Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gilteritinib
Drug ID BADD_D02505
Description Gilteritinib, also known as ASP2215, is a small molecule part of the FLT3 tyrosine kinase inhibitors that presented a greater selectivity and potency when compared with other agents from this group.[A40036] It is a pyrazinecarboxamide derivative that showed high selectivity to FLT3 preventing the c-Kit -driven myelosuppression observed in other therapies.[A40044] Gilteritinib was developed by Astellas Pharma and FDA approved on November 28, 2018. This drug was approved after being designed as an orphan drug with a fast track and priority review status.[L4830]
Indications and Usage Gilteritinib is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation detected by an FDA-approved test. This indication was expanded for a companion diagnostic to include use with gilteritinib such as the LeukoStrat CDx FLT3 Mutation Assay.[L4830] Acute myeloid leukemia is cancer that impacts the blood and bone marrow with a rapid progression. This condition produces low numbers of normal blood cells and the requirement of continuous need for transfusions.[L4832]
Marketing Status Not Available
ATC Code L01EX13
DrugBank ID DB12141
KEGG ID D10709
MeSH ID C000609080
PubChem ID 49803313
TTD Drug ID D04KZY
NDC Product Code 0469-1425
Synonyms gilteritinib | ASP-2215 | ASP2215 | Xospata
Chemical Information
Molecular Formula C29H44N8O3
CAS Registry Number 1254053-43-4
SMILES CCC1=C(N=C(C(=N1)C(=O)N)NC2=CC(=C(C=C2)N3CCC(CC3)N4CCN(CC4)C)OC)NC5CCOCC5
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)
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.000973%Not Available
Anaemia01.03.02.0010.000799%
Blood lactate dehydrogenase increased13.04.02.0020.000533%
Cardiac failure02.05.01.0010.000139%
Death08.04.01.0010.000764%
Diarrhoea07.02.01.001--
Dysphagia07.01.06.0030.000533%
Electrocardiogram QT prolonged13.14.05.0040.000799%
Febrile neutropenia01.02.03.002; 08.05.02.0040.000278%
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000533%Not Available
Hepatic function abnormal09.01.02.0010.003463%Not Available
Herpes zoster23.09.03.002; 11.05.02.0030.000533%
Hypokalaemia14.05.03.0020.000533%
Infection11.01.08.0020.000347%Not Available
Liver disorder09.01.08.0010.000533%Not Available
Lung disorder22.02.07.0010.000533%Not Available
Malaise08.01.01.003--
Melaena24.07.02.013; 07.12.02.0040.000533%Not Available
Neutropenia01.02.03.0040.001066%Not Available
Neutrophil count decreased13.01.06.0100.002931%
Pancytopenia01.03.03.0030.000533%Not Available
Platelet count decreased13.01.04.0010.004263%
Pleural effusion22.05.02.0020.000799%
Pneumonia22.07.01.003; 11.01.09.0030.000347%Not Available
Pyrexia08.05.02.0030.003730%
Rash23.03.13.0010.001598%Not Available
Rash generalised23.03.13.0020.000533%Not Available
Sepsis11.01.11.0030.000208%
Thrombocytopenia01.08.01.0020.000533%Not Available
Tumour lysis syndrome16.32.03.002; 14.05.01.0040.000533%
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