Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Capmatinib
Drug ID BADD_D02540
Description Capmatinib is a small molecule kinase inhibitor targeted against c-Met (a.k.a. hepatocyte growth factor receptor [HGFR]), a receptor tyrosine kinase that, in healthy humans, activates signaling cascades involved in organ regeneration and tissue repair.[A199122] Aberrant c-Met activation - via mutations, amplification, and/or overexpression - is known to occur in many types of cancer, and leads to overactivation of multiple downstream signaling pathways such as STAT3, PI3K/ATK, and RAS/MAPK.[A199122] Mutations in _MET_ have been detected in non-small cell lung cancer (NSCLC), and the prevalence of _MET_ amplification in epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)-naive patients with NSCLC has been reported to be 1.4% - 21%.[A199122] This co-occurrence has made c-Met a desirable target in the treatment of NSCLC. Manufactured by Novartis and marketed under the brand name Tabrecta, capmatinib was granted accelerated approval by the FDA on May 6, 2020,[L13380] for the treatment of NSCLC in patients whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping.[L13347] The presence of the mutation must be confirmed by an FDA-approved test, such as the FoundationOne CDx assay (manufactured by Foundation Medicine, Inc.), which was approved by the FDA on the same day.[L13380] As this indication was granted under an accelerated approval, its continued approval is contingent upon verification of capmatinib's benefit in confirmatory trials.[L13347]
Indications and Usage Capmatinib is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.[L13347]
Marketing Status approved; investigational
ATC Code L01EX17
DrugBank ID DB11791
KEGG ID D10696
MeSH ID C000613976
PubChem ID 25145656
TTD Drug ID D07OJZ
NDC Product Code 0078-0709; 0078-0716
UNII TY34L4F9OZ
Synonyms capmatinib | 2-fluoro-N-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide | 2-fluoro-N-methyl-4-(7-(quinolin-6-yl-methyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide | capmatinib dihydrochloride monohydrate | 2-fluoro-n-methyl-4-(7-((quinolin-6-yl)methyl)imidazo(1,2- b)(1,2,4)triazin-2-yl)benzamide dihydrochloride monohydrate | Tabrecta | capmatinib hydrochloride | CNJ-294 | capmatinib metabolite M18 | CNJ294 | 2-fluoro-4-(7-((quinolin-6-yl)methyl)imidazo(1,2-b)-(1,2,4)triazin-2-yl)benzamide | capmatinib dihydrochloride | capmatinib hydrochloride anhydrous | 2-fluoro-n-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzamide dihydrochloride | INC280 | INCB-28060 free base | INCB-28060 | NVP-INC280-NX | INC-280 | INCB28060 | NVP-INC280 | CMC-583 | CMC583 | 2-fluoro-4-(7-((quinolin-6-yl)methyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)benzoic acid | capmatinib metabolite M13
Chemical Information
Molecular Formula C23H17FN6O
CAS Registry Number 1029712-80-8
SMILES CNC(=O)C1=C(C=C(C=C1)C2=NN3C(=CN=C3N=C2)CC4=CC5=C(C=C4)N=CC=C5)F
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 distension07.01.04.0010.000112%
Asthenia08.01.01.0010.000750%-
Back pain15.03.04.0050.000358%
Cardiac tamponade02.06.01.0010.000112%
Chills08.01.09.001; 15.05.03.0160.000112%
Cholestasis09.01.01.0010.000112%-
Confusional state17.02.03.005; 19.13.01.0010.000280%
Cough22.02.03.0010.000851%
Deafness04.02.01.0010.000336%-
Death08.04.01.0010.005261%
Dehydration14.05.05.0010.000336%
Delirium19.13.02.0010.000112%
Dysphagia07.01.06.0030.004679%
Dyspnoea02.11.05.003; 22.02.01.0040.001332%
Electrolyte imbalance14.05.01.0020.000112%-
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.0040.000112%
Fatigue08.01.01.0020.002854%
Fluid retention14.05.06.002; 20.01.02.0030.000112%-
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.000358%
Gastrooesophageal reflux disease07.02.02.0030.000246%
Generalised oedema08.01.07.004; 14.05.06.0070.001153%
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.0060.000112%-
Hepatic function abnormal09.01.02.0010.000224%-
Hepatitis09.01.07.0040.000224%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.000504%-
Hypoalbuminaemia09.01.02.003; 14.10.01.0020.000112%
Hyponatraemia14.05.04.0020.000604%
Interstitial lung disease10.02.01.033; 22.01.02.0030.000112%-
Intestinal obstruction07.13.01.0020.000112%-
Joint swelling15.01.02.0040.000358%-
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