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

Stem definitionDrug idCAS RN
mouse origin 4915 853426-35-4

Description:

MoleculeDescription

Synonyms:

  • blinatumomab
  • blincyto
  • MEDI-538
  • MT-103
a single-chain bispecific recombinant antibody from Micromet's BiTE (bispecific T-cell engager) product platform that binds both the CD19 antigen and the T-cell receptor (CD3), for the potential treatment of B-cell lymphoma
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
18.70 mcg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Sept. 21, 2018 PMDA Amgen Astellas Biopharma KK
Nov. 23, 2015 EMA Amgen Europe B.V.
Dec. 3, 2014 FDA AMGEN

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
Acute lymphocytic leukaemia recurrent 1718.40 29.58 283 7863 2438 90617863
Cytokine release syndrome 1412.55 29.58 355 7791 27618 90592683
Neurotoxicity 713.95 29.58 196 7950 21271 90599030
Pyrexia 425.84 29.58 398 7748 660087 89960214
Central nervous system leukaemia 350.81 29.58 52 8094 199 90620102
Leukaemic infiltration extramedullary 273.76 29.58 40 8106 135 90620166
Immune effector cell-associated neurotoxicity syndrome 221.06 29.58 59 8087 5709 90614592
Blast cell count increased 183.02 29.58 33 8113 496 90619805
Intercepted product preparation error 141.71 29.58 31 8115 1289 90619012
Acute lymphocytic leukaemia refractory 129.37 29.58 19 8127 67 90620234
Seizure 118.86 29.58 103 8043 152526 90467775
Graft versus host disease in skin 117.79 29.58 33 8113 3820 90616481
Neoplasm recurrence 113.87 29.58 31 8115 3228 90617073
Febrile neutropenia 113.59 29.58 102 8044 158247 90462054
Acute lymphocytic leukaemia 103.76 29.58 28 8118 2820 90617481
Nervous system disorder 101.67 29.58 46 8100 21547 90598754
Leukaemia recurrent 101.07 29.58 24 8122 1443 90618858
Transformation to acute myeloid leukaemia 100.24 29.58 19 8127 380 90619921
Venoocclusive liver disease 91.19 29.58 30 8116 5963 90614338
Lineage switch leukaemia 90.37 29.58 13 8133 38 90620263
Philadelphia chromosome positive 90.30 29.58 18 8128 472 90619829
Accidental exposure to product 87.89 29.58 52 8094 42314 90577987
Tremor 87.49 29.58 87 8059 153086 90467215
Minimal residual disease 86.37 29.58 17 8129 417 90619884
Tumour lysis syndrome 79.89 29.58 32 8114 11120 90609181
Venoocclusive disease 79.50 29.58 22 8124 2433 90617868
Acute graft versus host disease in skin 73.13 29.58 24 8122 4732 90615569
Graft versus host disease in gastrointestinal tract 70.94 29.58 23 8123 4365 90615936
Acute graft versus host disease 69.85 29.58 24 8122 5444 90614857
Myelosuppression 69.60 29.58 49 8097 53542 90566759
Babesiosis 68.02 29.58 13 8133 272 90620029
Graft versus host disease 67.59 29.58 26 8120 8118 90612183
Infusion site haemorrhage 66.21 29.58 23 8123 5388 90614913
Aphasia 64.73 29.58 43 8103 42769 90577532
Neutropenia 61.94 29.58 88 8058 224816 90395485
Therapeutic response delayed 59.04 29.58 14 8132 836 90619465
Transplantation complication 52.38 29.58 10 8136 208 90620093
CSF cell count increased 52.21 29.58 8 8138 40 90620261
Neutrophil count decreased 51.04 29.58 46 8100 71486 90548815
Product preparation error 48.73 29.58 22 8124 10239 90610062
Haemophagocytic lymphohistiocytosis 48.67 29.58 25 8121 15434 90604867
Hepatotoxicity 46.22 29.58 36 8110 45806 90574495
Bone marrow leukaemic cell infiltration 45.20 29.58 7 8139 38 90620263
Occupational exposure to product 43.92 29.58 14 8132 2517 90617784
Pain 42.99 29.58 18 8128 996323 89623978
Leukoencephalopathy 42.02 29.58 16 8130 4857 90615444
Device related infection 41.65 29.58 27 8119 25759 90594542
Multiple organ dysfunction syndrome 41.16 29.58 40 8106 68296 90552005
Leukaemic infiltration renal 41.11 29.58 6 8140 20 90620281
Death 40.79 29.58 111 8035 456440 90163861
Interleukin level increased 40.45 29.58 10 8136 712 90619589
Neurological symptom 40.05 29.58 17 8129 6830 90613471
Therapy non-responder 39.83 29.58 55 8091 136649 90483652
Escherichia bacteraemia 39.49 29.58 16 8130 5719 90614582
Pancytopenia 39.03 29.58 51 8095 120212 90500089
Dysgraphia 38.77 29.58 14 8132 3669 90616632
Jaw operation 38.58 29.58 10 8136 861 90619440
Drug resistance 37.58 29.58 27 8119 30422 90589879
Fatigue 36.85 29.58 30 8116 1153993 89466308
Cytopenia 35.08 29.58 21 8125 17428 90602873
Sepsis 34.98 29.58 60 8086 179754 90440547
Off label use 33.97 29.58 191 7955 1102061 89518240
Hypoproteinaemia 33.28 29.58 12 8134 3130 90617171
Transaminases increased 32.78 29.58 27 8119 37165 90583136
Thrombotic microangiopathy 31.78 29.58 19 8127 15724 90604577
Encephalopathy 31.42 29.58 29 8117 46415 90573886
Dysarthria 31.15 29.58 31 8115 54451 90565850
Disseminated intravascular coagulation 31.02 29.58 21 8125 21517 90598784
Alopecia 30.96 29.58 4 8142 495067 90125234
Drug hypersensitivity 30.87 29.58 3 8143 463606 90156695
Condition aggravated 30.45 29.58 8 8138 595537 90024764
Acute motor-sensory axonal neuropathy 30.39 29.58 7 8139 368 90619933
Disease progression 30.11 29.58 52 8094 156563 90463738
Neuropathy peripheral 29.70 29.58 48 8098 136922 90483379

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
Acute lymphocytic leukaemia recurrent 1255.86 24.42 267 10180 3424 42607464
Cytokine release syndrome 1110.03 24.42 414 10033 44113 42566775
Neurotoxicity 505.15 24.42 197 10250 23454 42587434
Pyrexia 403.28 24.42 486 9961 393556 42217332
Leukaemic infiltration extramedullary 365.59 24.42 59 10388 122 42610766
Central nervous system leukaemia 358.73 24.42 65 10382 328 42610560
Blast cell count increased 212.99 24.42 51 10396 1134 42609754
Immune effector cell-associated neurotoxicity syndrome 191.79 24.42 76 10371 9385 42601503
Minimal residual disease 160.99 24.42 36 10411 585 42610303
Acute lymphocytic leukaemia refractory 145.54 24.42 26 10421 119 42610769
Tremor 96.93 24.42 119 10328 96810 42514078
Acute lymphocytic leukaemia 92.68 24.42 34 10413 3397 42607491
Nervous system disorder 90.62 24.42 55 10392 17140 42593748
Aphasia 85.18 24.42 60 10387 24023 42586865
Therapy non-responder 83.68 24.42 83 10364 53276 42557612
Venoocclusive liver disease 67.61 24.42 38 10409 10264 42600624
Cytopenia 67.51 24.42 46 10401 17451 42593437
Product preparation error 65.28 24.42 29 10418 4749 42606139
Encephalopathy 64.24 24.42 64 10383 41269 42569619
Transformation to acute myeloid leukaemia 62.05 24.42 19 10428 1086 42609802
Graft versus host disease in skin 59.76 24.42 28 10419 5184 42605704
Graft versus host disease 57.16 24.42 37 10410 12888 42598000
Graft versus host disease in gastrointestinal tract 57.03 24.42 27 10420 5116 42605772
Infusion site haemorrhage 55.26 24.42 18 10429 1259 42609629
Device related infection 54.82 24.42 43 10404 20236 42590652
Aspiration bone marrow abnormal 52.91 24.42 11 10436 124 42610764
B-cell aplasia 52.59 24.42 11 10436 128 42610760
Lineage switch leukaemia 51.60 24.42 8 10439 11 42610877
B-cell type acute leukaemia 50.12 24.42 15 10432 793 42610095
Acute graft versus host disease in skin 47.67 24.42 27 10420 7397 42603491
Blast cells present 47.43 24.42 13 10434 500 42610388
Hepatotoxicity 46.73 24.42 43 10404 25124 42585764
Accidental exposure to product 46.18 24.42 39 10408 20354 42590534
Graft versus host disease in liver 43.37 24.42 16 10431 1623 42609265
Intercepted product preparation error 42.46 24.42 25 10422 7364 42603524
Confusional state 41.66 24.42 112 10335 167485 42443403
Metastases to muscle 40.98 24.42 10 10437 241 42610647
Metastases to retroperitoneum 40.18 24.42 10 10437 262 42610626
Myelosuppression 39.27 24.42 49 10398 40412 42570476
Incorrect drug administration rate 39.08 24.42 16 10431 2144 42608744
Personality change due to a general medical condition 37.59 24.42 7 10440 42 42610846
Metastases to bone marrow 37.52 24.42 11 10436 541 42610347
Acute graft versus host disease 37.51 24.42 24 10423 8191 42602697
CSF cell count increased 37.45 24.42 7 10440 43 42610845
Febrile neutropenia 36.41 24.42 114 10333 185589 42425299
Precursor B-lymphoblastic lymphoma recurrent 36.09 24.42 6 10441 16 42610872
Diarrhoea 36.08 24.42 36 10411 460813 42150075
Venoocclusive disease 35.74 24.42 18 10429 3897 42606991
Metastases to spleen 33.97 24.42 10 10437 499 42610389
Tumour lysis syndrome 33.74 24.42 34 10413 22197 42588691
Drug interaction 33.23 24.42 12 10435 266987 42343901
Dyspnoea 33.03 24.42 36 10411 442585 42168303
Off label use 32.75 24.42 267 10180 638068 41972820
Seizure 32.40 24.42 83 10364 120478 42490410
CSF lymphocyte count increased 31.43 24.42 5 10442 9 42610879
Systemic mycosis 31.05 24.42 14 10433 2373 42608515
Chronic graft versus host disease 31.03 24.42 19 10428 6006 42604882
Neurological symptom 30.99 24.42 23 10424 9968 42600920
Fall 30.10 24.42 10 10437 234510 42376378
Vascular device occlusion 29.86 24.42 8 10439 282 42610606
Adverse reaction 29.70 24.42 16 10431 3977 42606911
Neutropenia 29.10 24.42 111 10336 199320 42411568
Leukaemia cutis 28.36 24.42 6 10441 74 42610814
Hypogammaglobulinaemia 27.45 24.42 23 10424 11868 42599020
Mental status changes 27.31 24.42 42 10405 42073 42568815
Bone marrow leukaemic cell infiltration 26.99 24.42 5 10442 29 42610859
Pancytopenia 26.56 24.42 76 10371 117667 42493221
Apraxia 26.51 24.42 11 10436 1524 42609364
Leukoencephalopathy 26.48 24.42 16 10431 4938 42605950
Intercepted medication error 25.35 24.42 8 10439 505 42610383

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
Acute lymphocytic leukaemia recurrent 2507.83 25.44 473 16360 5314 110567152
Cytokine release syndrome 2009.18 25.44 642 16191 69664 110502802
Neurotoxicity 928.23 25.44 317 16516 41890 110530576
Pyrexia 621.45 25.44 719 16114 897546 109674920
Central nervous system leukaemia 573.75 25.44 96 16737 495 110571971
Leukaemic infiltration extramedullary 526.93 25.44 83 16750 269 110572197
Immune effector cell-associated neurotoxicity syndrome 343.98 25.44 116 16717 14666 110557800
Blast cell count increased 269.39 25.44 60 16773 1577 110570889
Acute lymphocytic leukaemia refractory 224.43 25.44 37 16796 171 110572295
Minimal residual disease 190.61 25.44 41 16792 912 110571554
Graft versus host disease in skin 173.33 25.44 60 16773 8194 110564272
Acute lymphocytic leukaemia 165.31 25.44 53 16780 5712 110566754
Tremor 160.53 25.44 175 16658 202057 110370409
Nervous system disorder 155.25 25.44 82 16751 31639 110540827
Febrile neutropenia 152.46 25.44 213 16620 316554 110255912
Intercepted product preparation error 144.84 25.44 50 16783 6770 110565696
Venoocclusive liver disease 144.27 25.44 62 16771 15145 110557321
Graft versus host disease in gastrointestinal tract 127.88 25.44 49 16784 8919 110563547
Transformation to acute myeloid leukaemia 125.94 25.44 32 16801 1491 110570975
Aphasia 122.01 25.44 88 16745 58909 110513557
Therapy non-responder 121.07 25.44 134 16699 157173 110415293
Acute graft versus host disease in skin 119.32 25.44 49 16784 10691 110561775
Graft versus host disease 116.46 25.44 57 16776 18749 110553717
Philadelphia chromosome positive 115.82 25.44 27 16806 873 110571593
Seizure 109.69 25.44 151 16682 221034 110351432
Acute graft versus host disease 107.52 25.44 48 16785 12833 110559633
Infusion site haemorrhage 102.66 25.44 35 16798 4563 110567903
Lineage switch leukaemia 101.05 25.44 16 16817 54 110572412
Cytopenia 96.42 25.44 59 16774 30057 110542409
Tumour lysis syndrome 95.19 25.44 59 16774 30742 110541724
Device related infection 91.09 25.44 63 16770 39456 110533010
Encephalopathy 89.62 25.44 84 16749 80971 110491495
Venoocclusive disease 88.05 25.44 34 16799 6316 110566150
Neoplasm recurrence 87.02 25.44 32 16801 5200 110567266
Bone marrow leukaemic cell infiltration 86.20 25.44 15 16818 101 110572365
Leukaemia recurrent 82.50 25.44 27 16806 3104 110569362
Hepatotoxicity 82.46 25.44 72 16761 63328 110509138
Neutropenia 82.09 25.44 178 16655 374442 110198024
Myelosuppression 73.62 25.44 81 16752 94259 110478207
Dysgraphia 71.74 25.44 27 16806 4678 110567788
Product preparation error 70.44 25.44 34 16799 10845 110561621
Leukoencephalopathy 63.37 25.44 30 16803 9165 110563301
Pancytopenia 63.28 25.44 114 16719 209499 110362967
CSF cell count increased 63.04 25.44 12 16821 140 110572326
Accidental exposure to product 61.45 25.44 55 16778 49953 110522513
Neutrophil count decreased 57.54 25.44 81 16752 120860 110451606
Drug hypersensitivity 56.84 25.44 3 16830 454087 110118379
Disseminated intravascular coagulation 55.93 25.44 48 16785 41238 110531228
Blast cells present 54.35 25.44 15 16818 963 110571503
Babesiosis 54.04 25.44 13 16820 482 110571984
Pain 52.79 25.44 41 16792 954914 109617552
Joint swelling 52.23 25.44 4 16829 442841 110129625
Precursor B-lymphoblastic lymphoma recurrent 50.99 25.44 8 16825 25 110572441
Leukaemic infiltration renal 50.75 25.44 8 16825 26 110572440
Off label use 50.66 25.44 395 16438 1499790 109072676
Dyspnoea 50.08 25.44 57 16776 1106815 109465651
Fusarium infection 50.00 25.44 18 16815 2753 110569713
Platelet count decreased 48.69 25.44 108 16725 230335 110342131
Cytomegalovirus infection 48.21 25.44 50 16783 54394 110518072
Condition aggravated 48.14 25.44 26 16807 734810 109837656
Hypersensitivity 46.66 25.44 4 16829 403994 110168472
B-cell aplasia 46.39 25.44 11 16822 383 110572083
Diarrhoea 45.00 25.44 65 16768 1139440 109433026
Chronic graft versus host disease 44.99 25.44 24 16809 9433 110563033
Therapeutic response delayed 44.91 25.44 14 16819 1376 110571090
Graft versus host disease in liver 44.43 25.44 16 16817 2449 110570017
B-cell type acute leukaemia 44.19 25.44 14 16819 1450 110571016
Blood bilirubin increased 43.96 25.44 56 16777 75916 110496550
Pruritus 43.62 25.44 17 16816 581543 109990923
Blood lactate dehydrogenase increased 43.42 25.44 43 16790 44291 110528175
Drug effective for unapproved indication 43.42 25.44 27 16806 14140 110558326
Haemophagocytic lymphohistiocytosis 43.37 25.44 37 16796 31522 110540944
Escherichia bacteraemia 43.36 25.44 24 16809 10140 110562326
Swelling 41.87 25.44 3 16830 351038 110221428
Hypogammaglobulinaemia 41.60 25.44 30 16803 20046 110552420
Metastases to muscle 41.46 25.44 10 16823 375 110572091
Death 40.91 25.44 212 16621 698657 109873809
Fatigue 40.90 25.44 77 16756 1215881 109356585
Metastases to retroperitoneum 40.41 25.44 10 16823 418 110572048
Fall 40.02 25.44 21 16812 603461 109969005
Alanine aminotransferase increased 39.79 25.44 87 16746 183686 110388780
Thrombocytopenia 39.67 25.44 130 16703 348755 110223711
Transplantation complication 39.58 25.44 10 16823 455 110572011
Apraxia 38.80 25.44 16 16817 3524 110568942
Intercepted product administration error 37.73 25.44 11 16822 861 110571605
Acute biphenotypic leukaemia 37.67 25.44 8 16825 167 110572299
Systemic mycosis 37.59 25.44 16 16817 3813 110568653
Bone marrow failure 37.25 25.44 45 16788 57803 110514663
Alopecia 36.24 25.44 6 16827 364747 110207719
Metastases to bone marrow 36.09 25.44 11 16822 1003 110571463
Interleukin level increased 34.86 25.44 12 16821 1609 110570857
Serum ferritin increased 34.85 25.44 22 16811 11825 110560641
Disorientation 34.59 25.44 48 16785 70623 110501843
Nausea 34.32 25.44 87 16746 1235603 109336863
Arthralgia 34.28 25.44 41 16792 779591 109792875
Multiple organ dysfunction syndrome 34.19 25.44 73 16760 151637 110420829
Neurological symptom 33.90 25.44 24 16809 15584 110556882
Metastases to spleen 33.68 25.44 10 16823 834 110571632
Jaw operation 33.68 25.44 10 16823 834 110571632
Peripheral swelling 33.41 25.44 10 16823 404024 110168442
Trichosporon infection 33.40 25.44 11 16822 1289 110571177
Chronic graft versus host disease in skin 32.70 25.44 13 16820 2606 110569860
Disease progression 32.40 25.44 96 16737 243938 110328528
Drug interaction 32.28 25.44 18 16815 500165 110072301
Nasopharyngitis 32.18 25.44 10 16823 394351 110178115
Musculoskeletal stiffness 31.68 25.44 3 16830 279819 110292647
Aspiration bone marrow abnormal 31.68 25.44 7 16826 177 110572289
Transaminases increased 30.94 25.44 43 16790 63347 110509119
Capillary leak syndrome 30.75 25.44 15 16818 4893 110567573
Mental status changes 30.44 25.44 47 16786 76075 110496391
Insomnia 29.68 25.44 9 16824 360581 110211885
Incorrect drug administration rate 29.11 25.44 15 16818 5493 110566973
Acute graft versus host disease in intestine 28.78 25.44 15 16818 5624 110566842
Weight increased 28.70 25.44 14 16819 419630 110152836
Thrombotic microangiopathy 28.04 25.44 28 16805 29121 110543345
Confusional state 27.94 25.44 143 16690 468537 110103929
Personality change due to a general medical condition 27.93 25.44 7 16826 308 110572158
Cough 27.83 25.44 18 16815 461623 110110843
Fungaemia 27.70 25.44 15 16818 6071 110566395
Device infusion issue 27.51 25.44 12 16821 3033 110569433
Neoplasm progression 27.41 25.44 41 16792 64554 110507912
Hepatic calcification 26.91 25.44 7 16826 358 110572108
Dizziness 26.35 25.44 41 16792 698152 109874314
Gastrointestinal disorder 26.34 25.44 3 16830 241949 110330517
Pneumonia fungal 25.99 25.44 20 16813 14734 110557732
Depression 25.97 25.44 8 16825 317327 110255139
CSF lymphocyte count increased 25.88 25.44 4 16829 11 110572455
Wheezing 25.79 25.44 4 16829 255226 110317240
Dysarthria 25.67 25.44 46 16787 84075 110488391

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX07 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA CS M0018640 Recombinant Fusion Proteins
MeSH PA D000970 Antineoplastic Agents
FDA MoA N0000175617 CD3-directed Antibody Interactions
FDA MoA N0000175618 CD3 Receptor Agonists
FDA EPC N0000191421 Bispecific CD19-directed CD3-directed T Cell Engager
FDA MoA N0000191422 CD19-directed Antibody Interactions
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
amivantamabbelantamab mafodotinbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabgemtuzumab ozogamicinglofitamabipilimumab show all 29 →

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

DiseaseRelationSNOMED_IDDOID
Pre B-cell acute lymphoblastic leukemia indication 277572006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
B-lymphocyte antigen CD19 Surface antigen ANTIBODY BINDING Kd 9 IUPHAR DRUG LABEL
T-cell surface glycoprotein CD3 Surface antigen ANTIBODY BINDING Kd 7 IUPHAR DRUG LABEL

External reference:

IDSource
4FR53SIF3A UNII
D09325 KEGG_DRUG
4033958 VUID
N0000191284 NUI
4033958 VANDF
C3853839 UMLSCUI
CHEBI:750072 CHEBI
CHEMBL1742992 ChEMBL_ID
DB09052 DRUGBANK_ID
9028 INN_ID
C510808 MESH_SUPPLEMENTAL_RECORD_UI
7384 IUPHAR_LIGAND_ID
1597258 RXNORM
231126 MMSL
30709 MMSL
d08312 MMSL
015799 NDDF
716122004 SNOMEDCT_US
774173007 SNOMEDCT_US
C568788 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

None