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

Stem definitionDrug idCAS RN
839 24584-09-6

Description:

MoleculeDescription

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:

DoseUnitRoute
1.50 g P

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
May 26, 1995 FDA PHARMACIA AND UPJOHN

FDA Adverse Event Reporting System (Female)

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
Febrile neutropenia 260.68 38.92 94 1098 97573 50506359
Bone marrow failure 126.05 38.92 40 1152 27584 50576348
Neutropenia 104.16 38.92 56 1136 147909 50456023
Pyomyositis 89.40 38.92 14 1178 357 50603575
Quadriparesis 62.17 38.92 13 1179 1703 50602229
Aplastic anaemia 55.96 38.92 16 1176 7687 50596245
Off label use 51.32 38.92 59 1133 474367 50129565
Osteosarcoma 39.55 38.92 6 1186 123 50603809

FDA Adverse Event Reporting System (Male)

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
Febrile neutropenia 143.13 35.04 76 1149 112164 29461138
Off label use 55.99 35.04 65 1160 300735 29272567
Myelosuppression 46.91 35.04 18 1207 12209 29561093
Thymus hypoplasia 41.46 35.04 7 1218 160 29573142
Lymphoid tissue hypoplasia 41.46 35.04 7 1218 160 29573142
Bone marrow failure 38.63 35.04 20 1205 27429 29545873

FDA Adverse Event Reporting System (Geriatric)

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
Febrile neutropenia 336.49 31.34 154 2207 187503 64308868
Bone marrow failure 154.38 31.34 60 2301 47892 64448479
Neutropenia 100.04 31.34 77 2284 239547 64256824
Pyomyositis 77.94 31.34 14 2347 526 64495845
Lymphoid tissue hypoplasia 66.09 31.34 12 2349 479 64495892
Thymus hypoplasia 65.11 31.34 12 2349 521 64495850
Myelosuppression 63.27 31.34 26 2335 23804 64472567
Disseminated aspergillosis 62.41 31.34 12 2349 656 64495715
Off label use 61.91 31.34 94 2267 632712 63863659
Clostridium difficile colitis 53.47 31.34 24 2337 27199 64469172
Quadriparesis 49.84 31.34 13 2348 2844 64493527
Pyrexia 40.94 31.34 73 2288 558571 63937800
Aplastic anaemia 39.71 31.34 16 2345 13904 64482467
Neutrophil count decreased 34.64 31.34 26 2335 77170 64419201
Osteosarcoma 31.72 31.34 6 2355 300 64496071

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC V03AF02 VARIOUS
ALL OTHER THERAPEUTIC PRODUCTS
ALL OTHER THERAPEUTIC PRODUCTS
Detoxifying agents for antineoplastic treatment
FDA EPC N0000180854 Cytoprotective Agent
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
MeSH PA D000970 Antineoplastic Agents
MeSH PA D002316 Cardiotonic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D020011 Protective Agents
MeSH PA D059005 Topoisomerase II Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.61 acidic
pKa2 10.22 acidic
pKa3 6.83 Basic
pKa4 2.83 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
4023998 VUID
N0000189410 NUI
D03730 KEGG_DRUG
1263283-43-7 SECONDARY_CAS_RN
1294534 RXNORM
4020927 VANDF
4023998 VANDF
C0086444 UMLSCUI
CHEBI:50223 CHEBI
CHEMBL1738 ChEMBL_ID
CHEMBL1200778 ChEMBL_ID
DB00380 DRUGBANK_ID
D064730 MESH_DESCRIPTOR_UI
71384 PUBCHEM_CID
7330 IUPHAR_LIGAND_ID
6544 INN_ID
048L81261F UNII
136190 MMSL
1517 MMSL
4559 MMSL
64877 MMSL
d03841 MMSL
005011 NDDF
007168 NDDF
108825009 SNOMEDCT_US
417741009 SNOMEDCT_US
734473007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 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
Dexrazoxane HUMAN PRESCRIPTION DRUG LABEL 1 72611-716 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
Dexrazoxane HUMAN PRESCRIPTION DRUG LABEL 1 72611-716 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
Cardioxane HUMAN PRESCRIPTION DRUG LABEL 1 76310-002 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS Unapproved drug for use in drug shortage 3 sections
Totect HUMAN PRESCRIPTION DRUG LABEL 1 76310-110 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 30 sections
Totect HUMAN PRESCRIPTION DRUG LABEL 1 76310-110 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS NDA 30 sections