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

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
Infusion related reaction 653.48 19.51 570 19371 244951 63224130
Neutropenia 455.88 19.51 402 19539 174603 63294478
Neuropathy peripheral 348.49 19.51 287 19654 113380 63355701
Thrombocytopenia 276.50 19.51 286 19655 150871 63318210
Plasma cell myeloma 244.76 19.51 148 19793 35757 63433324
White blood cell count decreased 229.09 19.51 249 19692 138855 63330226
Pneumonia 199.94 19.51 441 19500 456326 63012755
Platelet count decreased 186.11 19.51 205 19736 115917 63353164
Neutrophil count decreased 177.95 19.51 145 19796 56261 63412820
Off label use 166.74 19.51 526 19415 673936 62795145
Cytopenia 161.69 19.51 77 19864 11524 63457557
Polyneuropathy 144.98 19.51 77 19864 14512 63454569
Plasma cell myeloma recurrent 142.32 19.51 49 19892 3164 63465917
Febrile neutropenia 129.01 19.51 172 19769 118277 63350804
Crossmatch incompatible 120.61 19.51 19 19922 20 63469061
COVID-19 119.74 19.51 162 19779 112941 63356140
Tumour lysis syndrome 111.20 19.51 55 19886 8935 63460146
Light chain analysis increased 107.21 19.51 32 19909 1301 63467780
Disease progression 99.55 19.51 155 19786 122603 63346478
COVID-19 pneumonia 97.86 19.51 59 19882 14150 63454931
Coombs indirect test positive 95.50 19.51 16 19925 32 63469049
Meningitis listeria 95.07 19.51 25 19916 634 63468447
Myelosuppression 83.38 19.51 65 19876 23638 63445443
Cytomegalovirus infection 79.26 19.51 60 19881 20892 63448189
Sepsis 77.14 19.51 157 19784 152966 63316115
Plasmacytoma 72.03 19.51 28 19913 2551 63466530
Pancytopenia 71.14 19.51 117 19824 96816 63372265
Body dysmorphic disorder 69.11 19.51 17 19924 327 63468754
Atrial fibrillation 67.73 19.51 127 19814 116509 63352572
Leukopenia 67.41 19.51 101 19840 77189 63391892
Anaemia 65.75 19.51 222 19719 293208 63175873
Plasma cell leukaemia 65.05 19.51 21 19920 1109 63467972
Death 61.24 19.51 256 19685 374125 63094956
Diarrhoea 60.94 19.51 408 19533 714958 62754123
Full blood count decreased 60.00 19.51 56 19885 25968 63443113
Plasma cell myeloma refractory 58.48 19.51 15 19926 344 63468737
Morganella infection 57.85 19.51 17 19924 654 63468427
Bronchospasm 57.78 19.51 46 19895 17234 63451847
Therapy partial responder 57.69 19.51 38 19903 10620 63458461
Constipation 56.49 19.51 177 19764 224766 63244315
Drug hypersensitivity 54.66 19.51 15 19926 310672 63158409
Septic shock 53.77 19.51 84 19857 66545 63402536
Respiratory tract infection 50.96 19.51 64 19877 41419 63427662
Cardiac failure 50.41 19.51 96 19845 89046 63380035
Abdominal discomfort 50.25 19.51 19 19922 320866 63148215
Light chain analysis abnormal 47.22 19.51 11 19930 166 63468915
Pain 46.96 19.51 102 19839 740526 62728555
Endocarditis bacterial 45.57 19.51 14 19927 628 63468453
Cytomegalovirus infection reactivation 45.34 19.51 23 19918 3940 63465141
Product use in unapproved indication 44.09 19.51 140 19801 178940 63290141
Listeria sepsis 43.71 19.51 14 19927 721 63468360
Joint ankylosis 42.65 19.51 15 19926 1031 63468050
Arthralgia 42.60 19.51 71 19870 569639 62899442
Cerebellar haemangioma 42.23 19.51 9 19932 88 63468993
Laboratory test abnormal 42.13 19.51 47 19894 26865 63442216
Condition aggravated 41.69 19.51 39 19902 402178 63066903
Joint swelling 41.29 19.51 26 19915 327640 63141441
Headache 41.11 19.51 86 19855 633155 62835926
Acute myopia 40.78 19.51 9 19932 105 63468976
Thrombosis 40.70 19.51 73 19868 64682 63404399
Pseudomyopia 40.43 19.51 8 19933 52 63469029
Swelling 40.36 19.51 18 19923 275360 63193721
Arthropathy 40.05 19.51 12 19929 234780 63234301
Hypogammaglobulinaemia 39.92 19.51 26 19915 7129 63461952
Wound 39.82 19.51 3 19938 163260 63305821
Cardiac amyloidosis 38.21 19.51 13 19928 809 63468272
Osteolysis 36.78 19.51 18 19923 2856 63466225
Pyrexia 36.72 19.51 263 19678 470215 62998866
Musculoskeletal stiffness 36.25 19.51 7 19934 184611 63284470
Pneumococcal sepsis 36.22 19.51 12 19929 688 63468393
Pseudomembranous colitis 35.42 19.51 18 19923 3094 63465987
Drug interaction 35.13 19.51 14 19927 229117 63239964
Toxicity to various agents 34.93 19.51 17 19924 247233 63221848
Therapeutic product effect decreased 34.57 19.51 9 19932 193178 63275903
Thrombotic microangiopathy 32.94 19.51 27 19914 10534 63458547
Treatment failure 32.47 19.51 11 19930 199032 63270049
Cerebral toxoplasmosis 32.29 19.51 12 19929 966 63468115
Deep vein thrombosis 32.04 19.51 77 19864 83723 63385358
Transplant 30.85 19.51 11 19930 787 63468294
Plasma cells decreased 30.73 19.51 6 19935 36 63469045
Alopecia 30.19 19.51 37 19904 337499 63131582
Discomfort 29.56 19.51 8 19933 167366 63301715
Meningitis cryptococcal 28.31 19.51 12 19929 1365 63467716
Coombs direct test positive 28.31 19.51 6 19935 57 63469024
Parainfluenzae virus infection 28.07 19.51 14 19927 2313 63466768
Intraductal proliferative breast lesion 27.72 19.51 15 19926 2930 63466151
Partial seizures 27.25 19.51 19 19922 5823 63463258
Visceral leishmaniasis 26.55 19.51 9 19932 554 63468527
Pneumonia pneumococcal 25.76 19.51 13 19928 2202 63466879
Respiratory failure 25.37 19.51 80 19861 101778 63367303
Blister 25.31 19.51 5 19936 129809 63339272
Chills 24.62 19.51 85 19856 113293 63355788
Hypoglobulinaemia 23.93 19.51 5 19936 44 63469037
Lymphopenia 23.66 19.51 29 19912 18298 63450783
Cholestasis 23.58 19.51 37 19904 29397 63439684
Light chain analysis 22.98 19.51 4 19937 11 63469070
Mobility decreased 22.93 19.51 5 19936 121154 63347927
Endocarditis 22.93 19.51 17 19924 5733 63463348
Monoclonal immunoglobulin present 22.92 19.51 9 19932 842 63468239
Pneumonia cytomegaloviral 22.88 19.51 12 19929 2202 63466879
Weight increased 22.87 19.51 29 19912 260763 63208318
Progressive multifocal leukoencephalopathy 22.65 19.51 24 19917 12947 63456134
Cytokine release syndrome 22.40 19.51 25 19916 14289 63454792
Pathological fracture 22.29 19.51 20 19921 8814 63460267
Impaired healing 22.11 19.51 3 19938 102539 63366542
Contusion 21.66 19.51 10 19931 150034 63319047
Injection site pain 21.46 19.51 7 19934 129793 63339288
Hypoperfusion 21.24 19.51 10 19931 1457 63467624
Gait disturbance 21.10 19.51 16 19925 183162 63285919
Peripheral sensorimotor neuropathy 21.01 19.51 10 19931 1493 63467588
Febrile infection 20.67 19.51 10 19931 1547 63467534
Hepatic enzyme increased 20.48 19.51 20 19921 202308 63266773
Haemorrhoidal haemorrhage 20.16 19.51 14 19927 4265 63464816
Migraine 20.11 19.51 4 19937 103342 63365739
Respiratory syncytial virus infection 19.94 19.51 17 19924 7001 63462080
Pain in extremity 19.82 19.51 47 19894 331439 63137642
Enterocolitis bacterial 19.77 19.51 6 19935 258 63468823

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 1250.82 16.96 643 23213 52414 34880661
Neuropathy peripheral 237.38 16.96 288 23568 82975 34850100
Plasma cell myeloma recurrent 211.16 16.96 88 23768 4377 34928698
Polyneuropathy 196.60 16.96 124 23732 14772 34918303
Pneumonia 187.84 16.96 607 23249 362020 34571055
Off label use 183.07 16.96 663 23193 418861 34514214
Neutropenia 176.65 16.96 353 23503 156425 34776650
Plasmacytoma 175.39 16.96 73 23783 3618 34929457
Plasma cell myeloma refractory 175.23 16.96 47 23809 568 34932507
White blood cell count decreased 174.26 16.96 266 23590 95179 34837896
Plasma cell myeloma 166.98 16.96 173 23683 41864 34891211
COVID-19 pneumonia 153.95 16.96 112 23744 16855 34916220
COVID-19 149.84 16.96 222 23634 77328 34855747
Platelet count decreased 148.66 16.96 281 23575 119436 34813639
Thrombocytopenia 133.76 16.96 315 23541 155932 34777143
Drug interaction 122.97 16.96 8 23848 225938 34707137
Febrile neutropenia 108.56 16.96 268 23588 136581 34796494
Neutrophil count decreased 108.40 16.96 153 23703 50951 34882124
BK virus infection 94.30 16.96 55 23801 5683 34927392
Therapy partial responder 88.39 16.96 64 23792 9552 34923523
Cytopenia 80.71 16.96 68 23788 12655 34920420
Respiratory tract infection 79.77 16.96 82 23774 19630 34913445
Light chain analysis increased 74.36 16.96 30 23826 1371 34931704
Sepsis 71.76 16.96 263 23593 166298 34766777
Disease progression 70.62 16.96 197 23659 107880 34825195
Tumour lysis syndrome 63.72 16.96 68 23788 16991 34916084
Chills 63.38 16.96 158 23698 80885 34852190
Product use in unapproved indication 63.28 16.96 200 23656 117299 34815776
Parainfluenzae virus infection 62.62 16.96 33 23823 2797 34930278
Influenza 62.00 16.96 117 23739 49549 34883526
Coombs indirect test positive 60.18 16.96 11 23845 14 34933061
Product use issue 60.05 16.96 133 23723 63083 34869992
Crossmatch incompatible 56.62 16.96 9 23847 0 34933075
Myelosuppression 53.69 16.96 66 23790 19199 34913876
Pancytopenia 51.23 16.96 162 23694 94995 34838080
Monoclonal immunoglobulin present 51.13 16.96 21 23835 1005 34932070
Overdose 50.12 16.96 3 23853 91056 34842019
Spinal column injury 49.83 16.96 18 23838 606 34932469
Cystitis haemorrhagic 48.14 16.96 36 23820 5643 34927432
Toxicity to various agents 45.35 16.96 42 23814 200320 34732755
Cytomegalovirus infection reactivation 44.62 16.96 33 23823 5085 34927990
Progressive multifocal leukoencephalopathy 43.87 16.96 43 23813 9721 34923354
Infection 43.74 16.96 149 23707 90766 34842309
Cytomegalovirus infection 43.60 16.96 70 23786 26065 34907010
Septic shock 41.15 16.96 125 23731 71709 34861366
Respirovirus test positive 37.11 16.96 9 23847 70 34933005
Troponin T increased 37.04 16.96 22 23834 2349 34930726
Pyrexia 36.56 16.96 367 23489 332646 34600429
Pseudomyopia 35.85 16.96 8 23848 41 34933034
Hypercalcaemia 35.28 16.96 48 23808 15420 34917655
JC virus infection 33.23 16.96 20 23836 2188 34930887
Condition aggravated 33.08 16.96 50 23806 192146 34740929
Diverticular perforation 31.88 16.96 23 23833 3411 34929664
HCoV-OC43 infection 30.59 16.96 7 23849 41 34933034
Anaemia 30.48 16.96 267 23589 233068 34700007
Bronchospasm 30.28 16.96 37 23819 10694 34922381
Monoclonal immunoglobulin increased 30.23 16.96 9 23847 162 34932913
Cytomegalovirus viraemia 30.21 16.96 31 23825 7399 34925676
Plasma cell leukaemia 29.75 16.96 14 23842 930 34932145
Atrial fibrillation 29.64 16.96 163 23693 122230 34810845
Cerebral toxoplasmosis 29.61 16.96 17 23839 1704 34931371
Cardiac failure 29.55 16.96 132 23724 91116 34841959
H1N1 influenza 29.50 16.96 14 23842 948 34932127
Headache 29.23 16.96 58 23798 200577 34732498
Hypogammaglobulinaemia 29.16 16.96 31 23825 7709 34925366
Metapneumovirus pneumonia 29.11 16.96 5 23851 3 34933072
Pneumonia influenzal 28.74 16.96 16 23840 1512 34931563
Keratopathy 28.11 16.96 12 23844 633 34932442
Laboratory test abnormal 27.89 16.96 50 23806 20341 34912734
Polyomavirus-associated nephropathy 27.42 16.96 22 23834 3822 34929253
Bacterial parotitis 26.09 16.96 6 23850 36 34933039
Cutaneous T-cell lymphoma 25.95 16.96 15 23841 1523 34931552
Spinal compression fracture 25.92 16.96 28 23828 7088 34925987
Neuromyotonia 25.68 16.96 6 23850 39 34933036
Full blood count decreased 25.57 16.96 45 23811 18043 34915032
Pityriasis rubra pilaris 24.76 16.96 7 23849 104 34932971
Autologous haematopoietic stem cell transplant 24.48 16.96 6 23850 49 34933026
Pneumonia respiratory syncytial viral 24.00 16.96 12 23844 911 34932164
Bacteraemia 22.80 16.96 45 23811 19672 34913403
Herpes zoster 22.70 16.96 63 23793 34336 34898739
N-terminal prohormone brain natriuretic peptide increased 22.54 16.96 17 23839 2698 34930377
Arthralgia 22.39 16.96 52 23804 169989 34763086
Depression 22.35 16.96 20 23836 97078 34835997
Blood immunoglobulin G decreased 21.29 16.96 13 23843 1460 34931615
Pathological fracture 20.97 16.96 20 23836 4371 34928704
Light chain analysis decreased 20.84 16.96 5 23851 37 34933038
Neoplasm 20.78 16.96 22 23834 5445 34927630
Blood creatine phosphokinase increased 20.66 16.96 3 23853 44854 34888221
Cytokine release syndrome 20.43 16.96 47 23809 22830 34910245
Mastoiditis 20.40 16.96 10 23846 727 34932348
B precursor type acute leukaemia 20.20 16.96 7 23849 208 34932867
Agitation 20.14 16.96 7 23849 57392 34875683
Myelodysplastic syndrome 20.03 16.96 42 23814 19166 34913909
Respiratory syncytial virus infection 19.79 16.96 20 23836 4689 34928386
Cardiac pacemaker evaluation 19.37 16.96 6 23850 124 34932951
Squamous cell carcinoma of skin 19.32 16.96 30 23826 10851 34922224
Pneumocystis jirovecii pneumonia 19.29 16.96 42 23814 19668 34913407
Intentional product misuse 18.94 16.96 4 23852 45607 34887468
Pneumonia cytomegaloviral 18.70 16.96 16 23840 3038 34930037
Blood immunoglobulin M increased 18.70 16.96 7 23849 261 34932814
Minimal residual disease 18.61 16.96 8 23848 429 34932646
Viral haemorrhagic cystitis 18.57 16.96 11 23845 1169 34931906
Bone pain 17.93 16.96 42 23814 20644 34912431
Back pain 17.79 16.96 143 23713 121646 34811429
Bronchopulmonary aspergillosis 17.61 16.96 34 23822 14625 34918450
Dizziness 17.59 16.96 83 23773 218438 34714637
Hyperkalaemia 17.57 16.96 13 23843 69376 34863699
Blood immunoglobulin A increased 17.35 16.96 7 23849 320 34932755
Breathing-related sleep disorder 17.20 16.96 6 23850 182 34932893
Chloroma 17.19 16.96 8 23848 518 34932557
Weight increased 17.17 16.96 23 23833 93010 34840065
Somnolence 17.14 16.96 31 23825 111085 34821990
Lower respiratory tract infection 17.12 16.96 54 23802 31583 34901492
Bone lesion 17.09 16.96 15 23841 2948 34930127
Injection site pain 17.08 16.96 3 23853 39002 34894073
Alanine aminotransferase increased 17.03 16.96 18 23838 80797 34852278
Diarrhoea 16.98 16.96 366 23490 389546 34543529

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
Infusion related reaction 1244.76 16.75 942 35202 229295 79478949
Neutropenia 510.55 16.75 639 35505 287071 79421173
Neuropathy peripheral 418.76 16.75 411 35733 140894 79567350
Pneumonia 416.75 16.75 919 35225 659327 79048917
Thrombocytopenia 387.82 16.75 536 35608 264723 79443521
Plasma cell myeloma 338.32 16.75 241 35903 53018 79655226
Off label use 322.15 16.75 1019 35125 906196 78802048
Platelet count decreased 303.35 16.75 406 35738 194258 79513986
Plasma cell myeloma recurrent 292.50 16.75 103 36041 4898 79703346
Polyneuropathy 288.49 16.75 163 35981 23988 79684256
Febrile neutropenia 280.79 16.75 428 35716 230571 79477673
COVID-19 pneumonia 279.47 16.75 170 35974 28679 79679565
Neutrophil count decreased 266.42 16.75 267 35877 93692 79614552
White blood cell count decreased 260.68 16.75 371 35773 187917 79520327
COVID-19 250.33 16.75 332 35812 157342 79550902
Cytopenia 233.83 16.75 134 36010 20249 79687995
Plasmacytoma 228.50 16.75 83 36061 4320 79703924
Sepsis 179.00 16.75 384 35760 269044 79439200
Plasma cell myeloma refractory 165.24 16.75 42 36102 630 79707614
Tumour lysis syndrome 162.78 16.75 113 36031 23826 79684418
Coombs indirect test positive 147.74 16.75 26 36118 46 79708198
Myelosuppression 141.61 16.75 129 36015 40167 79668077
Cytomegalovirus infection 131.58 16.75 127 36017 42517 79665727
Drug interaction 130.72 16.75 17 36127 415166 79293078
Pancytopenia 120.14 16.75 245 35899 165500 79542744
Light chain analysis increased 114.43 16.75 39 36105 1679 79706565
Product use in unapproved indication 112.54 16.75 307 35837 250052 79458192
Crossmatch incompatible 111.35 16.75 19 36125 25 79708219
Septic shock 110.48 16.75 199 35945 122602 79585642
Atrial fibrillation 106.81 16.75 260 35884 197626 79510618
Respiratory tract infection 103.71 16.75 119 36025 48570 79659674
Meningitis listeria 102.59 16.75 32 36112 1037 79707207
Disease progression 99.24 16.75 242 35902 184120 79524124
Cytomegalovirus infection reactivation 99.13 16.75 57 36087 8659 79699585
Plasma cell leukaemia 97.66 16.75 35 36109 1751 79706493
Anaemia 95.66 16.75 427 35717 444588 79263656
Therapy partial responder 95.18 16.75 72 36072 17325 79690919
BK virus infection 93.32 16.75 55 36089 8749 79699495
Headache 92.68 16.75 96 36048 653676 79054568
Pyrexia 88.28 16.75 567 35577 678142 79030102
Arthralgia 86.77 16.75 79 36065 571724 79136520
Drug hypersensitivity 79.35 16.75 19 36125 298897 79409347
Bronchospasm 78.49 16.75 75 36069 24784 79683460
Parainfluenzae virus infection 77.85 16.75 42 36102 5640 79702604
Chills 77.49 16.75 202 35942 160032 79548212
Leukopenia 72.56 16.75 162 35982 116351 79591893
Joint swelling 71.58 16.75 21 36123 288625 79419619
Pseudomyopia 70.65 16.75 15 36129 95 79708149
Toxicity to various agents 70.37 16.75 53 36091 421487 79286757
Monoclonal immunoglobulin present 69.81 16.75 24 36120 1061 79707183
Hypogammaglobulinaemia 69.52 16.75 53 36091 12898 79695346
Cardiac failure 68.61 16.75 189 35955 154653 79553591
Condition aggravated 65.01 16.75 79 36065 501045 79207199
Death 62.63 16.75 455 35689 566059 79142185
Intentional product use issue 60.89 16.75 179 35965 151933 79556311
Overdose 56.81 16.75 8 36136 184198 79524046
Weight increased 55.80 16.75 28 36116 277358 79430886
Abdominal discomfort 55.63 16.75 22 36122 250705 79457539
Swelling 55.13 16.75 15 36129 216696 79491548
Hypercalcaemia 54.91 16.75 77 36067 38353 79669891
Body dysmorphic disorder 54.50 16.75 15 36129 310 79707934
Influenza 52.33 16.75 153 35991 129453 79578791
Progressive multifocal leukoencephalopathy 51.90 16.75 55 36089 20545 79687699
Alopecia 51.82 16.75 20 36124 231335 79476909
Pain 51.78 16.75 156 35988 703646 79004598
Arthropathy 49.52 16.75 10 36134 177101 79531143
Cytokine release syndrome 48.30 16.75 70 36074 35928 79672316
Deep vein thrombosis 48.10 16.75 142 36002 120777 79587467
Lymphopenia 47.84 16.75 64 36080 30493 79677751
Pathological fracture 47.69 16.75 39 36105 10498 79697746
Pneumonia cytomegaloviral 47.37 16.75 29 36115 4940 79703304
Myelodysplastic syndrome 46.73 16.75 63 36081 30238 79678006
Therapeutic product effect decreased 46.34 16.75 9 36135 163854 79544390
Respiratory failure 46.05 16.75 183 35961 180728 79527516
Cystitis haemorrhagic 45.88 16.75 36 36108 9136 79699108
Morganella infection 43.10 16.75 17 36127 1110 79707134
Cerebral toxoplasmosis 42.58 16.75 21 36123 2341 79705903
Pneumocystis jirovecii pneumonia 41.86 16.75 62 36082 32446 79675798
Musculoskeletal stiffness 41.10 16.75 14 36130 174994 79533250
Product use issue 40.26 16.75 195 35949 209627 79498617
Contraindicated product administered 39.88 16.75 11 36133 157527 79550717
Blister 39.77 16.75 4 36140 119472 79588772
Osteolysis 39.71 16.75 25 36119 4473 79703771
Cerebellar haemangioma 38.94 16.75 9 36135 88 79708156
Squamous cell carcinoma of skin 38.10 16.75 39 36105 13994 79694250
Listeria sepsis 38 16.75 14 36130 758 79707486
Treatment failure 37.74 16.75 15 36129 170471 79537773
Injection site pain 36.98 16.75 7 36137 129831 79578413
Acute myopia 36.74 16.75 9 36135 115 79708129
Depression 36.45 16.75 27 36117 216763 79491481
Light chain analysis abnormal 36.41 16.75 10 36134 205 79708039
Pneumonia influenzal 35.74 16.75 20 36124 2884 79705360
Cytomegalovirus viraemia 35.48 16.75 36 36108 12785 79695459
Respirovirus test positive 35.47 16.75 9 36135 134 79708110
Respiratory syncytial virus infection 34.79 16.75 31 36113 9371 79698873
Troponin T increased 34.72 16.75 21 36123 3501 79704743
Mobility decreased 33.93 16.75 7 36137 122168 79586076
Pericarditis 33.39 16.75 4 36140 104232 79604012
Peripheral sensory neuropathy 33.19 16.75 35 36109 12998 79695246
Diarrhoea 33.04 16.75 571 35573 879918 78828326
Anxiety 32.35 16.75 39 36105 248473 79459771
Spinal column injury 32.23 16.75 17 36127 2181 79706063
Cardiac amyloidosis 32.10 16.75 16 36128 1824 79706420
Keratopathy 32.09 16.75 14 36130 1180 79707064
Endocarditis bacterial 31.82 16.75 15 36129 1514 79706730
Somnolence 31.65 16.75 37 36107 238944 79469300
Wound 31.56 16.75 7 36137 116172 79592072
Diverticular perforation 31.37 16.75 24 36120 5869 79702375
Neutropenic sepsis 31.15 16.75 49 36095 27015 79681229
Bronchopulmonary aspergillosis 30.85 16.75 44 36100 22250 79685994
JC virus infection 30.38 16.75 20 36124 3861 79704383
H1N1 influenza 30.06 16.75 17 36127 2502 79705742
Pneumonia pneumococcal 29.67 16.75 20 36124 4017 79704227
Visceral leishmaniasis 29.64 16.75 13 36131 1110 79707134
Enterocolitis bacterial 28.97 16.75 11 36133 648 79707596
Plasma cells decreased 28.54 16.75 6 36138 36 79708208
Contusion 28.45 16.75 16 36128 148760 79559484
Cytomegalovirus chorioretinitis 28.44 16.75 22 36122 5468 79702776
Infection 28.26 16.75 197 35947 241515 79466729
Bacteraemia 27.97 16.75 52 36092 32772 79675472
Polyomavirus-associated nephropathy 27.96 16.75 22 36122 5605 79702639
Urosepsis 27.80 16.75 46 36098 26449 79681795
Transplant 27.68 16.75 12 36132 996 79707248
Full blood count decreased 27.39 16.75 46 36098 26773 79681471
Blood cholesterol increased 27.35 16.75 3 36141 83717 79624527
Pityriasis rubra pilaris 27.06 16.75 7 36137 113 79708131
Pseudomembranous colitis 26.68 16.75 21 36123 5353 79702891
Haematotoxicity 26.62 16.75 34 36110 15485 79692759
Pulmonary embolism 26.35 16.75 150 35994 171504 79536740
Metapneumovirus pneumonia 25.93 16.75 6 36138 59 79708185
Hepatic enzyme increased 25.57 16.75 27 36117 182583 79525661
Spinal cord compression 25.55 16.75 22 36122 6355 79701889
Gait disturbance 25.51 16.75 34 36110 207472 79500772
Intentional product misuse 25.32 16.75 6 36138 95159 79613085
Intraductal proliferative breast lesion 24.93 16.75 15 36129 2476 79705768
Pneumococcal sepsis 24.78 16.75 13 36131 1649 79706595
Discomfort 24.76 16.75 13 36131 125604 79582640
Minimal residual disease 24.24 16.75 9 36135 498 79707746
Plasmablastic lymphoma 23.90 16.75 9 36135 518 79707726
Cutaneous T-cell lymphoma 23.80 16.75 15 36129 2688 79705556
Herpes zoster 23.53 16.75 94 36050 92989 79615255
American trypanosomiasis 23.39 16.75 8 36136 348 79707896
Abdominal pain upper 23.35 16.75 41 36103 223778 79484466
Atrial flutter 23.30 16.75 38 36106 21587 79686657
Stress 23.30 16.75 4 36140 79608 79628636
Bone lesion 22.87 16.75 20 36124 5899 79702345
Neuromyotonia 22.74 16.75 6 36138 105 79708139
Colorectal adenocarcinoma 22.60 16.75 8 36136 386 79707858
Pain in extremity 22.51 16.75 87 36057 364451 79343793
Injury 22.45 16.75 4 36140 77492 79630752
N-terminal prohormone brain natriuretic peptide increased 22.36 16.75 18 36126 4737 79703507
Bacterial parotitis 22.31 16.75 5 36139 42 79708202
Mastoiditis 21.69 16.75 12 36132 1692 79706552
Helicobacter infection 21.54 16.75 3 36141 69701 79638543
Joint ankylosis 21.49 16.75 13 36131 2167 79706077
Cardiac pacemaker evaluation 21.49 16.75 6 36138 131 79708113
Rhinovirus infection 21.40 16.75 22 36122 7931 79700313
Bone marrow failure 21.25 16.75 61 36083 51046 79657198
Inflammation 21.15 16.75 8 36136 93745 79614499
Gastrointestinal infection 21.07 16.75 26 36118 11435 79696809
Nasopharyngitis 21.04 16.75 53 36091 253828 79454416
Guillain-Barre syndrome 20.94 16.75 23 36121 8942 79699302
Pneumonia bacterial 20.87 16.75 34 36110 19297 79688947
Dry mouth 20.73 16.75 7 36137 88012 79620232
Migraine 20.53 16.75 7 36137 87486 79620758
Osteoarthritis 20.46 16.75 7 36137 87302 79620942
Hepatitis B reactivation 20.37 16.75 19 36125 6089 79702155
Escherichia sepsis 20.17 16.75 22 36122 8486 79699758
Hepatitis E 20.07 16.75 14 36130 2972 79705272
Ill-defined disorder 19.97 16.75 3 36141 65872 79642372
Psoriasis 19.62 16.75 8 36136 89579 79618665
Oropharyngeal discomfort 19.61 16.75 20 36124 7146 79701098
Acute pulmonary oedema 19.57 16.75 28 36116 14202 79694042
Pulmonary sepsis 19.50 16.75 15 36129 3697 79704547
Malaise 18.98 16.75 137 36007 489732 79218512
Memory impairment 18.66 16.75 14 36130 111720 79596524
Dizziness 18.63 16.75 151 35993 526290 79181954
Encephalopathy 18.61 16.75 70 36074 67327 79640917
Embolism 18.48 16.75 27 36117 13955 79694289
Breathing-related sleep disorder 18.45 16.75 6 36138 223 79708021
Blood pressure fluctuation 18.33 16.75 4 36140 67141 79641103
Coombs direct test positive 18.25 16.75 7 36137 424 79707820
Acute myeloid leukaemia 18.16 16.75 42 36102 30843 79677401
Weight decreased 18.15 16.75 91 36053 355107 79353137
Vaccination failure 18.14 16.75 11 36133 1842 79706402
Rectal haemorrhage 18.09 16.75 6 36138 76294 79631950
Stomatitis 18.08 16.75 24 36120 146733 79561511
Meningitis cryptococcal 18.05 16.75 14 36130 3492 79704752
Coombs test positive 17.98 16.75 6 36138 242 79708002
Pneumonia respiratory syncytial viral 17.94 16.75 11 36133 1879 79706365
Hypoglycaemia 17.93 16.75 12 36132 101582 79606662
Blood creatine phosphokinase increased 17.91 16.75 4 36140 66086 79642158
Coma 17.61 16.75 12 36132 100637 79607607
Abdominal pain 17.59 16.75 104 36040 389465 79318779
Partial seizures 17.54 16.75 21 36123 8957 79699287
Sudden hearing loss 17.52 16.75 11 36133 1958 79706286
Peripheral swelling 17.51 16.75 63 36081 269554 79438690
Thrombosis 17.45 16.75 80 36064 84020 79624224
Palpitations 17.40 16.75 19 36125 126591 79581653
Oxygen saturation decreased 17.38 16.75 109 36035 128938 79579306
Gait inability 17.15 16.75 3 36141 58914 79649330
Injection site erythema 17.10 16.75 7 36137 78190 79630054
Viral haemorrhagic cystitis 17.06 16.75 11 36133 2050 79706194
Abdominal sepsis 17.06 16.75 11 36133 2051 79706193

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
CD38 (Clusters of Differentiation 38) inhibitors
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 | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Systemic AL amyloidosis indication 23132008
Multiple myeloma indication 109989006 DOID:9538




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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DARZALEX HUMAN PRESCRIPTION DRUG LABEL 1 57894-502 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
DARZALEX HUMAN PRESCRIPTION DRUG LABEL 1 57894-502 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
DARZALEX HUMAN PRESCRIPTION DRUG LABEL 1 57894-502 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
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
Darzalex Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-503 INJECTION 1800 mg SUBCUTANEOUS BLA 32 sections
Darzalex Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-503 INJECTION 1800 mg SUBCUTANEOUS BLA 32 sections
Darzalex Faspro HUMAN PRESCRIPTION DRUG LABEL 2 57894-503 INJECTION 1800 mg SUBCUTANEOUS BLA 32 sections
Darzalex IV HUMAN PRESCRIPTION DRUG LABEL 1 57894-505 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
Darzalex IV HUMAN PRESCRIPTION DRUG LABEL 1 57894-505 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
Darzalex IV HUMAN PRESCRIPTION DRUG LABEL 1 57894-505 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections
Darzalex IV HUMAN PRESCRIPTION DRUG LABEL 1 57894-505 INJECTION, SOLUTION, CONCENTRATE 100 mg INTRAVENOUS BLA 32 sections