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

Stem definition	Drug id	CAS RN
antiviral, monoclonal antibodies	5698	1989556-22-0

Description:

Molecule	Description
Molfile Synonyms: nirsevimab beyfortus MEDI8897 nirsevimab-alip	Nirsevimab is a recombinant neutralising human IgG1kappa long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab binds to a highly conserved epitope in antigenic site OE on the prefusion protein with dissociation constants Kd = 0.12 nM and Kd = 1.22 nM for RSV subtype A and B strains, respectively. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell-to-cell fusion. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

nirsevimab
beyfortus
MEDI8897
nirsevimab-alip

Nirsevimab is a recombinant neutralising human IgG1kappa long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab binds to a highly conserved epitope in antigenic site OE on the prefusion protein with dissociation constants Kd = 0.12 nM and Kd = 1.22 nM for RSV subtype A and B strains, respectively. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell-to-cell fusion.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Oct. 31, 2022	EMA	ASTRAZENECA AB
July 17, 2023	FDA	ASTRAZENECA AB

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J06BD08	ANTIINFECTIVES FOR SYSTEMIC USE IMMUNE SERA AND IMMUNOGLOBULINS IMMUNOGLOBULINS Antiviral monoclonal antibodies
FDA MoA	N0000175615	Fusion Protein Inhibitors
FDA EPC	N0000175623	Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody

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

Disease	Relation	SNOMED_ID	DOID
Prevention of respiratory Syncytial Virus (RSV) lower respiratory tract disease	indication	55735004	DOID:1273

🐶 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
Fusion glycoprotein F0	Surface antigen		FUS_HRSVA	BINDING AGENT	Kd	9.92		DRUG LABEL	DRUG LABEL
Fusion glycoprotein F0	Surface antigen		Q6V2E7_HRSV	BINDING AGENT	Kd	8.91		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
CHEMBL4297575	ChEMBL_ID
C000709769	MESH_SUPPLEMENTAL_RECORD_UI
DB16258	DRUGBANK_ID
019497	NDDF
C5418478	UMLSCUI
10780	INN_ID
D11380	KEGG_DRUG
2642401	RXNORM
41819	MMSL
VRN8S9CW5V	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BEYFORTUS	HUMAN PRESCRIPTION DRUG LABEL	1	49281-574	INJECTION	100 mg	INTRAMUSCULAR	BLA	26 sections
BEYFORTUS	HUMAN PRESCRIPTION DRUG LABEL	1	49281-575	INJECTION	50 mg	INTRAMUSCULAR	BLA	26 sections