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

Stem definitionDrug idCAS RN
B-cell lymphoma 2 (Bcl-2) inhibitors, antineoplastics 5133 1257044-40-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • venclyxto
  • venetoclax
  • ABT-199
  • venclexta
  • GDC-0199
Venetoclax is a selective and orally bioavailable small-molecule inhibitor of BCL-2, an anti-apoptotic protein. Overexpression of BCL-2 has been demonstrated in CLL cells where it mediates tumor cell survival and has been associated with resistance to chemotherapeutics. Venetoclax helps restore the process of apoptosis by binding directly to the BCL-2 protein, displacing pro-apoptotic proteins like BIM, triggering mitochondrial outer membrane permeabilization and the activation of caspases. In nonclinical studies, venetoclax has demonstrated cytotoxic activity in tumor cells that overexpress BCL-2.
  • Molecular weight: 868.45
  • Formula: C45H50ClN7O7S
  • CLOGP: 10.21
  • LIPINSKI: 3
  • HAC: 14
  • HDO: 3
  • TPSA: 172.03
  • ALOGS: -5.97
  • ROTB: 12
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O

ADMET properties:

PropertyValueReference
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.057 Moderate 0.75
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.350 Moderate 0.75
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.098 10^-6 cm/s Moderate 0.75
dh-clint Dog hepatocyte intrinsic clearance 6.412 uL/min/10^6 cells Moderate 0.75
dppb Dog plasma protein binding (% unbound) 0.240 % Moderate 0.75
fcs-ppb Fetal calf serum protein binding (% unbound) 0.150 % Moderate 0.75
herg hERG pIC50 4.719 pIC50 Moderate 0.75
hh-clint Human hepatocyte intrinsic clearance 8.318 uL/min/10^6 cells Moderate 0.75
hlm-clint Human liver microsomal intrinsic clearance 14.191 uL/min/mg protein Moderate 0.75
hppb Human plasma protein binding (% unbound) 0.490 % Moderate 0.75
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AURKB,AXL,BMX,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK2,CDK5,CDK9,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,EPHA2,EPHB4,ERBB2,FGFR1,FLT3,GRK1,GRK2,GSK3B,IKBKB,INSR,ITK,JAK1,JAK2,JAK3,KDR,KIT,MAP2K1,MAP2K6,MAP3K1,MAP3K10,MAP3K11,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK1,MAPK10,MAPK14,MAPK7,MAPK8,MAPK9,MAPKAPK2,MARK4,MELK,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM2,PRKCD,PRKDC,SIK2,SIK3,SRC,STK33,SYK,TEK,TTK,UHMK1,ULK1,ULK2,ZAP70 82
kinase-selectivity-class ACVR2B,AXL,DDR1,ERBB2,GRK2,MAPK7,PDK4,SIK2,STK33,TEK,TTK 11
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.143 Moderate 0.75
mh-clint Mouse hepatocyte intrinsic clearance 5.861 Moderate 0.75
mppb Mouse plasma protein binding (% unbound) 0.230 Moderate 0.75
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.153 Moderate 0.75
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.120 % Moderate 0.75
rh-clint Rat hepatocyte intrinsic clearance 6.855 uL/min/10^6 cells Moderate 0.75
rh-fuinc Rat hepatocyte fraction unbound in incubation 0.320 % Moderate 0.75
rppb Rat plasma protein binding (% unbound) 0.150 % Moderate 0.75
solubility-dd Solubility at pH 7.4 in DMSO 1.730 uM Moderate 0.75

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2019 PMDA AbbVie GK
Dec. 5, 2016 EMA AbbVie Ltd
April 11, 2016 FDA ABBVIE INC

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
Myelosuppression 2726.39 21.50 921 29798 52670 90545058
Death 2284.17 21.50 1582 29137 454969 90142759
Febrile neutropenia 1520.38 21.50 835 29884 157514 90440214
Neutropenia 1334.80 21.50 870 29849 224034 90373694
Off label use 1184.83 21.50 1639 29080 1100613 89497115
Tumour lysis syndrome 819.53 21.50 254 30465 10898 90586830
Cytopenia 692.90 21.50 250 30469 17199 90580529
Acute myeloid leukaemia recurrent 672.91 21.50 153 30566 1904 90595824
Thrombocytopenia 514.46 21.50 481 30238 208244 90389484
Hospice care 500.47 21.50 169 30550 9535 90588193
Pancytopenia 495.31 21.50 373 30346 119890 90477838
Neutrophil count decreased 432.80 21.50 281 30438 71251 90526477
Platelet count decreased 419.24 21.50 357 30362 136612 90461116
Disease progression 414.88 21.50 376 30343 156239 90441489
Sepsis 370.73 21.50 376 30343 179438 90418290
White blood cell count decreased 334.53 21.50 344 30375 166765 90430963
COVID-19 265.25 21.50 306 30413 168537 90429191
Anaemia 238.89 21.50 428 30291 352374 90245354
Pyrexia 215.72 21.50 598 30121 659887 89937841
Allogenic stem cell transplantation 173.67 21.50 32 30687 121 90597607
Pain 171.87 21.50 62 30657 996279 89601449
Pneumonia 162.95 21.50 530 30189 637529 89960199
Acute myeloid leukaemia 157.33 21.50 94 30625 20546 90577182
Pneumonia fungal 152.33 21.50 65 30654 6966 90590762
Joint swelling 148.40 21.50 5 30714 503295 90094433
Agranulocytosis 144.76 21.50 109 30610 34893 90562835
Blast cell count increased 144.53 21.50 34 30685 495 90597233
Bacteraemia 143.10 21.50 91 30628 22209 90575519
Granulocyte count decreased 127.55 21.50 43 30676 2409 90595319
Blood lactate dehydrogenase increased 125.93 21.50 89 30630 25843 90571885
Septic shock 124.42 21.50 148 30571 84012 90513716
Blood disorder 123.88 21.50 58 30661 7732 90589996
Lymphadenopathy 117.21 21.50 108 30611 45667 90552061
Intentional product use issue 114.37 21.50 237 30482 216655 90381073
Minimal residual disease 113.90 21.50 27 30692 407 90597321
Arthralgia 112.75 21.50 62 30657 778460 89819268
Systemic lupus erythematosus 101.89 21.50 5 30714 361891 90235837
Swelling 100.66 21.50 12 30707 419046 90178682
Headache 99.44 21.50 88 30631 862658 89735070
Bone marrow failure 98.38 21.50 84 30635 32137 90565591
Synovitis 98.11 21.50 3 30716 329749 90267979
Hospitalisation 96.27 21.50 163 30556 127937 90469791
Acute myeloid leukaemia refractory 95.88 21.50 19 30700 114 90597614
COVID-19 pneumonia 92.02 21.50 64 30655 18113 90579615
Bone marrow transplant 91.06 21.50 26 30693 834 90596894
Bone marrow disorder 89.53 21.50 35 30684 2997 90594731
Protothecosis 86.54 21.50 22 30697 449 90597279
Wound 85.87 21.50 4 30715 302976 90294752
Chronic lymphocytic leukaemia recurrent 85.09 21.50 21 30698 378 90597350
Bronchopulmonary aspergillosis 84.49 21.50 51 30668 11347 90586381
Stem cell transplant 82.22 21.50 30 30689 2124 90595604
Infection 80.83 21.50 288 30431 361806 90235922
Maternal exposure during pregnancy 80.13 21.50 13 30706 360050 90237678
Nasopharyngitis 77.68 21.50 21 30698 407083 90190645
Haematotoxicity 77.55 21.50 50 30669 12485 90585243
Systemic candida 76.01 21.50 36 30683 4923 90592805
Alopecia 75.15 21.50 37 30682 495034 90102694
Abdominal discomfort 75.02 21.50 34 30685 477294 90120434
Peripheral swelling 72.17 21.50 25 30694 413081 90184647
Rash 71.05 21.50 100 30619 796000 89801728
Product dose omission issue 70.89 21.50 8 30711 291679 90306049
Urticaria 70.23 21.50 11 30708 312723 90285005
Leukopenia 70.22 21.50 124 30595 100586 90497142
Weight increased 70.12 21.50 27 30692 417900 90179828
Leukaemia 69.72 21.50 34 30685 4958 90592770
Transplant 69.12 21.50 22 30697 1027 90596701
Splenomegaly 68.94 21.50 47 30672 12877 90584851
Hypoaesthesia 68.45 21.50 12 30707 314198 90283530
Infusion related reaction 68.16 21.50 28 30691 416752 90180976
Exposure during pregnancy 68.03 21.50 3 30716 238407 90359321
Cord blood transplant therapy 66.62 21.50 11 30708 17 90597711
Hyperuricaemia 65.67 21.50 36 30683 6683 90591045
Febrile bone marrow aplasia 65.62 21.50 41 30678 9697 90588031
Transformation to acute myeloid leukaemia 65.32 21.50 17 30702 382 90597346
Pericarditis 64.18 21.50 8 30711 270143 90327585
Aspergillus infection 64.08 21.50 42 30677 10781 90586947
Therapeutic product effect decreased 64.08 21.50 9 30710 277562 90320166
Impaired healing 63.52 21.50 4 30715 234195 90363533
Blister 61.94 21.50 7 30712 254991 90342737
Wheezing 61.89 21.50 5 30714 238075 90359653
Discomfort 60.80 21.50 10 30709 274325 90323403
Pseudomonas infection 60.80 21.50 46 30673 14819 90582909
Hyperphosphataemia 60.15 21.50 28 30691 3683 90594045
Lymphocytosis 59.33 21.50 26 30693 2971 90594757
Drug hypersensitivity 58.63 21.50 43 30676 463566 90134162
Atrial fibrillation 57.87 21.50 135 30584 133476 90464252
Hypersensitivity 57.72 21.50 42 30677 454635 90143093
Lymphoma 57.68 21.50 43 30676 13548 90584180
Asthma 55.55 21.50 8 30711 242152 90355576
Blast cells present 55.37 21.50 16 30703 536 90597192
Hyperbilirubinaemia 54.52 21.50 42 30677 13894 90583834
Pruritus 54.50 21.50 62 30657 541463 90056265
Pleural effusion 53.89 21.50 118 30601 111873 90485855
Soft tissue infection 53.70 21.50 24 30695 2873 90594855
Escherichia sepsis 53.66 21.50 30 30689 5786 90591942
Granulocytopenia 53.45 21.50 31 30688 6410 90591318
Rhinovirus infection 52.96 21.50 30 30689 5933 90591795
Respiratory failure 51.66 21.50 120 30599 118298 90479430
Type 2 diabetes mellitus 50.84 21.50 5 30714 203239 90394489
Pain in extremity 49.34 21.50 48 30671 450481 90147247
Myelodysplastic syndrome 49.04 21.50 47 30672 20856 90576872
Hepatic enzyme increased 48.87 21.50 31 30688 360705 90237023
Neutropenic sepsis 48.78 21.50 44 30675 18086 90579642
Escherichia bacteraemia 48.65 21.50 28 30691 5707 90592021
Dizziness 48.64 21.50 78 30641 589206 90008522
Full blood count decreased 48.51 21.50 55 30664 29634 90568094
Pneumonia adenoviral 47.67 21.50 12 30707 235 90597493
Multiple organ dysfunction syndrome 47.44 21.50 84 30635 68252 90529476
Blood phosphorus increased 47.42 21.50 25 30694 4293 90593435
Chronic lymphocytic leukaemia refractory 47.31 21.50 9 30710 42 90597686
Condition aggravated 47.14 21.50 81 30638 595464 90002264
Leukaemia recurrent 47.11 21.50 18 30701 1449 90596279
Injection site pain 47.00 21.50 3 30716 173696 90424032
Sleep disorder 46.70 21.50 6 30713 198024 90399704
Malaise 46.10 21.50 80 30639 585906 90011822
Insomnia 46.08 21.50 28 30691 333446 90264282
Subdural haematoma 45.98 21.50 41 30678 16604 90581124
Sinusitis 45.77 21.50 30 30689 343058 90254670
Cerebral haemorrhage 44.99 21.50 57 30662 34465 90563263
Dry mouth 44.82 21.50 5 30714 184054 90413674
Chronic lymphocytic leukaemia transformation 44.60 21.50 9 30710 60 90597668
Dyspnoea 44.32 21.50 152 30567 880803 89716925
Staphylococcal bacteraemia 44.26 21.50 29 30690 7440 90590288
Drug intolerance 44.20 21.50 52 30667 447539 90150189
Myeloblast count increased 43.60 21.50 7 30712 8 90597720
Injury 41.96 21.50 8 30711 197341 90400387
Periorbital cellulitis 41.89 21.50 14 30705 763 90596965
Haemoglobin decreased 41.48 21.50 135 30584 161821 90435907
Graft versus host disease in skin 41.44 21.50 22 30697 3831 90593897
Muscle spasms 41.02 21.50 17 30702 251866 90345862
Lower respiratory tract infection 40.69 21.50 17 30702 250642 90347086
Adenoviral hepatitis 40.49 21.50 12 30707 440 90597288
Anxiety 40.09 21.50 28 30691 309744 90287984
Lymphocyte count decreased 39.67 21.50 54 30665 34996 90562732
Osteoarthritis 39.42 21.50 9 30710 195721 90402007
Paraesthesia 39.01 21.50 18 30701 250308 90347420
Parainfluenzae virus infection 38.87 21.50 19 30700 2784 90594944
Gait disturbance 38.67 21.50 20 30699 260476 90337252
Autoimmune haemolytic anaemia 38.62 21.50 24 30695 5621 90592107
Pneumonia bacterial 38.33 21.50 33 30686 12757 90584971
Ill-defined disorder 38.25 21.50 8 30711 184883 90412845
Migraine 37.86 21.50 9 30710 190383 90407345
Osteolysis 37.42 21.50 20 30699 3530 90594198
Blood pressure increased 36.05 21.50 11 30708 197206 90400522
Somnolence 35.88 21.50 13 30706 209071 90388657
Abdominal pain upper 35.76 21.50 36 30683 332638 90265090
Fatigue 35.30 21.50 238 30481 1153785 89443943
Plasma cells increased 35.06 21.50 8 30711 101 90597627
Fibrosis 35.00 21.50 23 30696 5929 90591799
Hypogammaglobulinaemia 34.99 21.50 29 30690 10645 90587083
Musculoskeletal pain 34.23 21.50 8 30711 171243 90426485
Fusarium infection 33.75 21.50 13 30706 1069 90596659
Treatment failure 33.69 21.50 32 30687 303896 90293832
Chemotherapy 33.43 21.50 15 30704 1812 90595916
Depression 32.91 21.50 32 30687 300569 90297159
Hypertension 32.83 21.50 66 30653 457466 90140262
Leukaemia cutis 32.31 21.50 8 30711 146 90597582
Overdose 32.26 21.50 7 30712 157702 90440026
Pseudomonal bacteraemia 32.18 21.50 15 30704 1979 90595749
Mobility decreased 31.99 21.50 23 30696 250711 90347017
Pneumonia klebsiella 31.52 21.50 17 30702 3055 90594673
Non-small cell lung cancer 30.92 21.50 19 30700 4362 90593366
Mucormycosis 30.67 21.50 18 30701 3803 90593925
Chest pain 30.61 21.50 38 30681 319607 90278121
Cytokine release syndrome 30.01 21.50 42 30677 27931 90569797
Joint range of motion decreased 29.91 21.50 5 30714 135638 90462090
Haemorrhage intracranial 29.86 21.50 31 30688 15131 90582597
Renal failure 29.83 21.50 105 30614 130902 90466826
Hypokalaemia 29.78 21.50 105 30614 131011 90466717
Lymphocyte count increased 29.66 21.50 18 30701 4041 90593687
Scedosporium infection 29.66 21.50 11 30708 815 90596913
Blood uric acid increased 29.66 21.50 23 30696 7681 90590047
Contusion 29.57 21.50 25 30694 251191 90346537
Human herpesvirus 6 encephalitis 28.61 21.50 9 30710 404 90597324
Differentiation syndrome 27.82 21.50 12 30707 1319 90596409
Splenic abscess 27.63 21.50 8 30711 270 90597458
Autologous haematopoietic stem cell transplant 27.33 21.50 5 30714 18 90597710
Neutropenic infection 27.32 21.50 13 30706 1796 90595932
Liver injury 26.98 21.50 12 30707 170555 90427173
Plasma cell myeloma recurrent 26.48 21.50 17 30702 4211 90593517
Bacterial sepsis 26.38 21.50 18 30701 4937 90592791
Fungal sepsis 26.14 21.50 12 30707 1529 90596199
Arthritis 26.11 21.50 12 30707 167303 90430425
Wound infection 25.62 21.50 3 30716 106399 90491329
Clostridium difficile colitis 25.58 21.50 38 30681 26668 90571060
Full blood count abnormal 25.41 21.50 45 30674 36552 90561176
C-reactive protein abnormal 25.37 21.50 6 30713 127423 90470305
Obesity 25.35 21.50 3 30716 105504 90492224
Gait inability 25.30 21.50 9 30710 146447 90451281
Clonal evolution 25.15 21.50 6 30713 93 90597635
Muscular weakness 25.02 21.50 20 30699 206646 90391082
Skin maceration 24.93 21.50 7 30712 211 90597517
Mantle cell lymphoma recurrent 24.60 21.50 8 30711 400 90597328
Inappropriate schedule of product administration 24.59 21.50 10 30709 149923 90447805
Lung infiltration 24.44 21.50 28 30691 15254 90582474
Disseminated mucormycosis 24.33 21.50 9 30710 662 90597066
Mantle cell lymphoma 24.23 21.50 9 30710 670 90597058
Disseminated intravascular coagulation 24.09 21.50 33 30686 21505 90576223
Memory impairment 23.99 21.50 19 30700 197225 90400503
Pseudomonal skin infection 23.92 21.50 4 30715 7 90597721
Portal vein cavernous transformation 23.81 21.50 6 30713 118 90597610
Road traffic accident 23.66 21.50 4 30715 107622 90490106
Hypocalcaemia 23.10 21.50 47 30672 42321 90555407
Platelet transfusion 23.09 21.50 10 30709 1110 90596618
Li-Fraumeni syndrome 22.95 21.50 4 30715 10 90597718
Blood calcium increased 22.58 21.50 24 30695 12034 90585694
Acute graft versus host disease 22.53 21.50 17 30702 5451 90592277
Malignant neoplasm progression 22.08 21.50 83 30636 106787 90490941
Enterobacter sepsis 22.03 21.50 7 30712 325 90597403
Transfusion related complication 21.95 21.50 4 30715 14 90597714
Amnesia 21.82 21.50 5 30714 108500 90489228
Sciatica 21.78 21.50 4 30715 101378 90496350
Leukostasis syndrome 21.71 21.50 5 30714 66 90597662
Abdominal mass 21.67 21.50 14 30705 3507 90594221
Hypercholesterolaemia 21.63 21.50 4 30715 100888 90496840

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
Myelosuppression 2305.33 17.19 1064 48808 39397 42532066
Death 2298.50 17.19 2767 47105 468418 42103045
Febrile neutropenia 1540.69 17.19 1453 48419 184250 42387213
Neutropenia 1333.76 17.19 1388 48484 198043 42373420
Off label use 1311.25 17.19 2510 47362 635825 41935638
Tumour lysis syndrome 1221.71 17.19 571 49301 21660 42549803
Acute myeloid leukaemia recurrent 573.73 17.19 198 49674 3314 42568149
Hospice care 569.46 17.19 251 49621 8262 42563201
Cytopenia 548.28 17.19 308 49564 17189 42554274
Thrombocytopenia 477.93 17.19 822 49050 189457 42382006
Pancytopenia 416.81 17.19 596 49276 117147 42454316
Neutrophil count decreased 362.75 17.19 408 49464 63007 42508456
COVID-19 351.61 17.19 546 49326 115402 42456061
Disease progression 315.65 17.19 586 49286 143070 42428393
Infection 269.99 17.19 476 49396 111592 42459871
Platelet count decreased 263.60 17.19 532 49340 138049 42433414
Intentional product use issue 261.75 17.19 369 49503 71464 42499999
Pneumonia 232.04 17.19 1041 48831 421108 42150355
White blood cell count decreased 228.18 17.19 439 49433 109957 42461506
Lymphadenopathy 203.23 17.19 222 49650 33143 42538320
Pyrexia 187.24 17.19 932 48940 393110 42178353
Acute myeloid leukaemia 169.57 17.19 167 49705 22089 42549374
Sepsis 169.23 17.19 565 49307 198769 42372694
Anaemia 167.82 17.19 710 49162 279568 42291895
Chronic lymphocytic leukaemia recurrent 154.58 17.19 49 49823 619 42570844
Toxicity to various agents 148.77 17.19 42 49830 229094 42342369
Pneumonia fungal 141.01 17.19 103 49769 9043 42562420
Product dose omission issue 136.37 17.19 12 49860 154353 42417110
Blast cell count increased 134.27 17.19 51 49821 1134 42570329
Bacteraemia 131.00 17.19 154 49718 24886 42546577
Minimal residual disease 129.14 17.19 42 49830 579 42570884
COVID-19 pneumonia 118.20 17.19 136 49736 21477 42549986
Transplant 111.50 17.19 42 49830 912 42570551
Allogenic stem cell transplantation 108.10 17.19 27 49845 129 42571334
Autoimmune haemolytic anaemia 103.96 17.19 71 49801 5600 42565863
Haematotoxicity 103.96 17.19 93 49779 10892 42560571
Chronic lymphocytic leukaemia 99.46 17.19 65 49807 4764 42566699
Bronchopulmonary aspergillosis 95.87 17.19 116 49756 19313 42552150
Completed suicide 95.64 17.19 4 49868 96461 42475002
Splenomegaly 94.44 17.19 108 49764 16939 42554524
Granulocyte count decreased 94.43 17.19 43 49829 1527 42569936
Septic shock 94.30 17.19 278 49594 91394 42480069
Condition aggravated 91.77 17.19 102 49770 260652 42310811
Acute myeloid leukaemia refractory 86.44 17.19 22 49850 115 42571348
Headache 86.02 17.19 92 49780 239277 42332186
Inappropriate schedule of product administration 83.20 17.19 8 49864 95894 42475569
Pruritus 81.65 17.19 61 49811 188710 42382753
Somnolence 79.15 17.19 33 49839 141072 42430391
Blood lactate dehydrogenase increased 76.28 17.19 121 49751 25960 42545503
Hyperuricaemia 76.04 17.19 73 49799 9351 42562112
Lymphocyte count increased 74.78 17.19 51 49821 4013 42567450
Hospitalisation 74.13 17.19 223 49649 74107 42497356
Blood pressure increased 73.28 17.19 15 49857 101913 42469550
Stem cell transplant 72.86 17.19 43 49829 2629 42568834
Leukaemia 71.36 17.19 57 49815 5715 42565748
Overdose 70.67 17.19 18 49854 105246 42466217
Neutropenic sepsis 68.76 17.19 89 49783 15857 42555606
Hypogammaglobulinaemia 68.70 17.19 77 49795 11814 42559649
Pain in extremity 68.61 17.19 46 49826 150558 42420905
Lymphocytosis 67.86 17.19 43 49829 2988 42568475
Anxiety 66.04 17.19 28 49844 118532 42452931
Weight increased 64.28 17.19 23 49849 107960 42463503
Bone marrow transplant 63.05 17.19 30 49842 1179 42570284
Chemotherapy 61.15 17.19 26 49846 781 42570682
Tremor 58.80 17.19 20 49852 96909 42474554
Anal inflammation 58.50 17.19 35 49837 2194 42569269
Mantle cell lymphoma recurrent 58.34 17.19 27 49845 996 42570467
Arthralgia 58.20 17.19 94 49778 205144 42366319
SARS-CoV-2 test negative 57.60 17.19 32 49840 1743 42569720
Bacillus infection 56.41 17.19 24 49848 722 42570741
Injection site pain 55.33 17.19 3 49869 57795 42513668
Asthma 54.56 17.19 5 49867 62309 42509154
Rash 54.30 17.19 156 49716 276798 42294665
Chronic lymphocytic leukaemia transformation 54.04 17.19 17 49855 209 42571254
Dizziness 53.69 17.19 134 49738 249120 42322343
Depression 53.47 17.19 32 49840 111331 42460132
Drug interaction 53.37 17.19 149 49723 266850 42304613
Joint swelling 53.27 17.19 8 49864 68014 42503449
Agranulocytosis 52.70 17.19 113 49759 30499 42540964
Blood disorder 52.52 17.19 41 49831 3976 42567487
Agitation 51.68 17.19 7 49865 64307 42507156
Pain 50.91 17.19 134 49738 244714 42326749
Myelodysplastic syndrome 50.02 17.19 93 49779 22652 42548811
Proctalgia 49.91 17.19 51 49821 7042 42564421
Seizure 49.51 17.19 41 49831 120520 42450943
Dyspnoea 49.25 17.19 310 49562 442311 42129152
Insomnia 48.83 17.19 40 49832 118213 42453250
Skin infection 47.90 17.19 57 49815 9323 42562140
Hypocalcaemia 45.89 17.19 106 49766 30067 42541396
Respiratory moniliasis 45.89 17.19 16 49856 276 42571187
Gait disturbance 45.88 17.19 29 49843 97971 42473492
Nasopharyngitis 44.94 17.19 21 49851 83975 42487488
Atrial fibrillation 44.70 17.19 298 49574 139295 42432168
Hypersensitivity 43.77 17.19 15 49857 72355 42499108
Blast cell count decreased 43.47 17.19 8 49864 3 42571460
Chest pain 43.31 17.19 60 49812 139470 42431993
Transfusion 42.72 17.19 57 49815 10457 42561006
Rhinovirus infection 42.34 17.19 45 49827 6503 42564960
Lymphoma 41.26 17.19 66 49806 14255 42557208
Soft tissue infection 40.76 17.19 30 49842 2663 42568800
Disease risk factor 40.71 17.19 10 49862 44 42571419
Palliative care 40.40 17.19 22 49850 1152 42570311
Escherichia sepsis 39.86 17.19 41 49831 5706 42565757
Bone marrow failure 39.51 17.19 106 49766 32987 42538476
Rhabdomyolysis 39.48 17.19 21 49851 77998 42493465
Bone marrow disorder 39.12 17.19 26 49846 1960 42569503
Emphysematous cholecystitis 38.99 17.19 11 49861 90 42571373
Hypoglycaemia 38.71 17.19 11 49861 59843 42511620
Confusional state 38.52 17.19 87 49785 167510 42403953
Rheumatoid arthritis 38.26 17.19 3 49869 42437 42529026
Escherichia bacteraemia 38.02 17.19 38 49834 5111 42566352
Hyperphosphataemia 37.56 17.19 60 49812 12944 42558519
Wheezing 37.46 17.19 9 49863 54772 42516691
International normalised ratio increased 36.95 17.19 6 49866 48162 42523301
Granulocytopenia 35.94 17.19 43 49829 7071 42564392
Hyperhidrosis 35.67 17.19 32 49840 90480 42480983
FLT3 gene mutation 35.42 17.19 7 49865 7 42571456
Paraesthesia 35.40 17.19 21 49851 73438 42498025
Blood glucose increased 34.23 17.19 22 49850 73677 42497786
Accident 34 17.19 40 49832 6463 42565000
Bradycardia 33.95 17.19 30 49842 85454 42486009
Dehydration 33.88 17.19 72 49800 141695 42429768
Sinusitis fungal 33.82 17.19 17 49855 754 42570709
Transformation to acute myeloid leukaemia 33.36 17.19 19 49853 1086 42570377
Mantle cell lymphoma refractory 33.22 17.19 10 49862 105 42571358
Muscle spasms 33.21 17.19 31 49841 86013 42485450
Dry mouth 32.86 17.19 4 49868 39875 42531588
Loss of personal independence in daily activities 32.50 17.19 9 49863 49807 42521656
Blood uric acid abnormal 32.18 17.19 12 49860 253 42571210
Swelling 32.12 17.19 12 49860 54873 42516590
Cerebral candidiasis 32.08 17.19 9 49863 72 42571391
Bacillus bacteraemia 32.03 17.19 11 49861 181 42571282
Oral fungal infection 31.50 17.19 22 49850 1799 42569664
Hallucination 31.34 17.19 14 49858 57493 42513970
Dry skin 31.04 17.19 9 49863 48329 42523134
Squamous cell carcinoma 30.97 17.19 55 49817 12927 42558536
Hypotension 30.90 17.19 176 49696 257455 42314008
Feeling abnormal 30.84 17.19 22 49850 69764 42501699
Bacterial sepsis 30.83 17.19 38 49834 6444 42565019
Sleep disorder 30.80 17.19 9 49863 48086 42523377
Fungal infection 30.78 17.19 70 49802 19652 42551811
Stress 30.75 17.19 7 49865 44205 42527258
Blood pressure decreased 30.56 17.19 15 49857 58317 42513146
Chronic lymphocytic leukaemia refractory 30.29 17.19 9 49863 90 42571373
Myalgia 30.12 17.19 41 49831 96039 42475424
Stomatococcal infection 30.04 17.19 11 49861 220 42571243
Vision blurred 29.38 17.19 13 49859 53686 42517777
Heart rate decreased 29.29 17.19 4 49868 36528 42534935
Blood creatine phosphokinase increased 29.26 17.19 10 49862 48328 42523135
Coma 29.24 17.19 13 49859 53541 42517922
Diabetes mellitus 29.20 17.19 17 49855 60070 42511393
Haematochezia 29.17 17.19 16 49856 58420 42513043
Drug ineffective 28.93 17.19 542 49330 629655 41941808
White blood cell count abnormal 28.45 17.19 28 49844 3697 42567766
Intentional product misuse 28.03 17.19 19 49853 61881 42509582
B-cell small lymphocytic lymphoma 28.03 17.19 10 49862 185 42571278
Myocardial infarction 27.97 17.19 65 49807 123944 42447519
Erythema 27.91 17.19 53 49819 108740 42462723
Eosinophilia 27.85 17.19 3 49869 32896 42538567
B-cell small lymphocytic lymphoma recurrent 27.61 17.19 6 49866 13 42571450
Blast cells present 27.58 17.19 13 49859 500 42570963
Abdominal distension 27.50 17.19 26 49846 71709 42499754
Neutrophil count abnormal 27.29 17.19 24 49848 2747 42568716
Balance disorder 26.92 17.19 11 49861 47634 42523829
Drug hypersensitivity 26.76 17.19 47 49825 99342 42472121
Haemoglobin abnormal 26.73 17.19 31 49841 4933 42566530
Tubulointerstitial nephritis 26.40 17.19 3 49869 31545 42539918
Chloroma 26.13 17.19 13 49859 564 42570899
Acute kidney injury 25.91 17.19 290 49582 367047 42204416
Cellulitis 25.75 17.19 141 49731 61444 42510019
Abdominal pain 25.68 17.19 125 49747 190346 42381117
Rectal haemorrhage 25.61 17.19 13 49859 49593 42521870
Febrile bone marrow aplasia 25.41 17.19 44 49828 10137 42561326
Brain abscess 25.18 17.19 28 49844 4256 42567207
SARS-CoV-2 test positive 25.08 17.19 39 49833 8221 42563242
Hypoaesthesia 25.02 17.19 28 49844 71435 42500028
Vena cava thrombosis 25.01 17.19 18 49854 1543 42569920
Thrombosis 24.92 17.19 26 49846 68485 42502978
Liver function test abnormal 24.92 17.19 4 49868 32387 42539076
Abdominal discomfort 24.73 17.19 31 49841 75224 42496239
Full blood count decreased 24.68 17.19 66 49806 20494 42550969
Disturbance in attention 24.59 17.19 3 49869 29863 42541600
Lymphocyte count decreased 24.53 17.19 80 49792 27729 42543734
Chest discomfort 24.45 17.19 23 49849 63593 42507870
Treatment noncompliance 24.21 17.19 7 49865 37665 42533798
Renal impairment 23.88 17.19 59 49813 110169 42461294
Splenic infarction 23.83 17.19 21 49851 2410 42569053
Respiratory tract infection 23.47 17.19 76 49796 26246 42545217
Platelet count abnormal 23.46 17.19 25 49847 3624 42567839
Leukocytosis 23.16 17.19 82 49790 29626 42541837
Opportunistic infection 23.12 17.19 19 49853 1982 42569481
Pneumocystis jirovecii pneumonia 22.71 17.19 73 49799 25108 42546355
Cytarabine syndrome 22.60 17.19 6 49866 38 42571425
Clostridium difficile infection 22.58 17.19 68 49804 22591 42548872
Blood pressure systolic increased 22.57 17.19 3 49869 27965 42543498
Diffuse large B-cell lymphoma 22.48 17.19 40 49832 9414 42562049
Blood phosphorus increased 22.44 17.19 47 49825 12478 42558985
Vomiting 22.32 17.19 224 49648 289499 42281964
Wrong technique in product usage process 22.27 17.19 11 49861 42624 42528839
Pseudomonal sepsis 21.99 17.19 26 49846 4223 42567240
Memory impairment 21.97 17.19 16 49856 50206 42521257
Klebsiella sepsis 21.93 17.19 21 49851 2680 42568783
Blood phosphorus abnormal 21.75 17.19 8 49864 162 42571301
Fall 21.71 17.19 173 49699 234347 42337116
Restlessness 21.65 17.19 4 49868 29245 42542218
Medication error 21.61 17.19 6 49866 33148 42538315
Febrile infection 21.48 17.19 21 49851 2750 42568713
Blood cholesterol increased 21.26 17.19 3 49869 26738 42544725
Autologous haematopoietic stem cell transplant 20.92 17.19 7 49865 106 42571357
Hepatic cytolysis 20.84 17.19 74 49798 26770 42544693
Unrelated donor bone marrow transplantation therapy 20.77 17.19 4 49868 3 42571460
Fungal sepsis 20.77 17.19 14 49858 1080 42570383
Hypercalcaemia 20.71 17.19 57 49815 18001 42553462
Therapeutic product effect incomplete 20.64 17.19 148 49724 70791 42500672
Cord blood transplant therapy 20.47 17.19 6 49866 57 42571406
Acute myeloid leukaemia (in remission) 20.24 17.19 4 49868 4 42571459
Venous aneurysm 20.24 17.19 4 49868 4 42571459
Megakaryocytes decreased 20.24 17.19 4 49868 4 42571459
Immunodeficiency 20.18 17.19 33 49839 7257 42564206
Transfusion reaction 20.11 17.19 13 49859 935 42570528
Myeloblast count increased 20.00 17.19 5 49867 24 42571439
Leukaemia recurrent 20.00 17.19 17 49855 1859 42569604
Arthropathy 19.96 17.19 5 49867 29592 42541871
Urticaria 19.94 17.19 35 49837 74001 42497462
Blood product transfusion dependent 19.90 17.19 10 49862 443 42571020
Unresponsive to stimuli 19.88 17.19 6 49866 31397 42540066
Oxygen saturation decreased 19.87 17.19 28 49844 64659 42506804
Aspiration bone marrow abnormal 19.70 17.19 7 49865 128 42571335
Hypertension 19.60 17.19 115 49757 167089 42404374
Heart rate increased 19.60 17.19 20 49852 53235 42518228
Loss of consciousness 19.56 17.19 50 49822 92304 42479159
Erysipelas 19.50 17.19 30 49842 6266 42565197
Neoplasm 19.47 17.19 30 49842 6275 42565188
Blood pressure fluctuation 19.24 17.19 4 49868 26904 42544559
Dysgeusia 19.14 17.19 8 49864 34181 42537282
Peripheral swelling 19.02 17.19 49 49823 90221 42481242
Leukopenia 18.96 17.19 151 49721 74595 42496868
Amnesia 18.81 17.19 5 49867 28432 42543031
Hypothyroidism 18.80 17.19 7 49865 32077 42539386
Haemorrhoids 18.65 17.19 53 49819 17044 42554419
Dysplasia 18.50 17.19 13 49859 1073 42570390
Irritability 18.50 17.19 5 49867 28123 42543340
Leukostasis syndrome 18.41 17.19 7 49865 156 42571307
Escherichia infection 18.39 17.19 41 49831 11355 42560108
Herpes simplex 18.15 17.19 31 49841 7064 42564399
Nasal congestion 18.03 17.19 6 49866 29495 42541968
Atypical pneumonia 17.86 17.19 23 49849 4074 42567389
Blood uric acid increased 17.75 17.19 49 49823 15498 42555965
Migraine 17.72 17.19 4 49868 25410 42546053
Oesophageal candidiasis 17.66 17.19 27 49845 5608 42565855
Decreased appetite 17.62 17.19 143 49729 192994 42378469
Gamma-glutamyltransferase increased 17.56 17.19 8 49864 32489 42538974
Blood immunoglobulin A increased 17.42 17.19 9 49863 423 42571040
Plasma cell myeloma 17.36 17.19 18 49854 47560 42523903
Blast cells 17.26 17.19 3 49869 0 42571463
Pulmonary mucormycosis 17.20 17.19 14 49858 1441 42570022
Haemolysis 17.20 17.19 36 49836 9553 42561910

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
Myelosuppression 4270.17 16.83 1742 66000 92598 110428959
Febrile neutropenia 3282.77 16.83 2166 65576 314601 110206956
Death 2799.59 16.83 2732 65010 696137 109825420
Neutropenia 2443.91 16.83 1936 65806 372684 110148873
Tumour lysis syndrome 1859.11 16.83 702 67040 30099 110491458
Acute myeloid leukaemia recurrent 1153.55 16.83 318 67424 4821 110516736
Cytopenia 1065.24 16.83 468 67274 29648 110491909
Off label use 1035.86 16.83 2592 65150 1497593 109023964
Thrombocytopenia 1024.28 16.83 1161 66581 347724 110173833
Neutrophil count decreased 864.48 16.83 662 67080 120279 110401278
Platelet count decreased 733.91 16.83 801 66941 229642 110291915
Pancytopenia 731.72 16.83 765 66977 208848 110312709
Sepsis 622.51 16.83 878 66864 326468 110195089
Disease progression 592.46 16.83 738 67004 243296 110278261
White blood cell count decreased 573.35 16.83 704 67038 228686 110292871
Pneumonia 524.45 16.83 1441 66301 875273 109646284
COVID-19 519.34 16.83 693 67049 244367 110277190
Pyrexia 470.66 16.83 1408 66334 896857 109624700
Anaemia 427.27 16.83 996 66746 546090 109975467
Bacteraemia 302.35 16.83 232 67510 42158 110479399
Pneumonia fungal 297.56 16.83 156 67586 14598 110506959
Acute myeloid leukaemia 270.53 16.83 208 67534 37902 110483655
Blast cell count increased 262.66 16.83 78 67664 1559 110519998
Infection 259.05 16.83 638 67104 361562 110159995
Septic shock 249.03 16.83 388 67354 157140 110364417
Lymphadenopathy 245.85 16.83 246 67496 63589 110457968
Hospice care 232.10 16.83 125 67617 12348 110509209
Pain 229.51 16.83 152 67590 954803 109566754
Joint swelling 228.77 16.83 10 67732 442835 110078722
Bronchopulmonary aspergillosis 227.44 16.83 170 67572 29693 110491864
COVID-19 pneumonia 223.56 16.83 184 67558 36959 110484598
Granulocyte count decreased 215.94 16.83 84 67658 3890 110517667
Allogenic stem cell transplantation 214.98 16.83 46 67696 213 110521344
Minimal residual disease 213.94 16.83 59 67683 894 110520663
Headache 195.52 16.83 153 67589 882224 109639333
Chronic lymphocytic leukaemia recurrent 190.39 16.83 55 67687 994 110520563
Arthralgia 190.01 16.83 122 67620 779510 109742047
Blood lactate dehydrogenase increased 189.66 16.83 181 67561 44153 110477404
Agranulocytosis 182.86 16.83 207 67535 61553 110460004
Rheumatoid arthritis 168.43 16.83 3 67739 299610 110221947
Arthropathy 157.20 16.83 4 67738 287518 110234039
Hyperuricaemia 155.72 16.83 102 67640 14429 110507128
Lymphocytosis 152.99 16.83 72 67670 5339 110516218
Synovitis 149.15 16.83 4 67738 274088 110247469
Swelling 147.81 16.83 20 67722 351021 110170536
Nasopharyngitis 143.20 16.83 33 67709 394328 110127229
Atrial fibrillation 140.72 16.83 382 67360 229260 110292297
Pruritus 138.85 16.83 93 67649 581467 109940090
Splenomegaly 138.37 16.83 117 67625 24381 110497176
Weight increased 137.51 16.83 43 67699 419601 110101956
Systemic lupus erythematosus 137.32 16.83 4 67738 254334 110267223
Product dose omission issue 136.27 16.83 18 67724 321764 110199793
Acute myeloid leukaemia refractory 134.17 16.83 32 67710 260 110521297
Completed suicide 133.92 16.83 3 67739 242378 110279179
Maternal exposure during pregnancy 130.74 16.83 6 67736 254877 110266680
Condition aggravated 127.35 16.83 158 67584 734678 109786879
Drug hypersensitivity 124.95 16.83 61 67681 454029 110067528
Pain in extremity 122.98 16.83 73 67669 487045 110034512
Hypersensitivity 122.69 16.83 47 67695 403951 110117606
Glossodynia 121.68 16.83 3 67739 222001 110299556
Bone marrow failure 113.74 16.83 158 67584 57690 110463867
Asthma 113.49 16.83 11 67731 250280 110271277
Hypoaesthesia 112.65 16.83 27 67715 314196 110207361
Abdominal discomfort 111.27 16.83 51 67691 393807 110127750
Wheezing 111.16 16.83 13 67729 255217 110266340
Contraindicated product administered 109.75 16.83 12 67730 248255 110273302
Rash 109.26 16.83 211 67531 820753 109700804
Alopecia 106.56 16.83 45 67697 364708 110156849
Autoimmune haemolytic anaemia 103.16 16.83 70 67672 10497 110511060
Neutropenic sepsis 103.03 16.83 110 67632 30636 110490921
Systemic candida 101.99 16.83 68 67674 9906 110511651
Wound 101.95 16.83 12 67730 234425 110287132
Bone marrow disorder 100.68 16.83 50 67692 4173 110517384
Escherichia sepsis 100.17 16.83 68 67674 10204 110511353
Peripheral swelling 99.92 16.83 62 67680 403972 110117585
Febrile bone marrow aplasia 99.84 16.83 84 67658 17381 110504176
Hypogammaglobulinaemia 99.49 16.83 89 67653 19987 110501570
Blood cholesterol increased 99.39 16.83 3 67739 184782 110336775
Toxicity to various agents 99.22 16.83 89 67653 480466 110041091
Infusion related reaction 97.76 16.83 56 67686 381106 110140451
Dizziness 97.68 16.83 174 67568 698019 109823538
Blood disorder 95.81 16.83 65 67677 9745 110511812
Urticaria 95.29 16.83 38 67704 318819 110202738
Injection site pain 95.29 16.83 3 67739 177919 110343638
Chronic lymphocytic leukaemia 95.08 16.83 54 67688 5914 110515643
Helicobacter infection 94.19 16.83 4 67738 181873 110339684
Hyperphosphataemia 94.08 16.83 79 67663 16302 110505255
Anxiety 93.91 16.83 47 67695 345031 110176526
Transformation to acute myeloid leukaemia 92.81 16.83 35 67707 1488 110520069
Dry mouth 92.75 16.83 8 67734 199940 110321617
Haematotoxicity 91.92 16.83 87 67655 20995 110500562
Soft tissue infection 91.72 16.83 50 67692 5057 110516500
Escherichia bacteraemia 91.38 16.83 64 67678 10100 110511457
Transplant 91.36 16.83 33 67709 1241 110520316
Blood pressure increased 91.04 16.83 23 67719 258350 110263207
Insomnia 89.62 16.83 55 67687 360535 110161022
Therapeutic product effect decreased 89.53 16.83 20 67722 244296 110277261
Respiratory failure 88.76 16.83 312 67430 215020 110306537
Full blood count decreased 87.28 16.83 103 67639 31996 110489561
Irritable bowel syndrome 87.12 16.83 3 67739 164212 110357345
Blister 86.64 16.83 17 67725 227359 110294198
Impaired healing 85.70 16.83 10 67732 196707 110324850
Hypocalcaemia 85.61 16.83 148 67594 65218 110456339
Granulocytopenia 85 16.83 67 67675 12648 110508909
Inappropriate schedule of product administration 84.74 16.83 12 67730 203625 110317932
Leukopenia 84.65 16.83 241 67501 148550 110373007
Paraesthesia 82.55 16.83 33 67709 276488 110245069
Overdose 82.01 16.83 21 67721 233773 110287784
Depression 80.82 16.83 47 67695 317288 110204269
Myelodysplastic syndrome 80.69 16.83 107 67635 37377 110484180
Cord blood transplant therapy 79.40 16.83 17 67725 79 110521478
Somnolence 78.72 16.83 42 67700 297407 110224150
Leukaemia 78.67 16.83 52 67690 7466 110514091
Stem cell transplant 78.56 16.83 43 67699 4384 110517173
Sleep disorder 77.49 16.83 14 67728 198630 110322927
Intentional product use issue 77.45 16.83 329 67413 247577 110273980
Malaise 76.61 16.83 188 67554 671631 109849926
Rhinovirus infection 74.28 16.83 60 67682 11729 110509828
Migraine 74.09 16.83 9 67733 171643 110349914
Gait disturbance 74.03 16.83 39 67703 278169 110243388
Ill-defined disorder 73.50 16.83 6 67736 156847 110364710
Anal inflammation 73.00 16.83 34 67708 2462 110519095
Psoriasis 72.75 16.83 3 67739 139990 110381567
Injury 72.47 16.83 11 67731 177254 110344303
Discomfort 72.08 16.83 21 67721 214686 110306871
Proctalgia 70.29 16.83 61 67681 13161 110508396
Protothecosis 70.00 16.83 22 67720 535 110521022
Chronic lymphocytic leukaemia transformation 69.76 16.83 19 67723 274 110521283
Muscle spasms 69.69 16.83 42 67700 278115 110243442
Drug intolerance 69.67 16.83 88 67654 406424 110115133
Folliculitis 69.47 16.83 10 67732 167643 110353914
Staphylococcal bacteraemia 69.21 16.83 67 67675 16621 110504936
Osteoarthritis 68.84 16.83 14 67728 182609 110338948
SARS-CoV-2 test negative 68.20 16.83 31 67711 2122 110519435
Hepatic enzyme increased 67.91 16.83 58 67684 320834 110200723
Bursitis 66.79 16.83 3 67739 129915 110391642
Bone marrow transplant 65.86 16.83 28 67714 1632 110519925
Skin infection 62.48 16.83 73 67669 22436 110499121
Hyperbilirubinaemia 62.12 16.83 85 67657 30586 110490971
Multiple organ dysfunction syndrome 61.78 16.83 219 67523 151491 110370066
Lymphocyte count increased 61.62 16.83 44 67698 7159 110514398
Blast cells present 61.50 16.83 23 67719 955 110520602
Bacterial sepsis 61.36 16.83 51 67691 10375 110511182
Dyspnoea 61.31 16.83 412 67330 1106460 109415097
Musculoskeletal pain 61.25 16.83 18 67724 183005 110338552
Abdominal pain upper 59.37 16.83 76 67666 349035 110172522
Subdural haematoma 57.81 16.83 90 67652 36364 110485193
Pseudomonas infection 57.64 16.83 78 67664 27775 110493782
Tremor 57.36 16.83 26 67716 202206 110319351
Memory impairment 56.36 16.83 25 67717 196919 110324638
Joint range of motion decreased 56.15 16.83 5 67737 121827 110399730
Chest pain 55.10 16.83 91 67651 376284 110145273
Autologous haematopoietic stem cell transplant 54.46 16.83 13 67729 106 110521451
Leukaemia recurrent 54.42 16.83 30 67712 3101 110518456
Sinusitis 54.25 16.83 61 67681 296627 110224930
Mobility decreased 53.88 16.83 40 67702 237382 110284175
Road traffic accident 53.55 16.83 3 67739 107395 110414162
Bacillus infection 53.54 16.83 24 67718 1590 110519967
C-reactive protein abnormal 53.12 16.83 8 67734 129687 110391870
Medication error 52.36 16.83 3 67739 105363 110416194
Cellulitis 52.24 16.83 183 67559 125833 110395724
Clostridium difficile colitis 52.01 16.83 95 67647 43683 110477874
Lymphoma 52.00 16.83 63 67679 20108 110501449
Aspergillus infection 51.89 16.83 71 67671 25545 110496012
Suicide attempt 51.21 16.83 3 67739 103391 110418166
Feeling abnormal 50.06 16.83 24 67718 180687 110340870
Pericarditis 49.61 16.83 37 67705 219077 110302480
Contusion 49.58 16.83 42 67700 233319 110288238
Emphysematous cholecystitis 49.02 16.83 12 67730 110 110521447
Obesity 48.77 16.83 6 67736 113345 110408212
Blood phosphorus increased 48.74 16.83 55 67687 16285 110505272
Leukocytosis 48.48 16.83 104 67638 53724 110467833
Pleural effusion 48.05 16.83 226 67516 177483 110344074
Pneumonia bacterial 47.58 16.83 69 67673 26192 110495365
Treatment failure 47.49 16.83 60 67682 277174 110244383
Pneumocystis jirovecii pneumonia 47.35 16.83 90 67652 42645 110478912
Myeloblast count increased 46.10 16.83 10 67732 50 110521507
FLT3 gene mutation 45.65 16.83 8 67734 8 110521549
Blood uric acid abnormal 45.36 16.83 15 67727 431 110521126
Periorbital cellulitis 45.26 16.83 19 67723 1073 110520484
Fatigue 45.21 16.83 502 67240 1215456 109306101
Hospitalisation 45.15 16.83 190 67552 142303 110379254
Squamous cell carcinoma 44.91 16.83 56 67686 18407 110503150
Respiratory moniliasis 44.65 16.83 15 67727 453 110521104
Hypokalaemia 44.30 16.83 225 67517 182223 110339334
Hypertension 44.21 16.83 162 67580 509922 110011635
Lymphocyte count decreased 44.17 16.83 104 67638 57139 110464418
Blood product transfusion dependent 43.83 16.83 15 67727 480 110521077
Chronic lymphocytic leukaemia refractory 43.29 16.83 11 67731 119 110521438
Angioedema 42.91 16.83 5 67737 98495 110423062
Gait inability 42.81 16.83 15 67727 136361 110385196
Pulmonary fibrosis 42.47 16.83 6 67736 102036 110419521
Blast cells 42.30 16.83 7 67735 3 110521554
Klebsiella sepsis 41.71 16.83 28 67714 4125 110517432
Sinusitis fungal 41.69 16.83 24 67718 2696 110518861
Respiratory tract infection 41.68 16.83 117 67625 71500 110450057
Loss of personal independence in daily activities 41.44 16.83 20 67722 150000 110371557
Type 2 diabetes mellitus 41.33 16.83 29 67713 177203 110344354
Chest discomfort 41.13 16.83 28 67714 173820 110347737
Blood uric acid increased 41.11 16.83 58 67684 21471 110500086
Cerebral haemorrhage 40.66 16.83 109 67633 64859 110456698
Pseudomonal bacteraemia 40.41 16.83 28 67714 4343 110517214
Febrile infection 39.97 16.83 28 67714 4420 110517137
Bacillus bacteraemia 39.80 16.83 12 67730 253 110521304
Escherichia infection 39.45 16.83 60 67682 23756 110497801
Disease risk factor 39.41 16.83 12 67730 262 110521295
Lower respiratory tract infection 39.20 16.83 55 67687 243051 110278506
Cytokine release syndrome 39.11 16.83 113 67629 70193 110451364
White blood cell count abnormal 39.01 16.83 33 67709 6876 110514681
Neutrophil count abnormal 38.58 16.83 29 67713 5103 110516454
Neck pain 37.88 16.83 14 67728 123116 110398441
Amnesia 37.86 16.83 9 67733 105399 110416158
Cerebral candidiasis 37.86 16.83 9 67733 72 110521485
Platelet count abnormal 37.53 16.83 31 67711 6251 110515306
Atypical pneumonia 37.27 16.83 34 67708 7828 110513729
Liver injury 37.25 16.83 23 67719 150390 110371167
Parainfluenzae virus infection 36.72 16.83 32 67710 6942 110514615
Leukostasis syndrome 36.71 16.83 11 67731 227 110521330
Blood pressure systolic increased 36.68 16.83 4 67738 82987 110438570
Systemic mycosis 36.51 16.83 25 67717 3804 110517753
Muscular weakness 36.41 16.83 60 67682 248408 110273149
Agitation 36.24 16.83 12 67730 113039 110408518
Chloroma 35.97 16.83 15 67727 833 110520724
Drug interaction 35.80 16.83 171 67571 500012 110021545
Arthritis 35.79 16.83 30 67712 167556 110354001
Fungal infection 35.66 16.83 89 67653 50717 110470840
Mucormycosis 35.56 16.83 38 67704 10590 110510967
Erythema 35.19 16.83 79 67663 291368 110230189
Inflammation 35.02 16.83 40 67702 193198 110328359
Lower limb fracture 34.97 16.83 3 67739 75345 110446212
Confusional state 34.86 16.83 158 67584 468522 110053035
Intentional product misuse 34.79 16.83 19 67723 132885 110388672
Haemoglobin decreased 34.69 16.83 266 67476 248461 110273096
Accident 34.62 16.83 38 67704 10914 110510643
Rectal haemorrhage 34.61 16.83 15 67727 119818 110401739
Hypoglycaemia 34.39 16.83 14 67728 116090 110405467
Feeling hot 34.29 16.83 7 67735 91099 110430458
Clostridium difficile infection 34.18 16.83 89 67653 52040 110469517
Disseminated intravascular coagulation 34.04 16.83 77 67665 41209 110480348
Graft versus host disease in skin 33.97 16.83 33 67709 8221 110513336
Fusarium infection 33.52 16.83 21 67721 2750 110518807
Dry skin 33.52 16.83 12 67730 107641 110413916
Vomiting 33.36 16.83 377 67365 910298 109611259
Injection site reaction 33.20 16.83 7 67735 89063 110432494
Blood glucose increased 33.18 16.83 20 67722 132476 110389081
Wound infection 33.17 16.83 9 67733 96456 110425101
Oral fungal infection 33.12 16.83 25 67717 4427 110517130
Stenotrophomonas infection 33.12 16.83 28 67714 5830 110515727
Fall 33.11 16.83 225 67517 603257 109918300
Chemotherapy 33.07 16.83 19 67723 2127 110519430
Mantle cell lymphoma refractory 32.84 16.83 9 67733 133 110521424
Peripheral venous disease 32.64 16.83 6 67736 84111 110437446
Fungal sepsis 32.33 16.83 19 67723 2218 110519339
Nasal congestion 32.27 16.83 10 67732 98272 110423285
Osteoporosis 32.18 16.83 7 67735 87145 110434412
Diffuse large B-cell lymphoma 32.10 16.83 44 67698 15854 110505703
Haemophagocytic lymphohistiocytosis 31.96 16.83 64 67678 31495 110490062
Heart rate decreased 31.90 16.83 6 67736 82750 110438807
Stomatococcal infection 31.42 16.83 11 67731 377 110521180
Oesophageal candidiasis 31.33 16.83 37 67705 11497 110510060
Splenic infarction 31.30 16.83 24 67718 4350 110517207
Lung infiltration 31.24 16.83 55 67687 24573 110496984
Acute febrile neutrophilic dermatosis 30.84 16.83 25 67717 4911 110516646
Platelet transfusion 30.54 16.83 20 67722 2826 110518731
Dysplasia 30.19 16.83 17 67725 1831 110519726
Frequent bowel movements 30.18 16.83 4 67738 71386 110450171
Pneumonia klebsiella 30.12 16.83 28 67714 6604 110514953
Clostridium colitis 30.09 16.83 21 67721 3294 110518263
B-cell small lymphocytic lymphoma recurrent 30.08 16.83 6 67736 18 110521539
Balance disorder 30.03 16.83 17 67725 116543 110405014
Epilepsy 29.82 16.83 12 67730 100197 110421360
Blood pressure fluctuation 29.77 16.83 5 67737 74819 110446738
Unrelated donor bone marrow transplantation therapy 29.64 16.83 5 67737 3 110521554
Haemorrhage intracranial 29.64 16.83 59 67683 28910 110492647
Hyperhidrosis 29.57 16.83 43 67699 187255 110334302
Haematochezia 29.54 16.83 17 67725 115507 110406050
Campylobacter gastroenteritis 29.51 16.83 17 67725 1912 110519645
Pneumonia adenoviral 29.45 16.83 12 67730 628 110520929
Differentiation syndrome 29.32 16.83 20 67722 3024 110518533
Seizure 29.18 16.83 57 67685 221128 110300429
Erysipelas 28.99 16.83 38 67704 13120 110508437
Plasma cells increased 28.96 16.83 8 67734 122 110521435
Staphylococcal sepsis 28.95 16.83 44 67698 17410 110504147
Palliative care 28.93 16.83 16 67726 1664 110519893
Flushing 28.86 16.83 14 67728 104722 110416835
Opportunistic infection 28.84 16.83 21 67721 3522 110518035
Cardiac failure 28.62 16.83 205 67537 187421 110334136
Hypercholesterolaemia 28.49 16.83 10 67732 90827 110430730
Coronavirus infection 28.25 16.83 32 67710 9513 110512044
Therapy partial responder 28.23 16.83 67 67675 36994 110484563
Myalgia 27.90 16.83 59 67683 222322 110299235
Hyperkalaemia 27.89 16.83 160 67582 135636 110385921
Rhabdomyolysis 27.67 16.83 20 67722 120381 110401176
Acute leukaemia 27.50 16.83 16 67726 1833 110519724
Adenoviral hepatitis 27.18 16.83 13 67729 999 110520558
Klebsiella infection 27.10 16.83 46 67696 19963 110501594
Wrong technique in product usage process 26.75 16.83 10 67732 87338 110434219
Knee arthroplasty 26.61 16.83 4 67738 64944 110456613
Graft versus host disease 26.49 16.83 44 67698 18762 110502795
Stress 26.24 16.83 16 67726 105332 110416225
Aspiration bone marrow abnormal 26.21 16.83 8 67734 176 110521381
Phlebitis 25.80 16.83 31 67711 9810 110511747
SARS-CoV-2 test positive 25.73 16.83 41 67701 16894 110504663
Coma 25.29 16.83 21 67721 117848 110403709
B-cell small lymphocytic lymphoma 25.28 16.83 8 67734 199 110521358
Eosinophilia 25.09 16.83 3 67739 57933 110463624
Abdominal lymphadenopathy 25.05 16.83 15 67727 1813 110519744
Acute graft versus host disease 25.04 16.83 35 67707 12846 110508711
Adverse drug reaction 24.97 16.83 17 67725 105542 110416015
Hypoalbuminaemia 24.97 16.83 55 67687 28919 110492638
Blood phosphorus abnormal 24.80 16.83 9 67733 343 110521214
Autoimmune disorder 24.71 16.83 5 67737 65478 110456079
Anal abscess 24.70 16.83 33 67709 11605 110509952
Burning sensation 24.67 16.83 6 67736 69206 110452351
Haemoglobin abnormal 24.56 16.83 29 67713 9009 110512548
Enterococcal bacteraemia 24.56 16.83 21 67721 4440 110517117
Sciatica 24.49 16.83 13 67729 92386 110429171
Blast cell count decreased 24.37 16.83 5 67737 18 110521539
Tinnitus 24.19 16.83 4 67738 60536 110461021
Epstein-Barr virus infection reactivation 24.08 16.83 20 67722 4064 110517493
Brain abscess 24.05 16.83 25 67717 6749 110514808
Leukaemia cutis 23.96 16.83 8 67734 237 110521320
Nausea 23.83 16.83 576 67166 1235114 109286443
Anaphylactic reaction 23.75 16.83 21 67721 114279 110407278
Clonal evolution 23.74 16.83 8 67734 244 110521313
Heart rate increased 23.72 16.83 32 67710 143802 110377755
Abdominal pain 23.52 16.83 201 67541 512788 110008769
Human herpesvirus 6 encephalitis 23.50 16.83 12 67730 1062 110520495
Pulmonary sepsis 23.42 16.83 22 67720 5256 110516301
Cytomegalovirus infection reactivation 23.33 16.83 41 67701 18292 110503265
Pseudomonal sepsis 22.91 16.83 28 67714 9018 110512539
Neoplasm 22.86 16.83 31 67711 11056 110510501
Pulmonary mucormycosis 22.85 16.83 15 67727 2128 110519429
Granulocyte-colony stimulating factor level decreased 22.82 16.83 4 67738 4 110521553
Colitis 22.63 16.83 123 67619 102200 110419357
Haemorrhoids 22.47 16.83 60 67682 35612 110485945
Rash erythematous 22.46 16.83 11 67731 81821 110439736
Herpes simplex 22.36 16.83 37 67705 15727 110505830
Transplantation complication 22.36 16.83 9 67733 456 110521101
Gastrooesophageal reflux disease 22.36 16.83 48 67694 179928 110341629
Oedema 22.15 16.83 61 67681 209915 110311642
Visual impairment 22.07 16.83 30 67712 134398 110387159
Full blood count abnormal 22.02 16.83 80 67662 55972 110465585
Blood beta-D-glucan positive 21.93 16.83 4 67738 6 110521551
Lymphopenia 21.79 16.83 64 67678 40106 110481451
General physical condition abnormal 21.71 16.83 25 67717 7565 110513992
Platelet disorder 21.67 16.83 18 67724 3657 110517900
Swelling face 21.66 16.83 15 67727 92306 110429251
Fibrosis 21.57 16.83 25 67717 7617 110513940
Splenic abscess 21.38 16.83 11 67731 989 110520568
Influenza like illness 21.23 16.83 14 67728 88398 110433159
Mantle cell lymphoma recurrent 21.12 16.83 11 67731 1015 110520542
Candida pneumonia 20.95 16.83 11 67731 1032 110520525
Disturbance in attention 20.91 16.83 6 67736 61989 110459568
Transfusion reaction 20.80 16.83 14 67728 2071 110519486
Tubulointerstitial nephritis 20.79 16.83 4 67738 54280 110467277
Loss of consciousness 20.73 16.83 57 67685 196249 110325308
Osteolysis 20.73 16.83 21 67721 5502 110516055
Herpes virus infection 20.69 16.83 26 67716 8612 110512945
Blood pressure decreased 20.65 16.83 24 67718 115067 110406490
Hyperleukocytosis 20.61 16.83 17 67725 3422 110518135
Acute respiratory failure 20.54 16.83 96 67646 75164 110446393
Acute myeloid leukaemia (in remission) 20.51 16.83 5 67737 45 110521512
Dyspepsia 20.50 16.83 55 67687 190910 110330647
Transfusion 20.44 16.83 47 67695 25425 110496132
Cytarabine syndrome 20.39 16.83 6 67736 116 110521441
Incorrect route of product administration 20.18 16.83 7 67735 64054 110457503
Venous aneurysm 20.06 16.83 4 67738 12 110521545
Vision blurred 19.99 16.83 30 67712 128992 110392565
Alpha haemolytic streptococcal infection 19.96 16.83 17 67725 3576 110517981
Abdominal distension 19.90 16.83 49 67693 175054 110346503
Streptococcal bacteraemia 19.84 16.83 19 67723 4650 110516907
Neoplasm recurrence 19.83 16.83 20 67722 5212 110516345
Plasma cell myeloma recurrent 19.81 16.83 23 67719 7019 110514538
Treatment noncompliance 19.74 16.83 10 67732 72980 110448577
Megakaryocytes decreased 19.69 16.83 5 67737 54 110521503
Portal vein cavernous transformation 19.66 16.83 6 67736 132 110521425
Anorectal infection 19.58 16.83 9 67733 632 110520925
Hepatic cytolysis 19.49 16.83 76 67666 54977 110466580
Drug level increased 19.41 16.83 3 67739 47716 110473841
Anaphylactic shock 19.32 16.83 4 67738 51542 110470015
Renal failure 19.27 16.83 218 67524 226356 110295201
Dyskinesia 19.26 16.83 4 67738 51442 110470115
Device related bacteraemia 19.25 16.83 11 67731 1219 110520338
Refractory cancer 19.21 16.83 7 67735 270 110521287
Pyoderma gangrenosum 19.07 16.83 20 67722 5456 110516101
Neutropenic colitis 18.88 16.83 24 67718 8041 110513516
Progressive multifocal leukoencephalopathy 18.88 16.83 45 67697 24911 110496646
Neoplasm progression 18.82 16.83 84 67658 64511 110457046
Fluid retention 18.79 16.83 18 67724 94289 110427268
Testicular neoplasm 18.79 16.83 4 67738 18 110521539
Pseudomonal skin infection 18.79 16.83 4 67738 18 110521539
Transient aphasia 18.72 16.83 9 67733 700 110520857
Hypercalcaemia 18.67 16.83 67 67675 46590 110474967
Diabetes mellitus 18.63 16.83 20 67722 99361 110422196
Li-Fraumeni syndrome 18.61 16.83 4 67738 19 110521538
Obstructive airways disorder 18.54 16.83 3 67739 46146 110475411
Cataract 18.53 16.83 13 67729 79472 110442085
White blood cell count increased 18.52 16.83 112 67630 96730 110424827
Streptococcal sepsis 18.51 16.83 19 67723 5053 110516504
Throat irritation 18.40 16.83 5 67737 53547 110468010
Hypothyroidism 18.25 16.83 11 67731 72888 110448669
Enterobacter sepsis 18.25 16.83 11 67731 1345 110520212
Weight decreased 18.19 16.83 191 67551 467866 110053691
Adverse event 18.15 16.83 24 67718 108785 110412772
Malassezia infection 18.05 16.83 5 67737 77 110521480
Inflammatory marker increased 17.95 16.83 32 67710 14437 110507120
Oxygen saturation decreased 17.78 16.83 44 67698 156938 110364619
Hip arthroplasty 17.75 16.83 6 67736 55807 110465750
Leukaemic infiltration 17.65 16.83 6 67736 188 110521369
Citrobacter bacteraemia 17.55 16.83 4 67738 26 110521531
Osteonecrosis of jaw 17.44 16.83 4 67738 48013 110473544
Oral blood blister 17.43 16.83 5 67737 88 110521469
Systemic toxicity 17.39 16.83 7 67735 355 110521202
Irritability 17.33 16.83 4 67738 47805 110473752
Neutropenic infection 17.31 16.83 15 67727 3230 110518327
Corynebacterium bacteraemia 17.30 16.83 6 67736 200 110521357
Adenovirus infection 17.23 16.83 27 67715 10967 110510590
Angiodysplasia 17.21 16.83 11 67731 1491 110520066
Pneumonia influenzal 17.15 16.83 16 67726 3789 110517768
Endocarditis 17.14 16.83 30 67712 13341 110508216
Haemophilus infection 17.11 16.83 14 67728 2786 110518771
Primary myelofibrosis 17.10 16.83 6 67736 207 110521350
Skin maceration 16.94 16.83 6 67736 213 110521344
Unresponsive to stimuli 16.87 16.83 9 67733 63781 110457776
Hepatosplenomegaly 16.85 16.83 21 67721 6898 110514659

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XX52 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Other antineoplastic agents
FDA PE N0000009176 Increased Cellular Death
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA EPC N0000192515 BCL-2 Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:68495 apoptosis inducer
CHEBI has role CHEBI:133022 B-cell lymphoma 2 inhibitor
CHEBI has role CHEBI:231911 renoprotective agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

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

DiseaseRelationSNOMED_IDDOID
Acute myeloid leukemia, disease indication 91861009
Chronic lymphoid leukemia, disease indication 92814006
Malignant lymphoma - small lymphocytic indication 302841002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.0 acidic
pKa2 13.01 acidic
pKa3 7.73 Basic
pKa4 4.24 Basic
pKa5 3.47 Basic
pKa6 0.56 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT IN COMBINATION WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9174982 May 26, 2030 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 10993942 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11413282 Sept. 6, 2033 TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11590128 Sept. 6, 2033 TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9539251 Sept. 6, 2033 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 10993942 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11413282 Sept. 6, 2033 TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11590128 Sept. 6, 2033 TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9539251 Sept. 6, 2033 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 10993942 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP THAT INCLUDES A DOSE OF 50 MG PER DAY FOR 1 WEEK FOLLOWED BY 100 MG PER DAY FOR 1 WEEK
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE IN ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11110087 Sept. 6, 2033 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) BY ORALLY ADMINISTERING VENETOCLAX TO AN ADULT ACCORDING TO A DOSE RAMP-UP INCLUDING A 100 MG PER DAY DOSE
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11413282 Sept. 6, 2033 TREATMENT OF ADULTS WITH RELAPSED, REFRACTORY OR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA INCLUDING A DOSE RAMP-UP AND IN COMBINATION WITH OBINUTUZUMAB IN MULTIPLE 28-DAY DOSING CYCLES FOLLOWED BY ADMINISTRATION IN ABSENCE OF OBINUTUZUMAB
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 11590128 Sept. 6, 2033 TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL 9539251 Sept. 6, 2033 TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) IN COMBINATION WITH A GA101 ANTIBODY SUCH AS OBINUTUZUMAB FOR ONE OR MORE DOSING PERIODS, WHEREIN THE CLL OR SLL IS A CD20-EXPRESSING CANCER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL May 15, 2026 TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
10MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL May 15, 2026 TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
50MG VENCLEXTA ABBVIE N208573 April 11, 2016 RX TABLET ORAL May 15, 2026 TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Apoptosis regulator Bcl-2 Cytosolic other INHIBITOR Ki 11 SCIENTIFIC LITERATURE DRUG LABEL
Cytochrome P450 2C9 Enzyme IC50 5.75 CHEMBL
Aspartyl/asparaginyl beta-hydroxylase Enzyme IC50 5.89 CHEMBL
Bcl2-associated agonist of cell death Cytosolic other Ki 4.80 CHEMBL
Bcl-2-like protein 1 Cytosolic other INHIBITOR Ki 7.32 SCIENTIFIC LITERATURE
Apoptosis regulator Bcl-W Cytosolic other INHIBITOR Ki 6.61 SCIENTIFIC LITERATURE

External reference:

IDSource
N54AIC43PW UNII
D10679 KEGG_DRUG
4035629 VANDF
C4079830 UMLSCUI
CHEBI:133021 CHEBI
LBM PDB_CHEM_ID
CHEMBL3137309 ChEMBL_ID
49846579 PUBCHEM_CID
DB11581 DRUGBANK_ID
9925 INN_ID
C579720 MESH_SUPPLEMENTAL_RECORD_UI
8318 IUPHAR_LIGAND_ID
1747556 RXNORM
240227 MMSL
31601 MMSL
d08429 MMSL
016803 NDDF
720491001 SNOMEDCT_US
763511000 SNOMEDCT_US
N54AIC43PW INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Venclexta HUMAN PRESCRIPTION DRUG LABEL 1 0074-0561 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Venclexta HUMAN PRESCRIPTION DRUG LABEL 1 0074-0566 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Venclexta HUMAN PRESCRIPTION DRUG LABEL 1 0074-0576 TABLET, FILM COATED 100 mg ORAL NDA 32 sections