Filgrastim
Biograstim, Granix, Neupogen, Nivestym, Releuko, Zarxio (filgrastim) is a protein pharmaceutical. Filgrastim was first approved as Neupogen on 1991-02-20. It is used to treat neutropenia in the USA. It has been approved in Europe to treat hematopoietic stem cell transplantation, neoplasms, and neutropenia. It is known to target macrophage colony-stimulating factor 1 receptor and granulocyte colony-stimulating factor receptor.
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Commercial
Trade Name
FDA
EMA
Granix, Neupogen, Nivestym, Releuko, Zarxio
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)
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
filgrastim, Neupogen, Amgen Inc. | |||
| 2122-03-30 | Orphan excl. | ||
filgrastim, Granix, UAB Teva Baltics | |||
| 2024-08-29 | Reference product excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1442 | Injection, filgrastim (g-csf), excludes biosimilars, 1 microgram |
| J1447 | Injection, tbo-filgrastim, 1 microgram |
| J2506 | Injection, pegfilgrastim, excludes biosimilar, 0.5 mg |
| Q5101 | Injection, filgrastim-sndz, biosimilar, (zarxio), 1 microgram |
| Q5108 | Injection, pegfilgrastim-jmdb, biosimilar, (fulphila), 0.5 mg |
| Q5110 | Injection, filgrastim-aafi, biosimilar, (nivestym), 1 microgram |
| Q5111 | Injection, pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg |
| Q5120 | Injection, pegfilgrastim-bmez, biosimilar, (ziextenzo), 0.5 mg |
| Q5122 | Injection, pegfilgrastim-apgf, biosimilar, (nyvepria), 0.5 mg |
Clinical
Clinical Trials
1001 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | C85.9 | 36 | 112 | 24 | 1 | 11 | 168 | |
| Leukemia | D007938 | C95 | 39 | 81 | 15 | 3 | 8 | 127 | |
| Myelodysplastic syndromes | D009190 | D46 | 32 | 53 | 14 | 1 | 8 | 88 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 25 | 47 | 14 | 4 | 6 | 83 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 12 | 29 | 7 | 1 | 5 | 46 | |
| Neoplasms | D009369 | C80 | 28 | 14 | 6 | 1 | 1 | 46 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 9 | 26 | 5 | 1 | 7 | 44 | |
| Plasma cell neoplasms | D054219 | 11 | 25 | 5 | 1 | 4 | 43 | ||
| Neutropenia | D009503 | D70 | 6 | 11 | 7 | 1 | 1 | 26 | |
| Graft vs host disease | D006086 | D89.81 | 4 | 5 | 3 | 1 | 5 | 16 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 33 | 40 | 7 | — | 2 | 69 | |
| Multiple myeloma | D009101 | C90.0 | 20 | 45 | 7 | — | 6 | 69 | |
| Sarcoma | D012509 | 13 | 32 | 9 | — | 1 | 51 | ||
| Neuroblastoma | D009447 | EFO_0000621 | 20 | 20 | 9 | — | 2 | 48 | |
| Central nervous system neoplasms | D016543 | 16 | 27 | 4 | — | 1 | 44 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 19 | 26 | 3 | — | 2 | 40 |
| Hodgkin disease | D006689 | C81 | 4 | 17 | 7 | — | 2 | 28 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 6 | 13 | 1 | — | 3 | 20 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 7 | 12 | 2 | — | 3 | 20 | |
| Myeloproliferative disorders | D009196 | D47.1 | 8 | 8 | 1 | — | 5 | 20 |
Show 64 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | C83.1 | 6 | 12 | — | — | 3 | 18 | |
| Myelodysplastic-myeloproliferative diseases | D054437 | 5 | 8 | — | — | 2 | 14 | ||
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 5 | — | — | 3 | 11 |
| Biphenotypic leukemia acute | D015456 | C95.0 | 6 | 7 | — | — | — | 9 | |
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 5 | 6 | — | — | 1 | 9 |
| Fallopian tube neoplasms | D005185 | 5 | 3 | — | — | 1 | 8 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 5 | — | — | 1 | 8 |
| Waldenstrom macroglobulinemia | D008258 | C88.0 | 2 | 4 | — | — | 2 | 7 | |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 4 | — | — | — | 7 |
| B-cell lymphoma marginal zone | D018442 | C88.4 | 2 | 2 | — | — | 3 | 6 |
Show 95 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Astrocytoma | D001254 | EFO_0000271 | 3 | — | — | — | — | 3 | |
| Infertility | D007246 | EFO_0000545 | 1 | — | — | — | 2 | 3 | |
| Squamous cell carcinoma | D002294 | 2 | — | — | — | — | 2 | ||
| Glioma | D005910 | EFO_0000520 | 2 | — | — | — | — | 2 | |
| Oligodendroglioma | D009837 | EFO_0000631 | 2 | — | — | — | — | 2 | |
| Primitive neuroectodermal tumors | D018242 | 2 | — | — | — | — | 2 | ||
| Coronary artery disease | D003324 | I25.1 | 1 | — | — | — | 1 | 2 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | — | — | — | — | 2 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 1 | — | — | — | — | 1 |
| Basal cell carcinoma | D002280 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hairy cell leukemia | D007943 | C91.4 | — | — | — | — | 3 | 3 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 2 | 2 |
| Diamond-blackfan anemia | D029503 | D61.01 | — | — | — | — | 1 | 1 | |
| Hemophagocytic lymphohistiocytosis | D051359 | D76.1 | — | — | — | — | 1 | 1 | |
| Chediak-higashi syndrome | D002609 | Orphanet_167 | D72.0 | — | — | — | — | 1 | 1 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | — | — | — | 1 | 1 |
| Juvenile arthritis | D001171 | EFO_0002609 | M08 | — | — | — | — | 1 | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | — | 1 | 1 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | — | — | — | — | 1 | 1 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FILGRASTIM |
| INN | filgrastim |
| Description | Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It may also be used to increase white blood cells for gathering during leukapheresis. It is given either by injection into a vein or under the skin.
|
| Classification | Protein |
| Drug class | colony-stimulating factors: granulocyte colony-stimulating factors (G-CSF) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 121181-53-1 |
| RxCUI | 68442 |
| ChEMBL ID | CHEMBL1201567 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00099 |
| UNII ID | PVI5M0M1GW (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
CSF1R
CSF1R
CSF3R
CSF3R
Organism
Homo sapiens
Gene name
CSF1R
Gene synonyms
FMS
NCBI Gene ID
Protein name
macrophage colony-stimulating factor 1 receptor
Protein synonyms
CD115, CD115 antigen, CSF-1 receptor, CSF-1-R, CSF-1R, FMS proto-oncogene, M-CSF-R, macrophage colony stimulating factor I receptor, McDonough feline sarcoma viral (v-fms) oncogene homolog, Proto-oncogene c-Fms
Uniprot ID
Mouse ortholog
Csf1r (12978)
macrophage colony-stimulating factor 1 receptor (Q9DBH9)
Variants
Clinical Variant
No data
Financial
Neupogen - Amgen
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,230 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,420 adverse events reported
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