Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Ibrutinib
Drug ID BADD_D01119
Description Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and it presents a very promising activity in B cell malignancies.[A32299] Ibrutinib was developed by Pharmacyclics Inc and in November 2013 was FDA-approved for the treatment of mantle cell lymphoma. Later, in February 2014, ibrutinib was approved for the treatment of chronic lymphocytic leukemia and it is also indicated for the treatment of patients with Waldenström's Macroglobulinemia.[L1926] Ibrutinib has also been approved by the EMA for the treatment of chronic lymphocytic leukemia and mantle cell lymphoma.[A32299] Ibrutinib was approved for use in chronic graft versus host disease in August 2017 [L937].
Indications and Usage Ibrutinib acquired an accelerated approval for the treatment of mantle cell lymphoma who have received at least one prior therapy.[FDA label] Mantle cell lymphoma (MCL) is a B-cell non-Hodgkin lymphoma that develops in the outer edge of a lymph node. MCL is usually diagnosed at late stages and it is easily spread into bone marrow, spleen, liver and gastrointestinal tract.[L1929] Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) who have at least one prior therapy.[FDA label] CLL is a type of cancer caused by an overproduction of lymphocytes by the bone marrow. Some of the symptoms include swollen lymph nodes and tiredness.[L1931] Ibrutinib is indicated for the treatment of chronic lymphocytic leukemia (CLL) with 17p deletion.[FDA label] CLL with 17p is a type of leukemia in which a deletion in 17p disrupts the tumor suppressor p53 by deleting one allele of the TP53 gene. The remaining allele is mainly inactivated and thus, this type of leukemia is unresponsive to p53-dependent treatments.[A32305] Ibrutinib is indicated for the treatment of patients with Waldenstrom's Macroglobulinemia (WM).[FDA label] WM, also called lymphoplasmacytic lymphoma, is a type of non-Hodgkin lymphoma in which the cancer cells make large amounts of macroglobulin. The macroglobulin is a monoclonal protein that corresponds to the type of IgM antibodies and the unrestricted formation of this protein causes typical symptoms such as excessive bleeding and effects in vision and nervous system.[L1934]
Marketing Status approved
ATC Code L01EL01
DrugBank ID DB09053
KEGG ID D10223
MeSH ID C551803
PubChem ID 24821094
TTD Drug ID D09KTS
NDC Product Code 42185-7078; 55111-982; 65129-1377; 83137-0004; 57962-007; 57962-560; 11014-0328; 57962-070; 11014-0327; 68554-0109; 57962-420; 11014-0329; 65129-1460; 65129-1471; 11014-0326; 71796-053; 11014-0397; 40006-040; 11014-0163; 11014-0417; 58175-0602; 63850-8089; 82920-031; 57962-014; 57962-140; 57962-280
UNII 1X70OSD4VX
Synonyms ibrutinib | 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)piperidin-1- yl)prop-2-en-1-one | PCI 32765 | PCI32765 | PCI-32765 | Imbruvica
Chemical Information
Molecular Formula C25H24N6O2
CAS Registry Number 936563-96-1
SMILES C=CC(=O)N1CCCC(C1)N2C3=NC=NC(=C3C(=N2)C4=CC=C(C=C4)OC5=CC=CC=C5)N
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)
Bone cancer15.09.03.012; 16.29.02.0020.000168%Not Available
Brain neoplasm malignant17.20.04.002; 16.30.04.0020.000112%Not Available
Breast haemorrhage24.07.03.021; 21.05.05.0140.000112%Not Available
Central nervous system lymphoma16.20.01.005; 01.12.01.005; 18.04.04.013; 17.02.10.0280.000392%Not Available
Chronic gastritis11.07.01.016; 10.04.04.011; 07.08.02.0050.000112%Not Available
Chronic lymphocytic leukaemia recurrent16.01.06.003; 01.10.06.0030.000280%Not Available
Chronic lymphocytic leukaemia refractory16.01.06.004; 01.10.06.0040.000168%Not Available
Cryoglobulinaemia24.12.04.007; 10.04.04.0130.000112%Not Available
Hypermetabolism14.11.01.0180.000112%Not Available
Intracranial tumour haemorrhage24.07.04.028; 17.08.01.052; 16.32.03.0230.000168%Not Available
Lung adenocarcinoma22.08.01.007; 16.19.01.0020.000168%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000112%Not Available
Mantle cell lymphoma recurrent16.28.05.002; 01.15.05.0020.000951%Not Available
Palindromic rheumatism15.01.01.014; 10.04.06.0060.000112%Not Available
Penile ulceration23.07.03.020; 21.12.01.0190.000168%Not Available
Senile dementia19.20.02.009; 17.03.01.0080.000112%Not Available
Splenic haematoma12.01.17.019; 24.07.01.079; 01.09.02.0140.000112%Not Available
Splenic haemorrhage12.01.17.020; 24.07.01.080; 01.09.02.0150.000224%Not Available
Splenic vein thrombosis24.01.03.005; 01.09.02.0190.000112%Not Available
Tachycardia paroxysmal02.03.02.0280.000112%Not Available
Temporal lobe epilepsy17.12.02.0040.000112%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.000392%Not Available
Wolff-Parkinson-White syndrome02.03.01.0160.000112%Not Available
Terminal state08.01.03.0790.000302%Not Available
Vertebral lesion15.02.04.0400.000112%Not Available
Axillary mass15.03.02.0140.000246%Not Available
Neck mass15.03.02.0070.000526%Not Available
Tongue haemorrhage24.07.02.058; 07.14.01.0150.000437%Not Available
Consciousness fluctuating17.02.04.0190.000168%Not Available
Ocular neoplasm16.34.03.001; 06.12.03.0010.000112%Not Available
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