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

Stem definition	Drug id	CAS RN
fibroblast growth factors	4804	162394-19-6

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
4.20	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 15, 2004	FDA	BIOVITRUM AB

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

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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
Mucosal inflammation	48.65	45.77	17	322	38605	34917987

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FDA Adverse Event Reporting System (Geriatric)

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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
Mucosal inflammation	82.27	55.67	24	294	75556	79668514

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V03AF08	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment
FDA CS	M0168688	Fibroblast Growth Factor 7
FDA EPC	N0000175671	Mucocutaneous Epithelial Cell Growth Factor
FDA PE	N0000175675	Increased Epithelial Proliferation

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

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

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🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Fibroblast growth factor receptor 2	Kinase	P21802	FGFR2_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
008779	NDDF
19097	MMSL
196319	RXNORM
4024900	VUID
4024900	VANDF
416470008	SNOMEDCT_US
416572003	SNOMEDCT_US
417092008	SNOMEDCT_US
417550009	SNOMEDCT_US
63977	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Kepivance	HUMAN PRESCRIPTION DRUG LABEL	1	66658-112	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	6.25 mg	INTRAVENOUS	BLA	24 sections
Kepivance	HUMAN PRESCRIPTION DRUG LABEL	1	66658-112	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	6.25 mg	INTRAVENOUS	BLA	24 sections
KEPIVANCE	HUMAN PRESCRIPTION DRUG LABEL	1	66658-113	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5.16 mg	INTRAVENOUS	BLA	24 sections

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