Stem definition | Drug id | CAS RN |
---|---|---|
5133 | 1257044-40-8 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
Dec. 5, 2016 | EMA | AbbVie Ltd | |
April 11, 2016 | FDA | ABBVIE INC | |
Sept. 20, 2019 | PMDA | AbbVie GK |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Death | 1185.50 | 21.70 | 821 | 11749 | 324558 | 50267996 |
Febrile neutropenia | 683.77 | 21.70 | 376 | 12194 | 97291 | 50495263 |
Off label use | 584.08 | 21.70 | 647 | 11923 | 473779 | 50118775 |
Neutropenia | 445.65 | 21.70 | 335 | 12235 | 147630 | 50444924 |
Tumour lysis syndrome | 413.01 | 21.70 | 127 | 12443 | 7294 | 50585260 |
Intentional product use issue | 299.57 | 21.70 | 204 | 12366 | 76714 | 50515840 |
Hospice care | 271.92 | 21.70 | 87 | 12483 | 5685 | 50586869 |
Sepsis | 181.81 | 21.70 | 193 | 12377 | 132732 | 50459822 |
Thrombocytopenia | 172.15 | 21.70 | 184 | 12386 | 127489 | 50465065 |
Pancytopenia | 149.81 | 21.70 | 141 | 12429 | 83889 | 50508665 |
Cytopenia | 147.90 | 21.70 | 62 | 12508 | 8713 | 50583841 |
COVID-19 | 147.26 | 21.70 | 109 | 12461 | 46553 | 50546001 |
Neutrophil count decreased | 137.40 | 21.70 | 104 | 12466 | 45922 | 50546632 |
Acute myeloid leukaemia recurrent | 136.35 | 21.70 | 37 | 12533 | 1353 | 50591201 |
Pneumonia | 128.86 | 21.70 | 287 | 12283 | 378114 | 50214440 |
Platelet count decreased | 113.01 | 21.70 | 132 | 12438 | 100594 | 50491960 |
Disease progression | 104.82 | 21.70 | 124 | 12446 | 95742 | 50496812 |
Lymphadenopathy | 75.01 | 21.70 | 64 | 12506 | 33435 | 50559119 |
White blood cell count decreased | 74.13 | 21.70 | 116 | 12454 | 116606 | 50475948 |
Infection | 72.33 | 21.70 | 143 | 12427 | 172811 | 50419743 |
Pyrexia | 65.46 | 21.70 | 225 | 12345 | 379978 | 50212576 |
Acute myeloid leukaemia | 63.34 | 21.70 | 42 | 12528 | 15032 | 50577522 |
Hyperuricaemia | 62.28 | 21.70 | 28 | 12542 | 4652 | 50587902 |
Bone marrow transplant | 62.23 | 21.70 | 17 | 12553 | 637 | 50591917 |
Pain | 59.81 | 21.70 | 35 | 12535 | 578868 | 50013686 |
Myelosuppression | 57.61 | 21.70 | 38 | 12532 | 13479 | 50579075 |
Blood lactate dehydrogenase increased | 53.50 | 21.70 | 42 | 12528 | 19520 | 50573034 |
Allogenic stem cell transplantation | 52.87 | 21.70 | 8 | 12562 | 8 | 50592546 |
Pneumonia fungal | 51.68 | 21.70 | 24 | 12546 | 4296 | 50588258 |
Rhinovirus infection | 49.77 | 21.70 | 22 | 12548 | 3512 | 50589042 |
Joint swelling | 49.03 | 21.70 | 3 | 12567 | 245283 | 50347271 |
Drug ineffective | 48.50 | 21.70 | 81 | 12489 | 819252 | 49773302 |
Aspergillus infection | 46.72 | 21.70 | 26 | 12544 | 6795 | 50585759 |
Blast cell count increased | 45.75 | 21.70 | 12 | 12558 | 384 | 50592170 |
Chronic lymphocytic leukaemia transformation | 43.92 | 21.70 | 8 | 12562 | 41 | 50592513 |
Chronic lymphocytic leukaemia refractory | 43.76 | 21.70 | 8 | 12562 | 42 | 50592512 |
Escherichia sepsis | 42.53 | 21.70 | 21 | 12549 | 4303 | 50588251 |
Hospitalisation | 42.36 | 21.70 | 67 | 12503 | 67870 | 50524684 |
Minimal residual disease | 42.20 | 21.70 | 9 | 12561 | 114 | 50592440 |
Arthralgia | 41.84 | 21.70 | 29 | 12541 | 438673 | 50153881 |
Hyperphosphataemia | 41.10 | 21.70 | 16 | 12554 | 1855 | 50590699 |
Bone marrow failure | 41.00 | 21.70 | 42 | 12528 | 27582 | 50564972 |
Non-small cell lung cancer | 40.44 | 21.70 | 18 | 12552 | 2919 | 50589635 |
Anaemia | 38.68 | 21.70 | 144 | 12426 | 252312 | 50340242 |
Septic shock | 37.89 | 21.70 | 58 | 12512 | 57117 | 50535437 |
Headache | 34.81 | 21.70 | 45 | 12525 | 506490 | 50086064 |
COVID-19 pneumonia | 34.32 | 21.70 | 23 | 12547 | 8372 | 50584182 |
Pleural effusion | 33.55 | 21.70 | 67 | 12503 | 81387 | 50511167 |
Swelling | 33.47 | 21.70 | 5 | 12565 | 200867 | 50391687 |
Escherichia bacteraemia | 33.24 | 21.70 | 16 | 12554 | 3100 | 50589454 |
Rash | 33.11 | 21.70 | 36 | 12534 | 437435 | 50155119 |
Atrial fibrillation | 33.05 | 21.70 | 76 | 12494 | 101669 | 50490885 |
Transformation to acute myeloid leukaemia | 32.99 | 21.70 | 8 | 12562 | 185 | 50592369 |
Blood phosphorus increased | 32.93 | 21.70 | 15 | 12555 | 2567 | 50589987 |
Febrile bone marrow aplasia | 32.51 | 21.70 | 20 | 12550 | 6291 | 50586263 |
Myelodysplastic syndrome | 32.01 | 21.70 | 28 | 12542 | 15104 | 50577450 |
Soft tissue infection | 30.84 | 21.70 | 13 | 12557 | 1849 | 50590705 |
Product dose omission issue | 29.67 | 21.70 | 5 | 12565 | 183833 | 50408721 |
Nasopharyngitis | 29.53 | 21.70 | 6 | 12564 | 192921 | 50399633 |
Autoimmune haemolytic anaemia | 29.47 | 21.70 | 16 | 12554 | 3983 | 50588571 |
Drug hypersensitivity | 29.07 | 21.70 | 13 | 12557 | 250997 | 50341557 |
Blood uric acid increased | 27.31 | 21.70 | 15 | 12555 | 3819 | 50588735 |
Cerebral haemorrhage | 26.27 | 21.70 | 33 | 12537 | 27019 | 50565535 |
Fungal sepsis | 25.81 | 21.70 | 10 | 12560 | 1144 | 50591410 |
Stem cell transplant | 25.49 | 21.70 | 11 | 12559 | 1657 | 50590897 |
Nonspecific reaction | 24.81 | 21.70 | 11 | 12559 | 1768 | 50590786 |
Bronchopulmonary aspergillosis | 24.50 | 21.70 | 18 | 12552 | 7574 | 50584980 |
Maternal exposure during pregnancy | 24.38 | 21.70 | 5 | 12565 | 159773 | 50432781 |
Colitis | 24.00 | 21.70 | 38 | 12532 | 38491 | 50554063 |
Terminal ileitis | 23.87 | 21.70 | 8 | 12562 | 603 | 50591951 |
Abdominal discomfort | 23.83 | 21.70 | 14 | 12556 | 231627 | 50360927 |
Campylobacter gastroenteritis | 23.37 | 21.70 | 7 | 12563 | 366 | 50592188 |
Chronic lymphocytic leukaemia recurrent | 23.15 | 21.70 | 6 | 12564 | 183 | 50592371 |
Hypophosphataemia | 22.86 | 21.70 | 18 | 12552 | 8396 | 50584158 |
Splenomegaly | 22.73 | 21.70 | 19 | 12551 | 9641 | 50582913 |
Lymphocyte count decreased | 22.28 | 21.70 | 30 | 12540 | 26277 | 50566277 |
Subacute combined cord degeneration | 22.01 | 21.70 | 6 | 12564 | 223 | 50592331 |
Prolymphocytic leukaemia | 21.90 | 21.70 | 3 | 12567 | 0 | 50592554 |
Peripheral swelling | 21.82 | 21.70 | 12 | 12558 | 205924 | 50386630 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Death | 1417.14 | 18.69 | 1484 | 20611 | 340600 | 29211832 |
Off label use | 896.00 | 18.69 | 1104 | 20991 | 299696 | 29252736 |
Tumour lysis syndrome | 738.59 | 18.69 | 305 | 21790 | 13579 | 29538853 |
Febrile neutropenia | 654.79 | 18.69 | 592 | 21503 | 111648 | 29440784 |
Neutropenia | 473.64 | 18.69 | 535 | 21560 | 131176 | 29421256 |
Intentional product use issue | 434.49 | 18.69 | 312 | 21783 | 42186 | 29510246 |
Hospice care | 398.80 | 18.69 | 148 | 21947 | 4920 | 29547512 |
COVID-19 | 304.37 | 18.69 | 236 | 21859 | 35778 | 29516654 |
Pneumonia | 181.95 | 18.69 | 587 | 21508 | 319585 | 29232847 |
Cytopenia | 178.92 | 18.69 | 104 | 21991 | 9755 | 29542677 |
Sepsis | 154.08 | 18.69 | 333 | 21762 | 142349 | 29410083 |
Disease progression | 151.27 | 18.69 | 241 | 21854 | 81675 | 29470757 |
Thrombocytopenia | 147.08 | 18.69 | 316 | 21779 | 134507 | 29417925 |
Pancytopenia | 139.10 | 18.69 | 234 | 21861 | 82934 | 29469498 |
Infection | 131.06 | 18.69 | 218 | 21877 | 76533 | 29475899 |
Lymphadenopathy | 129.45 | 18.69 | 124 | 21971 | 24925 | 29527507 |
Neutrophil count decreased | 107.48 | 18.69 | 147 | 21948 | 43420 | 29509012 |
Platelet count decreased | 100.13 | 18.69 | 233 | 21862 | 104439 | 29447993 |
Autoimmune haemolytic anaemia | 81.70 | 18.69 | 45 | 22050 | 3803 | 29548629 |
Hyperphosphataemia | 79.29 | 18.69 | 37 | 22058 | 2201 | 29550231 |
Chronic lymphocytic leukaemia recurrent | 78.49 | 18.69 | 23 | 22072 | 355 | 29552077 |
Lymphocyte count increased | 77.30 | 18.69 | 39 | 22056 | 2755 | 29549677 |
Transplant | 76.21 | 18.69 | 26 | 22069 | 671 | 29551761 |
Acute myeloid leukaemia recurrent | 74.33 | 18.69 | 33 | 22062 | 1747 | 29550685 |
Pyrexia | 72.62 | 18.69 | 413 | 21682 | 287209 | 29265223 |
Myelosuppression | 71.76 | 18.69 | 65 | 22030 | 12162 | 29540270 |
COVID-19 pneumonia | 70.88 | 18.69 | 58 | 22037 | 9464 | 29542968 |
Pneumonia fungal | 69.59 | 18.69 | 47 | 22048 | 5730 | 29546702 |
Splenomegaly | 67.17 | 18.69 | 65 | 22030 | 13214 | 29539218 |
Chronic lymphocytic leukaemia | 65.03 | 18.69 | 38 | 22057 | 3595 | 29548837 |
Toxicity to various agents | 63.82 | 18.69 | 25 | 22070 | 173636 | 29378796 |
White blood cell count decreased | 59.26 | 18.69 | 166 | 21929 | 83196 | 29469236 |
Blood phosphorus increased | 57.01 | 18.69 | 32 | 22063 | 2805 | 29549627 |
Completed suicide | 55.18 | 18.69 | 3 | 22092 | 90243 | 29462189 |
Hospitalisation | 53.66 | 18.69 | 111 | 21984 | 45877 | 29506555 |
Acute myeloid leukaemia | 52.12 | 18.69 | 63 | 22032 | 16450 | 29535982 |
Bacteraemia | 51.07 | 18.69 | 62 | 22033 | 16261 | 29536171 |
Soft tissue infection | 49.84 | 18.69 | 25 | 22070 | 1744 | 29550688 |
Product dose omission issue | 48.79 | 18.69 | 7 | 22088 | 96376 | 29456056 |
Septic shock | 47.84 | 18.69 | 128 | 21967 | 62432 | 29490000 |
Hyperuricaemia | 47.20 | 18.69 | 40 | 22055 | 6849 | 29545583 |
Neutropenic sepsis | 45.88 | 18.69 | 50 | 22045 | 11677 | 29540755 |
Lymphocytosis | 44.83 | 18.69 | 24 | 22071 | 1916 | 29550516 |
Blast cell count increased | 43.29 | 18.69 | 19 | 22076 | 978 | 29551454 |
Skin infection | 40.87 | 18.69 | 36 | 22059 | 6491 | 29545941 |
Blood pressure increased | 40.70 | 18.69 | 4 | 22091 | 73799 | 29478633 |
Drug interaction | 40.43 | 18.69 | 53 | 22042 | 197332 | 29355100 |
Mantle cell lymphoma refractory | 39.87 | 18.69 | 10 | 22085 | 82 | 29552350 |
Stem cell transplant | 38.81 | 18.69 | 22 | 22073 | 1965 | 29550467 |
Headache | 37.43 | 18.69 | 45 | 22050 | 173962 | 29378470 |
Blast cell count decreased | 37.20 | 18.69 | 6 | 22089 | 0 | 29552432 |
Somnolence | 37.07 | 18.69 | 12 | 22083 | 93943 | 29458489 |
Leukaemia | 36.60 | 18.69 | 27 | 22068 | 3783 | 29548649 |
Bone marrow transplant | 34.72 | 18.69 | 16 | 22079 | 924 | 29551508 |
Blood uric acid increased | 34.50 | 18.69 | 31 | 22064 | 5737 | 29546695 |
Minimal residual disease | 34.42 | 18.69 | 12 | 22083 | 331 | 29552101 |
Hypogammaglobulinaemia | 33.86 | 18.69 | 31 | 22064 | 5876 | 29546556 |
Anaemia | 33.75 | 18.69 | 261 | 21834 | 200690 | 29351742 |
Blood lactate dehydrogenase increased | 33.28 | 18.69 | 55 | 22040 | 19154 | 29533278 |
Hypocalcaemia | 32.93 | 18.69 | 57 | 22038 | 20608 | 29531824 |
Chronic lymphocytic leukaemia transformation | 32.69 | 18.69 | 10 | 22085 | 180 | 29552252 |
Condition aggravated | 32.34 | 18.69 | 37 | 22058 | 146258 | 29406174 |
Chemotherapy | 32.23 | 18.69 | 13 | 22082 | 541 | 29551891 |
Squamous cell carcinoma | 32.16 | 18.69 | 39 | 22056 | 10212 | 29542220 |
Overdose | 31.83 | 18.69 | 10 | 22085 | 79809 | 29472623 |
Myelodysplastic syndrome | 30.90 | 18.69 | 51 | 22044 | 17743 | 29534689 |
Allogenic stem cell transplantation | 30.62 | 18.69 | 6 | 22089 | 12 | 29552420 |
Blood uric acid abnormal | 30.21 | 18.69 | 8 | 22087 | 83 | 29552349 |
Full blood count abnormal | 30.16 | 18.69 | 46 | 22049 | 14967 | 29537465 |
Depression | 30.03 | 18.69 | 13 | 22082 | 85134 | 29467298 |
Weight increased | 29.88 | 18.69 | 10 | 22085 | 76657 | 29475775 |
Tremor | 29.71 | 18.69 | 9 | 22086 | 73529 | 29478903 |
Haemolysis | 29.58 | 18.69 | 31 | 22064 | 6925 | 29545507 |
Bronchopulmonary aspergillosis | 29.42 | 18.69 | 41 | 22054 | 12303 | 29540129 |
Escherichia bacteraemia | 29.15 | 18.69 | 21 | 22074 | 2837 | 29549595 |
Pain in extremity | 28.95 | 18.69 | 24 | 22071 | 110409 | 29442023 |
Pruritus | 28.70 | 18.69 | 27 | 22068 | 116822 | 29435610 |
Anxiety | 28.60 | 18.69 | 14 | 22081 | 85351 | 29467081 |
Acute myeloid leukaemia refractory | 28.19 | 18.69 | 6 | 22089 | 21 | 29552411 |
Pain | 27.56 | 18.69 | 54 | 22041 | 171378 | 29381054 |
Atrial fibrillation | 26.66 | 18.69 | 152 | 21943 | 105494 | 29446938 |
Mantle cell lymphoma recurrent | 26.63 | 18.69 | 11 | 22084 | 487 | 29551945 |
Influenza | 26.44 | 18.69 | 80 | 22015 | 41801 | 29510631 |
Chronic lymphocytic leukaemia refractory | 25.66 | 18.69 | 7 | 22088 | 82 | 29552350 |
Lymphocyte count decreased | 25.44 | 18.69 | 49 | 22046 | 19222 | 29533210 |
White blood cell count abnormal | 24.81 | 18.69 | 19 | 22076 | 2816 | 29549616 |
Coronavirus infection | 24.40 | 18.69 | 20 | 22075 | 3268 | 29549164 |
Rash | 23.96 | 18.69 | 68 | 22027 | 189751 | 29362681 |
Dizziness | 23.90 | 18.69 | 68 | 22027 | 189616 | 29362816 |
Arthralgia | 23.29 | 18.69 | 43 | 22052 | 139574 | 29412858 |
Hallucination | 23.20 | 18.69 | 3 | 22092 | 44709 | 29507723 |
Agitation | 23.17 | 18.69 | 5 | 22090 | 51299 | 29501133 |
Haemoglobin abnormal | 22.99 | 18.69 | 19 | 22076 | 3142 | 29549290 |
General physical health deterioration | 22.14 | 18.69 | 142 | 21953 | 102715 | 29449717 |
Gait disturbance | 21.73 | 18.69 | 14 | 22081 | 73335 | 29479097 |
Fungal sepsis | 21.52 | 18.69 | 11 | 22084 | 798 | 29551634 |
Cellulitis | 21.33 | 18.69 | 79 | 22016 | 45761 | 29506671 |
Drug ineffective | 21.15 | 18.69 | 172 | 21923 | 362998 | 29189434 |
Transfusion reaction | 20.85 | 18.69 | 11 | 22084 | 852 | 29551580 |
International normalised ratio increased | 20.71 | 18.69 | 4 | 22091 | 44368 | 29508064 |
Aspergillus infection | 20.66 | 18.69 | 32 | 22063 | 10549 | 29541883 |
Joint swelling | 20.17 | 18.69 | 6 | 22089 | 49624 | 29502808 |
Transfusion | 20.08 | 18.69 | 26 | 22069 | 7272 | 29545160 |
Angiodysplasia | 19.76 | 18.69 | 9 | 22086 | 506 | 29551926 |
Respiratory tract infection | 19.69 | 18.69 | 39 | 22056 | 15612 | 29536820 |
Seizure | 19.03 | 18.69 | 25 | 22070 | 93098 | 29459334 |
Hypercalcaemia | 18.78 | 18.69 | 34 | 22061 | 12725 | 29539707 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Death | 1404.27 | 18.50 | 1364 | 27128 | 481341 | 63988899 |
Febrile neutropenia | 1370.13 | 18.50 | 912 | 27580 | 186745 | 64283495 |
Tumour lysis syndrome | 1018.19 | 18.50 | 366 | 28126 | 19074 | 64451166 |
Neutropenia | 798.26 | 18.50 | 733 | 27759 | 238891 | 64231349 |
Off label use | 694.31 | 18.50 | 1097 | 27395 | 631709 | 63838531 |
Pneumonia | 376.78 | 18.50 | 787 | 27705 | 558789 | 63911451 |
Sepsis | 373.59 | 18.50 | 483 | 28009 | 229858 | 64240382 |
Thrombocytopenia | 325.41 | 18.50 | 445 | 28047 | 223356 | 64246884 |
COVID-19 | 288.04 | 18.50 | 235 | 28257 | 64905 | 64405335 |
Cytopenia | 274.87 | 18.50 | 135 | 28357 | 15336 | 64454904 |
Neutrophil count decreased | 257.31 | 18.50 | 237 | 28255 | 76959 | 64393281 |
Intentional product use issue | 236.30 | 18.50 | 249 | 28243 | 95115 | 64375125 |
Pancytopenia | 206.45 | 18.50 | 284 | 28208 | 143025 | 64327215 |
Platelet count decreased | 200.21 | 18.50 | 304 | 28188 | 167407 | 64302833 |
Infection | 175.47 | 18.50 | 302 | 28190 | 184578 | 64285662 |
Lymphadenopathy | 174.55 | 18.50 | 153 | 28339 | 46533 | 64423707 |
Hospice care | 170.57 | 18.50 | 78 | 28414 | 7547 | 64462693 |
Disease progression | 167.86 | 18.50 | 256 | 28236 | 141424 | 64328816 |
Acute myeloid leukaemia recurrent | 166.79 | 18.50 | 58 | 28434 | 2726 | 64467514 |
Pyrexia | 156.66 | 18.50 | 571 | 27921 | 558073 | 63912167 |
Myelosuppression | 129.08 | 18.50 | 97 | 28395 | 23733 | 64446507 |
White blood cell count decreased | 121.96 | 18.50 | 236 | 28256 | 157601 | 64312639 |
Hyperphosphataemia | 115.84 | 18.50 | 49 | 28443 | 3932 | 64466308 |
Pneumonia fungal | 113.14 | 18.50 | 62 | 28430 | 8815 | 64461425 |
Hyperuricaemia | 113.11 | 18.50 | 65 | 28427 | 10126 | 64460114 |
COVID-19 pneumonia | 102.55 | 18.50 | 73 | 28419 | 16431 | 64453809 |
Septic shock | 95.65 | 18.50 | 169 | 28323 | 105268 | 64364972 |
Pain | 93.96 | 18.50 | 65 | 28427 | 553446 | 63916794 |
Autoimmune haemolytic anaemia | 89.02 | 18.50 | 49 | 28443 | 7027 | 64463213 |
Bacteraemia | 88.33 | 18.50 | 82 | 28410 | 26829 | 64443411 |
Anaemia | 86.97 | 18.50 | 364 | 28128 | 378316 | 64091924 |
Acute myeloid leukaemia | 86.91 | 18.50 | 82 | 28410 | 27381 | 64442859 |
Chronic lymphocytic leukaemia recurrent | 85.80 | 18.50 | 24 | 28468 | 542 | 64469698 |
Soft tissue infection | 84.98 | 18.50 | 37 | 28455 | 3186 | 64467054 |
Blood lactate dehydrogenase increased | 84.71 | 18.50 | 88 | 28404 | 32990 | 64437250 |
Blast cell count increased | 81.87 | 18.50 | 28 | 28464 | 1251 | 64468989 |
Toxicity to various agents | 78.89 | 18.50 | 31 | 28461 | 363482 | 64106758 |
Blood phosphorus increased | 78.50 | 18.50 | 40 | 28452 | 4906 | 64465334 |
Splenomegaly | 75.52 | 18.50 | 63 | 28429 | 17898 | 64452342 |
Joint swelling | 72.70 | 18.50 | 6 | 28486 | 215376 | 64254864 |
Atrial fibrillation | 72.45 | 18.50 | 202 | 28290 | 170887 | 64299353 |
Lymphocytosis | 71.34 | 18.50 | 34 | 28458 | 3610 | 64466630 |
Arthralgia | 68.49 | 18.50 | 57 | 28435 | 442203 | 64028037 |
Allogenic stem cell transplantation | 67.87 | 18.50 | 12 | 28480 | 23 | 64470217 |
Headache | 67.41 | 18.50 | 81 | 28411 | 529386 | 63940854 |
Escherichia sepsis | 62.13 | 18.50 | 39 | 28453 | 7126 | 64463114 |
Escherichia bacteraemia | 61.40 | 18.50 | 35 | 28457 | 5368 | 64464872 |
Blood pressure increased | 60.53 | 18.50 | 4 | 28488 | 172548 | 64297692 |
Chronic lymphocytic leukaemia | 60.18 | 18.50 | 32 | 28460 | 4283 | 64465957 |
Rhinovirus infection | 57.16 | 18.50 | 35 | 28457 | 6121 | 64464119 |
Bronchopulmonary aspergillosis | 56.62 | 18.50 | 55 | 28437 | 19030 | 64451210 |
Pruritus | 55.17 | 18.50 | 35 | 28457 | 312365 | 64157875 |
Product dose omission issue | 54.61 | 18.50 | 10 | 28482 | 194737 | 64275503 |
Rash | 52.34 | 18.50 | 76 | 28416 | 458473 | 64011767 |
Myelodysplastic syndrome | 51.11 | 18.50 | 62 | 28430 | 27517 | 64442723 |
Nasopharyngitis | 50.99 | 18.50 | 12 | 28480 | 196061 | 64274179 |
Lymphocyte count increased | 50.63 | 18.50 | 30 | 28462 | 4945 | 64465295 |
Chronic lymphocytic leukaemia transformation | 50.01 | 18.50 | 13 | 28479 | 220 | 64470020 |
Drug ineffective | 49.28 | 18.50 | 198 | 28294 | 840049 | 63630191 |
Aspergillus infection | 48.21 | 18.50 | 47 | 28445 | 16332 | 64453908 |
Skin infection | 47.76 | 18.50 | 45 | 28447 | 14992 | 64455248 |
Hypogammaglobulinaemia | 47.23 | 18.50 | 38 | 28454 | 10261 | 64459979 |
Chronic lymphocytic leukaemia refractory | 47.21 | 18.50 | 11 | 28481 | 115 | 64470125 |
Pain in extremity | 46.94 | 18.50 | 39 | 28453 | 303046 | 64167194 |
Squamous cell carcinoma | 46.94 | 18.50 | 43 | 28449 | 13826 | 64456414 |
Febrile bone marrow aplasia | 46.32 | 18.50 | 39 | 28453 | 11216 | 64459024 |
Hypocalcaemia | 45.92 | 18.50 | 73 | 28419 | 41680 | 64428560 |
Blood uric acid increased | 45.91 | 18.50 | 34 | 28458 | 8129 | 64462111 |
Swelling | 45.40 | 18.50 | 8 | 28484 | 160210 | 64310030 |
Drug interaction | 43.30 | 18.50 | 58 | 28434 | 362025 | 64108215 |
Drug hypersensitivity | 42.86 | 18.50 | 26 | 28466 | 237789 | 64232451 |
Neutropenic sepsis | 42.60 | 18.50 | 52 | 28440 | 23220 | 64447020 |
Minimal residual disease | 42.52 | 18.50 | 13 | 28479 | 404 | 64469836 |
Somnolence | 41.50 | 18.50 | 19 | 28473 | 203626 | 64266614 |
Condition aggravated | 40.27 | 18.50 | 64 | 28428 | 372362 | 64097878 |
Overdose | 39.12 | 18.50 | 11 | 28481 | 159555 | 64310685 |
Mantle cell lymphoma refractory | 38.13 | 18.50 | 9 | 28483 | 100 | 64470140 |
Weight increased | 37.50 | 18.50 | 24 | 28468 | 213324 | 64256916 |
Leukaemia | 37.48 | 18.50 | 25 | 28467 | 5063 | 64465177 |
Respiratory failure | 36.90 | 18.50 | 155 | 28337 | 161028 | 64309212 |
Dizziness | 36.84 | 18.50 | 85 | 28407 | 430078 | 64040162 |
Anxiety | 36.72 | 18.50 | 22 | 28470 | 202627 | 64267613 |
Urticaria | 36.40 | 18.50 | 10 | 28482 | 147307 | 64322933 |
Bone marrow transplant | 34.66 | 18.50 | 15 | 28477 | 1272 | 64468968 |
Blood uric acid abnormal | 34.64 | 18.50 | 9 | 28483 | 152 | 64470088 |
Depression | 34.49 | 18.50 | 19 | 28473 | 183272 | 64286968 |
Hypoaesthesia | 33.34 | 18.50 | 10 | 28482 | 139098 | 64331142 |
Synovitis | 32.76 | 18.50 | 3 | 28489 | 99087 | 64371153 |
Abdominal discomfort | 32.74 | 18.50 | 20 | 28472 | 182302 | 64287938 |
Hyperkalaemia | 32.08 | 18.50 | 108 | 28384 | 101021 | 64369219 |
Multiple organ dysfunction syndrome | 31.90 | 18.50 | 108 | 28384 | 101305 | 64368935 |
Tremor | 31.51 | 18.50 | 13 | 28479 | 148217 | 64322023 |
Maternal exposure during pregnancy | 31.44 | 18.50 | 3 | 28489 | 95881 | 64374359 |
Asthma | 31.17 | 18.50 | 3 | 28489 | 95222 | 64375018 |
Fungal sepsis | 31.03 | 18.50 | 15 | 28477 | 1643 | 64468597 |
Bacterial sepsis | 31.02 | 18.50 | 26 | 28466 | 7431 | 64462809 |
Hospitalisation | 31.00 | 18.50 | 88 | 28404 | 75119 | 64395121 |
Inappropriate schedule of product administration | 29.96 | 18.50 | 3 | 28489 | 92283 | 64377957 |
Klebsiella sepsis | 29.77 | 18.50 | 17 | 28475 | 2615 | 64467625 |
Rhabdomyolysis | 29.74 | 18.50 | 3 | 28489 | 91723 | 64378517 |
Cellulitis | 29.69 | 18.50 | 100 | 28392 | 93557 | 64376683 |
Transplant | 29.58 | 18.50 | 12 | 28480 | 866 | 64469374 |
Gait disturbance | 29.39 | 18.50 | 20 | 28472 | 172135 | 64298105 |
General physical health deterioration | 29.24 | 18.50 | 172 | 28320 | 204253 | 64265987 |
Contraindicated product administered | 29.23 | 18.50 | 6 | 28486 | 107823 | 64362417 |
Pleural effusion | 29.19 | 18.50 | 122 | 28370 | 126437 | 64343803 |
Lymphocyte count decreased | 29.12 | 18.50 | 59 | 28433 | 40640 | 64429600 |
Systemic toxicity | 29.08 | 18.50 | 7 | 28485 | 85 | 64470155 |
Respiratory tract infection | 28.90 | 18.50 | 56 | 28436 | 37351 | 64432889 |
Hypophosphataemia | 28.76 | 18.50 | 34 | 28458 | 14686 | 64455554 |
Peripheral swelling | 28.72 | 18.50 | 30 | 28462 | 209123 | 64261117 |
Bone marrow failure | 27.98 | 18.50 | 64 | 28428 | 47888 | 64422352 |
Infusion related reaction | 26.90 | 18.50 | 20 | 28472 | 164447 | 64305793 |
Blast cells | 26.90 | 18.50 | 4 | 28488 | 0 | 64470240 |
Campylobacter gastroenteritis | 26.80 | 18.50 | 12 | 28480 | 1104 | 64469136 |
Feeling abnormal | 26.39 | 18.50 | 13 | 28479 | 133589 | 64336651 |
Pneumocystis jirovecii pneumonia | 25.94 | 18.50 | 45 | 28447 | 27589 | 64442651 |
Transfusion reaction | 25.25 | 18.50 | 13 | 28479 | 1628 | 64468612 |
Full blood count abnormal | 24.78 | 18.50 | 46 | 28446 | 29711 | 64440529 |
Therapeutic product effect decreased | 24.70 | 18.50 | 10 | 28482 | 115341 | 64354899 |
White blood cell count abnormal | 24.60 | 18.50 | 19 | 28473 | 4835 | 64465405 |
Non-small cell lung cancer | 24.48 | 18.50 | 19 | 28473 | 4871 | 64465369 |
Flushing | 24.41 | 18.50 | 3 | 28489 | 78645 | 64391595 |
Malaise | 23.99 | 18.50 | 92 | 28400 | 396155 | 64074085 |
Chest discomfort | 23.38 | 18.50 | 11 | 28481 | 116095 | 64354145 |
Erythema | 23.32 | 18.50 | 29 | 28463 | 187041 | 64283199 |
Transformation to acute myeloid leukaemia | 23.08 | 18.50 | 10 | 28482 | 851 | 64469389 |
Hypersensitivity | 22.91 | 18.50 | 32 | 28460 | 196420 | 64273820 |
Wheezing | 22.87 | 18.50 | 4 | 28488 | 80575 | 64389665 |
Vascular device infection | 22.56 | 18.50 | 20 | 28472 | 6160 | 64464080 |
Insomnia | 22.31 | 18.50 | 33 | 28459 | 197803 | 64272437 |
Leukaemia recurrent | 22.19 | 18.50 | 14 | 28478 | 2580 | 64467660 |
Sinusitis fungal | 21.97 | 18.50 | 12 | 28480 | 1694 | 64468546 |
Hypercalcaemia | 21.83 | 18.50 | 45 | 28447 | 31371 | 64438869 |
Pseudomonal sepsis | 21.44 | 18.50 | 18 | 28474 | 5154 | 64465086 |
Acute myeloid leukaemia refractory | 21.31 | 18.50 | 5 | 28487 | 54 | 64470186 |
Colitis | 20.71 | 18.50 | 65 | 28427 | 58609 | 64411631 |
General physical condition abnormal | 20.53 | 18.50 | 18 | 28474 | 5464 | 64464776 |
Chemotherapy | 20.52 | 18.50 | 11 | 28481 | 1496 | 64468744 |
Coronavirus infection | 20.40 | 18.50 | 18 | 28474 | 5512 | 64464728 |
Alopecia | 20.32 | 18.50 | 26 | 28466 | 165664 | 64304576 |
Angiodysplasia | 20.18 | 18.50 | 9 | 28483 | 820 | 64469420 |
Clostridium colitis | 20.04 | 18.50 | 13 | 28479 | 2512 | 64467728 |
Herpes simplex | 20.03 | 18.50 | 24 | 28468 | 10512 | 64459728 |
Agitation | 20.02 | 18.50 | 7 | 28485 | 88360 | 64381880 |
Blood product transfusion dependent | 19.77 | 18.50 | 7 | 28485 | 347 | 64469893 |
Chondrocalcinosis pyrophosphate | 19.50 | 18.50 | 11 | 28481 | 1653 | 64468587 |
Wound | 19.25 | 18.50 | 5 | 28487 | 76472 | 64393768 |
Terminal ileitis | 19.03 | 18.50 | 8 | 28484 | 632 | 64469608 |
Wrong technique in product usage process | 18.94 | 18.50 | 3 | 28489 | 64971 | 64405269 |
Paraesthesia | 18.79 | 18.50 | 19 | 28473 | 134503 | 64335737 |
Platelet disorder | 18.71 | 18.50 | 12 | 28480 | 2275 | 64467965 |
Bradycardia | 18.54 | 18.50 | 15 | 28477 | 118204 | 64352036 |
None
Source | Code | Description |
---|---|---|
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 agents |
CHEBI has role | CHEBI:68495 | Type I cell-death inducers |
CHEBI has role | CHEBI:133022 | B-cell lymphoma 2 inhibitors |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Acute myeloid leukemia, disease | indication | 91861009 | |
Chronic lymphoid leukemia, disease | indication | 92814006 | |
Malignant lymphoma - small lymphocytic | indication | 302841002 |
None
None
Dissociation level | Dissociation constant | Type (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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
100MG | VENCLEXTA | ABBVIE INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 INC | 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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | May 15, 2022 | VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | April 11, 2023 | TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Oct. 16, 2023 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Oct. 16, 2023 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Oct. 16, 2023 | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2 |
100MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE 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 INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE 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 INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | June 8, 2025 | INDICATED FOR THE 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 INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
10MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
50MG | VENCLEXTA | ABBVIE INC | N208573 | April 11, 2016 | RX | TABLET | ORAL | Nov. 21, 2025 | INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY |
100MG | VENCLEXTA | ABBVIE INC | 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 INC | 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 INC | 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) |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Apoptosis regulator Bcl-2 | Cytosolic other | INHIBITOR | Ki | 11 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
Aspartyl/asparaginyl beta-hydroxylase | Enzyme | IC50 | 5.89 | 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 |
ID | Source |
---|---|
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 |
8318 | IUPHAR_LIGAND_ID |
1747556 | RXNORM |
240227 | MMSL |
31601 | MMSL |
d08429 | MMSL |
720491001 | SNOMEDCT_US |
763511000 | SNOMEDCT_US |
016803 | NDDF |
C579720 | MESH_SUPPLEMENTAL_RECORD_UI |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0561 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 31 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0566 | TABLET, FILM COATED | 50 mg | ORAL | NDA | 31 sections |
Venclexta | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0074-0576 | TABLET, FILM COATED | 100 mg | ORAL | NDA | 31 sections |