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 approved; investigational
ATC Code L01EX13
DrugBank ID DB12141
KEGG ID D10709
MeSH ID C000609080
PubChem ID 49803313
TTD Drug ID D04KZY
NDC Product Code 0469-1425
UNII 66D92MGC8M
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
*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)
Acute febrile neutrophilic dermatosis23.03.03.033; 01.02.01.0060.000112%Not Available
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.005261%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.000112%Not Available
Anaemia01.03.02.0010.000582%
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000112%
Aspiration22.02.07.0070.000112%
Cardiac failure02.05.01.0010.000560%
Cardio-respiratory arrest22.02.06.007; 02.03.04.0020.000168%Not Available
Cardiomyopathy02.04.01.0010.000112%Not Available
Cerebral haemorrhage24.07.04.001; 17.08.01.0030.000280%Not Available
Cholecystitis09.03.01.0010.000224%
Death08.04.01.0010.002350%
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.000168%
Dysphagia07.01.06.0030.000907%
Febrile neutropenia08.05.02.004; 01.02.03.0020.000895%
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.000224%Not Available
Graft versus host disease12.02.09.001; 10.02.01.0270.000728%Not Available
Haemolytic anaemia01.06.03.0020.000112%Not Available
Hepatic failure09.01.03.0020.000112%
Hepatic function abnormal09.01.02.0010.001231%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.000280%Not Available
Hyperglycaemia14.06.02.002; 05.06.02.0020.000112%
Hyponatraemia14.05.04.0020.000302%
Interstitial lung disease22.01.02.003; 10.02.01.0330.000448%Not Available
Leukocytosis01.02.01.0020.000112%
Liver disorder09.01.08.0010.000504%Not Available
Lung disorder22.02.07.0010.000302%Not Available
Melaena24.07.02.013; 07.12.02.0040.000112%Not Available
Myalgia15.05.02.0010.000492%
Nervous system disorder17.02.10.0010.000224%Not Available
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