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 Not Available
ATC Code L01ED03
DrugBank ID DB11363
KEGG ID D10542
MeSH ID C582670
PubChem ID 49806720
TTD Drug ID D0U3SY
NDC Product Code 69988-0047
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pruritus generalised23.03.12.0030.000533%Not Available
Transaminases increased13.03.01.0150.001598%Not Available
Ocular icterus06.08.03.009; 09.01.01.007; 01.06.04.0070.000799%Not Available
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.000208%Not Available
Metastases to central nervous system17.02.10.013; 16.22.02.0040.000695%Not Available
Blood alkaline phosphatase increased13.04.02.0040.000533%
Drug resistance08.06.01.0050.000139%Not Available
Hepatic enzyme increased13.03.01.0190.001865%Not Available
Lung infection22.07.01.008; 11.01.09.0080.000208%
Neoplasm progression16.16.02.0050.000139%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Disease progression08.01.03.0380.001042%
Drug intolerance08.06.01.013--Not Available
Non-small cell lung cancer22.08.01.002; 16.19.01.0010.000347%Not Available
Renal impairment20.01.03.0100.001598%Not Available
Liver injury12.01.02.003; 09.01.07.0220.000533%Not Available
Acute kidney injury20.01.03.016--
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000799%Not Available
Drug reaction with eosinophilia and systemic symptoms23.03.05.005; 10.01.01.0210.000533%Not Available
Liver function test increased13.03.01.0440.002131%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000208%Not Available
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