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

Stem definitionDrug idCAS RN
human origin 5063 945721-28-8

Description:

MoleculeDescription

Synonyms:

  • daratumumab
  • HuMax-CD38
  • 3003-005
  • darzalex
Daratumumab is an IgG1k human monoclonal antibody (mAb) that binds to CD38 and inhibits the growth of CD38 expressing tumor cells by inducing apoptosis directly through Fc mediated cross linking as well as by immune-mediated tumor cell lysis through complement dependent cytotoxicity (CDC), antibody dependent cell mediated cytotoxicity (ADCC) and antibody dependent cellular phagocytosis (ADCP).
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2017 PMDA Janssen Pharmaceutical KK
May 20, 2016 EMA Janssen-Cilag International N.V.
Nov. 16, 2015 FDA JANSSEN BIOTECH

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 814.63 20.10 333 11338 44145 46630246
Infusion related reaction 738.44 20.10 401 11270 100807 46573584
Neutropenia 244.70 20.10 235 11436 142969 46531422
Neuropathy peripheral 181.75 20.10 163 11508 90730 46583661
White blood cell count decreased 159.78 20.10 167 11504 112064 46562327
Neutrophil count decreased 149.08 20.10 107 11564 43319 46631072
Pneumonia 139.14 20.10 296 11375 376024 46298367
Platelet count decreased 139.04 20.10 147 11524 99877 46574514
Thrombocytopenia 128.40 20.10 158 11513 126423 46547968
Crossmatch incompatible 124.95 20.10 19 11652 20 46674371
Plasma cell myeloma recurrent 103.82 20.10 34 11637 2373 46672018
Coombs indirect test positive 95.10 20.10 15 11656 24 46674367
Tumour lysis syndrome 85.72 20.10 40 11631 7196 46667195
Off label use 75.60 20.10 237 11434 379604 46294787
Plasma cell leukaemia 72.94 20.10 22 11649 1171 46673220
Disease progression 72.31 20.10 101 11570 91199 46583192
Body dysmorphic disorder 67.30 20.10 14 11657 155 46674236
Febrile neutropenia 63.76 20.10 97 11574 94530 46579861
Cytopenia 62.47 20.10 33 11638 7735 46666656
Plasmacytoma 60.78 20.10 23 11648 2454 46671937
COVID-19 59.65 20.10 44 11627 18531 46655860
Morganella infection 53.05 20.10 14 11657 456 46673935
Product use in unapproved indication 49.13 20.10 84 11587 90189 46584202
Endocarditis bacterial 45.27 20.10 13 11658 582 46673809
Bronchospasm 43.36 20.10 34 11637 15673 46658718
Full blood count decreased 42.62 20.10 39 11632 22172 46652219
Joint ankylosis 41.47 20.10 12 11659 552 46673839
Cytomegalovirus infection 41.09 20.10 35 11636 18109 46656282
Pseudomyopia 41.02 20.10 8 11663 62 46674329
Pyrexia 38.03 20.10 180 11491 348622 46325769
Acute myopia 37.86 20.10 8 11663 96 46674295
Toxicity to various agents 36.24 20.10 5 11666 211761 46462630
Sepsis 35.74 20.10 94 11577 135920 46538471
Anaemia 34.70 20.10 141 11530 255638 46418753
Light chain analysis increased 33.83 20.10 12 11659 1066 46673325
Intraductal proliferative breast lesion 32.62 20.10 15 11656 2607 46671784
Plasma cells decreased 32.25 20.10 6 11665 35 46674356
Drug hypersensitivity 31.23 20.10 11 11660 243814 46430577
Visceral leishmaniasis 30.44 20.10 9 11662 447 46673944
Coombs direct test positive 30.07 20.10 6 11665 53 46674338
Meningitis cryptococcal 28.97 20.10 11 11660 1184 46673207
Laboratory test abnormal 28.89 20.10 32 11639 22815 46651576
Diarrhoea 28.24 20.10 237 11434 559365 46115026
Septic shock 26.52 20.10 50 11621 57843 46616548
Adverse drug reaction 26.41 20.10 43 11628 44319 46630072
Polyneuropathy 25.42 20.10 22 11649 11622 46662769
Respiratory tract infection 24.95 20.10 34 11637 29938 46644453
Atrial fibrillation 24.60 20.10 69 11602 103521 46570870
Headache 24.48 20.10 52 11619 478300 46196091
Constipation 24.39 20.10 97 11574 174000 46500391
Light chain analysis 24.17 20.10 4 11667 10 46674381
COVID-19 pneumonia 23.77 20.10 13 11658 3262 46671129
Condition aggravated 22.55 20.10 17 11654 245035 46429356
Pancytopenia 22.54 20.10 59 11612 84999 46589392
Hypogammaglobulinaemia 22.38 20.10 15 11656 5423 46668968
Bone marrow failure 22.23 20.10 32 11639 29637 46644754
Death 21.84 20.10 151 11520 335397 46338994
Dyspnoea 21.69 20.10 210 11461 515338 46159053
Cardiac amyloidosis 21.12 20.10 7 11664 507 46673884
Drug ineffective 20.91 20.10 93 11578 677745 45996646
Hypoperfusion 20.60 20.10 9 11662 1388 46673003
Disseminated cryptococcosis 20.51 20.10 6 11665 287 46674104
Cytomegalovirus infection reactivation 20.14 20.10 9 11662 1463 46672928

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
Infusion related reaction 1107.76 17.94 486 13800 40078 29898114
Plasma cell myeloma 765.13 17.94 412 13874 53050 29885142
Pneumonia 131.28 17.94 402 13884 333904 29604288
White blood cell count decreased 128.27 17.94 178 14108 83769 29854423
Platelet count decreased 122.07 17.94 197 14089 105932 29832260
Neuropathy peripheral 117.59 17.94 156 14130 70319 29867873
Plasma cell myeloma recurrent 112.74 17.94 47 14239 3367 29934825
Neutropenia 110.64 17.94 210 14076 128330 29809862
Plasmacytoma 110.15 17.94 46 14240 3310 29934882
Neutrophil count decreased 88.32 17.94 105 14181 42349 29895843
Off label use 79.64 17.94 280 14006 249010 29689182
Disease progression 67.96 17.94 130 14156 79744 29858448
Light chain analysis increased 62.36 17.94 22 14264 998 29937194
Crossmatch incompatible 59.84 17.94 9 14277 0 29938192
Thrombocytopenia 58.24 17.94 170 14116 136874 29801318
Coombs indirect test positive 54.67 17.94 9 14277 7 29938185
Influenza 53.10 17.94 83 14203 43315 29894877
Chills 49.93 17.94 108 14178 72230 29865962
Sepsis 49.67 17.94 168 14118 146227 29791965
Monoclonal immunoglobulin present 45.83 17.94 17 14269 891 29937301
Tumour lysis syndrome 44.91 17.94 42 14244 12843 29925349
Respiratory tract infection 43.71 17.94 45 14241 15461 29922731
COVID-19 43.52 17.94 48 14238 17830 29920362
Cytomegalovirus infection 43.44 17.94 55 14231 23619 29914573
Pyrexia 41.69 17.94 261 14025 294228 29643964
Cytopenia 39.01 17.94 32 14254 8224 29929968
Plasma cell leukaemia 38.34 17.94 15 14271 910 29937282
Hypercalcaemia 32.95 17.94 35 14251 12460 29925732
Product use in unapproved indication 32.76 17.94 93 14193 73600 29864592
Polyneuropathy 32.75 17.94 34 14252 11789 29926403
Progressive multifocal leukoencephalopathy 32.61 17.94 30 14256 8983 29929209
Toxicity to various agents 31.71 17.94 23 14263 177160 29761032
Cerebral toxoplasmosis 31.64 17.94 15 14271 1457 29936735
Respirovirus test positive 31.53 17.94 7 14279 53 29938139
Febrile neutropenia 31.45 17.94 117 14169 106576 29831616
Full blood count decreased 31.21 17.94 38 14248 15679 29922513
Bronchospasm 30.95 17.94 31 14255 10307 29927885
Cytomegalovirus viraemia 30.90 17.94 24 14262 5705 29932487
Product use issue 29.79 17.94 67 14219 45949 29892243
Overdose 29.49 17.94 3 14283 84334 29853858
Product dose omission issue 28.27 17.94 102 14184 91529 29846663
Plasma cell myeloma refractory 27.31 17.94 6 14280 43 29938149
Diverticular perforation 25.62 17.94 17 14269 3160 29935032
Infusion site thrombosis 25.21 17.94 5 14281 20 29938172
Oropharyngeal discomfort 25.20 17.94 13 14273 1514 29936678
Blood immunoglobulin G decreased 24.65 17.94 11 14275 929 29937263
Laboratory test abnormal 23.63 17.94 35 14251 17407 29920785
Infection 23.31 17.94 86 14200 77988 29860204
Pancytopenia 23.18 17.94 91 14195 84961 29853231
Blood immunoglobulin M increased 23.03 17.94 7 14279 197 29937995
Oxygen saturation decreased 22.47 17.94 58 14228 43382 29894810
Septic shock 22.39 17.94 74 14212 63533 29874659
Infusion site extravasation 21.62 17.94 14 14272 2499 29935693
Chloroma 21.23 17.94 8 14278 438 29937754
Lower respiratory tract infection 20.87 17.94 42 14244 26672 29911520
JC virus infection 20.57 17.94 12 14274 1778 29936414
Squamous cell carcinoma of skin 19.72 17.94 23 14263 9072 29929120
Sternal fracture 19.34 17.94 8 14278 561 29937631
Spinal compression fracture 19.22 17.94 19 14267 6215 29931977
Throat irritation 19.17 17.94 22 14264 8526 29929666
Therapy partial responder 18.90 17.94 15 14271 3676 29934516
Adverse drug reaction 18.81 17.94 37 14249 23108 29915084
Atrial fibrillation 18.55 17.94 101 14185 108023 29830169
Product preparation error 18.46 17.94 11 14275 1695 29936497
Cytomegalovirus chorioretinitis 18.30 17.94 14 14272 3254 29934938

Pharmacologic Action:

SourceCodeDescription
ATC L01XC24 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Monoclonal antibodies
FDA CS M0001357 Antibodies, Monoclonal
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000192335 CD38-directed Antibody Interactions
FDA EPC N0000192336 CD38-directed Cytolytic Antibody

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Multiple myeloma indication 109989006 DOID:9538

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
Lymphocyte differentiation antigen CD38 Tumour-associated antigen ANTIBODY BINDING Kd 8.22 IUPHAR DRUG LABEL

External reference:

IDSource
D10777 KEGG_DRUG
4035125 VANDF
C2346801 UMLSCUI
CHEMBL1743007 ChEMBL_ID
DB09331 DRUGBANK_ID
C556306 MESH_SUPPLEMENTAL_RECORD_UI
7395 IUPHAR_LIGAND_ID
9128 INN_ID
4Z63YK6E0E UNII
1721947 RXNORM
237137 MMSL
31294 MMSL
d08399 MMSL
016591 NDDF
716016006 SNOMEDCT_US
781328004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DARZALEX HUMAN PRESCRIPTION DRUG LABEL 1 57894-502 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
Darzalex Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-503 INJECTION 1800 mg SUBCUTANEOUS BLA 32 sections