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

Stem definition	Drug id	CAS RN
	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:

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

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
Venoocclusive liver disease	184.06	105.39	33	569	4388	56287077
Off label use	141.41	105.39	81	521	556099	55735366
Death	135.07	105.39	67	535	341359	55950106
Multiple organ dysfunction syndrome	115.23	105.39	36	566	52734	56238731

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
Venoocclusive liver disease	333.91	92.41	71	981	7341	31688951
Venoocclusive disease	174.91	92.41	35	1017	2637	31693655
Off label use	166.39	92.41	115	937	347159	31349133
Multiple organ dysfunction syndrome	137.20	92.41	59	993	68144	31628148
Death	128.11	92.41	100	952	360469	31335823

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
Venoocclusive liver disease	533.80	94.25	106	1635	10572	70916131
Venoocclusive disease	323.13	94.25	60	1681	4140	70922563
Off label use	277.47	94.25	188	1553	742872	70183831
Death	271.94	94.25	162	1579	509899	70416804
Multiple organ dysfunction syndrome	271.68	94.25	101	1640	108414	70818289
Interstitial lung disease	95.69	94.25	48	1693	104637	70822066

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

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)

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)

Orange Book exclusivity data (new drug applications)

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).

Bioactivity Summary:

None

External reference:

ID	Source
D07423	KEGG_DRUG
C0057257	UMLSCUI
CHEMBL2108396	ChEMBL_ID
135565962	PUBCHEM_CID
DB04932	DRUGBANK_ID
CHEMBL3707226	ChEMBL_ID
C036901	MESH_SUPPLEMENTAL_RECORD_UI
9087	IUPHAR_LIGAND_ID
L7CHH2B2J0	UNII
1311089	RXNORM
221104	MMSL
31588	MMSL
d06744	MMSL
010017	NDDF
016771	NDDF
441573002	SNOMEDCT_US
442263003	SNOMEDCT_US
717036000	SNOMEDCT_US
4035614	VANDF
4035615	VANDF
4876	INN_ID

Pharmaceutical products:

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