tisotumab vedotin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
synthetic derivatives of dolastatin series 5477 1418731-10-8

Description:

MoleculeDescription

Molfile

Synonyms:

  • tisotumab vedotin
  • tisotumab vedotin-tftv
  • tivdak
  • HuMax-TF-ADC
Tisotumab vedotin-tftv is a tissue factor (TF)-directed antibody drug conjugate (ADC). The antibody is a human IgG1 directed against cell surface TF. TF is the primary initiator of the extrinsic blood coagulation cascade. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Nonclinical data suggests that the anticancer activity of tisotumab vedotin-tftv is due to the binding of the ADC to TF expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin-tftv also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2021 FDA SEAGEN

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
Neuropathy peripheral 124.17 50.66 49 950 136921 90490527
Conjunctivitis 109.46 50.66 30 969 26676 90600772
Malignant neoplasm progression 99.39 50.66 39 960 106831 90520617
Dry eye 94.39 50.66 32 967 57899 90569549
Ocular toxicity 85.13 50.66 14 985 1063 90626385
Keratitis 66.77 50.66 14 985 3992 90623456
Punctate keratitis 53.45 50.66 9 990 787 90626661
Ulcerative keratitis 51.43 50.66 11 988 3442 90624006

FDA Adverse Event Reporting System (Male)

None

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
Malignant neoplasm progression 97.08 44.94 36 562 174531 110414170
Conjunctivitis 69.72 44.94 19 579 33773 110554928
Dry eye 56.16 44.94 18 580 55775 110532926

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX23 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D018796 Immunoconjugates
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
amivantamabbelantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabgemtuzumab ozogamicinglofitamab show all 29 →

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

DiseaseRelationSNOMED_IDDOID
Recurrent or metastatic cervical cancer indication 285432005 DOID:2893




🐶 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Tissue factor Membrane receptor BINDING AGENT EC50 8.51 DRUG LABEL DRUG LABEL

External reference:

IDSource
T41737F88A UNII
C4724800 UMLSCUI
CHEBI:757283 CHEBI
CHEMBL4297841 ChEMBL_ID
DB16732 DRUGBANK_ID
D11814 KEGG_DRUG
10148 INN_ID
C000707142 MESH_SUPPLEMENTAL_RECORD_UI
11719 IUPHAR_LIGAND_ID
4040835 VANDF
4040836 VANDF
350441 MMSL
39906 MMSL
39934 MMSL
d09810 MMSL
018851 NDDF
2571093 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TIVDAK HUMAN PRESCRIPTION DRUG LABEL 1 51144-003 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS BLA 33 sections
TIVDAK HUMAN PRESCRIPTION DRUG LABEL 1 51144-003 INJECTION, POWDER, FOR SOLUTION 40 mg INTRAVENOUS BLA 33 sections