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

Stem definitionDrug idCAS RN
antiviral, monoclonal antibodies 5698 1989556-22-0

Description:

MoleculeDescription

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Oct. 31, 2022 EMA ASTRAZENECA AB
July 17, 2023 FDA ASTRAZENECA AB

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
Respiratory syncytial virus bronchiolitis 807.52 102.06 89 753 338 90627267
Bronchiolitis 319.72 102.06 50 792 3362 90624243
Incorrect dose administered 238.91 102.06 67 775 78863 90548742
Drug ineffective 138.11 102.06 107 735 1384191 89243414
Respiratory syncytial virus infection 131.09 102.06 28 814 10452 90617153
Extra dose administered 123.38 102.06 26 816 9092 90618513
Respiratory syncytial virus test positive 117.43 102.06 18 824 1040 90626565

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
Respiratory syncytial virus bronchiolitis 1065.20 123.79 134 1059 525 42619617
Bronchiolitis 391.06 123.79 71 1122 3835 42616307
Respiratory syncytial virus infection 312.88 123.79 65 1128 7087 42613055
Incorrect dose administered 263.62 123.79 85 1108 52889 42567253
Drug ineffective 221.77 123.79 161 1032 630036 41990106
Respiratory syncytial virus test positive 180.90 123.79 27 1166 415 42619727
Oxygen therapy 124.58 123.79 23 1170 1335 42618807

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
Respiratory syncytial virus bronchiolitis 1088.55 112.05 123 865 652 110587659
Respiratory syncytial virus infection 335.28 112.05 64 924 14420 110573891
Incorrect dose administered 308.40 112.05 86 902 103555 110484756
Bronchiolitis 222.27 112.05 39 949 5454 110582857
Drug ineffective 147.46 112.05 114 874 1520426 109067885

FDA Adverse Event Reporting System (Pediatric)

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
Incorrect dose administered 138.74 99.16 32 202 49 113670

Pharmacologic Action:

SourceCodeDescription
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
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35441 antiinfective agent

Related Drugs by ATC class:

J06BD Antiviral monoclonal antibodies 10 drugs
ansuvimabcasirivimabcilgavimabclesrovimabimdevimabpalivizumabregdanvimabsipavibartsotrovimabtixagevimab

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

DiseaseRelationSNOMED_IDDOID
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Fusion glycoprotein F0 Surface antigen BINDING AGENT Kd 9.92 DRUG LABEL DRUG LABEL
Fusion glycoprotein F0 Surface antigen BINDING AGENT Kd 8.91 DRUG LABEL DRUG LABEL

External reference:

IDSource
CHEBI:757050 CHEBI
CHEMBL4297575 ChEMBL_ID
C000709769 MESH_SUPPLEMENTAL_RECORD_UI
DB16258 DRUGBANK_ID
58331000087101 SNOMEDCT_US
4042488 VANDF
4042489 VANDF
C5418478 UMLSCUI
10780 INN_ID
D11380 KEGG_DRUG
41819 MMSL
019497 NDDF
VRN8S9CW5V UNII
2642401 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
BEYFORTUS HUMAN PRESCRIPTION DRUG LABEL 1 49281-574 INJECTION 100 mg INTRAMUSCULAR BLA 31 sections
BEYFORTUS HUMAN PRESCRIPTION DRUG LABEL 1 49281-574 INJECTION 100 mg INTRAMUSCULAR BLA 31 sections
BEYFORTUS HUMAN PRESCRIPTION DRUG LABEL 1 49281-575 INJECTION 100 mg INTRAMUSCULAR BLA 31 sections
BEYFORTUS HUMAN PRESCRIPTION DRUG LABEL 1 49281-575 INJECTION 100 mg INTRAMUSCULAR BLA 31 sections