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

DoseUnitRoute
16.70 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

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

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
Disease progression 182.75 33.03 68 976 156547 90470856
Interstitial lung disease 56.48 33.03 24 1020 76381 90551022
Hypothyroidism 43.62 33.03 18 1026 53109 90574294
Hyperthyroidism 40.87 33.03 13 1031 18297 90609106
Cholangitis 33.33 33.03 9 1035 7173 90620230

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
Pemphigoid 85.04 30.81 29 2140 11438 42607728
Myocarditis 77.77 30.81 31 2138 18907 42600259
Disease progression 72.14 30.81 59 2110 143597 42475569
Blood thyroid stimulating hormone increased 53.80 30.81 17 2152 5275 42613891
Myositis 46.34 30.81 20 2149 14846 42604320
Pneumocephalus 45.48 30.81 8 2161 189 42618977
Squamous cell carcinoma of skin 42.56 30.81 18 2151 12708 42606458
Cholangitis 38.65 30.81 16 2153 10711 42608455
Pneumonitis 34.03 30.81 23 2146 41695 42577471
Cytokine storm 33.29 30.81 8 2161 900 42618266
Ear haemorrhage 31.81 30.81 8 2161 1086 42618080

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
Disease progression 126.79 31.70 76 2534 243958 110342731
Myocarditis 110.27 31.70 37 2573 30018 110556671
Pemphigoid 79.20 31.70 26 2584 19681 110567008
Cholangitis 67.45 31.70 22 2588 16313 110570376
Immune-mediated hepatitis 53.46 31.70 15 2595 6696 110579993
Pneumonitis 53.46 31.70 29 2581 76502 110510187
Blood thyroid stimulating hormone increased 48.49 31.70 16 2594 12285 110574404
Pneumocephalus 44.21 31.70 8 2602 490 110586199
Myositis 43.61 31.70 19 2591 31097 110555592
Squamous cell carcinoma of skin 43.24 31.70 16 2594 17187 110569502
Interstitial lung disease 41.99 31.70 31 2579 139303 110447386
Cytokine release syndrome 36.60 31.70 22 2588 70284 110516405
Hepatic cytolysis 36.05 31.70 20 2590 55033 110531656
Cholestasis 35.70 31.70 21 2589 64497 110522192
Cytokine storm 35.46 31.70 8 2602 1482 110585207
Immune-mediated enterocolitis 35.19 31.70 12 2598 10173 110576516
Immune-mediated lung disease 33.95 31.70 10 2600 5293 110581396
Hypothyroidism 33.33 31.70 21 2589 72878 110513811
Dermatitis bullous 32.26 31.70 13 2597 17516 110569173
Adrenal insufficiency 32.21 31.70 17 2593 42373 110544316

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/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000970 Antineoplastic Agents
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent

Related Drugs by ATC class:

L01FF PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors 11 drugs
atezolizumabavelumabdostarlimabdurvalumabnivolumabpembrolizumabretifanlimabserplulimabsugemalimabtislelizumabtoripalimab

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
4037905 VANDF
4037906 VANDF
C4724806 UMLSCUI
CHEBI:757176 CHEBI
CHEMBL4297723 ChEMBL_ID
DB14707 DRUGBANK_ID
D11108 KEGG_DRUG
10691 INN_ID
C000627974 MESH_SUPPLEMENTAL_RECORD_UI
10090 IUPHAR_LIGAND_ID
781555007 SNOMEDCT_US
781611008 SNOMEDCT_US
292661 MMSL
35140 MMSL
35147 MMSL
d08950 MMSL
017771 NDDF
2058825 RXNORM

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