Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Venetoclax
Drug ID BADD_D02345
Description Venetoclax is a BCL-2 inhibitor that was initially approved by the FDA in April 2016 [FDA label]. Proteins in the B cell CLL/lymphoma 2 (BCL-2) family are important regulators of the apoptotic (programmed cell death) process [A18565], [A18566]. Venetoclax is used to treat chronic lymphocytic leukemia (CLL) and certain types of small lymphocytic lymphoma [FDA label]. CLL is the most prevalent leukemia diagnosed in Western countries [A40022]. Venetoclax was developed through reverse engineering of the BCL-2 protein family inhibitor, navitoclax [A40022]. Venetoclax is approximately 10 times more potent than navitoclax with regard to induction of apoptosis in CLL cells [A40022]. A new indication was approved in 2018 for the treatment patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label]. Previously, this drug was indicated only for patients with 17p gene deletion [F2130].
Indications and Usage A BCL-2 inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy [FDA label].
Marketing Status approved; investigational
ATC Code L01XX52
DrugBank ID DB11581
KEGG ID D10679
MeSH ID C579720
PubChem ID 49846579
TTD Drug ID Not Available
NDC Product Code 76462-0576; 0074-0576; 0074-0579; 71796-008; 0074-0566; 68543-0576; 54893-0090; 68513-0566; 0074-0561; 68513-0576; 68513-0561
UNII N54AIC43PW
Synonyms venetoclax | 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide | benzamide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethyl-1-cyclohexen-1-yl)methyl)-1-piperazinyl)-n-((3-nitro-4-(((tetrahydro-2h-pyran-4-yl)methyl)amino)phenyl)sulfonyl)-2-(1h-pyrrolo(2,3-b)pyridin-5-yloxy)- | GDC-0199 | RG-7601 | RG7601 | ABT-199 | Venclexta
Chemical Information
Molecular Formula C45H50ClN7O7S
CAS Registry Number 1257044-40-8
SMILES CC1(CCC(=C(C1)C2=CC=C(C=C2)Cl)CN3CCN(CC3)C4=CC(=C(C=C4)C(=O)NS(=O)(=O)C5=CC(=C(C =C5)NCC6CCOCC6)[N+](=O)[O-])OC7=CN=C8C(=C7)C=CN8)C
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)
Anorectal discomfort07.03.03.0030.000381%Not Available
Posterior reversible encephalopathy syndrome17.13.02.0070.000168%
Central nervous system haemorrhage24.07.04.016; 17.08.01.0350.000112%Not Available
Autoimmune haemolytic anaemia10.04.01.005; 01.06.01.0040.001735%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.001231%
Abdominal mass07.01.01.0030.000112%Not Available
B-cell small lymphocytic lymphoma01.15.06.001; 16.28.06.0010.000280%Not Available
Chloroma16.01.08.003; 01.10.08.0030.000112%Not Available
Chronic lymphocytic leukaemia recurrent16.01.06.003; 01.10.06.0030.000448%Not Available
Chronic lymphocytic leukaemia refractory16.01.06.004; 01.10.06.0040.000280%Not Available
Haemosiderosis14.13.03.004; 12.02.08.0070.000112%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000112%Not Available
Mantle cell lymphoma recurrent16.28.05.002; 01.15.05.0020.000112%Not Available
Mantle cell lymphoma refractory16.28.05.003; 01.15.05.0030.000112%Not Available
Neuralgic amyotrophy10.04.10.014; 17.09.03.018; 15.05.05.0170.000112%Not Available
Recurrent cancer16.16.01.0150.000112%Not Available
Terminal state08.01.03.0790.000224%Not Available
Anaemia of malignant disease01.03.04.0030.000112%Not Available
Live birth18.08.02.0070.000381%Not Available
Biliary dilatation09.02.03.0040.000112%Not Available
Cell death14.11.02.005; 08.03.03.0030.000112%Not Available
Chronic lymphocytic leukaemia transformation16.01.06.005; 01.10.06.0050.000448%Not Available
Richter's syndrome01.15.02.005; 16.28.02.0050.003638%Not Available
Acute myeloid leukaemia recurrent16.01.05.004; 01.10.05.0040.001791%Not Available
Leukaemia recurrent16.01.03.005; 01.10.03.0050.000112%Not Available
Acute lymphocytic leukaemia recurrent16.01.01.003; 01.10.01.0030.000168%Not Available
Multimorbidity08.01.03.0750.000280%Not Available
Central nervous system leukaemia17.02.10.019; 16.01.03.004; 01.10.03.0040.000168%Not Available
Oncologic complication16.32.03.0250.000112%Not Available
Subretinal fluid06.09.03.027; 12.01.04.0310.000112%Not Available
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