elotuzumab Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
humanized origin 5072 915296-00-3

Description:

MoleculeDescription

Synonyms:

  • elotuzumab
  • empliciti
  • BMS-901608
  • HuLuc63
a humanized monoclonal antibody that selectively targets glycoproteins expressed on myeloma cells
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 28, 2016 PMDA Bristol-Myers Squibb
May 11, 2016 EMA Bristol-Myers Squibb
Nov. 30, 2015 FDA BRISTOL MYERS SQUIBB

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
Plasma cell myeloma 357.96 27.32 119 2394 47755 53298798
Malignant neoplasm progression 197.34 27.32 86 2427 71455 53275098
Pneumonia 67.76 27.32 89 2424 407080 52939473
Platelet count decreased 54.12 27.32 43 2470 108056 53238497
Cytomegalovirus infection 52.04 27.32 23 2490 19516 53327037
Pyrexia 49.04 27.32 76 2437 403117 52943436
Lymphocyte count decreased 47.01 27.32 24 2489 28028 53318525
Death 42.91 27.32 67 2446 357165 52989388
Neutrophil count decreased 34.56 27.32 24 2489 49074 53297479
Febrile neutropenia 31.00 27.32 31 2482 104905 53241648
Anaemia 29.18 27.32 49 2464 276669 53069884
Diarrhoea 28.87 27.32 79 2434 625467 52721086
Neuropathy peripheral 27.78 27.32 29 2484 103158 53243395

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
Plasma cell myeloma 328.40 28.55 146 3253 57468 32452659
Malignant neoplasm progression 151.95 28.55 97 3302 78399 32431728
Pneumonia 94.19 28.55 147 3252 355105 32155022
Platelet count decreased 42.63 28.55 56 3343 114535 32395592
Campylobacter gastroenteritis 37.32 28.55 10 3389 841 32509286
Sepsis 36.59 28.55 62 3337 158772 32351355
Pneumonia respiratory syncytial viral 32.54 28.55 9 3390 853 32509274
Squamous cell carcinoma of skin 31.77 28.55 17 3382 9809 32500318
Febrile infection 31.65 28.55 11 3388 2218 32507909
Visceral leishmaniasis 31.20 28.55 8 3391 567 32509560
Pneumonia mycoplasmal 31.13 28.55 8 3391 572 32509555
Neutropenia 29.46 28.55 53 3346 142122 32368005
Neuropathy peripheral 29.16 28.55 38 3361 76944 32433183

Pharmacologic Action:

SourceCodeDescription
ATC L01FX08 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA CS M0001357 Antibodies, Monoclonal
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000192337 SLAMF7-directed Antibody Interactions
FDA EPC N0000192338 SLAMF7-directed Immunostimulatory Antibody

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Multiple myeloma indication 109989006 DOID:9538
Relapse multiple myeloma indication

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
SLAM family member 7 Membrane receptor ANTIBODY BINDING Kd 8.05 IUPHAR DRUG LABEL

External reference:

IDSource
1351PE5UGS UNII
4035187 VANDF
C1832049 UMLSCUI
CHEMBL1743010 ChEMBL_ID
DB06317 DRUGBANK_ID
C546027 MESH_SUPPLEMENTAL_RECORD_UI
8361 IUPHAR_LIGAND_ID
9074 INN_ID
1726104 RXNORM
237251 MMSL
31305 MMSL
d08403 MMSL
016608 NDDF
715660001 SNOMEDCT_US
781350003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
EMPLICITI HUMAN PRESCRIPTION DRUG LABEL 1 0003-2291 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 mg INTRAVENOUS BLA 26 sections
EMPLICITI HUMAN PRESCRIPTION DRUG LABEL 1 0003-4522 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRAVENOUS BLA 26 sections