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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.000973%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 haemorrhage07.12.02.001; 24.07.02.0090.000533%Not Available
Hepatic function abnormal09.01.02.0010.003463%Not Available
Herpes zoster11.05.02.003; 23.09.03.0020.000533%
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--
Melaena07.12.02.004; 24.07.02.0130.000533%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%
Pneumonia11.01.09.003; 22.07.01.0030.000347%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 syndrome14.05.01.004; 16.32.03.0020.000533%
The 1th Page    1 2    Next   Last    Total 2 Pages