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

Stem definitionDrug idCAS RN
granulocyte macrophage colony stimulating factor (GM-CSF) types substances 5025 123774-72-1

Description:

MoleculeDescription

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:

DoseUnitRoute
0.45 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 5, 1991 FDA BERLEX LABS

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
Device related bacteraemia 50.32 27.98 7 1103 82 50603932
Pyrexia 34.76 27.98 42 1068 380161 50223853
Hyperhidrosis 28.55 27.98 20 1090 89406 50514608

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
Device related bacteraemia 59.66 25.90 10 1629 161 29572727
Pyrexia 34.73 25.90 59 1580 287563 29285325
Bone pain 31.89 25.90 17 1622 18435 29554453
Pain 31.77 25.90 43 1596 171389 29401499
Hypotension 30.48 25.90 45 1594 194309 29378579
Chills 27.09 25.90 26 1613 71274 29501614

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
Device related bacteraemia 106.52 27.07 17 2281 318 64496116
Pyrexia 69.90 27.07 92 2206 558552 63937882
Device related infection 45.27 27.07 22 2276 30604 64465830
Hypotension 44.74 27.07 61 2237 380913 64115521
Pain 40.25 27.07 71 2227 553440 63942994
Device occlusion 30.69 27.07 12 2286 9901 64486533
Chills 27.64 27.07 29 2269 137235 64359199

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Granulocyte macrophage colony-stimulating factor receptor Membrane receptor AGONIST Kd 8.30 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

IDSource
5TAA004E22 UNII
D05803 KEGG_DRUG
4019558 VUID
N0000147658 NUI
4019558 VANDF
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
108967001 SNOMEDCT_US
388375003 SNOMEDCT_US
003580 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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