blinatumomab 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 834.84 27.28 146 3865 1949 46680102
Cytokine release syndrome 467.28 27.28 108 3903 6115 46675936
Neurotoxicity 437.75 27.28 120 3891 13597 46668454
Pyrexia 269.64 27.28 228 3783 348574 46333477
Acute lymphocytic leukaemia 125.17 27.28 32 3979 2741 46679310
Acute lymphocytic leukaemia refractory 108.28 27.28 16 3995 63 46681988
Neoplasm recurrence 100.34 27.28 26 3985 2347 46679704
Leukaemic infiltration extramedullary 88.01 27.28 13 3998 51 46682000
Philadelphia chromosome positive 87.01 27.28 16 3995 283 46681768
Blast cell count increased 84.00 27.28 16 3995 345 46681706
Graft versus host disease in skin 72.02 27.28 20 3991 2347 46679704
Therapeutic response delayed 65.78 27.28 14 3997 535 46681516
Leukaemia recurrent 58.54 27.28 15 3996 1294 46680757
Graft versus host disease 55.51 27.28 21 3990 6567 46675484
Febrile neutropenia 51.01 27.28 51 3960 94576 46587475
Seizure 49.88 27.28 57 3954 122997 46559054
Venoocclusive disease 48.11 27.28 14 3997 1942 46680109
Graft versus host disease in gastrointestinal tract 44.45 27.28 14 3997 2536 46679515
Intercepted product preparation error 44.08 27.28 8 4003 131 46681920
Infusion site haemorrhage 42.36 27.28 13 3998 2161 46679890
Transplantation complication 41.67 27.28 7 4004 71 46681980
B precursor type acute leukaemia 41.25 27.28 8 4003 190 46681861
Hypoproteinaemia 40.11 27.28 12 3999 1831 46680220
Central nervous system leukaemia 40.01 27.28 7 4004 92 46681959
Transformation to acute myeloid leukaemia 38.05 27.28 7 4004 124 46681927
Device related infection 37.36 27.28 23 3988 21018 46661033
Venoocclusive liver disease 33.82 27.28 13 3998 4238 46677813
Leukaemic infiltration renal 33.77 27.28 5 4006 20 46682031
Aphasia 33.24 27.28 24 3987 28543 46653508
Nervous system disorder 32.17 27.28 19 3992 16110 46665941
Neutropenia 31.19 27.28 49 3962 143155 46538896
Leukoencephalopathy 30.99 27.28 12 3999 3992 46678059
Accidental exposure to product 29.89 27.28 20 3991 21061 46660990
Therapy non-responder 29.48 27.28 26 3985 41126 46640925
Drug resistance 28.35 27.28 18 3993 17350 46664701
Interleukin level increased 27.34 27.28 6 4005 265 46681786

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 552.17 24.42 120 4935 2547 29944876
Cytokine release syndrome 505.44 24.42 145 4910 9788 29937635
Pyrexia 280.72 24.42 292 4763 294197 29653226
Neurotoxicity 253.47 24.42 92 4963 13090 29934333
Acute lymphocytic leukaemia 202.35 24.42 55 5000 3017 29944406
Blast cell count increased 150.33 24.42 35 5020 1014 29946409
Central nervous system leukaemia 114.54 24.42 22 5033 242 29947181
Acute lymphocytic leukaemia refractory 111.57 24.42 19 5036 98 29947325
Leukaemic infiltration extramedullary 89.55 24.42 14 5041 37 29947386
Minimal residual disease 67.90 24.42 14 5041 226 29947197
Cytopenia 63.56 24.42 30 5025 8226 29939197
Aphasia 56.04 24.42 37 5018 19402 29928021
Encephalopathy 53.60 24.42 44 5011 32161 29915262
Nervous system disorder 50.59 24.42 30 5025 13039 29934384
Aspiration bone marrow abnormal 46.60 24.42 9 5046 102 29947321
Off label use 46.34 24.42 118 4937 249172 29698251
Metastases to muscle 46.33 24.42 10 5045 203 29947220
Metastases to retroperitoneum 46.10 24.42 10 5045 208 29947215
Tremor 44.47 24.42 59 4996 75304 29872119
Infusion site haemorrhage 43.44 24.42 11 5044 455 29946968
Febrile neutropenia 43.32 24.42 70 4985 106623 29840800
Metastases to bone marrow 42.47 24.42 11 5044 498 29946925
Metastases to spleen 41.59 24.42 10 5045 333 29947090
Product preparation error 40.68 24.42 14 5041 1692 29945731
Personality change due to a general medical condition 40.20 24.42 7 5048 42 29947381
Device related infection 38.70 24.42 28 5027 16987 29930436
Accidental exposure to product 38.57 24.42 23 5032 10092 29937331
Precursor B-lymphoblastic lymphoma recurrent 31.77 24.42 5 5050 14 29947409
Neurological symptom 31.13 24.42 14 5041 3433 29943990
Hepatotoxicity 30.60 24.42 25 5030 18120 29929303
Incorrect drug administration rate 29.74 24.42 10 5045 1126 29946297
B precursor type acute leukaemia 29.70 24.42 6 5049 87 29947336
Neoplasm progression 28.66 24.42 24 5031 17999 29929424
End stage renal disease 28.59 24.42 17 5038 7418 29940005
Graft versus host disease in skin 28.50 24.42 13 5042 3294 29944129
Spinal cord disorder 26.54 24.42 8 5047 633 29946790
Neutropenic sepsis 26.45 24.42 19 5036 11390 29936033
Apraxia 25.34 24.42 9 5046 1193 29946230
Systemic mycosis 25.24 24.42 9 5046 1207 29946216

Pharmacologic Action:

SourceCodeDescription
ATC L01XC19 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Monoclonal antibodies
FDA CS M0018640 Recombinant Fusion Proteins
FDA MoA N0000175617 CD3-directed Antibody Interactions
FDA MoA N0000175618 CD3 Receptor Agonists
MeSH PA D000970 Antineoplastic Agents
FDA EPC N0000191421 Bispecific CD19-directed CD3-directed T Cell Engager
FDA MoA N0000191422 CD19-directed Antibody Interactions

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pre B-cell acute lymphoblastic leukemia indication 277572006

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
1597258 RXNORM
231126 MMSL
30709 MMSL
d08312 MMSL
015799 NDDF
716122004 SNOMEDCT_US
774173007 SNOMEDCT_US

Pharmaceutical products:

None