trastuzumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
humanized origin	4979	180288-69-1

Description:

Molecule	Description
Synonyms: trastuzumab-dkst ogivri trastuzumab herceptin trastuzumab (genetical recombination)	The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab products are mediators of antibody-dependent cellular cytotoxicity (ADCC). In vitro, trastuzumab product-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

trastuzumab-dkst
ogivri
trastuzumab
herceptin
trastuzumab (genetical recombination)

The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab products have been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab products are mediators of antibody-dependent cellular cytotoxicity (ADCC). In vitro, trastuzumab product-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

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Date	Agency	Company
April 4, 2001	PMDA	ROCHE JAPAN
Aug. 28, 2000	EMA	ROCHE REGISTRATION GMBH
Sept. 25, 1998	FDA	GENENTECH

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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
Ejection fraction decreased	2866.37	13.99	1197	117599	21135	63349091
Myelosuppression	2561.85	13.99	1125	117671	22578	63347648
Disease progression	1737.40	13.99	1597	117199	121161	63249065
Metastases to central nervous system	1506.51	13.99	650	118146	12455	63357771
Palmar-plantar erythrodysaesthesia syndrome	1271.67	13.99	691	118105	22324	63347902
Diarrhoea	1265.09	13.99	3543	115253	711823	62658403
Cardiotoxicity	1227.17	13.99	495	118301	7943	63362283
Neuropathy peripheral	931.86	13.99	1105	117691	112562	63257664
Febrile neutropenia	743.06	13.99	1008	117788	117441	63252785
Drug ineffective	727.40	13.99	541	118255	1044224	62326002

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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
Disease progression	259.64	23.82	193	6548	107884	34842306
Myelosuppression	210.79	23.82	93	6648	19172	34931018
Off label use	143.98	23.82	274	6467	419250	34530940
Palmar-plantar erythrodysaesthesia syndrome	112.81	23.82	58	6683	16737	34933453
Delusion of grandeur	107.51	23.82	28	6713	1132	34949058
Oligohydramnios	104.31	23.82	22	6719	346	34949844
Rhinalgia	90.78	23.82	24	6717	1029	34949161
Death	76.40	23.82	207	6534	397842	34552348
Affective disorder	71.05	23.82	28	6713	4332	34945858
Pulmonary hypoplasia	66.00	23.82	16	6725	481	34949709

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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
Myelosuppression	2403.91	13.91	1104	94566	39192	79609526
Ejection fraction decreased	1874.74	13.91	887	94783	33690	79615028
Diarrhoea	998.02	13.91	2796	92874	877693	78771025
Disease progression	968.22	13.91	1148	94522	183214	79465504
Palmar-plantar erythrodysaesthesia syndrome	904.66	13.91	538	95132	32596	79616122
Metastases to central nervous system	895.91	13.91	423	95247	15952	79632766
Cardiotoxicity	724.78	13.91	334	95336	11905	79636813
Neuropathy peripheral	720.06	13.91	867	94803	140438	79508280
Bone marrow failure	497.12	13.91	444	95226	50663	79598055
Drug ineffective	449.85	13.91	384	95286	1080529	78568189

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01FD01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
ATC	L01XY02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Combinations of antineoplastic agents
FDA EPC	N0000175661	HER2/neu Receptor Antagonist
FDA MoA	N0000020008	HER2/Neu/cerbB2 Antagonists
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D000074322	Antineoplastic Agents, Immunological

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

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Disease	Relation	SNOMED_ID	DOID
Secondary malignant neoplasm of female breast	indication	94297009
Secondary malignant neoplasm of stomach	indication	94606003
Human epidermal growth factor 2 positive gastric cancer	indication	102453009
HER2-positive salivary gland tumors	indication	255072001
HER2-positive rectal cancer	indication	363351006	DOID:1993
HER2-positive colon cancer	indication	363406005	DOID:219
HER2-positive carcinoma of breast	indication	427685000

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🐶 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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN	ANTIBODY BINDING				DRUG LABEL	DRUG LABEL

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External reference:

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ID	Source
007663	NDDF
017423	NDDF
101306	RXNORM
11893	MMSL
266775	MMSL
327397006	SNOMEDCT_US
33398	MMSL
387003001	SNOMEDCT_US
4021140	VUID
4021140	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Herceptin	HUMAN PRESCRIPTION DRUG LABEL	1	50242-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	25 sections
Herceptin Hylecta	HUMAN PRESCRIPTION DRUG LABEL	2	50242-077	INJECTION, SOLUTION	600 mg	SUBCUTANEOUS	BLA	28 sections
HERZUMA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-303	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
HERZUMA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-303	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
HERZUMA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-303	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	29 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	420 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	420 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-132	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	420 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-141	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	28 sections
Kanjinti	HUMAN PRESCRIPTION DRUG LABEL	1	55513-141	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	150 mg	INTRAVENOUS	BLA	28 sections

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