All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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

Stem definition	Drug id	CAS RN
humanized origin	4980	220578-59-6

Description:

Molecule	Description
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:

Date	Agency	Company	Orphan
April 4, 2018	EMA	PFIZER EUROPE MA EEIG
May 17, 2000	FDA	WYETH PHARMS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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

amivantamabbelantamab mafodotinblinatumomabbrentuximab vedotincatumaxomabdatopotamab deruxtecanelotuzumabelranatamabenfortumab vedotinepcoritamabglofitamabipilimumab show all 29 →

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

Disease	Relation	SNOMED_ID	DOID
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:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Myeloid cell surface antigen CD33	Surface antigen	P20138	CD33_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Mylotarg	HUMAN PRESCRIPTION DRUG LABEL	1	0008-4510	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	5 mg	INTRAVENOUS	BLA	31 sections