Filgrastim
Highest phase reached
Approved
Drug type
Protein
First approval year
1991
- First approval year
- 1991
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Filgrastim
- accofil
- Accofil
- biograstim
- Biograstim
- filgrastim hexal
- Filgrastim hexal
- filgrastim ratiopharm
- Filgrastim ratiopharm
- gran 300
- Gran 300
- gran injection 150
- Gran injection 150
- granix
- Granix
- grastofil
- Grastofil
- neupogen
- Neupogen
- neupogen 30
- Neupogen 30
- neupogen 48
- Neupogen 48
- nivestim
- Nivestim
- nivestym
And 13 more, listed on the interactive page.
- colony stimulating factor human clone 1034 n l methionyl
- COLONY-STIMULATING FACTOR (HUMAN CLONE 1034), N-L-METHIONYL-
- ep 2006
- EP-2006
- ep2006
- Ep2006
- EP2006
- filgrastim
- Filgrastim
- FILGRASTIM
- Filgrastim (Eurofarma)
- FILGRASTIM (NEUPOGEN)
- FILGRASTIM (R-METHUG-CSF)
- FILGRASTIM [EMA EPAR]
- filgrastim [INN]
- FILGRASTIM [JAN]
- FILGRASTIM [MART.]
- FILGRASTIM [PURPLE BOOK CDER]
- FILGRASTIM [USAN]
- FILGRASTIM [USP MONOGRAPH]
- FILGRASTIM [VANDF]
- Filgrastim [WHO-DD]
- filgrastim aafi
- Filgrastim aafi
- Filgrastim aafi [WHO-DD]
And 123 more, listed on the interactive page.
- ATC classification codes
- L03AA02
Sources for recorded values
- CAS registry numbers
- 121181-53-1
- ChEMBL ID
- CHEMBL1201567
- FDA ingredient codes (UNII)
- PVI5M0M1GW
- 68442
- 2057198
- Applicant
- AMGEN
- Approval date
- 20 Feb 1991
- Application number
- BLA103353
- Status
- Authorised
- Status date
- 15 Sept 2008
- Authorisation date
- 15 Sept 2008
- Approved indications
- Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
- Product number
- EMEA/H/C/000827
- Authorisation holder
- Teva GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- Yes
- Generic medicines
- 0
- Biosimilar medicines
- 7
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Cancer
- Hematopoietic Stem Cell Transplantation
European medicines record
- Patents
- 0
- Designations
- 4
- Earliest recorded loss of exclusivity
- 29 Feb 2024
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- filgrastim
- Type
- Peptide
- Drug name stem
- -stim
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Granulocyte colony stimulating factor receptor agonist
- Action type
- Agonist
- Target
- Granulocyte colony-stimulating factor receptor
- Protein identifier
- Q99062
Open Targets mechanisms
- Mechanism
- Granulocyte colony stimulating factor receptor agonist
- Action type
- Agonist
- Target
- Granulocyte colony-stimulating factor receptor
- Condition
- Hematopoietic Stem Cell Transplantation
- Highest recorded phase
- 4
- Subject identifier
- D018380
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000094
- Subject identifier
- D015456
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Sarcoma, Ewing
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000174
- Subject identifier
- D012512
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000191
- Subject identifier
- D018442
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Neoplasms, Plasma Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000200
- Subject identifier
- D054219
- Condition
- Leukemia, Biphenotypic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000209
- Subject identifier
- D015456
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000211
- Subject identifier
- D016411
- Condition
- Leukemia, Erythroblastic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000218
- Subject identifier
- D004915
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Monocytic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000221
- Subject identifier
- D007948
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Leukemia, Myelomonocytic, Acute
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000223
- Subject identifier
- D015479
- Condition
- Leukemia, Promyelocytic, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000224
- Subject identifier
- D015473
- Condition
- Pheochromocytoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000239
- Subject identifier
- D010673
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Glioma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000326
- Subject identifier
- D005910
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
And 158 more, listed on the interactive page.
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000198
- Condition identifier
- EFO_0000200
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000211
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000222
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000384
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000407
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000544
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 4
- Condition identifier
- EFO_0000545
- Condition identifier
- EFO_0000565
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000621
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000712
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001065
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Highest recorded phase
- 3
And 273 more, listed on the interactive page.
- Event
- acute myeloid leukaemia
- Reports
- 62
- Reporting signal score
- 97.333
- Event
- aortitis
- Reports
- 28
- Reporting signal score
- 95.3846
- Event
- application site bruise
- Reports
- 204
- Reporting signal score
- 693.756
- Event
- application site discomfort
- Reports
- 274
- Reporting signal score
- 896.75
- Event
- application site haemorrhage
- Reports
- 1,049
- Reporting signal score
- 3,705.05
- Event
- application site pain
- Reports
- 792
- Reporting signal score
- 1,774.71
- Event
- bone pain
- Reports
- 1,761
- Reporting signal score
- 2,767.47
- Event
- device adhesion issue
- Reports
- 5,341
- Reporting signal score
- 19,860.9
- Event
- device electrical finding
- Reports
- 168
- Reporting signal score
- 606.663
- Event
- device physical property issue
- Reports
- 596
- Reporting signal score
- 1,800.67
- Event
- device power source issue
- Reports
- 333
- Reporting signal score
- 1,117.3
- Event
- device use error
- Reports
- 4,867
- Reporting signal score
- 16,314.6
- Event
- disease recurrence
- Reports
- 114
- Reporting signal score
- 152.446
- Event
- febrile neutropenia
- Reports
- 2,326
- Reporting signal score
- 3,293.91
- Event
- heart rate abnormal
- Reports
- 43
- Reporting signal score
- 97.6987
- Event
- immune reconstitution inflammatory syndrome
- Reports
- 62
- Reporting signal score
- 114.545
- Event
- leukopenia
- Reports
- 138
- Reporting signal score
- 98.9335
- Event
- mucosal inflammation
- Reports
- 135
- Reporting signal score
- 166.433
- Event
- neutropenia
- Reports
- 1,733
- Reporting signal score
- 920.845
- Event
- neutrophil count decreased
- Reports
- 161
- Reporting signal score
- 184.025
- Event
- occupational exposure to product
- Reports
- 756
- Reporting signal score
- 1,939.97
- Event
- pancytopenia
- Reports
- 161
- Reporting signal score
- 139.174
- Event
- pyrexia
- Reports
- 629
- Reporting signal score
- 424.276
- Event
- splenomegaly
- Reports
- 72
- Reporting signal score
- 117.386
- Event
- staphylococcal bacteraemia
- Reports
- 103
- Reporting signal score
- 298.696
And 6 more, listed on the interactive page.
- NCT00000899
- NCT00002126
- NCT00002255
- NCT00001335
- NCT00002634
- NCT00002740
- NCT00003093
- NCT00003119
- NCT00003141
- NCT00003203
- NCT00003846
- NCT00003926
- NCT00004188
- NCT00005835
- NCT00005978
- NCT00017225
- NCT00017368
- NCT00024193
- NCT00025649
- NCT00030719
- NCT00040872
- NCT00053950
- NCT00070200
- NCT00075634
- NCT00083135
And 815 more, listed on the interactive page.
- Dose
- 5 mcg/kg
- Route
- Subcutaneous
- How often
- Once daily
Conditions of use
- Administer for at least 4 days before leukapheresis and until last leukapheresis
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- MTPLGPASSLPQSFLLKCLEQVRKIQGDGAALQEKLCATYKLCHPEELVLLGHSLGIPWAPLSSCPSQALQLAGCLSQLHSGLFLYQGLLQALEGISPELGPTLDTLQLDVADFATTIWQQMEELGMAPALQPTQGAMPAFASAFQRRAGGVLVASHLQSFLEVSYRVLRHLAQP
- 0069-0291
- 0069-0292
- 0069-0293
- 0069-0294
- 55513-209
- 55513-530
- 55513-546
- 55513-924
- 61314-318
- 61314-326
- 63459-910
- 63459-912
- 63459-918
- 63459-920
- 69097-429
- 69097-430
- 69448-008
- 69448-009
- 72374-101
- 72374-102
- 70121-1568
- 70121-1569
- 70121-1570
- 70121-1571
Related records
Trials (934)
- 131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
- 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
- 2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
- A Dose Finding Study of CycloSam® Combined With External Beam Radiotherapy
- A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
- A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)
- A Phase I - II Safety Study of Filgrastim (Neupogen) to Improve Left Ventricular Function After Severe Acute Myocardial Infarction
- A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients
- A Phase II Study of Dose Density Regimen With Fluorouracil, Epirubicin and Cyclophosphamide at Days 1, 4 Every 14 Days With Filgrastim Support Followed by Weekly Paclitaxel in Women With Primary Breast Cancer.
- A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
- A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor
- A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma
- A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.
- A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies
- A Randomized, Controlled, Multicenter Trial of Filgrastim (Recombinant-Methionyl Human Granulocyte Colony Stimulating Factor; G-CSF) for the Prevention of Grade 4 Neutropenia in Patients With HIV Infection.
- A Randomized, Multicenter Pragmatic Trial Comparing Bone Pain From a Single Dose of Pegfilgrastim to 5 Doses of Daily Filgrastim in Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy
- A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
- A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions
- A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
- A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
Approved for (3)
- Cancer
- Neoplasm
- Neutropenia
In development for (173)
- Acute basophilic leukemia Phase 3
- Acute erythroid leukemia Phase 3
- Acute leukemia of ambiguous lineage Phase 3
- Acute lymphoblastic leukemia Phase 3
- Acute megakaryoblastic leukemia Phase 3
- Acute monocytic leukemia Phase 3
- Acute myeloblastic leukemia without maturation Phase 3
- Acute myeloid leukemia Phase 3
- Acute myelomonocytic leukemia M4 Phase 3
- Acute myocardial infarction Phase 3
- Acute promyelocytic leukemia Phase 1
- Adrenal cortex carcinoma Phase 3
- Adrenal gland pheochromocytoma Phase 3
- Adult T-cell leukemia/lymphoma Phase 3
- AL amyloidosis Phase 3
- Alcoholic hepatitis Phase 3
- Alzheimer disease Phase 1
- Amyotrophic lateral sclerosis Phase 2
- Anaplastic ependymoma Phase 3
- Anaplastic large cell lymphoma Phase 2
Other linked conditions (1)
- Glycogen storage disease II
Targets (1)
- CSF3R Granulocyte colony stimulating factor receptor agonist