lenograstim 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
granulocyte colony stimulating factor (G-CSF) type substances	5167	135968-09-1

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.35	mg	P

ADMET properties:

None

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	269.26	27.29	150	5165	118299	63365408
Neutropenia	174.14	27.29	132	5183	174873	63308834
Thrombocytopenia	105.77	27.29	93	5222	151064	63332643
Mucosal inflammation	105.06	27.29	59	5256	46869	63436838
Pre-engraftment immune reaction	71.29	27.29	13	5302	225	63483482
Tissue infiltration	69.85	27.29	15	5300	614	63483093
Basal ganglion degeneration	68.97	27.29	14	5301	434	63483273
Encephalitis viral	68.96	27.29	18	5297	1714	63481993
Febrile bone marrow aplasia	68.37	27.29	25	5290	7300	63476407
Cystitis radiation	63.10	27.29	10	5305	70	63483637
Bladder tamponade	62.98	27.29	10	5305	71	63483636
Cystitis haemorrhagic	61.57	27.29	20	5295	4103	63479604
Uterine enlargement	59.39	27.29	15	5300	1253	63482454
Inguinal hernia	57.09	27.29	16	5299	1991	63481716
Acute graft versus host disease	56.20	27.29	19	5296	4409	63479298
Human herpesvirus 6 infection	55.17	27.29	17	5298	2940	63480767
Acute lymphocytic leukaemia recurrent	55.15	27.29	16	5299	2253	63481454
Cytomegalovirus infection	54.18	27.29	29	5286	20923	63462784
Neoplasm recurrence	52.77	27.29	16	5299	2622	63481085
Anaesthesia	51.87	27.29	11	5304	424	63483283
Psychogenic seizure	50.47	27.29	14	5301	1678	63482029
Bone marrow failure	47.65	27.29	30	5285	29260	63454447
Neurological decompensation	44.33	27.29	14	5301	2624	63481083
Product use in unapproved indication	44.11	27.29	64	5251	179016	63304691
Bronchopulmonary aspergillosis	43.86	27.29	19	5296	8616	63475091
Colony stimulating factor therapy	43.19	27.29	9	5306	318	63483389
Monocyte count decreased	42.82	27.29	13	5302	2140	63481567
Pyrexia	41.80	27.29	109	5206	470369	63013338
Monoplegia	41.67	27.29	14	5301	3187	63480520
Klebsiella infection	40.76	27.29	18	5297	8548	63475159
Hypochromic anaemia	39.79	27.29	12	5303	1930	63481777
Acute myeloid leukaemia	39.53	27.29	22	5293	17125	63466582
Acute myeloid leukaemia recurrent	37.48	27.29	11	5304	1612	63482095
Dysaesthesia	37.08	27.29	14	5301	4464	63479243
Neurotoxicity	37.00	27.29	21	5294	16969	63466738
Pancytopenia	36.93	27.29	43	5272	96890	63386817
Splenomegaly	36.22	27.29	18	5297	11139	63472568
Intervertebral disc disorder	36.01	27.29	14	5301	4829	63478878
Meningoencephalitis herpetic	35.92	27.29	10	5305	1214	63482493
Rash maculo-papular	35.90	27.29	26	5289	31870	63451837
Leukopenia	35.84	27.29	38	5277	77252	63406455
Neutropenic infection	34.83	27.29	10	5305	1357	63482350
Candida infection	33.95	27.29	24	5291	28327	63455380
Interstitial lung disease	33.35	27.29	33	5282	61875	63421832
Hyperpyrexia	32.42	27.29	12	5303	3620	63480087
Sepsis	32.38	27.29	51	5264	153072	63330635
Abdominal tenderness	32.03	27.29	15	5300	8151	63475556
Graft versus host disease	31.49	27.29	14	5301	6749	63476958
Renal cyst	28.72	27.29	15	5300	10287	63473420
Metastases to meninges	28.49	27.29	10	5305	2592	63481115
Bacterial sepsis	27.87	27.29	11	5304	3947	63479760

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	299.16	26.07	211	5184	136638	34814898
Neutropenia	117.24	26.07	132	5263	156646	34794890
Mucosal inflammation	103.85	26.07	68	5327	38554	34912982
Bone marrow failure	97.43	26.07	59	5336	29194	34922342
Product use in unapproved indication	94.71	26.07	103	5292	117396	34834140
Acute graft versus host disease	93.99	26.07	36	5359	6467	34945069
Sepsis	73.36	26.07	108	5287	166453	34785083
Pyrexia	56.56	26.07	144	5251	332869	34618667
Cytomegalovirus infection	55.92	26.07	40	5355	26095	34925441
Oesophagitis	52.67	26.07	30	5365	13231	34938305
Septic shock	50.94	26.07	59	5336	71775	34879761
Thrombocytopenia	47.83	26.07	86	5309	156161	34795375
Cytomegalovirus viraemia	44.18	26.07	22	5373	7408	34944128
Cystitis haemorrhagic	43.46	26.07	20	5375	5659	34945877
Hepatic candidiasis	39.41	26.07	7	5388	53	34951483
Neutrophil count decreased	37.93	26.07	43	5352	51061	34900475
Graft versus host disease in skin	37.01	26.07	16	5379	3909	34947627
Adenovirus infection	35.56	26.07	17	5378	5240	34946296
Chronic graft versus host disease	35.35	26.07	16	5379	4357	34947179
Febrile infection	34.68	26.07	13	5382	2198	34949338
Febrile bone marrow aplasia	33.75	26.07	19	5376	8190	34943346
Pancytopenia	32.46	26.07	55	5340	95102	34856434
Colony stimulating factor therapy	31.82	26.07	7	5388	171	34951365
Meningitis tuberculous	31.11	26.07	9	5386	676	34950860
Acute graft versus host disease in intestine	28.72	26.07	12	5383	2696	34948840
Hepatic necrosis	27.90	26.07	13	5382	3781	34947755
Acute graft versus host disease in skin	26.84	26.07	14	5381	5187	34946349
Interstitial lung disease	26.71	26.07	41	5354	65241	34886295

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	466.23	21.97	318	10059	230681	79503330
Neutropenia	243.46	21.97	239	10138	287471	79446540
Mucosal inflammation	198.18	21.97	123	10254	75457	79658554
Acute graft versus host disease	170.36	21.97	60	10317	10107	79723904
Product use in unapproved indication	151.07	21.97	174	10203	250185	79483826
Bone marrow failure	138.52	21.97	85	10292	51022	79682989
Thrombocytopenia	130.06	21.97	166	10211	265093	79468918
Cytomegalovirus infection	108.14	21.97	68	10309	42576	79691435
Sepsis	100.82	21.97	148	10229	269280	79464731
Febrile bone marrow aplasia	97.84	21.97	43	10334	12977	79721034
Cystitis haemorrhagic	94.76	21.97	38	10339	9134	79724877
Pre-engraftment immune reaction	90.16	21.97	18	10359	323	79733688
Encephalitis viral	78.84	21.97	24	10353	2555	79731456
Interstitial lung disease	77.57	21.97	84	10293	112516	79621495
Pyrexia	74.64	21.97	225	10152	678484	79055527
Chronic graft versus host disease	73.20	21.97	29	10348	6752	79727259
Colony stimulating factor therapy	71.41	21.97	16	10361	508	79733503
Pancytopenia	70.68	21.97	97	10280	165648	79568363
Septic shock	69.94	21.97	83	10294	122718	79611293
Human herpesvirus 6 infection	68.76	21.97	26	10351	5344	79728667
Graft versus host disease in skin	58.74	21.97	24	10353	6049	79727962
Cytomegalovirus viraemia	58.39	21.97	30	10347	12791	79721220
Acute graft versus host disease in intestine	53.31	21.97	20	10357	4021	79729990
Basal ganglion degeneration	51.99	21.97	12	10365	436	79733575
Tissue infiltration	51.76	21.97	13	10364	678	79733333
Acute myeloid leukaemia	51.44	21.97	38	10339	30847	79703164
Adenovirus infection	51.13	21.97	24	10353	8423	79725588
Cytomegalovirus infection reactivation	50.41	21.97	24	10353	8692	79725319
Acute graft versus host disease in skin	50.22	21.97	23	10354	7635	79726376
Cystitis radiation	49.59	21.97	10	10367	189	79733822
Uterine enlargement	48.24	21.97	13	10364	895	79733116
Bronchopulmonary aspergillosis	47.76	21.97	32	10345	22262	79711749
Acute myeloid leukaemia recurrent	45.57	21.97	17	10360	3366	79730645
Neutrophil count decreased	44.62	21.97	58	10319	93901	79640110
Bladder tamponade	43.66	21.97	11	10366	581	79733430
Leukopenia	43.44	21.97	64	10313	116449	79617562
Graft versus host disease	43.26	21.97	26	10351	15000	79719011
Oesophagitis	42.98	21.97	31	10346	24258	79709753
Rash maculo-papular	42.42	21.97	44	10333	56034	79677977
Meningoencephalitis herpetic	42.14	21.97	14	10363	1975	79732036
Aplasia	40.60	21.97	20	10357	7800	79726211
Acute lymphocytic leukaemia recurrent	40.06	21.97	17	10360	4707	79729304
Anaesthesia	39.90	21.97	10	10367	517	79733494
Neutropenic infection	39.41	21.97	14	10363	2413	79731598
Psychogenic seizure	38.56	21.97	13	10364	1918	79732093
Neoplasm recurrence	38.53	21.97	16	10361	4198	79729813
Hepatic candidiasis	38.08	21.97	7	10370	79	79733932
Platelet count decreased	36.33	21.97	79	10298	194585	79539426
Monocyte count decreased	32.15	21.97	13	10364	3188	79730823
Disseminated intravascular coagulation	30.53	21.97	30	10347	35812	79698199
Haematotoxicity	30.21	21.97	21	10356	15498	79718513
Monoplegia	29.45	21.97	13	10364	3958	79730053
Graft versus host disease in gastrointestinal tract	29.31	21.97	15	10362	6341	79727670
Inguinal hernia	29.01	21.97	15	10362	6473	79727538
Neurological decompensation	28.97	21.97	14	10363	5239	79728772
White blood cell count decreased	28.09	21.97	70	10307	188218	79545793
Venoocclusive liver disease	27.90	21.97	18	10359	11753	79722258
Meningitis tuberculous	27.61	21.97	9	10368	1196	79732815
Neutropenic sepsis	27.54	21.97	25	10352	27039	79706972
Cytomegalovirus test positive	27.32	21.97	14	10363	5933	79728078
Candida infection	27.14	21.97	29	10348	38185	79695826
Acute graft versus host disease in liver	27.07	21.97	10	10367	1925	79732086
Intervertebral disc disorder	27.03	21.97	13	10364	4812	79729199
Myelodysplastic syndrome	27.01	21.97	26	10351	30275	79703736
Bacterial sepsis	25.73	21.97	15	10362	8183	79725828
Fall	25.52	21.97	16	10361	487613	79246398
Lung disorder	25.45	21.97	41	10336	80516	79653495
Mucormycosis	25.27	21.97	15	10362	8454	79725557
Pain	25.07	21.97	33	10344	703769	79030242
Dysaesthesia	24.66	21.97	13	10364	5835	79728176
Venoocclusive disease	24.65	21.97	12	10365	4561	79729450
Pseudomonal sepsis	24	21.97	13	10364	6161	79727850
Fusarium infection	23.92	21.97	9	10368	1823	79732188
Hypochromic anaemia	23.66	21.97	10	10367	2741	79731270
Spinal pain	23.54	21.97	18	10359	15374	79718637
Progressive multifocal leukoencephalopathy	22.89	21.97	20	10357	20580	79713431
Pneumonia	22.61	21.97	155	10222	660091	79073920
Hypoalbuminaemia	22.31	21.97	20	10357	21277	79712734
Tumour lysis syndrome	22.20	21.97	21	10356	23918	79710093

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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

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

Disease	Relation	SNOMED_ID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Granulocyte colony-stimulating factor receptor	Membrane receptor	Q99062	CSF3R_HUMAN	ACTIVATOR				SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
6WS4C399GB	UNII
D03247	KEGG_DRUG
C0218640	UMLSCUI
CHEMBL2109128	ChEMBL_ID
DB13144	DRUGBANK_ID
D000078224	MESH_DESCRIPTOR_UI
6713	INN_ID
70167	RXNORM
004463	NDDF
327123007	SNOMEDCT_US
395767008	SNOMEDCT_US

Pharmaceutical products:

None