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

Stem definition	Drug id	CAS RN
benzodioxane derivatives	839	24584-09-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dexrazoxane zinecard savene totect dexrazoxane hydrochloride dexrazoxane HCl	The (+)-enantiomorph of razoxane. Molecular weight: 268.27 Formula: C11H16N4O4 CLOGP: -1.33 LIPINSKI: 0 HAC: 8 HDO: 2 TPSA: 98.82 ALOGS: -1.41 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dexrazoxane
zinecard
savene
totect
dexrazoxane hydrochloride
dexrazoxane HCl

The (+)-enantiomorph of razoxane.

Molecular weight: 268.27
Formula: C11H16N4O4
CLOGP: -1.33
LIPINSKI: 0
HAC: 8
HDO: 2
TPSA: 98.82
ALOGS: -1.41
ROTB: 3

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
1.50	g	P

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	42 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	3.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	2.50 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	11 mg/mL	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.55 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
May 26, 1995	FDA	PHARMACIA AND UPJOHN

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
Febrile neutropenia	450.39	39.41	148	1342	118301	63369231
Bone marrow failure	123.76	39.41	40	1450	29250	63458282
Neutropenia	97.99	39.41	57	1433	174948	63312584
Pyomyositis	89.28	39.41	14	1476	361	63487171
Aplastic anaemia	83.87	39.41	23	1467	9546	63477986
Off label use	82.36	39.41	89	1401	674373	62813159
Quadriparesis	60.03	39.41	13	1477	2016	63485516

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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
Febrile neutropenia	224.49	35.11	116	1604	136733	34818478
Lymphoid tissue hypoplasia	124.65	35.11	21	1699	397	34954814
Thymus hypoplasia	124.65	35.11	21	1699	397	34954814
Off label use	113.01	35.11	119	1601	419405	34535806
Disseminated aspergillosis	111.57	35.11	21	1699	759	34954452
Clostridium difficile colitis	84.44	35.11	31	1689	15699	34939512
Cytomegalovirus viraemia	64.56	35.11	21	1699	7409	34947802
Mucosal inflammation	57.70	35.11	31	1689	38591	34916620
Fungal infection	52.27	35.11	22	1698	15913	34939298
Lymphopenia	48.45	35.11	21	1699	16314	34938897

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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
Febrile neutropenia	590.80	34.04	248	2885	230751	79510504
Lymphoid tissue hypoplasia	151.49	34.04	27	3106	903	79740352
Thymus hypoplasia	150.28	34.04	27	3106	946	79740309
Disseminated aspergillosis	146.53	34.04	27	3106	1091	79740164
Bone marrow failure	146.38	34.04	60	3073	51047	79690208
Off label use	124.66	34.04	164	2969	907051	78834204
Clostridium difficile colitis	117.18	34.04	45	3088	32238	79709017
Aplastic anaemia	98.74	34.04	34	3099	17871	79723384
Neutropenia	84.69	34.04	78	3055	287632	79453623
Cytomegalovirus viraemia	81.12	34.04	27	3106	12794	79728461

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V03AF02	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Detoxifying agents for antineoplastic treatment
CHEBI has role	CHEBI:35554	cardiovascular agent
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:38161	Chelating agent
FDA EPC	N0000180854	Cytoprotective Agent
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D002316	Cardiotonic Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D004791	Enzyme Inhibitors

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

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Disease	Relation	SNOMED_ID
Extravasation Injury from Anthracycline Injection	indication
Doxorubicin Induced Cardiomyopathy	indication
Prevention of CMV Disease After Organ Transplant	indication
Impaired renal function disorder	contraindication	197663003
Non-infective meningitis	contraindication	230155003
Bone marrow depression	contraindication	307762000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.61	acidic
pKa2	10.22	acidic
pKa3	6.83	Basic
pKa4	2.83	Basic

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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
DNA topoisomerase 2-alpha	Enzyme	P11388	TOP2A_HUMAN		IC50	4.40		CHEMBL
DNA topoisomerase 2-beta	Enzyme	Q02880	TOP2B_HUMAN		IC50	4.30		CHEMBL

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External reference:

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ID	Source
005011	NDDF
007168	NDDF
048L81261F	UNII
108825009	SNOMEDCT_US
1263283-43-7	SECONDARY_CAS_RN
1294534	RXNORM
136190	MMSL
1517	MMSL
4020927	VANDF
4023998	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cardioxane	HUMAN PRESCRIPTION DRUG LABEL	1	76310-002	INJECTION, POWDER, FOR SOLUTION	500 mg	INTRAVENOUS	Unapproved drug for use in drug shortage	3 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9247	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	10 mg	INTRAVENOUS	ANDA	26 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9248	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	10 mg	INTRAVENOUS	ANDA	26 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	51991-942	INJECTION, SOLUTION	500 mg	INTRAVENOUS	ANDA	29 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	51991-942	INJECTION, SOLUTION	500 mg	INTRAVENOUS	ANDA	29 sections
Dexrazoxane	Human Prescription Drug Label	1	68083-195	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	25 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	72266-101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	25 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	72266-101	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	ANDA	25 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	72266-235	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	25 sections
Dexrazoxane	HUMAN PRESCRIPTION DRUG LABEL	1	72266-235	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 mg	INTRAVENOUS	ANDA	25 sections

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