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Identification
NameFilgrastim
Accession NumberDB00099  (BTD00072, BIOD00072)
TypeBiotech
GroupsApproved
DescriptionFilgrastim is a recombinant, non-pegylated human granulocyte colony stimulating factor (G-CSF) analogue manufactured by recombinant DNA technology using a strain of E. coli. It is marketed as the brand name Neupogen by Amgen. Chemically, it consists of 175 amino acid residues. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine necessary for expression in E coli. Tbo-filgrastim, which is marketed by Sicor Biotech and FDA approved on August 29, 2012, contains the same active ingredient as Neupogen and is biologically similar, but it is formulated to be short-acting. On March 6, 2015, the FDA approved the biosimilar Zarxio (filgrastim-sndz) and is indicated for use in the same conditions as Neupogen. Zarxio is marketed by Sandoz.
Protein structureDb00099
Related Articles
Protein chemical formulaC845H1343N223O243S9
Protein average weight18800.0 Da
Sequences
>Amino acid sequence for filgrastim
MTPLGPASSLPQSFLLKCLEQVRKIQGDGAALQEKLCATYKLCHPEELVLLGHSLGIPWA
PLSSCPSQALQLAGCLSQLHSGLFLYQGLLQALEGISPELGPTLDTLQLDVADFATTIWQ
QMEELGMAPALQPTQGAMPAFASAFQRRAGGVLVASHLQSFLEVSYRVLRHLAQP
Download FASTA Format
Synonyms
G-CSF
Granulocyte Colony Stimulating Factor
Tbo-filgrastim
External Identifiers Not Available
Approved Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
AccofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousAccord Healthcare Limited2014-09-18Not applicableEu
BiograstimInjection, solution30 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution48 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution48 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution30 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution30 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution48 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution30 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution48 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution48 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
BiograstimInjection, solution30 MIUIntravenous; SubcutaneousAb Z Pharma Gmb H2008-09-15Not applicableEu
GranixInjection, solution480 ug/.8mLSubcutaneousCephalon2013-11-11Not applicableUs
GranixInjection, solution300 ug/.5mLSubcutaneousCephalon2013-11-11Not applicableUs
GrastofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousApotex Europe Bv2013-10-18Not applicableEu
GrastofilSolution300 mcgIntravenous; SubcutaneousApotex Corporation2016-03-17Not applicableCanada
GrastofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousApotex Europe Bv2013-10-18Not applicableEu
GrastofilSolution480 mcgIntravenous; SubcutaneousApotex Corporation2016-11-28Not applicableCanada
GrastofilInjection, solution30 MU/0.5mlIntravenous; SubcutaneousApotex Europe Bv2013-10-18Not applicableEu
GrastofilInjection, solution48 MU/0.5mlIntravenous; SubcutaneousApotex Europe Bv2013-10-18Not applicableEu
NeupogenInjection, solution480 ug/1.6mLIntravenous; SubcutaneousAmgen1997-04-07Not applicableUs
NeupogenSolution600 mcgIntravenous; SubcutaneousAmgen2016-02-02Not applicableCanada
NeupogenInjection, solution300 ug/mLIntravenousPhysicians Total Care, Inc.1994-06-08Not applicableUs
NeupogenInjection, solution300 ug/.5mLIntravenous; SubcutaneousAmgen2000-10-02Not applicableUs
NeupogenInjection, solution480 ug/.8mLIntravenousPhysicians Total Care, Inc.2006-08-14Not applicableUs
NeupogenInjection, solution480 ug/.8mLIntravenous; SubcutaneousAmgen2000-10-02Not applicableUs
NeupogenSolution300 mcgIntravenous; SubcutaneousAmgen1992-12-31Not applicableCanada
NeupogenInjection, solution300 ug/.5mLIntravenousPhysicians Total Care, Inc.2004-03-11Not applicableUs
NeupogenInjection, solution300 ug/mLIntravenous; SubcutaneousAmgen1997-05-19Not applicableUs
NeupogenSolution600 mcgIntravenous; SubcutaneousAmgen2016-01-28Not applicableCanada
NivestimInjection, solution12 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution48 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution30 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution12 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution12 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution30 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution12 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution30 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution48 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution30 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution48 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
NivestimInjection, solution48 MUIntravenous; SubcutaneousHospira, Inc.2010-06-08Not applicableEu
RatiograstimInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
RatiograstimInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Approved Generic Prescription ProductsNot Available
Approved Over the Counter ProductsNot Available
Unapproved/Other Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Filgrastim RatiopharmInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution48 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
Filgrastim RatiopharmInjection, solution30 MIUIntravenous; SubcutaneousRatiopharm Inc2008-09-15Not applicableEu
International Brands
NameCompany
BiocilinNot Available
BiofigranNot Available
BiofilgranNot Available
EndufilNot Available
FilatilNot Available
FilgenNot Available
GranNot Available
GranulokineNot Available
GrimatinNot Available
InmunefNot Available
JiexinNot Available
LeucogenNot Available
LeucostimNot Available
MacroleucoNot Available
NeukineNot Available
NeutromaxNot Available
Neutroval Sicor Biotech
NivestimNot Available
RecombicyteNot Available
SciLocyteNot Available
TevagastrimNot Available
White-C Not Available
ZarzioNot Available
Brand mixturesNot Available
SaltsNot Available
Categories
UNIIPVI5M0M1GW
CAS number121181-53-1
Pharmacology
IndicationFilgrastim is used in patients with acute myeloid leukemia receiving induction or consolidation chemotherapy. It is also used in cancer patients receiving bone marrow transplant. In general, filgrastim increases neutrophil counts in order to decrease the risk of infection or duration of neutropenia in the aforementioned patient populations. Infection and neutropenia are adverse events associated with chemotherapy. Furthermore, filgrastim is also indicated for patients with severe chronic neutropenia. It mobilizes hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis to allow for a more rapid engraftment. Tbo-filgrastim has a narrower indication profile than Neupogen - it is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies.
Structured Indications
Clinical Trials
PhaseStatusPurposeConditionsCount
0Active Not RecruitingTreatmentAutologous Transplant / Malignant Lymphoma, Stem Cell Type1
0Active Not RecruitingTreatmentPrecursor Cell Lymphoblastic Leukemia-Lymphoma1
0Active Not RecruitingTreatmentStem Cell Transplant Patients1
0CompletedTreatmentPeripheral Vascular Disease (PVD)1
0RecruitingTreatmentMultiple Myeloma (MM) / Myeloma-Multiple1
0TerminatedTreatmentMultiple Myeloma (MM)1
1Active Not RecruitingNot AvailableHealthy Volunteers1
1Active Not RecruitingTreatmentAcute Myelogenous Leukaemia (AML) / Leukemias1
1Active Not RecruitingTreatmentCongenital Hypoplastic Anemia1
1Active Not RecruitingTreatmentLeukemias / Myelodysplastic Syndrome1
1Active Not RecruitingTreatmentMetastatic Cancers / Pancreatic Cancer Metastatic1
1Active Not RecruitingTreatmentMyelodysplastic Syndromes1
1Active Not RecruitingTreatmentMyelomas1
1Active Not RecruitingTreatmentStroke, Ischemic1
1Active Not RecruitingTreatmentSystemic Lupus Erythematosus (SLE)1
1CompletedNot AvailableHealthy Volunteers1
1CompletedTreatmentAdult Acute Megakaryoblastic Leukemia (M7) / Adult Acute Minimally Differentiated Myeloid Leukemia (M0) / Adult Acute Monoblastic Leukemia (M5a) / Adult Acute Monocytic Leukemia (M5b) / Adult Acute Myeloblastic Leukemia With Maturation (M2) / Adult Acute Myeloblastic Leukemia Without Maturation (M1) / Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities / Adult Acute Myeloid Leukemia With Del(5q) / Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) / Adult Acute Myeloid Leukemia With T(15;17)(q22;q12) / Adult Acute Myeloid Leukemia With T(16;16)(p13;q22) / Adult Acute Myeloid Leukemia With T(8;21)(q22;q22) / Adult Acute Myelomonocytic Leukemia (M4) / Adult Acute Promyelocytic Leukemia (M3) / Adult Erythroleukemia (M6a) / Adult Pure Erythroid Leukemia (M6b) / Recurrent Adult Acute Myeloid Leukemia / Untreated Adult Acute Myeloid Leukemia1
1CompletedTreatmentAdvanced Cancers1
1CompletedTreatmentCancer, Breast1
1CompletedTreatmentHealthy Male Subjects1
1CompletedTreatmentHematopoietic Stem Cell Transplantation (HSCT)1
1CompletedTreatmentInfection, Human Immunodeficiency Virus2
1CompletedTreatmentLeukemia, Myeloid, Acute1
1CompletedTreatmentLeukemias / Myelodysplastic Syndrome1
1CompletedTreatmentLiver Cirrhosis1
1CompletedTreatmentLymphoma NOS1
1CompletedTreatmentMiscellaneous Peripheral Blood Cell Abnormalities1
1CompletedTreatmentMultiple Sclerosis (MS)2
1CompletedTreatmentNeuroblastomas1
1CompletedTreatmentNeutropenias / Unspecified Adult Solid Tumor, Protocol Specific1
1CompletedTreatmentSevere Combined Immunodeficiency1
1Not Yet RecruitingTreatmentHealthy Subjects1
1Not Yet RecruitingTreatmentInfertilities1
1Not Yet RecruitingTreatmentLeukemias1
1RecruitingNot AvailableBlood Component Removal / Blood Donors / Granulocyte Colony-Stimulation Factor / Leukocyte Transfusion1
1RecruitingTreatmentAcute Myeloid Leukaemias (AML)1
1RecruitingTreatmentEnd Stage Liver Diseases1
1RecruitingTreatmentLeukemias / Lymphoma NOS / MDS / Myelofibrosis1
1RecruitingTreatmentMultiple Myeloma (MM)2
1RecruitingTreatmentMultiple Myeloma, Refractory to Standard Treatment / Multiple Myeloma, Relapsed1
1TerminatedSupportive CareBrain and Central Nervous System Tumors / Cancer, Ovarian / Childhood Germ Cell Tumor / Chordomas / Kidney Cancer / Liver Cancer / Neuroblastomas / Retinoblastoma / Sarcomas1
1TerminatedTreatmentCancer, Breast / Lymphoma NOS1
1WithdrawnTreatmentLeukemias / Lymphoma NOS / Pediatric Disorders / Transplantation, Stem Cell1
1WithdrawnTreatmentLung Cancer, Non-Small Cell1
1, 2Active Not RecruitingTreatmentLeukemia, Myeloid, Acute1
1, 2Active Not RecruitingTreatmentMetastatic Cancers / Pancreatic Cancer Metastatic1
1, 2CompletedSupportive CareAcute Lymphoblastic Leukaemias (ALL) / Acute Myeloid Leukaemias (AML) / Chronic Myeloid Leukemia (CML) / Myelodysplasia1
1, 2CompletedTreatmentAcute Lymphocytic Leukemia (ALL) / Leukemias1
1, 2CompletedTreatmentAcute Myocardial Infarction (AMI)1
1, 2CompletedTreatmentCancer, Breast1
1, 2CompletedTreatmentCongenital Hypoplastic Anemia1
1, 2CompletedTreatmentHodgkins Disease (HD) / Non-Hodgkin's Lymphoma (NHL)1
1, 2CompletedTreatmentLeukemias / Transplantation, Stem Cell1
1, 2CompletedTreatmentLymphoma NOS1
1, 2CompletedTreatmentPain / Prostate Cancers1
1, 2RecruitingTreatmentCentral Nervous System Embryonal Tumor / Germ Cell Tumors1
1, 2RecruitingTreatmentCongenital Hypoplastic Anemia1
1, 2RecruitingTreatmentLeukemias3
1, 2RecruitingTreatmentLeukemias / Lymphoma NOS2
1, 2RecruitingTreatmentLeukemias / Myelomas / Myeloproliferative Diseases1
1, 2RecruitingTreatmentLeukemias / Myeloproliferative Diseases1
1, 2RecruitingTreatmentLymphoma NOS1
1, 2RecruitingTreatmentMultiple Myeloma (MM)1
1, 2RecruitingTreatmentMyelomas2
1, 2RecruitingTreatmentNon-Hodgkin's Lymphoma (NHL)1
1, 2RecruitingTreatmentProstate Cancers1
1, 2TerminatedTreatmentLeukemia, Plasma Cell / Multiple Myeloma (MM)1
1, 2TerminatedTreatmentLeukemias1
1, 2TerminatedTreatmentRelapsed T-Cell Acute Lymphoblastic Leukemia / Relapsed T-Cell Lymphoblastic Lymphoma1
1, 2WithdrawnTreatmentDiffuse, Large B-cell Lymphoma / Large-Cell Lymphoma, Diffuse / Lymphoma, Diffuse Large-Cell / Lymphoma, Diffuse Large-Cell B-cell1
2Active Not RecruitingPreventionCancer, Ovarian / Endometrial Cancers / Uterine Cervical Cancer1
2Active Not RecruitingTreatmentAcute Lymphocytic Leukemia (ALL) / Acute Myeloid Leukaemias (AML) / Chronic Lymphocytic Leukaemia (CLL) / Chronic Myeloid Leukemia (CML) / Leukemias / Lymphoma, Hodgkins / Multiple Myeloma (MM) / Myelodysplastic Syndrome / Myeloproliferative Diseases / Non-Hodgkin's Lymphoma (NHL)1
2Active Not RecruitingTreatmentAcute Myeloid Leukaemias (AML) / Myelodysplastic Syndrome1
2Active Not RecruitingTreatmentBlood And Marrow Transplantation1
2Active Not RecruitingTreatmentBlood Stem Cell Transplant Failure / Leukemias / Malignancies, Hematologic1
2Active Not RecruitingTreatmentChronic Lymphocytic Leukaemia (CLL)1
2Active Not RecruitingTreatmentChronic Lymphocytic Leukaemia (CLL) / Diffuse, Large B-Cell, Lymphoma / Lymphoma, Hodgkins / Lymphoma, Low-Grade / Lymphoma, Mantle-Cell / Small Lymphocytic Lymphoma (SLL) / T-Cell Lymphomas1
2Active Not RecruitingTreatmentHemoglobinuria, Paroxysmal Nocturnal (PNH) / Juvenile Myelomonocytic Leukemia (JMML) / Leukemia, Acute Lymphocytic (ALL) / Leukemia, Myeloid, Acute(AML) / Leukemia, Myeloid, Chronic(CML) / Lymphoma, Hodgkins / Lymphoma, Non-Hodgkin (NHL) / Myelodysplastic Syndromes (MDS)1
2Active Not RecruitingTreatmentHodgkins Disease (HD)1
2Active Not RecruitingTreatmentLeukemias / Lymphoma NOS1
2Active Not RecruitingTreatmentLeukemias / Lymphoma NOS / Transplantation, Stem Cell1
2Active Not RecruitingTreatmentLymphoma NOS3
2Active Not RecruitingTreatmentMultiple Myeloma (MM)2
2Active Not RecruitingTreatmentMyelomas1
2Active Not RecruitingTreatmentNon-Hodgkin's Lymphoma (NHL)1
2Active Not RecruitingTreatmentParkinson's Disease (PD)1
2Active Not RecruitingTreatmentTransplantation, Kidney1
2CompletedNot AvailableAcute Myocardial Infarction (AMI)1
2CompletedPreventionNeutropenias / Sarcomas1
2CompletedTreatmentAcute Lymphoblastic Leukaemias (ALL) / Leukemias1
2CompletedTreatmentAmyotrophic Lateral Sclerosis (ALS)1
2CompletedTreatmentAnemia, Hemolytic, Autoimmune / Autoimmune Diseases / Felty's Syndrome / Thrombocytopenic Purpura1
2CompletedTreatmentBurkitt's Lymphoma / Burkitt'S-like Lymphoma1
2CompletedTreatmentCancer, Breast / Metastatic Breast Cancer (MBC)1
2CompletedTreatmentChronic Myelogenous Leukemia (CML) / Leukemias1
2CompletedTreatmentCongenital Hypoplastic Anemia / Dyskeratosis Congenita / Shwachman Syndrome / Thrombocytopenias1
2CompletedTreatmentCytopenias / Infection, Human Immunodeficiency Virus1
2CompletedTreatmentHematological Neoplasms / Tumors1
2CompletedTreatmentHematology / Lymphoma NOS / Lymphoma, Hodgkins / Non-Hodgkin's Lymphoma (NHL) / Oncology1
2CompletedTreatmentHodgkins Disease (HD) / Infection, Human Immunodeficiency Virus1
2CompletedTreatmentInfection, Human Immunodeficiency Virus / Kaposi s Sarcoma (KS)1
2CompletedTreatmentInfection, Human Immunodeficiency Virus / Non-Hodgkin's Lymphoma (NHL)1
2CompletedTreatmentInfection, Human Immunodeficiency Virus / Progressive Multifocal Leukoencephalopathy1
2CompletedTreatmentLeukemias3
2CompletedTreatmentLymphoma NOS3
2CompletedTreatmentLymphoma NOS / Mantle Cell Lymphoma (MCL)1
2CompletedTreatmentLymphoma, B-Cell1
2CompletedTreatmentMetastatic Breast Cancer (MBC)1
2CompletedTreatmentMetastatic Renal Cell Carcinoma / Renal Cell Carcinoma With Sarcomatoid Features1
2CompletedTreatmentMultiple Myeloma (MM)1
2CompletedTreatmentMultiple Myeloma (MM) / Refractory Multiple Myeloma / Stage I Multiple Myeloma / Stage II Multiple Myeloma / Stage III Multiple Myeloma1
2CompletedTreatmentMyelodysplastic Syndrome1
2CompletedTreatmentMyeloid Leukemias1
2CompletedTreatmentNeoplasms, Breast1
2CompletedTreatmentNon-Hodgkin's Lymphoma (NHL)2
2CompletedTreatmentPemphigus1
2CompletedTreatmentSarcomas2
2CompletedTreatmentStroke, Ischemic1
2Not Yet RecruitingPreventionCancer, Breast / Febrile Neutropenia / Neutropenias1
2Not Yet RecruitingTreatmentFibrolamellar Hepatocellular Carcinoma / Hepatocellular Carcinoma (Fibrolamellar Variant) / Hepatocellular Carcinomas1
2Not Yet RecruitingTreatmentMalignant Lymphoma, Stem Cell Type1
2Not Yet RecruitingTreatmentSevere Aplastic Anemia (SAA)1
2RecruitingTreatmentAcute Biphenotypic Leukemia (ABL) / Acute Lymphoblastic Leukemia (ALL)/T Lymphoblastic Lymphoma / Acute Myelogenous Leukaemia (AML) / Acute Undifferentiated Leukemia (AUL) / Chemotherapy-sensitive Lymphoma / Chronic Lymphocytic Leukaemia (CLL) / Myelodysplastic Syndromes (MDS)1
2RecruitingTreatmentAcute Myelogenous Leukaemia (AML)1
2RecruitingTreatmentAcute Myelogenous Leukaemia (AML) / Congenital Hypoplastic Anemia / Myelodysplastic Syndromes (MDS) / Severe Marrow Failure1
2RecruitingTreatmentAcute Myeloid Leukaemias (AML)1
2RecruitingTreatmentAcute Myeloid Leukaemias (AML) / Myelodysplastic Syndrome1
2RecruitingTreatmentBladder Cancers1
2RecruitingTreatmentDiffuse Large B Cell Lymphoma (DLBCL)1
2RecruitingTreatmentHHV-8 / HIV Disease / Lymphoproliferative Disorders / Malignancies1
2RecruitingTreatmentHead and Neck Cancers1
2RecruitingTreatmentHematopoietic Stem Cells / Lymphoma NOS / Multiple Myeloma (MM) / Transplantation, Bone Marrow1
2RecruitingTreatmentKidney Cancer / Leukemias / Lymphoma NOS / Multiple Myeloma (MM) / Myelodysplastic Syndromes / Plasma Cell Neoplasms1
2RecruitingTreatmentLeukemias5
2RecruitingTreatmentLeukemias / Lymphoma NOS / Multiple Myleoma / Myelodysplastic Syndrome / Myeloproliferative Disorders1
2RecruitingTreatmentMultiple Myeloma (MM)2
2RecruitingTreatmentMultiple Myeloma (MM) / Non-Hodgkin's Lymphoma (NHL)2
2RecruitingTreatmentMultiple Myeloma (MM) / Plasma Cell Myeloma1
2RecruitingTreatmentRetinoblastoma1
2RecruitingTreatmentRhabdomyosarcomas1
2RecruitingTreatmentStage II Childhood Hodgkin Lymphoma / Stage III Childhood Hodgkin Lymphoma / Stage IV Childhood Hodgkin Lymphoma1
2RecruitingTreatmentTumors, Solid1
2TerminatedDiagnosticLymphoma NOS1
2TerminatedTreatmentBrain and Central Nervous System Tumors / Drug/Agent Toxicity by Tissue/Organ / Lymphoma NOS / Thrombocytopenias1
2TerminatedTreatmentCrohn's Disease (CD)1
2TerminatedTreatmentLeukemias2
2TerminatedTreatmentLeukemias / Lymphoma NOS / Myelomas / Myeloproliferative Diseases1
2TerminatedTreatmentMalignant Lymphomas1
2TerminatedTreatmentMultiple Myeloma and Plasma Cell Neoplasm1
2TerminatedTreatmentRelapsed Acute Myelogenous Leukemia1
2TerminatedTreatmentT-Cell Non-Hodgkin Lymphoma1
2WithdrawnTreatmentLeukemias1
2WithdrawnTreatmentLymphoma NOS1
2WithdrawnTreatmentRecurrent Adult Soft Tissue Sarcoma / Stage IIB Adult Soft Tissue Sarcoma / Stage IIC Adult Soft Tissue Sarcoma / Stage III Adult Soft Tissue Sarcoma / Stage IVA Adult Soft Tissue Sarcoma1
2WithdrawnTreatmentTumors, Solid1
2, 3Active Not RecruitingTreatment(X-linked Adrenoleukodystrophy Cerebral Childhood) / Childhood Cerebral Adrenoleukodystrophy1
2, 3CompletedTreatmentAcute Respiratory Failure / Critically Ill1
2, 3CompletedTreatmentAmyotrophic Lateral Sclerosis (ALS)1
2, 3RecruitingSupportive CareLeukemia, Myeloid, Acute1
2, 3RecruitingTreatmentMature B-Cell Lymphoma1
2, 3RecruitingTreatmentMyocardial Infarction (MI)1
2, 3TerminatedTreatmentFollicular Lymphoma (FL) / Recurrent Grade 1 Follicular Lymphoma / Recurrent Grade 2 Follicular Lymphoma / Recurrent Grade 3 Follicular Lymphoma1
2, 3TerminatedTreatmentMetastatic Breast Cancer (MBC)1
3Active Not RecruitingPreventionG-CSF, Multiple Myeloma, Febrile Episode, Filgrastim, Leograstim1
3Active Not RecruitingTreatmentCancer, Breast / Cyclophosphamide / Doxorubicin / High Risk / Positive Nodes1
3Active Not RecruitingTreatmentLarge B Cell Lymphoma1
3Active Not RecruitingTreatmentMultiple Myeloma (MM)1
3CompletedPreventionNeutropenia in Breast Cancer1
3CompletedPreventionNeutropenia in Prematures1
3CompletedSupportive CareCancer, Breast / Chemotherapy Associated Neutropenia1
3CompletedTreatmentAML1
3CompletedTreatmentCancer, Breast1
3CompletedTreatmentHodgkins Disease (HD)1
3CompletedTreatmentInfection NOS / Neutropenias1
3CompletedTreatmentMultiple Myeloma (MM)1
3CompletedTreatmentNon-Hodgkin's Lymphoma (NHL)1
3Not Yet RecruitingNot AvailableMyelodysplastic Syndrome1
3RecruitingNot AvailableHealthy1
3RecruitingTreatmentAL Amyloidosis1
3RecruitingTreatmentAnterior Acute Myocardial Infarction / Left Ventricular Systolic Dysfunction1
3RecruitingTreatmentGraft Versus Host Disease (GVHD)1
3RecruitingTreatmentLiver Cirrhosis1
3RecruitingTreatmentMultiple Myeloma (MM)2
3RecruitingTreatmentMyelomas1
3RecruitingTreatmentNeuroblastomas1
3RecruitingTreatmentRepeated Embryo Implantation Failure1
3TerminatedTreatmentBladder Cancers1
4Active Not RecruitingTreatmentMultiple Myeloma (MM) / Non-Hodgkin's Lymphoma (NHL)1
4CompletedDiagnosticDiabetes Mellitus (DM)1
4CompletedPreventionMycoses1
4CompletedTreatmentMyocardial Infarction (MI)1
4CompletedTreatmentNon-Hodgkin's Lymphoma (NHL)1
4TerminatedTreatmentLeukemias1
4WithdrawnTreatmentLower Limb Ischemia1
Not AvailableActive Not RecruitingTreatmentAnemia, Hemolytic, Autoimmune / Arthritis, Juvenile Rheumatoid / Autoimmune Thrombocytopenic Purpura / Churg-Strauss Syndrome (CSS) / Giant Cell Arteritis / Graft Versus Host Disease (GVHD) / Polyarteritis Nodosa / Pure Red Cell Aplasia / Purpura, Schoenlein-Henoch / Rheumatoid Arthritis (RA) / Systemic Lupus Erythematosus (SLE) / Takayasu's Arteritis / Vasculitis, Hypersensitivity / Wegener Granulomatosis (WG)1
Not AvailableActive Not RecruitingTreatmentAplastic Anaemia (AA) / Paroxysmal Hemoglobinuria, Nocturnal1
Not AvailableActive Not RecruitingTreatmentChediak-Higashi Syndrome / Familial Erythrophagocytic Lymphohistiocytosis / Graft Versus Host Disease (GVHD) / Lymphohistiocytosis, Hemophagocytic / Virus-Associated Hemophagocytic Syndrome / X-Linked Lymphoproliferative Syndrome1
Not AvailableCompletedNot AvailableNormal PBPC Donors1
Not AvailableCompletedTreatmentAntiphospholipid Antibody Syndrome / Systemic Lupus Erythematosus (SLE)1
Not AvailableCompletedTreatmentCoronary Artery Disease1
Not AvailableCompletedTreatmentCytopenias / Infection, Human Immunodeficiency Virus1
Not AvailableCompletedTreatmentHematologic Diseases / Malignancies, Hematologic1
Not AvailableCompletedTreatmentInfection, Human Immunodeficiency Virus1
Not AvailableNot Yet RecruitingTreatmentAcute-On-Chronic Liver Failure1
Not AvailableRecruitingBasic ScienceHead and Neck Cancers / Malignant Melanoma1
Not AvailableRecruitingTreatmentAcute on Chronic Liver Failure1
Not AvailableRecruitingTreatmentAdult Acute Megakaryoblastic Leukemia (M7) / Adult Acute Minimally Differentiated Myeloid Leukemia (M0) / Adult Acute Monoblastic Leukemia (M5a) / Adult Acute Monocytic Leukemia (M5b) / Adult Acute Myeloblastic Leukemia With Maturation (M2) / Adult Acute Myeloblastic Leukemia Without Maturation (M1) / Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities / Adult Acute Myeloid Leukemia With Del(5q) / Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) / Adult Acute Myeloid Leukemia With T(16;16)(p13;q22) / Adult Acute Myeloid Leukemia With T(8;21)(q22;q22) / Adult Acute Myelomonocytic Leukemia (M4) / Adult Erythroleukemia (M6a) / Adult Pure Erythroid Leukemia (M6b) / Recurrent Adult Acute Myeloid Leukemia / Untreated Adult Acute Myeloid Leukemia1
Not AvailableRecruitingTreatmentDiffuse Large B Cell Lymphoma (DLBCL) / Post Transplant Lymphoproliferative Disorder / Primary Mediastinal (Thymic) Large B-cell Lymphoma1
Not AvailableRecruitingTreatmentLiver Failure, Acute1
Not AvailableRecruitingTreatmentLymphoma, Hodgkins1
Not AvailableRecruitingTreatmentMF / Myelofibrosis1
Not AvailableRecruitingTreatmentRetinoblastoma1
Not AvailableTerminatedTreatmentChronic Myeloproliferative Disorders / Congenital Hypoplastic Anemia / Graft Versus Host Disease (GVHD) / Leukemias / Lymphoma NOS / Multiple Myeloma and Plasma Cell Neoplasm / Myelodysplastic Syndromes / Myelodysplastic/Myeloproliferative Diseases1
Not AvailableTerminatedTreatmentGraft Versus Host Disease (GVHD)1
Not AvailableTerminatedTreatmentMalignancies, Hematologic1
Not AvailableTerminatedTreatmentNon Hodgkin Lymphoma (NHL)1
Not AvailableWithdrawnTreatmentInfection, Human Immunodeficiency Virus1
PharmacodynamicsUsed in the treatment of chemotherapy-induced neutropenia by enhancing the production of neutrophils. Filgrastim acts on hematopoietic cells by binding to specific cell surface receptors thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. When tbo-filgrastim is administered to cancer patients, it took 3-5 days to reach maximum absolute neutrophil count (ANC). Levels of neutrophils returned to baseline by 21 days following completion of chemotherapy. In the healthy volunteer trials, doubling the tbo-filgrastim subcutaneous dose from 5 to 10 mcg/kg resulted in a 16-19% increase in the ANCmax and a 33-36% increase in the area under the effect curve for ANC.
Mechanism of actionFilgrastim binds to the G-CSF receptor and stimulates the production of neutrophils in the bone marrow. As a G-CSF analog, it controls proliferation of committed progenitor cells and influences their maturation into mature neutrophils. Filgrastim also stimulates the release of neutrophils from bone marrow storage pools and reduces their maturation time. Filgrastim acts to increase the phagocytic activity of mature neutrophils. In patients receiving cytotoxic chemotherapy, Filgrastim can accelerate neutrophil recovery, leading to a reduction in duration of the neutropenic phase
TargetKindPharmacological actionActionsOrganismUniProt ID
Granulocyte colony-stimulating factor receptorProteinyes
stimulator
HumanQ99062 details
Neutrophil elastaseProteinunknown
other/unknown
HumanP08246 details
Related Articles
AbsorptionAbsorption and clearance of Neupogen follows first-order pharmacokinetic modeling without apparent concentration dependence. When 3.45 mcg/kg and 11.5 mcg/kg of Neupogen is subcutaneously administered, the maximum serum concentration is 4 and 49 ng/mL‚ respectively‚ within 2 to 8 hours. Neupogen does not accumulate. It is estimated that when filgrastim is subcutaneously administered, the absolute bioavailability is approximately 62% and 71% for 375 mcg and 750 mcg doses respectively. When 5 mcg/kg tbo-filgrastim is subcutaneously administered, the absolute bioavailability is 33%. It takes 4-6 hours for tho-filgrastim to reach maximum concentration. Like Neupogen, accumulation was not observed.
Volume of distribution

Vd, healthy subjects and cancer patients = 150 mL/kg

Protein bindingNot Available
MetabolismNot Available
Route of eliminationFilgrastim is primarily eliminated by the kidney and neutrophils/neutrophil precursors; the latter presumably involves binding of the growth factor to the G-CSF receptor on the cell surface, internalization of the growth factor-receptor complexes via endocytosis, and subsequent degradation inside the cells.
Half lifeElimination half-life, healthy subjects and cancer patients, Neopogen = 3.5 hours; Elimination half-life, cancer patients, tbo-filgrastim = 3.2-3.8 hours
Clearance

0.5 – 0.7 mL/minute/kg (SC administration of 3.45 mcg/kg and 11.5 mcg/kg in both normal subjects and cancer patients, Neupogen)

ToxicityNot Available
Affected organisms
  • Humans and other mammals
PathwaysNot Available
SNP Mediated EffectsNot Available
SNP Mediated Adverse Drug ReactionsNot Available
Interactions
Drug Interactions
DrugInteractionDrug group
BleomycinThe risk or severity of adverse effects can be increased when Filgrastim is combined with Bleomycin.Approved
CyclophosphamideThe risk or severity of adverse effects can be increased when Filgrastim is combined with Cyclophosphamide.Approved, Investigational
TopotecanThe risk or severity of adverse effects can be increased when Filgrastim is combined with Topotecan.Approved, Investigational
Food InteractionsNot Available
References
Synthesis Reference

Tetsuro Kuga, Hiromasa Miyaji, Moriyuki Sato, Masami Okabe, Makoto Morimoto, Seiga Itoh, Motoo Yamasaki, Yoshiharu Yokoo, Kazuo Yamaguchi, Hajime Yoshida, Yoshinori Komatsu, “Method of producing a polypeptide having human granulocyte colony stimulating factor activity.” U.S. Patent US5994518, issued February, 1988.

US5994518
General References
  1. Wang B, Ludden TM, Cheung EN, Schwab GG, Roskos LK: Population pharmacokinetic-pharmacodynamic modeling of filgrastim (r-metHuG-CSF) in healthy volunteers. J Pharmacokinet Pharmacodyn. 2001 Aug;28(4):321-42. [PubMed:11677930 ]
External Links
ATC CodesL03AA02
AHFS Codes
  • 20:16.00
PDB Entries
FDA labelDownload (769 KB)
MSDSDownload (125 KB)
Pharmacoeconomics
ManufacturersNot Available
Packagers
Dosage forms
FormRouteStrength
Injection, solutionIntravenous; Subcutaneous30 MU/0.5ml
Injection, solutionIntravenous; Subcutaneous48 MU/0.5ml
Injection, solutionIntravenous; Subcutaneous30 MIU
Injection, solutionIntravenous; Subcutaneous48 MIU
Injection, solutionSubcutaneous300 ug/.5mL
Injection, solutionSubcutaneous480 ug/.8mL
SolutionIntravenous; Subcutaneous480 mcg
Injection, solutionIntravenous300 ug/mL
Injection, solutionIntravenous300 ug/.5mL
Injection, solutionIntravenous480 ug/.8mL
Injection, solutionIntravenous; Subcutaneous300 ug/.5mL
Injection, solutionIntravenous; Subcutaneous300 ug/mL
Injection, solutionIntravenous; Subcutaneous480 ug/.8mL
Injection, solutionIntravenous; Subcutaneous480 ug/1.6mL
SolutionIntravenous; Subcutaneous300 mcg
SolutionIntravenous; Subcutaneous600 mcg
Injection, solutionIntravenous; Subcutaneous12 MU
Injection, solutionIntravenous; Subcutaneous30 MU
Injection, solutionIntravenous; Subcutaneous48 MU
Prices
Unit descriptionCostUnit
Neupogen 480 mcg/0.8ml Solution 1 Box Contains Ten 0.8ml Syringes4998.24USD box
Neupogen 480 mcg/1.6ml Solution 1 Box Contains Ten 1.6ml Syringes4554.58USD box
Neupogen 300 mcg/0.5ml Solution 1 Box Contains Ten 0.5ml Syringes3138.1USD box
Neupogen 480 mcg/1.6 ml vial437.94USD ml
Neupogen 300 mcg/ml vial286.04USD vial
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
CA1339071 No1997-07-292014-07-29Canada
CA1341537 No2007-07-312024-07-31Canada
Properties
StateLiquid
Experimental Properties
PropertyValueSource
melting point60 °CLuo, P., Protein Science 11:1218-1226 (2002)
hydrophobicity0.209Not Available
isoelectric point5.65Not Available
Taxonomy
DescriptionNot Available
KingdomOrganic Compounds
Super ClassOrganic Acids
ClassCarboxylic Acids and Derivatives
Sub ClassAmino Acids, Peptides, and Analogues
Direct ParentPeptides
Alternative ParentsNot Available
SubstituentsNot Available
Molecular FrameworkNot Available
External DescriptorsNot Available

Targets

Kind
Protein
Organism
Human
Pharmacological action
yes
Actions
stimulator
General Function:
Receptor activity
Specific Function:
Receptor for granulocyte colony-stimulating factor (CSF3), essential for granulocytic maturation. Plays a crucial role in the proliferation, differientation and survival of cells along the neutrophilic lineage. In addition it may function in some adhesion or recognition events at the cell surface.
Gene Name:
CSF3R
Uniprot ID:
Q99062
Molecular Weight:
92155.615 Da
References
  1. Erkeland SJ, Aarts LH, Irandoust M, Roovers O, Klomp A, Valkhof M, Gits J, Eyckerman S, Tavernier J, Touw IP: Novel role of WD40 and SOCS box protein-2 in steady-state distribution of granulocyte colony-stimulating factor receptor and G-CSF-controlled proliferation and differentiation signaling. Oncogene. 2007 Mar 29;26(14):1985-94. Epub 2006 Sep 25. [PubMed:17001306 ]
  2. Link DC, Kunter G, Kasai Y, Zhao Y, Miner T, McLellan MD, Ries RE, Kapur D, Nagarajan R, Dale DC, Bolyard AA, Boxer LA, Welte K, Zeidler C, Donadieu J, Bellanne-Chantelot C, Vardiman JW, Caligiuri MA, Bloomfield CD, DiPersio JF, Tomasson MH, Graubert TA, Westervelt P, Watson M, Shannon W, Baty J, Mardis ER, Wilson RK, Ley TJ: Distinct patterns of mutations occurring in de novo AML versus AML arising in the setting of severe congenital neutropenia. Blood. 2007 Sep 1;110(5):1648-55. Epub 2007 May 9. [PubMed:17494858 ]
  3. Cao YR, Shao ZH, Liu H, Shi J, Bai J, Tu MF, Wang HQ, Xing LM, Cui ZZ, Sun J, Jia HR, Yang TY: [The response of bone marrow hematopoietic cells to G-CSF in paroxysmal nocturnal hemoglobinuria patients]. Zhonghua Xue Ye Xue Za Zhi. 2005 Apr;26(4):235-8. [PubMed:15949269 ]
  4. Ward AC: The role of the granulocyte colony-stimulating factor receptor (G-CSF-R) in disease. Front Biosci. 2007 Jan 1;12:608-18. [PubMed:17127322 ]
  5. Zhuang D, Qiu Y, Haque SJ, Dong F: Tyrosine 729 of the G-CSF receptor controls the duration of receptor signaling: involvement of SOCS3 and SOCS1. J Leukoc Biol. 2005 Oct;78(4):1008-15. Epub 2005 Jul 20. [PubMed:16033816 ]
Kind
Protein
Organism
Human
Pharmacological action
unknown
Actions
other/unknown
General Function:
Serine-type endopeptidase activity
Specific Function:
Modifies the functions of natural killer cells, monocytes and granulocytes. Inhibits C5a-dependent neutrophil enzyme release and chemotaxis.
Gene Name:
ELANE
Uniprot ID:
P08246
Molecular Weight:
28517.81 Da
References
  1. Carter CR, Whitmore KM, Thorpe R: The significance of carbohydrates on G-CSF: differential sensitivity of G-CSFs to human neutrophil elastase degradation. J Leukoc Biol. 2004 Mar;75(3):515-22. Epub 2003 Dec 4. [PubMed:14657210 ]
  2. Jian MY, Koizumi T, Tsushima K, Fujimoto K, Kubo K: Effects of granulocyte colony-stimulating factor (G-CSF) and neutrophil elastase inhibitor (ONO-5046) on acid-induced lung injury in rats. Inflammation. 2004 Dec;28(6):327-36. [PubMed:16245075 ]
  3. Donini M, Fontana S, Savoldi G, Vermi W, Tassone L, Gentili F, Zenaro E, Ferrari D, Notarangelo LD, Porta F, Facchetti F, Notarangelo LD, Dusi S, Badolato R: G-CSF treatment of severe congenital neutropenia reverses neutropenia but does not correct the underlying functional deficiency of the neutrophil in defending against microorganisms. Blood. 2007 Jun 1;109(11):4716-23. Epub 2007 Feb 20. [PubMed:17311988 ]
  4. Schepers H, Wierenga AT, van Gosliga D, Eggen BJ, Vellenga E, Schuringa JJ: Reintroduction of C/EBPalpha in leukemic CD34+ stem/progenitor cells impairs self-renewal and partially restores myelopoiesis. Blood. 2007 Aug 15;110(4):1317-25. Epub 2007 May 2. [PubMed:17475913 ]
  5. Druhan LJ, Ai J, Massullo P, Kindwall-Keller T, Ranalli MA, Avalos BR: Novel mechanism of G-CSF refractoriness in patients with severe congenital neutropenia. Blood. 2005 Jan 15;105(2):584-91. Epub 2004 Sep 7. [PubMed:15353486 ]
  6. El Ouriaghli F, Fujiwara H, Melenhorst JJ, Sconocchia G, Hensel N, Barrett AJ: Neutrophil elastase enzymatically antagonizes the in vitro action of G-CSF: implications for the regulation of granulopoiesis. Blood. 2003 Mar 1;101(5):1752-8. Epub 2002 Oct 17. [PubMed:12393522 ]
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Drug created on June 13, 2005 07:24 / Updated on August 17, 2016 12:23