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

Stem definition	Drug id	CAS RN
human origin	5186	1246264-45-8

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company
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)

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
Clostridium difficile infection	69.12	67.72	16	159	29906	63458941

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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
Clostridium difficile infection	86.12	66.71	21	230	42664	79701473

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Toxin B	Enzyme		TOXB_CLODI	ANTIBODY BINDING	Kd	9		DRUG LABEL	DRUG LABEL

External reference:

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

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ZINPLAVA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3025	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	29 sections
ZINPLAVA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3025	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	29 sections
ZINPLAVA	HUMAN PRESCRIPTION DRUG LABEL	1	0006-3025	INJECTION, SOLUTION	25 mg	INTRAVENOUS	BLA	29 sections