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)

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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

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FDA Adverse Event Reporting System (Male)

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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

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FDA Adverse Event Reporting System (Geriatric)

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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

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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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 EPC	N0000175571	CD33-directed Immunoconjugate
FDA MoA	N0000175077	CD33-directed Antibody Interactions
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