Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Sotorasib
Drug ID BADD_D02596
Description Sotorasib, also known as AMG-510, is an acrylamide derived KRAS inhibitor developed by Amgen.[A187547,A187556] It is indicated in the treatment of adult patients with KRAS G12C mutant non small cell lung cancer.[L34288] This mutation makes up >50% of all KRAS mutations.[A187550] Mutant KRAS discovered in 1982 but was not considered a druggable target until the mid-2010s.[A235168] It is the first experimental KRAS inhibitor.[A187547] The drug [MRTX849] is also currently being developed and has the same target.[A187547] Sotorasib was granted FDA approval on 28 May 2021.[L34288]
Indications and Usage Sotorasib is indicated in the treatment of adults with KRAS G12C mutant non small cell lung cancer.[L34288]
Marketing Status approved; investigational
ATC Code L01XX73
DrugBank ID DB15569
KEGG ID D12055
MeSH ID C000706028
PubChem ID 137278711
TTD Drug ID D0R7LD
NDC Product Code 50683-0573; 55513-504; 69988-0057; 55513-488; 58272-065
UNII 2B2VM6UC8G
Synonyms sotorasib | lumakras | AMG-510 | AMG 510 | AMG510 | 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-1-(4-methyl-2-propan-2-ylpyridin-3-yl)-4-((2S)-2-methyl-4-prop-2-enoylpiperazin-1-yl)pyrido(2,3-d)pyrimidin-2-one
Chemical Information
Molecular Formula C30H30F2N6O3
CAS Registry Number 2252403-56-6
SMILES CC1CN(CCN1C2=NC(=O)N(C3=NC(=C(C=C32)F)C4=C(C=CC=C4F)O)C5=C(C=CN=C5C(C)C)C)C(=O)C =C
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)
Pneumothorax22.05.02.0030.000112%
Proteinuria20.02.01.0110.000381%
Pulmonary embolism22.06.02.001; 24.01.06.0010.000414%-
Pulmonary oedema02.05.02.003; 22.01.03.0030.000112%
Sudden death02.03.04.013; 08.04.01.0030.000112%
Therapeutic response decreased08.06.01.0160.000246%-
General physical health deterioration08.01.03.0180.000470%-
Lung cancer metastatic16.19.02.003; 22.08.01.0040.000224%-
Malignant neoplasm progression16.16.01.0050.000660%-
Colorectal cancer metastatic07.21.01.005; 16.13.01.0050.000112%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.000918%-
Gastrointestinal toxicity07.08.03.006; 12.03.01.0190.000381%-
Metastases to central nervous system16.22.02.004; 17.02.10.0130.000280%-
Adverse event08.06.01.0100.001231%-
Neoplasm progression16.16.02.0050.000392%-
Decreased appetite08.01.09.028; 14.03.01.0050.001019%
Colorectal cancer07.21.01.002; 16.13.01.0020.000112%-
Disease progression08.01.03.0380.003492%
Drug intolerance08.06.01.0130.000492%-
Non-small cell lung cancer16.19.01.001; 22.08.01.0020.006660%-
Hypertransaminasaemia09.01.02.0050.000627%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000224%-
Lung adenocarcinoma16.19.01.002; 22.08.01.0070.000336%-
Metastases to meninges16.22.02.003; 17.02.10.0120.000112%-
Non-small cell lung cancer metastatic16.19.01.009; 22.08.01.0210.001063%-
Hepatic cytolysis09.01.07.0360.000224%-
Immune-mediated enterocolitis07.08.01.021; 10.02.01.0840.000112%-
Lung adenocarcinoma recurrent16.19.01.011; 22.08.01.0240.000112%-
Therapy non-responder08.06.01.0630.000571%-
Therapy partial responder08.06.01.0640.000660%-
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