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)
Neutropenia01.02.03.0040.000783%Not Available
Oedema08.01.07.006; 14.05.06.0100.000168%Not Available
Pancytopenia01.03.03.0030.000783%Not Available
Pericardial effusion02.06.01.0020.000168%
Pericarditis constrictive02.06.02.0020.000112%Not Available
Pleural effusion22.05.02.0020.000336%
Pyrexia08.05.02.0030.001645%
Respiratory failure22.02.06.002; 14.01.04.0030.000168%
Rhabdomyolysis15.05.05.0020.000112%
Skin cancer23.08.02.002; 16.03.02.0020.000112%Not Available
Stomatitis07.05.06.0050.000112%
Therapeutic response decreased08.06.01.0160.000336%Not Available
Thrombocytopenia01.08.01.0020.000839%Not Available
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000224%
Urinary retention20.02.02.0110.000112%
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000112%Not Available
General physical health deterioration08.01.03.0180.000526%Not Available
Malignant neoplasm progression16.16.01.0050.000336%Not Available
Haemorrhage24.07.01.0020.000168%Not Available
Disease progression08.01.03.0380.000728%
Renal impairment20.01.03.0100.000280%Not Available
Bone marrow failure01.03.03.0050.000168%
Acute graft versus host disease12.02.09.002; 10.02.01.0280.000224%Not Available
Chronic graft versus host disease12.02.09.003; 10.02.01.0290.000112%Not Available
Cytopenia01.03.03.0120.001847%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000280%
Acute myeloid leukaemia recurrent16.01.05.004; 01.10.05.0040.001511%Not Available
Leukaemia recurrent01.10.03.005; 16.01.03.0050.000112%Not Available
Graft versus host disease in skin23.07.04.025; 12.02.09.031; 10.02.01.0620.000168%Not Available
Cardiorenal syndrome20.01.03.018; 02.05.01.0120.000112%Not Available
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