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

Stem definitionDrug idCAS RN
humanized origin 5758 1858168-59-8

Description:

MoleculeDescription

Molfile

Synonyms:

  • tislelizumab
  • tevimbra
  • BGB-A317
Tislelizumab is a humanised immunoglobulin G4 (IgG4) variant monoclonal antibody against PD-1, binding to the extracellular domain of human PD-1. It competitively blocks the binding of both PD-L1 and PD-L2, inhibiting PD-1-mediated negative signalling and enhancing the functional activity in T cells in in vitro cell-based assays.
  • 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. 15, 2023 EMA NOVARTIS EUROPHARM LIMITED

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
Myelosuppression 956.68 62.61 187 608 53404 90574248

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
Myelosuppression 2455.50 42.75 552 2241 39909 42578633
Liver injury 117.69 42.75 45 2748 19103 42599439
Hepatic function abnormal 99.49 42.75 54 2739 51513 42567029
White blood cell count decreased 94.54 42.75 69 2724 110327 42508215
Drug eruption 79.85 42.75 36 2757 23039 42595503
Neutrophil count decreased 69.06 42.75 46 2747 63369 42555173
Immune-mediated lung disease 52.32 42.75 16 2777 3457 42615085
Interstitial lung disease 49.50 42.75 41 2752 78421 42540121

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
Myelosuppression 9839.78 45.86 2021 5727 92319 110489232
Hepatic function abnormal 406.04 45.86 172 7576 89123 110492428
Liver injury 262.83 45.86 151 7597 150262 110431289
White blood cell count decreased 241.49 45.86 167 7581 229223 110352328
Drug eruption 239.06 45.86 102 7646 53557 110527994
Granulocyte count decreased 199.62 45.86 48 7700 3926 110577625
Platelet count decreased 156.06 45.86 129 7619 230314 110351237
Interstitial lung disease 147.66 45.86 102 7646 139232 110442319
Neutrophil count decreased 119.84 45.86 85 7663 120856 110460695
Immune-mediated lung disease 106.58 45.86 31 7717 5272 110576279
Myocardial necrosis marker increased 97.48 45.86 27 7721 3853 110577698
Drug-induced liver injury 84.86 45.86 69 7679 119998 110461553
Chest discomfort 77.44 45.86 77 7671 173771 110407780
Immune-mediated hepatic disorder 76.27 45.86 23 7725 4427 110577124
Hypothyroidism 73.92 45.86 52 7696 72847 110508704
Drug ineffective 64.68 45.86 14 7734 1520526 109061025
Transaminases increased 50.25 45.86 39 7709 63351 110518200
Decreased appetite 47.98 45.86 104 7644 475742 110105809
Pruritus 47.54 45.86 117 7631 581443 110000108
Agranulocytosis 46.80 45.86 37 7711 61723 110519828
Hypoproteinaemia 46.49 45.86 17 7731 5928 110575623

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FF09 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000191259 Programmed Death Receptor-1-directed Antibody Interactions
FDA EPC N0000191260 Programmed Death Receptor-1 Blocking Antibody
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors 11 drugs
atezolizumabavelumabcemiplimabdostarlimabdurvalumabnivolumabpembrolizumabretifanlimabserplulimabsugemalimabtoripalimab

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

DiseaseRelationSNOMED_IDDOID
Oesophageal squamous cell carcinoma indication 276804009 DOID:3748




🐶 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
Programmed cell death protein 1 Membrane receptor BINDING AGENT Kd 9.82 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEMBL4297840 ChEMBL_ID
C000707970 MESH_SUPPLEMENTAL_RECORD_UI
9592 IUPHAR_LIGAND_ID
DB14922 DRUGBANK_ID
4043346 VANDF
C4733463 UMLSCUI
CHEBI:757282 CHEBI
10553 INN_ID
390662 MMSL
43430 MMSL
d10231 MMSL
0KVO411B3N UNII
2677426 RXNORM
1363351004 SNOMEDCT_US
D11487 KEGG_DRUG

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TEVIMBRA HUMAN PRESCRIPTION DRUG LABEL 1 72579-121 INJECTION, SOLUTION, CONCENTRATE 10 mg INTRAVENOUS BLA 31 sections
TEVIMBRA HUMAN PRESCRIPTION DRUG LABEL 1 72579-125 INJECTION, SOLUTION, CONCENTRATE 10 mg INTRAVENOUS BLA 31 sections