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
NDC Product Code 69988-0047
Synonyms alectinib | Alecensa | CH5424802 | RO5424802
Chemical Information
Molecular Formula C30H34N4O2
CAS Registry Number 1256580-46-7
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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.001066%
Acute respiratory distress syndrome22.01.03.0010.000139%
Arrhythmia02.03.02.0010.000533%Not Available
Aspartate aminotransferase increased13.03.01.0060.000533%
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; Available
Atrial fibrillation02.03.03.0020.000799%
Atrioventricular block02.03.01.0020.000533%Not Available
Back pain15.03.04.0050.001066%
Blood bilirubin increased13.03.01.0080.001332%
Blood creatine phosphokinase increased13.04.01.0010.002931%
Blood creatinine increased13.13.01.0040.002398%
Blood lactate dehydrogenase increased13.04.02.0020.000533%
Bone pain15.02.01.0010.000533%
Bradycardia02.03.02.0020.003197%Not Available
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.0010.000556%
Cardiac failure congestive02.05.01.002--Not Available
Cardiac tamponade02.06.01.0010.000533%
Cerebral haemorrhage17.08.01.003; Available
Cerebrovascular accident24.03.05.001;
Chronic obstructive pulmonary disease22.03.01.0070.000278%Not Available
Colon cancer16.13.01.001; Available
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