Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Alectinib
Drug ID BADD_D02480
Description Alectinib is a second generation oral drug that selectively inhibits the activity of anaplastic lymphoma kinase (ALK) tyrosine kinase. It is specifically used in the treatment of non-small cell lung cancer (NSCLC) expressing the ALK-EML4 (echinoderm microtubule-associated protein-like 4) fusion protein that causes proliferation of NSCLC cells. Inhibition of ALK prevents phosphorylation and subsequent downstream activation of STAT3 and AKT resulting in reduced tumour cell viability. Approved under accelerated approval in 2015, alectinib is indicated for use in patients who have progressed on or were not tolerant of crizotinib, which is associated with the development of resistance.
Indications and Usage Alectinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Marketing Status approved; investigational
ATC Code L01ED03
DrugBank ID DB11363
KEGG ID D10542
MeSH ID C582670
PubChem ID 49806720
TTD Drug ID D0U3SY
NDC Product Code 69988-0047
UNII LIJ4CT1Z3Y
Synonyms alectinib | Alecensa | CH5424802 | RO5424802
Chemical Information
Molecular Formula C30H34N4O2
CAS Registry Number 1256580-46-7
SMILES CCC1=CC2=C(C=C1N3CCC(CC3)N4CCOCC4)C(C5=C(C2=O)C6=C(N5)C=C(C=C6)C#N)(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)
Diabetes mellitus14.06.01.001; 05.06.01.0010.000224%Not Available
Disturbance in attention19.21.02.002; 17.03.03.0010.000112%
Drug eruption10.01.01.005; 08.01.06.015; 23.03.05.0010.000224%Not Available
Dysgeusia07.14.03.001; 17.02.07.0030.000492%
Dysphagia07.01.06.0030.003492%
Dyspnoea02.11.05.003; 22.02.01.0040.003011%
Dyspnoea exertional02.11.05.005; 22.02.01.0050.000112%Not Available
Epilepsy17.12.03.0020.000168%Not Available
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.0150.000112%
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.0030.000604%
Fatigue08.01.01.0020.004500%
Fluid retention20.01.02.003; 14.05.06.002--Not Available
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Gastric cancer16.13.03.001; 07.21.02.0010.000168%Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000112%
Gastrointestinal disorder07.11.01.001--Not Available
Haematoma24.07.01.001--
Haemolysis01.06.04.0020.000783%
Haemolytic anaemia01.06.03.0020.001231%Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.000414%Not Available
Hepatic failure09.01.03.0020.000470%
Hepatic function abnormal09.01.02.0010.000728%Not Available
Hepatitis09.01.07.0040.000504%Not Available
Hepatocellular injury09.01.07.0080.000504%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.000358%Not Available
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.0030.000951%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.000381%
Hypokalaemia14.05.03.0020.000168%
Hypoxia22.02.02.0030.000168%
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