Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mobocertinib
Drug ID BADD_D02573
Description Mobocertinib is a kinase inhibitor targeted against human epidermal growth factor receptor (EGFR). It is used specifically in the treatment of non-small cell lung cancer (NSCLC) caused by exon 20 insertion mutations in the _EGFR_ gene,[L38368] which are typically associated with a poorer prognosis (as compared to "classical" _EGFR_ mutants causing NSCLC) and are associated with resistance to standard targeted EGFR inhibitors.[A238828] Mobocertinib appears to be an effective means of treating this otherwise treatment-resistant NSCLC, exerting an inhibitory effect on _EGFR_ exon 20 insertion mutant variants at concentrations 1.5- to 10-fold lower than those required to inhibit wild-type EGFR.[L38319] Mobocertinib, under the brand name Exkivity (Takeda Pharmaceuticals Inc.), was granted accelerated approval by the FDA in September 2021 for the treatment of locally advanced or metastatic NSCLC in patients with _EGFR_ exon 20 insertion mutations who have failed previous therapies.[L38368]
Indications and Usage Mobocertinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.[L38319]
Marketing Status approved; investigational
ATC Code L01EB10
DrugBank ID DB16390
KEGG ID D12001
MeSH ID C000720862
PubChem ID 118607832
TTD Drug ID DI4HA7
NDC Product Code 48957-0104; 63020-040
UNII 39HBQ4A67L
Synonyms mobocertinib | propan-2-yl 2-(4-(2-(dimethylamino)ethyl-methylamino)-2-methoxy-5-(prop-2-enoylamino)anilino)-4-(1-methylindol-3-yl)pyrimidine-5-carboxylate | TAK-788
Chemical Information
Molecular Formula C32H39N7O4
CAS Registry Number 1847461-43-1
SMILES CC(C)OC(=O)C1=CN=C(N=C1C2=CN(C3=CC=CC=C32)C)NC4=C(C=C(C(=C4)NC(=O)C=C)N(C)CCN(C) C)OC
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)
Abdominal discomfort07.01.06.0010.000112%Not Available
Anaemia01.03.02.0010.000112%
Arthralgia15.01.02.0010.000112%
Asthenia08.01.01.0010.000392%Not Available
Constipation07.02.02.0010.000168%
Death08.04.01.0010.001231%
Dehydration14.05.05.0010.000224%
Depression19.15.01.0010.000112%
Diarrhoea07.02.01.0010.002720%
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.0070.000224%
Dry eye06.08.02.0010.000112%
Dry mouth07.06.01.0020.000280%
Dry skin23.03.03.0010.000582%
Dyspepsia07.01.02.0010.000112%
Dysphagia07.01.06.0030.000168%
Dyspnoea02.11.05.003; 22.02.01.0040.000280%
Epistaxis24.07.01.005; 22.04.03.0010.000168%
Eye irritation06.04.05.0030.000168%Not Available
Fatigue08.01.01.0020.000336%
Feeling abnormal08.01.09.0140.000168%Not Available
Gastrooesophageal reflux disease07.02.02.0030.000112%
Gastrointestinal disorder07.11.01.0010.000112%Not Available
Hypokalaemia14.05.03.0020.000112%
Insomnia19.02.01.002; 17.15.03.0020.000112%
Mouth ulceration07.05.06.0040.000112%Not Available
Nasal dryness22.04.03.0020.000112%Not Available
Nausea07.01.07.0010.000448%
Neoplasm16.16.02.0010.000112%Not Available
Oral pain07.05.05.0340.000168%
Pneumonitis22.01.01.0060.000168%
The 1th Page    1 2 3    Next   Last    Total 3 Pages