Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alectinib hydrochloride
Drug ID BADD_D00063
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 D10450
MeSH ID C582670
PubChem ID 53239799
TTD Drug ID D0U3SY
NDC Product Code 50242-130; 54893-0087
UNII P9YY73LO6J
Synonyms alectinib | Alecensa | CH5424802 | RO5424802
Chemical Information
Molecular Formula C30H35ClN4O2
CAS Registry Number 1256589-74-8
SMILES CCC1=CC2=C(C=C1N3CCC(CC3)N4CCOCC4)C(C5=C(C2=O)C6=C(N5)C=C(C=C6)C#N)(C)C.Cl
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)
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Aspartate aminotransferase increased13.03.04.011--
Back pain15.03.04.005--
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Constipation07.02.02.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hyperbilirubinaemia14.11.01.010; 09.01.01.003; 01.06.04.003---
Hyperglycaemia05.06.02.002; 14.06.02.002--
Hypocalcaemia14.04.01.004--
Hypokalaemia14.05.03.002--
Hyponatraemia14.05.04.002--
Hypophosphataemia14.04.03.001--
Lymphopenia01.02.02.002---
Myalgia15.05.02.001--
Nausea07.01.07.001--
Oedema14.05.06.010; 08.01.07.006---
Rash23.03.13.001---
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Blood alkaline phosphatase increased13.04.02.004--
The 1th Page    1    Total 1 Pages