1
Not AvailableCompletedNot AvailableAnemia, Neoplasms1
Not AvailableCompletedNot AvailableAnemias1
Not AvailableCompletedNot AvailableAnemias / Endometrial Diseases1
Not AvailableCompletedNot AvailableChronic Renal Failure (CRF)1
Not AvailableCompletedBasic ScienceInsulin Sensitivity1
Not AvailableCompletedPreventionMyocardial Ischemic Reperfusion Injury1
Not AvailableCompletedSupportive CareAnemias / Multiple Myeloma (MM) / Multiple Myeloma and Plasma Cell Neoplasm / Plasma Cell Neoplasms1
Not AvailableCompletedSupportive CareMultiple Myeloma (MM)1
Not AvailableCompletedTreatmentAnemias / Infant, Low Birth Weight1
Not AvailableCompletedTreatmentBlood Transfusions1
Not AvailableCompletedTreatmentCardiovascular Disease (CVD) / Disease, Chronic / Kidney Diseases1
Not AvailableCompletedTreatmentCerebral Palsy (CP)1
Not AvailableCompletedTreatmentCrohn's Disease (CD)1
Not AvailableCompletedTreatmentCytopenias / Human Immunodeficiency Virus (HIV) Infections8
Not AvailableCompletedTreatmentDiabetes, Diabetes Mellitus Type 1 / Hypoglycemia1
Not AvailableCompletedTreatmentLeukemias1
Not AvailableNot Yet RecruitingBasic ScienceHealthy Volunteers1
Not AvailableNot Yet RecruitingOtherAnemias / End Stage Renal Disease (ESRD)1
Not AvailableRecruitingNot AvailableAllogenic Transfusion / Hip Arthroplasty / Knee Replacement Surgery / Perioperative Anaemia1
Not AvailableRecruitingNot AvailableTraumatic Brain Injury (TBI)1
Not AvailableRecruitingPreventionAcute Kidney Injury (AKI) / Cardiac Diseases / General Surgery1
Not AvailableRecruitingTreatmentAnemia Renal1
Not AvailableTerminatedTreatmentAnemias1
Not AvailableTerminatedTreatmentIron-Deficiency Anemias1
Not AvailableUnknown StatusNot AvailableAnemias / Chronic Renal Failure (CRF)1
Not AvailableUnknown StatusBasic ScienceIron Metabolism Disorders1
Not AvailableUnknown StatusScreeningRetinopathy of Prematurity1
Not AvailableUnknown StatusSupportive CareAnemias / Unspecified Adult Solid Tumor, Protocol Specific1
Not AvailableWithdrawnSupportive CareTiredness / Unspecified Adult Solid Tumor, Protocol Specific1
Not AvailableWithdrawnTreatmentAnemias1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
  • Amgen Inc.
  • Centocor Ortho Biotech Inc.
  • DSM Corp.
  • Janssen-Ortho Inc.
  • JHP Pharmaceuticals LLC
  • Ortho-McNeil-Janssen Pharmaceuticals Inc.
  • Physicians Total Care Inc.
Dosage forms
FormRouteStrength
Injection, solutionIntravenous; Subcutaneous1000 IU/0.5ml
Injection, solutionIntravenous; Subcutaneous10000 IU/1.0ml
Injection, solutionIntravenous; Subcutaneous2000 IU/1.0ml
Injection, solutionIntravenous; Subcutaneous20000 IU/0.5ml
Injection, solutionIntravenous; Subcutaneous3000 IU/0.3ml
Injection, solutionIntravenous; Subcutaneous30000 IU/0.75ml
Injection, solutionIntravenous; Subcutaneous4000 IU/0.4ml
Injection, solutionIntravenous; Subcutaneous40000 IU/1ml
Injection, solutionIntravenous; Subcutaneous40000 IU/1.0ml
Injection, solutionIntravenous; Subcutaneous5000 IU/0.5ml
Injection, solutionIntravenous; Subcutaneous6000 IU/0.6ml
Injection, solutionIntravenous; Subcutaneous7000 IU/0.7ml
Injection, solutionIntravenous; Subcutaneous8000 IU/0.8ml
Injection, solutionIntravenous; Subcutaneous9000 IU/0.9ml
Injection, solutionIntravenous; Subcutaneous10000 IU/1ml
SolutionIntravenous; Subcutaneous10000 [iU]/1mL
SolutionIntravenous; Subcutaneous2000 [iU]/1mL
SolutionIntravenous; Subcutaneous20000 [iU]/1mL
SolutionIntravenous; Subcutaneous3000 [iU]/1mL
SolutionIntravenous; Subcutaneous4000 [iU]/1mL
SolutionIntravenous; Subcutaneous40000 1/1mL
Injection, solutionIntravenous; Subcutaneous2000 IU/0.5ml
Injection, solutionIntravenous; Subcutaneous20000 IU/1.0ml
Injection, solutionIntravenous; Subcutaneous3000 IU/0.5ml
Injection, solutionIntravenous; Subcutaneous30000 IU/1.0ml
Injection, solutionIntravenous; Subcutaneous4000 IU/0.5ml
SolutionIntravenous; Subcutaneous20000 unit
SolutionIntravenous; Subcutaneous30000 unit
SolutionIntravenous; Subcutaneous10000 unit
SolutionIntravenous; Subcutaneous1000 unit
SolutionIntravenous; Subcutaneous2000 unit
SolutionIntravenous; Subcutaneous3000 unit
SolutionIntravenous; Subcutaneous40000 unit
SolutionIntravenous; Subcutaneous4000 unit
SolutionIntravenous; Subcutaneous5000 unit
SolutionIntravenous; Subcutaneous6000 unit
SolutionIntravenous; Subcutaneous8000 unit
Injection, solutionIntravenous; Subcutaneous10000 [iU]/1mL
Injection, solutionIntravenous; Subcutaneous20000 [iU]/1mL
Injection, solutionIntravenous; Subcutaneous40000 [iU]/1mL
Injection, solutionIntravenous; Subcutaneous2000 [iU]/1mL
Injection, solutionIntravenous; Subcutaneous3000 [iU]/1mL
Injection, solutionIntravenous; Subcutaneous4000 [iU]/1mL
Injection, solutionIntravenous; Subcutaneous1000 IU/0.3ml
Injection, solutionIntravenous; Subcutaneous2000 IU/0.6ml
Injection, solutionIntravenous; Subcutaneous3000 IU/0.9ml
Prices
Unit descriptionCostUnit
Epogen 40000 unit/ml Solution 1 Box Contains Ten 1ml Vials6852.3USD box
Epogen 20000 unit/ml Solution 1 Box Contains Ten 1ml Vials3157.44USD box
Epogen 10000 unit/ml Solution 1 Box Contains Ten 1ml Vials1578.72USD box
Procrit 40000 unit/ml vial767.03USD vial
Procrit 10000 unit/ml vial710.87USD vial
Epogen 40000 unit/ml vial640.37USD ml
Procrit 20000 unit/ml vial388.97USD ml
Procrit 20000 unit/ml Solution378.14USD ml
Procrit 10000 unit/ml Solution 2ml Vial358.02USD vial
Epogen 10000 unit/ml Solution 2ml Vial315.74USD vial
Epogen 20000 unit/ml vial303.6USD ml
Epogen 10000 unit/ml vial151.8USD ml
Procrit 4000 unit/ml vial74.17USD vial
Epogen 4000 unit/ml vial61.34USD vial
Procrit 3000 unit/ml vial55.63USD vial
Epogen 3000 unit/ml vial47.53USD vial
Procrit 2000 unit/ml vial37.09USD vial
Epogen 2000 unit/ml vial34.14USD vial
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
CA1339047No1997-05-272014-05-27Canada

Properties

State
Liquid
Experimental Properties
PropertyValueSource
melting point (°C)53 °CArakawa, T. et al., Biosci. Biotechnol. Biochem. 65:1321-1327 (2001)
isoelectric point8.75Not Available

Taxonomy

Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available

Targets

Kind
Protein
Organism
Human
Pharmacological action
Yes
Actions
Agonist
General Function
Identical protein binding
Specific Function
Receptor for erythropoietin. Mediates erythropoietin-induced erythroblast proliferation and differentiation. Upon EPO stimulation, EPOR dimerizes triggering the JAK2/STAT5 signaling cascade. In som...
Gene Name
EPOR
Uniprot ID
P19235
Uniprot Name
Erythropoietin receptor
Molecular Weight
55064.725 Da
References
  1. LaMontagne KR, Butler J, Marshall DJ, Tullai J, Gechtman Z, Hall C, Meshaw A, Farrell FX: Recombinant epoetins do not stimulate tumor growth in erythropoietin receptor-positive breast carcinoma models. Mol Cancer Ther. 2006 Feb;5(2):347-55. [PubMed:16505108]
  2. Kokhaei P, Abdalla AO, Hansson L, Mikaelsson E, Kubbies M, Haselbeck A, Jernberg-Wiklund H, Mellstedt H, Osterborg A: Expression of erythropoietin receptor and in vitro functional effects of epoetins in B-cell malignancies. Clin Cancer Res. 2007 Jun 15;13(12):3536-44. [PubMed:17575216]
  3. Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [PubMed:11752352]

Drug created on June 13, 2005 07:24 / Updated on November 13, 2018 07:44