blinatumomab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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:

None

ADMET properties:

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 952.81 27.96 165 4753 1810 50598396
Cytokine release syndrome 710.04 27.96 165 4753 8469 50591737
Neurotoxicity 468.27 27.96 132 4786 14608 50585598
Pyrexia 307.56 27.96 269 4649 379934 50220272
Central nervous system leukaemia 128.83 27.96 20 4898 101 50600105
Leukaemic infiltration extramedullary 124.15 27.96 18 4900 51 50600155
Neoplasm recurrence 101.95 27.96 27 4891 2342 50597864
Acute lymphocytic leukaemia refractory 100.72 27.96 15 4903 54 50600152
Blast cell count increased 98.91 27.96 19 4899 377 50599829
Graft versus host disease in skin 86.00 27.96 24 4894 2532 50597674
Philadelphia chromosome positive 81.25 27.96 16 4902 363 50599843
Intercepted product preparation error 80.75 27.96 16 4902 375 50599831
Acute lymphocytic leukaemia 70.66 27.96 20 4898 2221 50597985
Febrile neutropenia 69.87 27.96 65 4853 97602 50502604
Babesiosis 69.85 27.96 13 4905 216 50599990
Leukaemia recurrent 67.10 27.96 17 4901 1237 50598969
Venoocclusive disease 64.69 27.96 18 4900 1878 50598328
Therapeutic response delayed 63.75 27.96 14 4904 547 50599659
Graft versus host disease 61.55 27.96 23 4895 6143 50594063
Seizure 54.41 27.96 62 4856 117812 50482394
Tumour lysis syndrome 50.56 27.96 21 4897 7400 50592806
Graft versus host disease in gastrointestinal tract 49.59 27.96 16 4902 2765 50597441
Escherichia bacteraemia 47.80 27.96 16 4902 3100 50597106
Aphasia 46.73 27.96 31 4887 28463 50571743
Venoocclusive liver disease 46.60 27.96 17 4901 4244 50595962
Transplantation complication 44.96 27.96 8 4910 102 50600104
Drug resistance 44.69 27.96 26 4892 18963 50581243
Infusion site haemorrhage 40.50 27.96 14 4904 2990 50597216
Transformation to acute myeloid leukaemia 40.47 27.96 8 4910 185 50600021
Therapy non-responder 40.42 27.96 36 4882 50986 50549220
Nervous system disorder 40.27 27.96 23 4895 16200 50584006
Device related infection 40.02 27.96 25 4893 20710 50579496
Jaw operation 38.91 27.96 10 4908 770 50599436
Neutropenia 38.87 27.96 59 4859 147906 50452300
Hypoproteinaemia 38.73 27.96 12 4906 1819 50598387
Hepatotoxicity 38.42 27.96 27 4891 27199 50573007
Accidental exposure to product 37.60 27.96 25 4893 23032 50577174
Leukoencephalopathy 33.41 27.96 13 4905 3870 50596336
Leukaemic infiltration renal 33.15 27.96 5 4913 20 50600186
Neurological symptom 31.32 27.96 13 4905 4569 50595637

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
Cytokine release syndrome 706.23 24.67 211 6132 12908 29555276
Acute lymphocytic leukaemia recurrent 612.47 24.67 135 6208 2381 29565803
Neurotoxicity 332.66 24.67 123 6220 14490 29553694
Pyrexia 327.74 24.67 351 5992 287271 29280913
Blast cell count increased 174.85 24.67 41 6302 956 29567228
Central nervous system leukaemia 145.71 24.67 28 6315 237 29567947
Leukaemic infiltration extramedullary 118.48 24.67 20 6323 72 29568112
Acute lymphocytic leukaemia refractory 96.02 24.67 17 6326 86 29568098
Minimal residual disease 81.10 24.67 18 6325 325 29567859
Aphasia 64.48 24.67 44 6299 19154 29549030
Tremor 64.37 24.67 79 6264 73459 29494725
Acute lymphocytic leukaemia 62.88 24.67 23 6320 2608 29565576
Cytopenia 59.86 24.67 33 6310 9826 29558358
Nervous system disorder 54.69 24.67 34 6309 12640 29555544
Device related infection 50.52 24.67 35 6308 15601 29552583
Aspiration bone marrow abnormal 50.08 24.67 10 6333 105 29568079
Product preparation error 49.08 24.67 17 6326 1645 29566539
Encephalopathy 47.76 24.67 45 6298 30998 29537186
Metastases to muscle 43.57 24.67 10 6333 211 29567973
Metastases to retroperitoneum 43.31 24.67 10 6333 217 29567967
Therapy non-responder 42.27 24.67 42 6301 30869 29537315
Graft versus host disease 41.97 24.67 26 6317 9602 29558582
Hepatotoxicity 41.95 24.67 33 6310 17834 29550350
Neurological symptom 40.62 24.67 18 6325 3352 29564832
Metastases to bone marrow 40.45 24.67 11 6332 471 29567713
Febrile neutropenia 40.40 24.67 80 6263 112160 29456024
Accidental exposure to product 39.34 24.67 26 6317 10727 29557457
Personality change due to a general medical condition 38.52 24.67 7 6336 42 29568142
Metastases to spleen 38.19 24.67 10 6333 370 29567814
Graft versus host disease in skin 37.38 24.67 17 6326 3362 29564822
Infusion site haemorrhage 36.09 24.67 11 6332 709 29567475
Blast cells present 35.65 24.67 10 6333 481 29567703
Confusional state 33.29 24.67 80 6263 127797 29440387
Incorrect drug administration rate 30.79 24.67 11 6332 1165 29567019
Tumour lysis syndrome 29.10 24.67 24 6319 13860 29554324
Off label use 27.38 24.67 132 6211 300668 29267516
Apraxia 26.88 24.67 10 6333 1188 29566996
Leukoencephalopathy 26.75 24.67 14 6329 3753 29564431
Neoplasm progression 26.75 24.67 26 6317 18586 29549598
Intercepted product preparation error 26.72 24.67 12 6331 2305 29565879
Serum ferritin increased 26.68 24.67 16 6327 5572 29562612
Systemic mycosis 25.93 24.67 10 6333 1311 29566873
Fall 25.09 24.67 4 6339 177174 29391010
Mental status changes 24.98 24.67 34 6309 34893 29533291
Hepatic calcification 24.95 24.67 7 6336 337 29567847
Adrenomegaly 24.69 24.67 7 6336 350 29567834

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 1249.61 23.81 251 10084 3775 64484622
Cytokine release syndrome 1098.09 23.81 309 10026 20520 64467877
Neurotoxicity 516.78 23.81 186 10149 27218 64461179
Pyrexia 472.11 23.81 508 9827 558136 63930261
Central nervous system leukaemia 219.12 23.81 40 10295 345 64488052
Blast cell count increased 197.93 23.81 45 10290 1234 64487163
Leukaemic infiltration extramedullary 181.46 23.81 30 10305 133 64488264
Acute lymphocytic leukaemia refractory 149.41 23.81 25 10310 121 64488276
Acute lymphocytic leukaemia 118.54 23.81 39 10296 4332 64484065
Febrile neutropenia 117.01 23.81 147 10188 187510 64300887
Graft versus host disease in skin 110.84 23.81 39 10296 5308 64483089
Graft versus host disease 92.85 23.81 45 10290 13768 64474629
Nervous system disorder 91.93 23.81 53 10282 23025 64465372
Aphasia 88.55 23.81 64 10271 40842 64447555
Therapy non-responder 86.76 23.81 77 10258 65822 64422575
Device related infection 78.14 23.81 53 10282 30573 64457824
Intercepted product preparation error 76.70 23.81 23 10312 1885 64486512
Infusion site haemorrhage 76.47 23.81 24 10311 2291 64486106
Neoplasm recurrence 76.45 23.81 27 10308 3712 64484685
Philadelphia chromosome positive 75.79 23.81 18 10317 599 64487798
Tremor 73.65 23.81 104 10231 148126 64340271
Minimal residual disease 71.73 23.81 16 10319 401 64487996
Cytopenia 71.02 23.81 39 10296 15432 64472965
Graft versus host disease in gastrointestinal tract 65.79 23.81 27 10308 5585 64482812
Venoocclusive disease 63.70 23.81 24 10311 3961 64484436
Tumour lysis syndrome 62.74 23.81 39 10296 19401 64468996
Babesiosis 60.43 23.81 13 10322 274 64488123
Leukaemia recurrent 54.06 23.81 19 10316 2575 64485822
Leukoencephalopathy 53.86 23.81 25 10310 6942 64481455
Hepatotoxicity 53.17 23.81 47 10288 39915 64448482
Venoocclusive liver disease 50.85 23.81 27 10308 9988 64478409
Therapeutic response delayed 50.49 23.81 14 10321 868 64487529
Escherichia bacteraemia 50.06 23.81 22 10313 5381 64483016
Neutropenia 47.64 23.81 113 10222 239511 64248886
Seizure 46.16 23.81 90 10245 166802 64321595
Product preparation error 46.03 23.81 19 10316 3986 64484411
Leukaemic infiltration renal 44.73 23.81 7 10328 20 64488377
Encephalopathy 44.62 23.81 51 10284 58768 64429629
Metastases to muscle 42.60 23.81 10 10325 316 64488081
Blast cells present 41.94 23.81 12 10323 834 64487563
Metastases to retroperitoneum 41.26 23.81 10 10325 363 64488034
Off label use 41.24 23.81 205 10130 632601 63855796
Pancytopenia 40.49 23.81 78 10257 143231 64345166
Metastases to bone marrow 40.07 23.81 11 10324 657 64487740
Metastases to spleen 38.24 23.81 10 10325 496 64487901
Neurological symptom 36.25 23.81 19 10316 6845 64481552
Disseminated intravascular coagulation 35.18 23.81 34 10301 32314 64456083
Fusarium infection 34.65 23.81 12 10323 1557 64486840
Fall 34.34 23.81 12 10323 416814 64071583
Jaw operation 34.22 23.81 10 10325 749 64487648
Transformation to acute myeloid leukaemia 32.98 23.81 10 10325 851 64487546
Disease progression 32.77 23.81 71 10264 141609 64346788
Apraxia 32.67 23.81 13 10322 2482 64485915
Personality change due to a general medical condition 32.56 23.81 7 10328 147 64488250
Serum ferritin increased 32.52 23.81 19 10316 8449 64479948
Neutrophil count decreased 32.28 23.81 50 10285 77146 64411251
Neoplasm progression 31.88 23.81 36 10299 40928 64447469
Blood lactate dehydrogenase increased 30.87 23.81 32 10303 33046 64455351
Precursor B-lymphoblastic lymphoma recurrent 30.27 23.81 5 10330 22 64488375
Platelet count decreased 30 23.81 76 10259 167635 64320762
Diarrhoea 29.48 23.81 44 10291 722660 63765737
Cytomegalovirus infection 29.47 23.81 33 10302 37166 64451231
Transaminases increased 29.40 23.81 36 10299 44558 64443839
Accidental exposure to product 29.21 23.81 28 10307 26336 64462061
Capillary leak syndrome 29.18 23.81 13 10322 3284 64485113
Trichosporon infection 28.43 23.81 9 10326 883 64487514
Acute graft versus host disease in skin 27.97 23.81 16 10319 6839 64481558
Blood bilirubin increased 27.96 23.81 40 10295 57513 64430884
White blood cell count increased 27.93 23.81 43 10292 65971 64422426
Drug resistance 27.57 23.81 31 10304 35071 64453326
Drug hypersensitivity 27.54 23.81 3 10332 237812 64250585
Pruritus 27.47 23.81 8 10327 312392 64176005
Bone marrow failure 27.32 23.81 36 10299 47916 64440481
Aspiration bone marrow abnormal 27.27 23.81 6 10329 141 64488256
Dyspnoea 27.18 23.81 46 10289 718628 63769769
Systemic mycosis 26.63 23.81 11 10324 2312 64486085
Hepatic calcification 26.57 23.81 7 10328 357 64488040
Adrenomegaly 26.29 23.81 7 10328 372 64488025
Hypoproteinaemia 25.72 23.81 12 10323 3370 64485027
Chronic graft versus host disease oral 25.51 23.81 5 10330 65 64488332
Interleukin level increased 25.48 23.81 7 10328 419 64487978
Haemolytic transfusion reaction 25.17 23.81 4 10331 13 64488384
Confusional state 24.87 23.81 95 10240 261049 64227348
Chronic graft versus host disease in skin 24.51 23.81 9 10326 1382 64487015
Pain 24.23 23.81 32 10303 553479 63934918
Escherichia urinary tract infection 24.14 23.81 18 10317 12019 64476378
Condition aggravated 24.06 23.81 15 10320 372411 64115986
Costal cartilage fracture 23.98 23.81 6 10329 249 64488148
Fatigue 23.89 23.81 53 10282 748677 63739720

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

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
CHEMBL1742992 ChEMBL_ID
DB09052 DRUGBANK_ID
9028 INN_ID
C510808 MESH_SUPPLEMENTAL_RECORD_UI
7384 IUPHAR_LIGAND_ID
C568788 MESH_SUPPLEMENTAL_RECORD_UI
1597258 RXNORM
231126 MMSL
30709 MMSL
d08312 MMSL
015799 NDDF
716122004 SNOMEDCT_US
774173007 SNOMEDCT_US

Pharmaceutical products:

None