Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Idelalisib
Drug ID BADD_D01130
Description Idelalisib is a phosphoinositide 3-kinase inhibitor indicated in the treatment of chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). For the treatment of relapsed CLL, it is currently indicated as a second-line agent in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities, while in the treatment of FL and SLL it is intended to be used in patients who have received at least two prior systemic therapies. More specifically, idelalisib targets P110δ, the delta isoform of the enzyme phosphatidylinositol-4,5-bisphosphate 3-kinase, also known as PI-3K. The PI-3Ks are a family of enzymes involved in cellular functions such as cell growth, proliferation, differentiation, motility, survival and intracellular trafficking, which in turn are involved in cancer. In contrast to the other class IA PI3Ks p110α and p110β, p110δ is principally expressed in leukocytes (white blood cells) and is important for the function of T cells, B cell, mast cells and neutrophils. By inhibiting this enzyme, idelalisib induces apoptosis of malignant cells and inhibits several cell signaling pathways, including B-cell receptor (BCR) signaling and C-X-C chemokine receptors type 5 and type 4 signalling, which are involved in trafficking and homing of B-cells to the lymph nodes and bone marrow. Treatment of lymphoma cells with idelalisib has been shown to result in inhibition of chemotaxis and adhesion, and reduced cell viability.
Indications and Usage Idelalisib is indicated in the treatment of chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). For the treatment of relapsed CLL, it is currently indicated as a second-line agent in combination with rituximab in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities, while in the treatment of FL and SLL it is intended to be used in patients who have received at least two prior systemic therapies.
Marketing Status approved
ATC Code L01EM01
DrugBank ID DB09054
KEGG ID D10560
MeSH ID C552946
PubChem ID 11625818
TTD Drug ID D0J5VR
NDC Product Code 63285-754; 61958-1701; 61958-1702; 12651-122; 63285-753; 68578-0013
UNII YG57I8T5M0
Synonyms idelalisib | GS-1101 | Zydelig | CAL 101 | CAL101 | CAL-101
Chemical Information
Molecular Formula C22H18FN7O
CAS Registry Number 870281-82-6
SMILES CCC(C1=NC2=C(C(=CC=C2)F)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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000168%Not Available
Acute respiratory failure14.01.04.004; 22.02.06.0010.000336%Not Available
Agranulocytosis01.02.03.0010.000168%Not Available
Alanine aminotransferase increased13.03.04.005--
Anuria20.01.03.0020.000112%Not Available
Aphthous ulcer07.05.06.0020.000112%Not Available
Arthralgia15.01.02.001--
Ascites07.07.01.001; 02.05.04.002; 09.01.05.0030.000168%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.0020.000616%
Atypical pneumonia22.07.01.010; 11.01.09.012--Not Available
B-cell lymphoma16.28.01.001; 01.15.01.0010.000560%Not Available
Blood triglycerides13.12.03.004--Not Available
Bronchiectasis22.03.02.0050.000168%Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Cachexia08.01.01.009; 16.32.03.011; 14.03.02.0010.000112%Not Available
Chills15.05.03.016; 08.01.09.0010.001142%
Chronic lymphocytic leukaemia16.01.06.001; 01.10.06.0010.001175%Not Available
Chronic myelomonocytic leukaemia16.01.04.004; 01.10.04.0040.000112%Not Available
Colitis07.08.01.0010.002933%
Cough22.02.03.0010.001533%
Death08.04.01.0010.013767%
Dehydration14.05.05.0010.002149%
Dementia19.20.02.001; 17.03.01.0010.000168%Not Available
Dermatitis23.03.04.0020.000168%Not Available
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