Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tucatinib
Drug ID BADD_D02603
Description Tucatinbib is a kinase inhibitor drug used with [trastuzumab] and [capecitabine] in the treatment of unresectable or metastatic HER-2 positive breast cancer. It was developed by Seattle Genetics and approved by the FDA on April 17, 2020.[L12951] Tucatinib is a promising new treatment for patients with metastatic breast cancer who have not responded adequately to other chemotherapy regimens.[L12945]
Indications and Usage Tucatinib is indicated with trastuzumab and capecitabine for treatment of adults diagnosed with advanced unresectable or metastatic HER2-positive breast cancer. This includes patients with brain metastases and those who have received one or more prior anti-HER2-based regimens in the metastatic setting.[L12945]
Marketing Status approved; investigational
ATC Code L01EH03
DrugBank ID DB11652
KEGG ID D11141
MeSH ID C000705452
PubChem ID 51039094
TTD Drug ID D09GRX
NDC Product Code 11014-0476; 43265-7481; 43265-7480; 51144-002; 57572-0723; 51144-001
UNII 234248D0HH
Synonyms tucatinib | irbinitinib | ONT-380 | tukysa | N6-(4,4-Dimethyl-4,5-dihydrooxazol-2-yl)-N4-(3-methyl-4-((1,2,4)triazolo(1,5-a)pyridin-7-yloxy)phenyl)quinazoline-4,6-diamine | N6-(4,5-dihydro-4,4-dmethyl-2-oxazolyl)-N4-(3-methyl-4-((1,2,4)triazolo(1,5-A)pyridin-7-Yloxy)phenyl)-4,6-quinazolinediamine
Chemical Information
Molecular Formula C26H24N8O2
CAS Registry Number 937263-43-9
SMILES CC1=C(C=CC(=C1)NC2=NC=NC3=C2C=C(C=C3)NC4=NC(CO4)(C)C)OC5=CC6=NC=NN6C=C5
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Peripheral coldness08.01.09.010; 23.06.04.008; 24.04.03.0060.000381%-
Peripheral sensory neuropathy17.09.03.0050.000381%
Piloerection23.02.06.0050.000381%-
Pleural effusion22.05.02.0020.000112%
Presyncope02.11.04.013; 17.02.05.009; 24.06.02.0100.000112%
Pulmonary oedema02.05.02.003; 22.01.03.0030.000112%
Pyrexia08.05.02.0030.001119%
Rash23.03.13.0010.002373%-
Rash erythematous23.03.13.0290.000246%-
Rash pruritic23.03.13.0300.000571%-
Renal disorder20.01.02.0020.000246%-
Rhinorrhoea22.12.03.0210.000627%
Skin discolouration23.03.03.0050.002854%-
Skin exfoliation23.03.07.0030.001388%-
Skin fissures23.03.03.0080.000246%-
Skin irritation23.03.04.0090.000683%-
Skin ulcer23.07.03.003; 24.04.03.0070.000437%
Somnolence17.02.04.006; 19.02.05.0030.001175%
Stomatitis07.05.06.0050.001936%
Swelling08.01.03.0150.000358%-
Swelling face08.01.03.100; 10.01.05.018; 23.04.01.0180.000358%-
Tenderness08.01.08.0050.000571%-
Thirst08.01.09.021; 14.03.02.0070.000381%-
Thrombosis24.01.01.0060.000168%-
Tremor17.01.06.0020.000604%
Visual impairment06.02.10.0130.000683%-
Vomiting07.01.07.0030.006548%
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000112%-
Peripheral swelling02.05.04.015; 08.01.03.0530.001668%-
Brain oedema12.01.10.010; 17.07.02.0030.000246%
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