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

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

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
Venoocclusive liver disease	250.13	38.81	55	2797	4780	63481390
Febrile neutropenia	206.22	38.81	102	2750	118347	63367823
Sepsis	154.76	38.81	92	2760	153031	63333139
Thrombocytopenia	103.17	38.81	71	2781	151086	63335084
Bone marrow failure	98.16	38.81	40	2812	29250	63456920
Alanine aminotransferase increased	64.27	38.81	46	2806	103724	63382446
Platelet count decreased	61.85	38.81	47	2805	116075	63370095
Septic shock	59.24	38.81	37	2815	66592	63419578
Lower respiratory tract infection fungal	54.91	38.81	10	2842	329	63485841
Blood bilirubin increased	52.76	38.81	28	2824	37112	63449058
Multiple organ dysfunction syndrome	51.66	38.81	32	2820	56720	63429450
Neutropenia	50.68	38.81	50	2802	174955	63311215
Acute myeloid leukaemia recurrent	49.34	38.81	12	2840	1611	63484559
Venoocclusive disease	46.51	38.81	12	2840	2046	63484124
Neutrophil count decreased	44.35	38.81	29	2823	56377	63429793
White blood cell count decreased	42.59	38.81	41	2811	139063	63347107
Graft versus host disease in skin	42.41	38.81	12	2840	2893	63483277
Aspartate aminotransferase increased	40.39	38.81	33	2819	90244	63395926
Cerebral haemorrhage	40.37	38.81	22	2830	30707	63455463
Bronchopulmonary aspergillosis	40.25	38.81	15	2837	8620	63477550

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	310.32	30.85	84	3361	7882	34945604
Febrile neutropenia	249.90	30.85	159	3286	136690	34816796
Sepsis	82.09	30.85	91	3354	166470	34787016
Disseminated intravascular coagulation	67.77	30.85	36	3409	21780	34931706
Bone marrow failure	63.06	30.85	38	3407	29215	34924271
Thrombocytopenia	62.89	30.85	77	3368	156170	34797316
Platelet count decreased	61.61	30.85	67	3378	119650	34833836
Neutrophil count decreased	61.03	30.85	46	3399	51058	34902428
Bronchopulmonary aspergillosis	44.96	30.85	24	3421	14635	34938851
Blood bilirubin increased	44.65	30.85	34	3411	38262	34915224
Neutropenic colitis	43.54	30.85	15	3430	3129	34950357
White blood cell count decreased	43.18	30.85	50	3395	95395	34858091
Pyrexia	42.66	30.85	98	3347	332915	34620571
Leukaemia recurrent	40.05	30.85	12	3433	1603	34951883
Neutropenia	38.52	30.85	61	3384	156717	34796769
Multiple organ dysfunction syndrome	37.82	30.85	42	3403	76524	34876962
Venoocclusive disease	37.08	30.85	13	3432	2854	34950632
Chills	35.87	30.85	42	3403	81001	34872485
Pancytopenia	35.14	30.85	45	3400	95112	34858374

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	457.41	34.88	113	4892	11658	79727725
Febrile neutropenia	375.16	34.88	212	4793	230787	79508596
Thrombocytopenia	138.76	34.88	122	4883	265137	79474246
Sepsis	129.19	34.88	118	4887	269310	79470073
Bone marrow failure	125.17	34.88	62	4943	51045	79688338
Venoocclusive disease	100.62	34.88	28	4977	4545	79734838
Septic shock	71.11	34.88	60	4945	122741	79616642
Neutropenic colitis	69.00	34.88	22	4983	5685	79733698
Acute myeloid leukaemia recurrent	66.64	34.88	19	4986	3364	79736019
Multiple organ dysfunction syndrome	66.04	34.88	57	4948	120189	79619194
Blood bilirubin increased	64.13	34.88	44	4961	66188	79673195
Neutropenia	63.63	34.88	84	4921	287626	79451757
Pyrexia	61.85	34.88	133	4872	678576	79060807
Leukaemia recurrent	61.09	34.88	17	4988	2757	79736626
Bronchopulmonary aspergillosis	60.39	34.88	29	4976	22265	79717118
Alanine aminotransferase increased	56.75	34.88	60	4945	162510	79576873
Neoplasm progression	56.42	34.88	37	4968	51645	79687738
White blood cell count decreased	52.84	34.88	62	4943	188226	79551157
Lower respiratory tract infection fungal	52.54	34.88	12	4993	876	79738507
Platelet count decreased	51.17	34.88	62	4943	194602	79544781
Pancytopenia	50.58	34.88	57	4948	165688	79573695
Aspartate aminotransferase increased	44.55	34.88	49	4956	138592	79600791
Acute respiratory distress syndrome	41.98	34.88	29	4976	44038	79695345
Graft versus host disease in skin	40.49	34.88	15	4990	6058	79733325
Bacteraemia	39.52	34.88	25	4980	32799	79706584
Colitis	36.70	34.88	33	4972	73274	79666109
Neutropenic infection	36.24	34.88	11	4994	2416	79736967

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	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological
MeSH PA	D018796	Immunoconjugates
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|

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
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
D000079982	MESH_DESCRIPTOR_UI
C1533699	UMLSCUI
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