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

Stem definitionDrug idCAS RN
humanized origin 4980 220578-59-6

Description:

MoleculeDescription

Synonyms:

  • gemtuzumab ozogamicin
  • mylotarg
Immunotoxin that consists of an anti-CD33 (CD33 ANTIGEN) monoclonal antibody conjugated to CALICHEAMICIN. It is used for the treatment of ACUTE MYELOID LEUKEMIA.
  • Molecular weight: 1680.67
  • Formula: C73H96GemtuzumabIN6O25S3
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
April 4, 2018 EMA PFIZER EUROPE MA EEIG
May 17, 2000 FDA WYETH PHARMS 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
Febrile neutropenia 340.07 42.59 150 3327 158199 90466771
Venoocclusive liver disease 308.39 42.59 66 3411 5927 90619043
Sepsis 191.93 42.59 106 3371 179708 90445262
Thrombocytopenia 134.29 42.59 89 3388 208636 90416334
Bone marrow failure 118.27 42.59 45 3432 32176 90592794
Alanine aminotransferase increased 70.01 42.59 48 3429 118290 90506680
Septic shock 69.20 42.59 42 3435 84118 90540852
Platelet count decreased 68.19 42.59 50 3427 136919 90488051
Neutropenia 65.37 42.59 60 3417 224844 90400126
Acute myeloid leukaemia recurrent 63.82 42.59 15 3462 2042 90622928
Multiple organ dysfunction syndrome 63.73 42.59 37 3440 68299 90556671
Bacteraemia 60.31 42.59 25 3452 22275 90602695
Lower respiratory tract infection fungal 58.60 42.59 10 3467 264 90624706
Venoocclusive disease 56.14 42.59 14 3463 2441 90622529
Blood bilirubin increased 55.59 42.59 29 3448 43441 90581529
Cerebral haemorrhage 49.85 42.59 25 3452 34497 90590473
Aspartate aminotransferase increased 47.66 42.59 36 3441 102901 90522069
White blood cell count decreased 45.44 42.59 43 3434 167066 90457904
Neutrophil count decreased 44.60 42.59 30 3447 71502 90553468

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
Venoocclusive liver disease 376.16 32.72 102 3870 10200 42607163
Febrile neutropenia 296.17 32.72 194 3778 185509 42431854
Venoocclusive disease 89.67 32.72 27 3945 3888 42613475
Sepsis 86.05 32.72 99 3873 199235 42418128
Bone marrow failure 76.25 32.72 44 3928 33049 42584314
Disseminated intravascular coagulation 70.87 32.72 38 3934 24756 42592607
Platelet count decreased 59.94 32.72 69 3903 138512 42478851
Thrombocytopenia 57.24 32.72 79 3893 190200 42427163
Neutrophil count decreased 54.51 32.72 46 3926 63369 42553994
Acute myeloid leukaemia recurrent 50.51 32.72 17 3955 3495 42613868
Blood bilirubin increased 47.73 32.72 36 3936 42216 42575147
Pyrexia 46.98 32.72 109 3863 393933 42223430
Neutropenic colitis 46.50 32.72 17 3955 4453 42612910
Bronchopulmonary aspergillosis 45.16 32.72 26 3946 19403 42597960
Multiple organ dysfunction syndrome 44.76 32.72 50 3922 96985 42520378
Chills 44.30 32.72 49 3923 94017 42523346
Hepatic failure 44.23 32.72 33 3939 38067 42579296
White blood cell count decreased 41.14 32.72 51 3921 110345 42507018
Leukaemia recurrent 38.94 32.72 12 3960 1864 42615499
Pancytopenia 33.98 32.72 48 3924 117695 42499668
Neoplasm progression 33.38 32.72 25 3947 28975 42588388
Neutropenia 32.74 32.72 63 3909 199368 42417995

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
Venoocclusive liver disease 592.90 37.58 143 6018 15064 110568074
Febrile neutropenia 545.57 37.58 290 5871 316477 110266661
Venoocclusive disease 183.33 37.58 47 6114 6303 110576835
Sepsis 166.86 37.58 141 6020 327205 110255933
Thrombocytopenia 159.05 37.58 141 6020 348744 110234394
Bone marrow failure 155.27 37.58 72 6089 57776 110525362
Acute myeloid leukaemia recurrent 105.28 37.58 29 6132 5110 110578028
Multiple organ dysfunction syndrome 88.88 37.58 71 6090 151639 110431499
Septic shock 88.64 37.58 72 6089 157456 110425682
Neutropenic colitis 88.21 37.58 28 6133 8037 110575101
Neoplasm progression 72.41 37.58 45 6116 64550 110518588
Neutropenia 71.83 37.58 96 6065 374524 110208614
Blood bilirubin increased 70.53 37.58 47 6114 75925 110507213
Bacteraemia 64.52 37.58 36 6125 42354 110540784
Pyrexia 64.42 37.58 149 6012 898116 109685022
Bronchopulmonary aspergillosis 61.41 37.58 31 6130 29832 110553306
Leukaemia recurrent 61.05 37.58 17 6144 3114 110580024
Alanine aminotransferase increased 60.12 37.58 62 6099 183711 110399427
Platelet count decreased 58.45 37.58 68 6093 230375 110352763
Lower respiratory tract infection fungal 54.38 37.58 12 6149 845 110582293
Pancytopenia 53.39 37.58 62 6099 209551 110373587
White blood cell count decreased 52.10 37.58 64 6097 229326 110353812
Acute respiratory distress syndrome 52.00 37.58 34 6127 53164 110529974
Aspartate aminotransferase increased 50.57 37.58 53 6108 159883 110423255
Drug resistance 50.20 37.58 34 6127 56340 110526798
Chills 49.59 37.58 57 6104 190523 110392615
Pulmonary veno-occlusive disease 48.08 37.58 13 6148 2135 110581003
Hepatic failure 39.83 37.58 32 6129 68707 110514431
Granulicatella infection 39.17 37.58 7 6154 165 110582973
Staphylococcal sepsis 38.48 37.58 19 6142 17435 110565703
Streptococcal bacteraemia 38.12 37.58 13 6148 4656 110578482
Colitis 37.98 37.58 37 6124 102286 110480852
Graft versus host disease in skin 37.75 37.58 15 6146 8239 110574899

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01FX02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Other monoclonal antibodies and antibody drug conjugates
FDA MoA N0000175077 CD33-directed Antibody Interactions
FDA EPC N0000175571 CD33-directed Immunoconjugate
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D000922 Immunotoxins
MeSH PA D000970 Antineoplastic Agents
MeSH PA D007155 Immunologic Factors
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

L01FX Other monoclonal antibodies and antibody drug conjugates 29 drugs
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Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Acute myeloid leukemia, disease indication 91861009




🐶 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
Myeloid cell surface antigen CD33 Surface antigen ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D03259 KEGG_DRUG
4021243 VUID
N0000023004 NUI
4021243 VANDF
CHEBI:749520 CHEBI
CHEMBL1201506 ChEMBL_ID
6775 IUPHAR_LIGAND_ID
DB00056 DRUGBANK_ID
1294580 RXNORM
32047 MMSL
8898 MMSL
d04540 MMSL
008288 NDDF
127964000 SNOMEDCT_US
386640004 SNOMEDCT_US
C1533699 UMLSCUI
D000079982 MESH_DESCRIPTOR_UI
10315 INN_ID
168322462 PUBCHEM_CID
8GZG754X6M UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Mylotarg HUMAN PRESCRIPTION DRUG LABEL 1 0008-4510 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 5 mg INTRAVENOUS BLA 31 sections