Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Duvelisib
Drug ID BADD_D02495
Description Duvelisib, also known as IPI-145 and INK-1197, is a small-molecule inhibitor of phosphoinositide-3 kinases that was designed initially to prove that simultaneous inhibition of the isoforms delta and gamma can produce a broad adaptative and innate immune cell inhibitory activity. All the work around duvelisib showed that this agent is a potent inhibitor of both forms.[A39025] Duvelisib was developed by Verastem, Inc and FDA approved on September 24, 2018.[L4585]
Indications and Usage Duvelisib is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.[L4586] The CLL is a cancer of the blood stem cells which are the blood cells that can develop into different types of cells. In leukemia, there is an overproduction of cells that are abnormal and do not mature into blood cells and thus, they just crowd out normal cells and impair their normal function. In lymphocyte leukemia, the abnormal cell growth is observed in the lymphoid cells which are the type of blood cells that mature into lymphocytes. The CLL is the type of lymphocytic leukemia that develops slowly over months or years.[L4587] The SLL is a very similar disease to the CLL and these terms are usually referred interchangeably. The only difference between these two diseases is that in CLL the cells are found mostly in the blood and bone marrow while in SLL, the cells are mainly found in the lymph nodes.[L4588] As well, duvelisib obtained an accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. This approval is still under the status of continued approval and it is restrained to confirmatory trials.[L4586] The follicular lymphoma is a B-cell lymphoma that clusters in the lymph nodes or other tissues.[L4589]
Marketing Status approved; investigational
ATC Code L01EM04
DrugBank ID DB11952
KEGG ID D10555
MeSH ID C586691
PubChem ID 50905713
TTD Drug ID D0RU0O
NDC Product Code 11014-0348; 71779-125; 73116-225; 11014-0347; 71779-115; 73116-215
UNII 610V23S0JI
Synonyms duvelisib | 8-chloro-2-phenyl-3-((1S)-1-(9H-purin-6-ylamino)ethyl)-1(2H)-isoquinolinone | Copiktra | IPI-145
Chemical Information
Molecular Formula C22H17ClN6O
CAS Registry Number 1201438-56-3
SMILES CC(C1=CC2=C(C(=CC=C2)Cl)C(=O)N1C3=CC=CC=C3)NC4=NC=NC5=C4NC=N5
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)
Neutropenia01.02.03.0040.000168%Not Available
Night sweats23.02.03.006; 08.01.03.0310.000246%Not Available
Pollakiuria20.02.02.0070.000246%
Pruritus23.03.12.0010.000246%
Pyrexia08.05.02.0030.001645%
Rash23.03.13.0010.001310%Not Available
Rash macular23.03.13.0030.000112%Not Available
Rash pruritic23.03.13.0300.000761%Not Available
Skin exfoliation23.03.07.0030.000246%Not Available
Stomatitis07.05.06.0050.000246%
Vomiting07.01.07.0030.000526%
Emotional distress19.04.02.0080.000437%Not Available
Malignant neoplasm progression16.16.01.0050.001075%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.000381%
Disease progression08.01.03.0380.000548%
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000571%
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.000381%Not Available
Illness08.01.03.0910.000112%Not Available
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