gemtuzumab ozogamicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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

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
Venoocclusive liver disease 223.82 39.19 50 2470 4211 50598393
Febrile neutropenia 170.14 39.19 87 2433 97580 50505024
Sepsis 137.25 39.19 84 2436 132841 50469763
Thrombocytopenia 95.51 39.19 66 2454 127607 50474997
Bone marrow failure 89.75 39.19 38 2482 27586 50575018
Alanine aminotransferase increased 66.71 39.19 46 2474 88313 50514291
Lower respiratory tract infection fungal 55.27 39.19 10 2510 285 50602319
Platelet count decreased 52.54 39.19 42 2478 100684 50501920
Multiple organ dysfunction syndrome 52.18 39.19 32 2488 50305 50552299
Blood bilirubin increased 51.10 39.19 27 2493 32011 50570593
Septic shock 50.89 39.19 33 2487 57142 50545462
Venoocclusive disease 46.26 39.19 12 2508 1884 50600720
Neutropenia 45.91 39.19 46 2474 147919 50454685
Neutrophil count decreased 44.50 39.19 28 2492 45998 50556606
White blood cell count decreased 39.37 39.19 38 2482 116684 50485920

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 305.81 31 82 3083 6835 29564527
Febrile neutropenia 191.45 31 129 3036 112111 29459251
Sepsis 82.25 31 88 3077 142594 29428768
Platelet count decreased 62.74 31 66 3099 104606 29466756
Bone marrow failure 62.41 31 38 3127 27411 29543951
Disseminated intravascular coagulation 62.36 31 34 3131 19946 29551416
Neutrophil count decreased 61.94 31 45 3120 43522 29527840
Thrombocytopenia 58.70 31 72 3093 134751 29436611
White blood cell count decreased 43.64 31 49 3116 83313 29488049
Blood bilirubin increased 43.63 31 33 3132 33860 29537502
Neutropenic colitis 42.20 31 14 3151 2397 29568965
Leukaemia recurrent 40.14 31 12 3153 1465 29569897
Pyrexia 40.11 31 92 3073 287530 29283832
Multiple organ dysfunction syndrome 39.88 31 41 3124 63075 29508287
Chills 35.75 31 41 3124 71259 29500103
Venoocclusive disease 33.75 31 12 3153 2527 29568835
Neutropenia 32.88 31 54 3111 131657 29439705
Pancytopenia 32.24 31 42 3123 83126 29488236

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 434.81 35.87 107 4331 9908 64484386
Febrile neutropenia 283.93 35.87 170 4268 187487 64306807
Thrombocytopenia 122.70 35.87 110 4328 223691 64270603
Bone marrow failure 120.62 35.87 61 4377 47891 64446403
Sepsis 114.13 35.87 107 4331 230234 64264060
Venoocclusive disease 83.67 35.87 24 4414 3961 64490333
Multiple organ dysfunction syndrome 67.88 35.87 56 4382 101357 64392937
Septic shock 61.90 35.87 54 4384 105383 64388911
Leukaemia recurrent 60.67 35.87 17 4421 2577 64491717
Pyrexia 58.14 35.87 122 4316 558522 63935772
Blood bilirubin increased 56.61 35.87 40 4398 57513 64436781
Alanine aminotransferase increased 56.36 35.87 58 4380 138973 64355321
Acute myeloid leukaemia recurrent 55.02 35.87 16 4422 2768 64491526
Neutropenia 53.97 35.87 74 4364 239550 64254744
Neoplasm progression 53.59 35.87 34 4404 40930 64453364
White blood cell count decreased 51.98 35.87 59 4379 157778 64336516
Lower respiratory tract infection fungal 51.89 35.87 12 4426 843 64493451
Platelet count decreased 47.43 35.87 58 4380 167653 64326641
Neutropenic colitis 47.18 35.87 16 4422 4565 64489729
Pancytopenia 46.20 35.87 53 4385 143256 64351038
Aspartate aminotransferase increased 43.23 35.87 47 4391 119741 64374553
Acute respiratory distress syndrome 42.83 35.87 29 4409 38906 64455388
Bronchopulmonary aspergillosis 38.57 35.87 21 4417 19064 64475230
Graft versus host disease in skin 37.33 35.87 14 4424 5333 64488961
Bacteraemia 36.85 35.87 23 4415 26888 64467406

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 D000970 Antineoplastic Agents
MeSH PA D000074322 Antineoplastic Agents, Immunological
MeSH PA D007155 Immunologic Factors
MeSH PA D000922 Immunotoxins
MeSH PA D009676 Noxae

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
CHEMBL1201506 ChEMBL_ID
6775 IUPHAR_LIGAND_ID
10315 INN_ID
DB00056 DRUGBANK_ID
8GZG754X6M UNII
1294580 RXNORM
32047 MMSL
8898 MMSL
d04540 MMSL
127964000 SNOMEDCT_US
386640004 SNOMEDCT_US
D000079982 MESH_DESCRIPTOR_UI
C1533699 UMLSCUI
008288 NDDF

Pharmaceutical products:

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