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

Stem definition	Drug id	CAS RN
granulocyte macrophage colony stimulating factor (GM-CSF) types substances	5025	123774-72-1

Description:

Molecule

Description

Synonyms:

sargramostim
sargramostim (genetical recombination)
leukine
BI 61.012

a glycosylated form of recombinant GM-CSF; used to treat drug-induced agranulocytosis; amino acid sequence known

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.45	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
March 5, 1991	FDA	BERLEX LABS

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
Device related bacteraemia	48.11	28.68	7	1125	126	56290809
Pyrexia	34.42	28.68	42	1090	418731	55872204
Hyperhidrosis	29.20	28.68	20	1112	94068	56196867

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
Device related bacteraemia	54.66	24.80	10	1674	284	31695376
Pyrexia	36.85	24.80	61	1623	303779	31391881
Pain	31.81	24.80	44	1640	186715	31508945
Bone pain	31.80	24.80	17	1667	19334	31676326
Hypotension	31.60	24.80	46	1638	204572	31491088
Chills	29.07	24.80	27	1657	74123	31621537

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
Device related bacteraemia	101.03	27.37	17	2336	480	70925611
Pyrexia	72.16	27.37	94	2259	606858	70319233
Hypotension	46.83	27.37	62	2291	404319	70521772
Device related infection	45.72	27.37	22	2331	32163	70893928
Pain	38.62	27.37	72	2281	628744	70297347
Device occlusion	30.75	27.37	12	2341	10583	70915508
Chills	29.90	27.37	30	2323	144756	70781335

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L03AA09	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSTIMULANTS IMMUNOSTIMULANTS Colony stimulating factors
FDA CS	M0024695	Granulocyte-Macrophage Colony-Stimulating Factor
FDA CS	M0024696	Granulocyte Colony-Stimulating Factor
FDA PE	N0000009451	Increased Myeloid Cell Production
MeSH PA	D007155	Immunologic Factors
FDA EPC	N0000175666	Leukocyte Growth Factor

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

Disease	Relation	SNOMED_ID	DOID
Chemotherapy-induced neutropenia	indication	425229001

🐶 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 macrophage colony-stimulating factor receptor	Membrane receptor	P15509 P32927	CSF2R_HUMAN IL3RB_HUMAN	AGONIST	Kd	8.30		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE

External reference:

ID	Source
5TAA004E22	UNII
D05803	KEGG_DRUG
4019558	VUID
N0000147658	NUI
C0216231	UMLSCUI
CHEMBL1201670	ChEMBL_ID
DB00020	DRUGBANK_ID
6842	INN_ID
C081222	MESH_SUPPLEMENTAL_RECORD_UI
7905	IUPHAR_LIGAND_ID
203878	RXNORM
1744	MMSL
5443	MMSL
d00513	MMSL
003580	NDDF
108967001	SNOMEDCT_US
388375003	SNOMEDCT_US
4019558	VANDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Leukine	HUMAN PRESCRIPTION DRUG LABEL	1	71837-5843	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 ug	SUBCUTANEOUS	BLA	29 sections
Leukine	HUMAN PRESCRIPTION DRUG LABEL	1	71837-5843	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 ug	SUBCUTANEOUS	BLA	29 sections
Leukine	HUMAN PRESCRIPTION DRUG LABEL	1	71837-5844	INJECTION, SOLUTION	500 ug	SUBCUTANEOUS	BLA	29 sections
Leukine	HUMAN PRESCRIPTION DRUG LABEL	1	71837-5844	INJECTION, SOLUTION	500 ug	SUBCUTANEOUS	BLA	29 sections