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)
Pericardial effusion02.06.01.0020.002664%
Peritonitis11.01.07.007; 07.19.05.0040.000533%
Pleural effusion22.05.02.0020.003197%
Pneumonia22.07.01.003; 11.01.09.0030.003996%Not Available
Pneumonitis22.01.01.0060.003197%
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.0010.001598%Not Available
Pulmonary oedema22.01.03.003; 02.05.02.0030.000533%
Pyrexia08.05.02.003--
Rash23.03.13.0010.005861%Not Available
Rash generalised23.03.13.0020.001066%Not Available
Rash maculo-papular23.03.13.0040.000799%
Rectal haemorrhage24.07.02.018; 07.12.03.0010.000533%
Renal disorder20.01.02.0020.001332%Not Available
Renal failure20.01.03.0050.000556%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000208%
Seizure17.12.03.001--
Sepsis11.01.11.003--
Septic shock24.06.02.011; 11.01.11.0040.000139%Not Available
Skin disorder23.03.03.0070.000533%Not Available
Throat irritation22.02.05.013; 07.05.03.0040.000533%Not Available
Thrombosis24.01.01.006--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.06.0080.001066%Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.0060.001598%
Peripheral swelling08.01.03.053; 02.05.04.0150.001066%Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000208%
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