lenograstim 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
granulocyte colony stimulating factor (G-CSF) type substances 5167 135968-09-1

Description:

MoleculeDescription

Synonyms:

  • lenograstim
  • granocyte
  • lenograstim (genetical recombination)
  • neutrogin
A glycosylated form of a recombinant therapeutic agent which is chemically identical to or similar to an endogenous human granulocyte colony-stimulating factor (G-CSF). Produced endogenously by monocytes, fibroblasts, and endothelial cells, G-CSF binds to and activates specific cell surface receptors, stimulating neutrophil progenitor proliferation and differentiation and selected neutrophil functions.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.35 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 1, 1993 UK Medicines and Healthcare Products Regulatory Agency (MHRA) Chugai Pharma UK Ltd
Dec. 1, 1991 PMDA CHUGAI PHARMACEUTICAL CO., LTD.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 278.30 27.85 153 5487 158196 90464611
Neutropenia 174.94 27.85 130 5510 224774 90398033
Thrombocytopenia 128.18 27.85 105 5535 208620 90414187
Febrile bone marrow aplasia 111.76 27.85 36 5604 9702 90613105
Mucosal inflammation 96.26 27.85 54 5586 57571 90565236
Acute lymphocytic leukaemia recurrent 75.64 27.85 20 5620 2701 90620106
Neoplasm recurrence 72.06 27.85 20 5620 3239 90619568
Cystitis radiation 64.78 27.85 10 5630 81 90622726
Basal ganglion degeneration 62.73 27.85 12 5628 370 90622437
Cystitis haemorrhagic 61.69 27.85 20 5620 5493 90617314
Bone marrow failure 61.52 27.85 33 5607 32188 90590619
Bladder tamponade 59.39 27.85 10 5630 146 90622661
Cytomegalovirus infection 58.64 27.85 30 5610 26572 90596235
Tissue infiltration 58.32 27.85 13 5627 857 90621950
Acute graft versus host disease 57.80 27.85 19 5621 5449 90617358
Colony stimulating factor therapy 55.40 27.85 11 5629 413 90622394
Anaesthesia 54.41 27.85 11 5629 453 90622354
Bronchopulmonary aspergillosis 54.31 27.85 22 5618 11376 90611431
Pre-engraftment immune reaction 53.99 27.85 10 5630 258 90622549
Uterine enlargement 52.66 27.85 13 5627 1335 90621472
Inguinal hernia 51.60 27.85 14 5626 2084 90620723
Acute myeloid leukaemia 50.55 27.85 25 5615 20615 90602192
Encephalitis viral 48.31 27.85 13 5627 1876 90620931
Thrombotic microangiopathy 47.47 27.85 22 5618 15721 90607086
Psychogenic seizure 47.47 27.85 13 5627 2003 90620804
Neurotoxicity 46.70 27.85 24 5616 21443 90601364
Acute promyelocytic leukaemia 44.67 27.85 11 5629 1118 90621689
Monocyte count decreased 44.24 27.85 13 5627 2578 90620229
Interstitial lung disease 43.76 27.85 37 5603 76368 90546439
Leukopenia 42.38 27.85 41 5599 100669 90522138
Sepsis 40.77 27.85 53 5587 179761 90443046
Neurological decompensation 40.39 27.85 13 5627 3488 90619319
Monoplegia 39.77 27.85 13 5627 3661 90619146
Klebsiella infection 39.40 27.85 17 5623 10280 90612527
Intervertebral disc disorder 38.42 27.85 14 5626 5446 90617361
Acute myeloid leukaemia recurrent 38.13 27.85 11 5629 2046 90620761
Pancytopenia 38.04 27.85 42 5598 120221 90502586
Hypochromic anaemia 37.54 27.85 11 5629 2160 90620647
Jugular vein occlusion 37.46 27.85 6 5634 63 90622744
Rash maculo-papular 37.00 27.85 26 5614 40907 90581900
Human herpesvirus 6 infection 36.57 27.85 12 5628 3420 90619387
Pyrexia 35.90 27.85 106 5534 660379 89962428
Dysaesthesia 35.22 27.85 13 5627 5242 90617565
Neutropenic infection 34.99 27.85 10 5630 1799 90621008
Anaemia 33.33 27.85 70 5570 352732 90270075
Graft versus host disease 32.98 27.85 14 5626 8130 90614677
Splenomegaly 32.67 27.85 16 5624 12908 90609899
Septic shock 31.22 27.85 32 5608 84128 90538679
Abdominal tenderness 31.16 27.85 14 5626 9310 90613497
Cytokine release syndrome 30.60 27.85 20 5620 27953 90594854
Candida infection 29.31 27.85 21 5619 34036 90588771
Hyperpyrexia 29.06 27.85 11 5629 4750 90618057
Metastases to meninges 27.86 27.85 10 5630 3725 90619082

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 308.39 27.40 235 5836 185468 42429796
Neutropenia 104.77 27.40 135 5936 199296 42415968
Acute graft versus host disease 95.54 27.40 38 6033 8177 42607087
Bone marrow failure 92.53 27.40 58 6013 33035 42582229
Mucosal inflammation 86.86 27.40 65 6006 49309 42565955
Sepsis 86.46 27.40 123 5948 199211 42416053
Pyrexia 70.04 27.40 165 5906 393877 42221387
Product use in unapproved indication 61.74 27.40 101 5970 184355 42430909
Adenovirus infection 57.25 27.40 25 6046 6784 42608480
Cytomegalovirus infection 53.38 27.40 41 6030 32265 42582999
Septic shock 52.61 27.40 65 6006 91607 42523657
Bronchopulmonary aspergillosis 51.64 27.40 33 6038 19396 42595868
Oesophagitis 51.01 27.40 30 6041 15217 42600047
Acute graft versus host disease in intestine 44.96 27.40 18 6053 3933 42611331
Chronic graft versus host disease 43.86 27.40 20 6051 6005 42609259
Cystitis haemorrhagic 43.11 27.40 21 6050 7308 42607956
Thrombocytopenia 43.05 27.40 88 5983 190191 42425073
Cytomegalovirus viraemia 38.92 27.40 22 6049 10355 42604909
Serratia sepsis 38.92 27.40 8 6063 152 42615112
Hepatic candidiasis 38.05 27.40 7 6064 72 42615192
Neutrophil count decreased 36.40 27.40 45 6026 63370 42551894
Pancytopenia 36.00 27.40 62 6009 117681 42497583
Renal hypertension 34.69 27.40 8 6063 264 42615000
Graft versus host disease 34.45 27.40 22 6049 12903 42602361
Acute graft versus host disease in skin 34.10 27.40 18 6053 7406 42607858
Graft versus host disease in skin 33.89 27.40 16 6055 5196 42610068
Febrile infection 32.84 27.40 13 6058 2758 42612506
Mucormycosis 31.91 27.40 17 6054 7126 42608138
Febrile bone marrow aplasia 31.36 27.40 19 6052 10162 42605102
Hepatic necrosis 28.51 27.40 13 6058 3900 42611364
Aspergillus infection 28.14 27.40 21 6050 15816 42599448
Meningitis tuberculous 27.43 27.40 8 6063 671 42614593

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 497.08 23.67 342 11099 316425 110261433
Neutropenia 238.15 23.67 240 11201 374380 110203478
Mucosal inflammation 179.38 23.67 116 11325 96025 110481833
Acute graft versus host disease 177.57 23.67 62 11379 12819 110565039
Bone marrow failure 152.15 23.67 87 11354 57761 110520097
Thrombocytopenia 138.21 23.67 175 11266 348710 110229148
Sepsis 134.11 23.67 167 11274 327179 110250679
Febrile bone marrow aplasia 131.39 23.67 54 11387 17411 110560447
Cytomegalovirus infection 112.21 23.67 70 11371 54374 110523484
Bronchopulmonary aspergillosis 98.00 23.67 52 11389 29811 110548047
Cystitis haemorrhagic 96.10 23.67 39 11402 12170 110565688
Product use in unapproved indication 94.22 23.67 167 11274 447210 110130648
Interstitial lung disease 87.67 23.67 89 11352 139245 110438613
Pyrexia 87.45 23.67 246 11195 898019 109679839
Septic shock 87.28 23.67 94 11347 157434 110420424
Chronic graft versus host disease 84.13 23.67 33 11408 9424 110568434
Pancytopenia 79.46 23.67 103 11338 209510 110368348
Adenovirus infection 79.32 23.67 33 11408 10961 110566897
Colony stimulating factor therapy 77.34 23.67 17 11424 625 110577233
Acute graft versus host disease in intestine 73.33 23.67 26 11415 5613 110572245
Acute myeloid leukaemia 71.03 23.67 46 11395 38064 110539794
Pre-engraftment immune reaction 65.67 23.67 14 11427 445 110577413
Acute graft versus host disease in skin 60.28 23.67 27 11414 10713 110567145
Graft versus host disease 59.59 23.67 32 11409 18774 110559084
Graft versus host disease in skin 56.94 23.67 24 11417 8230 110569628
Cytomegalovirus viraemia 55.65 23.67 30 11411 17734 110560124
Rash maculo-papular 55.23 23.67 52 11389 74170 110503688
Basal ganglion degeneration 55.06 23.67 12 11429 424 110577434
Cytomegalovirus infection reactivation 54.77 23.67 30 11411 18303 110559555
Acute lymphocytic leukaemia recurrent 54.33 23.67 21 11420 5766 110572092
Neoplasm recurrence 52.75 23.67 20 11421 5212 110572646
Encephalitis viral 51.34 23.67 17 11424 2990 110574868
Uterine enlargement 50.14 23.67 13 11428 972 110576886
Tissue infiltration 49.40 23.67 13 11428 1030 110576828
Cystitis radiation 49.29 23.67 10 11431 248 110577610
Neutrophil count decreased 48.25 23.67 61 11380 120880 110456978
Anaesthesia 45.95 23.67 11 11430 593 110577265
Platelet count decreased 45.79 23.67 84 11357 230359 110347499
Human herpesvirus 6 infection 44.94 23.67 19 11422 6562 110571296
Oesophagitis 44.71 23.67 31 11410 28684 110549174
White blood cell count decreased 43.55 23.67 82 11359 229308 110348550
Disseminated intravascular coagulation 42.93 23.67 35 11406 41251 110536607
Leukopenia 41.27 23.67 63 11378 148728 110429130
Venoocclusive liver disease 40.29 23.67 23 11418 15184 110562674
Acute myeloid leukaemia recurrent 39.01 23.67 16 11425 5123 110572735
Psychogenic seizure 38.90 23.67 13 11428 2351 110575507
Bladder tamponade 38.86 23.67 10 11431 726 110577132
Neutropenic infection 38.57 23.67 14 11427 3231 110574627
Hepatic candidiasis 37.30 23.67 7 11434 114 110577744
Serratia sepsis 37.03 23.67 8 11433 271 110577587
Mucormycosis 36.26 23.67 19 11422 10609 110567249
Monocyte count decreased 36.24 23.67 14 11427 3837 110574021
Aspergillus infection 36.05 23.67 26 11415 25590 110552268
Aplasia 35.48 23.67 17 11424 7856 110570002
Thrombotic microangiopathy 35.23 23.67 27 11414 29122 110548736
Meningoencephalitis herpetic 34.78 23.67 12 11429 2390 110575468
Acute promyelocytic leukaemia 33.50 23.67 11 11430 1885 110575973
Myelodysplastic syndrome 33.25 23.67 29 11412 37455 110540403
Jugular vein occlusion 32.62 23.67 6 11435 87 110577771
Neutropenic sepsis 31.83 23.67 26 11415 30720 110547138
Renal hypertension 31.78 23.67 7 11434 260 110577598
Intervertebral disc disorder 31.39 23.67 14 11427 5498 110572360
Inguinal hernia 29.79 23.67 15 11426 7710 110570148
Multiple organ dysfunction syndrome 29.73 23.67 55 11386 151655 110426203
Monoplegia 29.67 23.67 13 11428 4896 110572962
Haematotoxicity 28.76 23.67 21 11420 21061 110556797
Pain 28.71 23.67 34 11407 954921 109622937
Anaemia 28.49 23.67 122 11319 546964 110030894
Neurological decompensation 28.42 23.67 14 11427 6869 110570989
Cytomegalovirus test positive 28.13 23.67 14 11427 7022 110570836
Hypochromic anaemia 27.87 23.67 11 11430 3190 110574668
Graft versus host disease in gastrointestinal tract 27.68 23.67 15 11426 8953 110568905
Pseudomonal sepsis 27.56 23.67 15 11426 9031 110568827
Acute graft versus host disease in liver 27.38 23.67 10 11431 2349 110575509
Enamel anomaly 26.85 23.67 6 11435 238 110577620
Spinal pain 26.52 23.67 19 11422 18496 110559362
Hepatic function abnormal 26.45 23.67 39 11402 89256 110488602
Pneumonia 25.90 23.67 167 11274 876547 109701311
Dysaesthesia 25.54 23.67 13 11428 6834 110571024
Candida infection 25.41 23.67 28 11413 47981 110529877
Meningitis tuberculous 24.96 23.67 8 11433 1270 110576588
Fall 24.74 23.67 16 11425 603466 109974392
Tooth hypoplasia 24.58 23.67 6 11435 351 110577507
Enterobacter sepsis 24.49 23.67 8 11433 1348 110576510
Serratia infection 24.10 23.67 9 11432 2250 110575608
Lymphopenia 24.03 23.67 25 11416 40145 110537713

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L03AA10 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSTIMULANTS
IMMUNOSTIMULANTS
Colony stimulating factors
MeSH PA D000276 Adjuvants, Immunologic
MeSH PA D006401 Hematologic Agents
MeSH PA D007155 Immunologic Factors
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L03AA Colony stimulating factors 6 drugs
efbemalenograstim alfaeflapegrastimfilgrastimlipegfilgrastimpegfilgrastimsargramostim

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Chemotherapy-induced neutropenia indication 425229001
Relapsed acute myeloid leukemia indication 12281000132104
Refractory acute myeloid leukemia indication 12291000132102




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Granulocyte colony-stimulating factor receptor Membrane receptor ACTIVATOR SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

IDSource
6WS4C399GB UNII
D03247 KEGG_DRUG
C0218640 UMLSCUI
CHEBI:754020 CHEBI
CHEMBL2109128 ChEMBL_ID
DB13144 DRUGBANK_ID
D000078224 MESH_DESCRIPTOR_UI
6713 INN_ID
70167 RXNORM
327123007 SNOMEDCT_US
395767008 SNOMEDCT_US
004463 NDDF

Pharmaceutical products:

None