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

Stem definitionDrug idCAS RN
primate origin 5317 1801342-60-8

Description:

MoleculeDescription

Synonyms:

  • cemiplimab
  • libtayo
  • REGN2810
  • cemiplimab-rwlc
Cemiplimab-rwlc is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
June 28, 2019 EMA REGENERON IRELAND U.C.
Sept. 28, 2018 FDA REGENERON PHARMACEUTICALS
Dec. 23, 2022 PMDA Sanofi K.K.

FDA Adverse Event Reporting System (Female)

None

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
Pneumocephalus 54.48 36.49 8 676 159 34956088
Ear haemorrhage 40.35 36.49 8 676 970 34955277
Squamous cell carcinoma of skin 36.70 36.49 12 672 10869 34945378

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
Pneumocephalus 54.92 37.57 8 688 346 79743346
Cytokine release syndrome 43.46 37.57 15 681 35983 79707709
Immune-mediated hepatitis 41.87 37.57 9 687 3647 79740045
Ear haemorrhage 40.48 37.57 8 688 2149 79741543

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FF06 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000074322 Antineoplastic Agents, Immunological

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

DiseaseRelationSNOMED_IDDOID
Malignant tumor of cervix indication 363354003 DOID:4362
Squamous cell carcinoma indication 402815007 DOID:1749
Non-small cell lung cancer without mutation in epidermal growth factor receptor indication 703230006
Nonsmall cell lung cancer without mutation in epidermal growth factor receptor indication 703230006
Metastatic basal cell carcinoma indication 40641000146101




🐶 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 ANTIBODY BINDING Kd 7.10 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

IDSource
6QVL057INT UNII
C4724806 UMLSCUI
CHEMBL4297723 ChEMBL_ID
DB14707 DRUGBANK_ID
D11108 KEGG_DRUG
10691 INN_ID
10090 IUPHAR_LIGAND_ID
017771 NDDF
781555007 SNOMEDCT_US
781611008 SNOMEDCT_US
4037905 VANDF
4037906 VANDF
2058825 RXNORM
292661 MMSL
35140 MMSL
35147 MMSL
d08950 MMSL
C000627974 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
LIBTAYO HUMAN PRESCRIPTION DRUG LABEL 1 61755-008 INJECTION 50 mg INTRAVENOUS BLA 30 sections
LIBTAYO HUMAN PRESCRIPTION DRUG LABEL 1 61755-008 INJECTION 50 mg INTRAVENOUS BLA 30 sections
LIBTAYO HUMAN PRESCRIPTION DRUG LABEL 1 61755-008 INJECTION 50 mg INTRAVENOUS BLA 30 sections