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

Stem definitionDrug idCAS RN
human origin 5186 1246264-45-8

Description:

MoleculeDescription

Synonyms:

  • bezlotoxumab
  • zinplava
Bezlotoxumab is a human monoclonal antibody that binds C. difficile toxin B. Bezlotoxumab inhibits the binding of toxin B and prevents its effects on mammalian cells. Bezlotoxumab does not bind to C. difficile toxin A.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 18, 2017 EMA Merck Sharp & Dohme B.V.
Oct. 21, 2016 FDA MERCK SHARP DOHME
Sept. 27, 2017 PMDA MSD KK

FDA Adverse Event Reporting System (Female)

None

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
Clostridium difficile infection 66.67 62.21 17 214 36146 64462355
Avian influenza 63.25 62.21 7 224 80 64498421
Treatment failure 62.60 62.21 21 210 116795 64381706

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J06BC03 ANTIINFECTIVES FOR SYSTEMIC USE
IMMUNE SERA AND IMMUNOGLOBULINS
IMMUNOGLOBULINS
Antibacterial monoclonal antibodies

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

DiseaseRelationSNOMED_IDDOID
Clostridium difficile infection indication 186431008




🐶 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
Toxin B Enzyme ANTIBODY BINDING Kd 9 DRUG LABEL DRUG LABEL

External reference:

IDSource
4H5YMK1H2E UNII
D10453 KEGG_DRUG
4036281 VANDF
C4291320 UMLSCUI
CHEMBL2108670 ChEMBL_ID
DB13140 DRUGBANK_ID
1855048 RXNORM
246839 MMSL
32115 MMSL
d08497 MMSL
723524001 SNOMEDCT_US
763703008 SNOMEDCT_US
017023 NDDF
C000613978 MESH_SUPPLEMENTAL_RECORD_UI
9608 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ZINPLAVA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3025 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 28 sections
ZINPLAVA HUMAN PRESCRIPTION DRUG LABEL 1 0006-3025 INJECTION, SOLUTION 25 mg INTRAVENOUS BLA 28 sections