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

Stem definition	Drug id	CAS RN
peptides and glycopeptides	5092	83712-60-1

Description:

Molecule	Description
Synonyms: defibrotide defibrotide sodium JZP-381 defibrinotide defitelio	Single-stranded polydeoxyribonucleotide extracted from mammalian organs and used in the treatment of HEPATIC VENO-OCCLUSIVE DISEASE in patients with kidney or lung abnormalities following HEMATOPOIETIC STEM CELL TRANSPLANTATION. The compound is a sodium salt. Molecular weight: Formula: None CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

defibrotide
defibrotide sodium
JZP-381
defibrinotide
defitelio

Single-stranded polydeoxyribonucleotide extracted from mammalian organs and used in the treatment of HEPATIC VENO-OCCLUSIVE DISEASE in patients with kidney or lung abnormalities following HEMATOPOIETIC STEM CELL TRANSPLANTATION. The compound is a sodium salt.

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

Drug dosage:

Dose	Unit	Route
1.75	g	P

ADMET properties:

None

Approvals:

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Date	Agency	Company
June 18, 2019	PMDA	Nippon Shinyaku Co., Ltd.
March 30, 2016	FDA	GENTIUM SRL
Oct. 18, 2013	EMA	Gentium S.r.l.

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FDA Adverse Event Reporting System (Female)

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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
Off label use	157.83	91.19	94	604	674368	62813956
Death	147.56	91.19	74	624	374307	63114017
Multiple organ dysfunction syndrome	128.18	91.19	40	658	56712	63431612

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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
Off label use	203.67	84.22	144	1106	419380	34536301
Multiple organ dysfunction syndrome	154.91	84.22	68	1182	76498	34879183
Death	118.35	84.22	103	1147	397946	34557735
Venoocclusive disease	85.73	84.22	20	1230	2847	34952834

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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
Off label use	445.37	94.41	280	1852	906935	78835321
Venoocclusive disease	427.31	94.41	78	2054	4495	79737761
Multiple organ dysfunction syndrome	291.72	94.41	112	2020	120134	79622122
Death	264.52	94.41	171	1961	566343	79175913
Graft versus host disease	113.13	94.41	33	2099	14993	79727263
Acute graft versus host disease	97.60	94.41	27	2105	10140	79732116

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B01AX01	BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Other antithrombotic agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D005343	Fibrinolytic Agents
MeSH PA	D006401	Hematologic Agents
MeSH PA	D010975	Platelet Aggregation Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Veno-occlusive disease of the liver	indication	65617004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
200MG/2.5ML (80MG/ML)	DEFITELIO	JAZZ PHARMS INC	N208114	March 30, 2016	RX	SOLUTION	INTRAVENOUS	11236328	June 22, 2032	TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM-CELL TRANSPLANTATION (HSCT)

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
200MG/2.5ML (80MG/ML)	DEFITELIO	JAZZ PHARMS INC	N208114	March 30, 2016	RX	SOLUTION	INTRAVENOUS	March 30, 2023	FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH HEPATIC VENO-OCCLUSIVE DISEASE (VOD), ALSO KNOWN AS SINUSOIDAL OBSTRUCTION SYNDROME (SOS), WITH RENAL OR PULMONARY DYSFUNCTION FOLLOWING HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT).

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Bioactivity Summary:

None

External reference:

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ID	Source
010017	NDDF
016771	NDDF
1311089	RXNORM
135565962	PUBCHEM_CID
221104	MMSL
31588	MMSL
4035614	VANDF
4035615	VANDF
441573002	SNOMEDCT_US
442263003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
DEFITELIO	HUMAN PRESCRIPTION DRUG LABEL	1	68727-800	INJECTION, SOLUTION	80 mg	INTRAVENOUS	NDA	25 sections
DEFITELIO	HUMAN PRESCRIPTION DRUG LABEL	1	68727-800	INJECTION, SOLUTION	80 mg	INTRAVENOUS	NDA	25 sections

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