palifermin indications/contra

Stem definitionDrug idCAS RN
fibroblast growth factors 4804 162394-19-6

Description:

MoleculeDescription

Synonyms:

  • QMS40680K6
  • palifermin
  • kepivance
  • 24-163 fibroblast growth factor 7 (human)
  • 24-163-Keratinocyte growth factor (human)
A fibroblast growth factor that is a specific mitogen for EPITHELIAL CELLS. It binds a complex of HEPARAN SULFATE and FIBROBLAST GROWTH FACTOR RECEPTOR 2B.
  • Molecular weight: 16279.90
  • Formula: C724H1147N203O206S9
  • CLOGP:
  • LIPINSKI: None
  • HAC: 409
  • HDO: 234
  • TPSA: 6730.23
  • ALOGS:
  • ROTB: 563

Drug dosage:

DoseUnitRoute
4.20 mg P

Approvals:

DateAgencyCompanyOrphan
Dec. 15, 2004 FDA BIOVITRUM AB

FDA Adverse Event Reporting System

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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
Mucosal inflammation 112.38 51.04 23 171 7960 3377705
Rash 98.31 51.04 32 162 70789 3314876
Tongue disorder 77.68 51.04 13 181 1461 3384204
Erythema 73.79 51.04 21 173 28789 3356876
Face oedema 55.65 51.04 12 182 5172 3380493

Pharmacologic Action:

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SourceCodeDescription
ATC V03AF08 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Detoxifying agents for antineoplastic treatment
FDA Chemical/Ingredient N0000171009 Fibroblast Growth Factor 7
FDA PE N0000175675 Increased Epithelial Proliferation
FDA EPC N0000175671 Mucocutaneous Epithelial Cell Growth Factor

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Mucositis following radiation therapy indication 109257007
Drug-induced mucositis indication 403666006
Prevention of Radiation Therapy-Induced Mucositis indication

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:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Fibroblast growth factor receptor 2 Kinase AGONIST DRUG LABEL DRUG LABEL

External reference:

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IDSource
DB00039 DRUGBANK_ID
6954 IUPHAR_LIGAND_ID
D05338 KEGG_DRUG
4024900 VUID
N0000179582 NUI
C0677829 UMLSCUI
CHEMBL1201821 ChEMBL_ID
QMS40680K6 UNII
8186 INN_ID
D051523 MESH_DESCRIPTOR_UI
196319 RXNORM
416470008 SNOMEDCT_US
417092008 SNOMEDCT_US
416572003 SNOMEDCT_US
417550009 SNOMEDCT_US
19097 MMSL
d05417 MMSL
4024900 VANDF
N0000023082 NDFRT
N0000179582 NDFRT
008779 NDDF

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Kepivance HUMAN PRESCRIPTION DRUG LABEL 1 66658-112 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 6.25 mg INTRAVENOUS BLA 17 sections