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)
Ear neoplasm04.03.01.017; 16.16.05.0010.000112%Not Available
Gait inability17.02.05.069; 08.01.02.011--Not Available
Haematoma muscle24.07.01.091; 15.05.03.036; 12.01.07.0150.000112%Not Available
Haemoperitoneum24.07.02.065; 07.07.02.007; 12.01.17.0070.000448%Not Available
Haemophagocytic lymphohistiocytosis16.32.03.038; 10.02.01.077; 01.05.01.0260.001119%Not Available
Hyperleukocytosis01.02.01.0180.000504%Not Available
Hypoglobulinaemia01.05.01.0290.000112%Not Available
Immune thrombocytopenia10.02.01.083; 01.08.01.0130.000728%Not Available
Intra-abdominal fluid collection21.07.04.014; 07.07.01.0140.000246%Not Available
Limb mass15.03.05.0190.000224%Not Available
Loss of therapeutic response08.06.01.0410.000112%Not Available
Marginal zone lymphoma16.28.09.001; 01.15.09.0010.000224%Not Available
Mucosal disorder08.01.06.0290.000112%Not Available
Myelosuppression01.03.03.0150.000783%Not Available
Myocardial injury02.04.02.0460.000112%Not Available
Nail bed bleeding24.07.01.102; 23.02.05.029; 12.01.09.0220.000358%Not Available
Prostatic mass21.04.01.0120.000112%Not Available
Renal tubular injury20.01.07.0200.000112%Not Available
Scrotal haematocoele24.07.03.035; 21.12.02.0110.000112%Not Available
Skin laceration23.03.11.041; 12.01.06.016--Not Available
Subcapsular renal haematoma20.01.02.021; 12.01.05.008; 24.07.07.0060.000112%Not Available
Superficial vein thrombosis24.01.02.0160.000112%Not Available
Swelling of eyelid23.04.01.026; 10.01.05.026; 06.04.04.0180.000112%Not Available
Taste disorder17.02.07.029; 07.14.03.004--Not Available
Therapeutic product effect decreased08.06.01.0500.001791%Not Available
Therapeutic product ineffective08.06.01.057--Not Available
Therapy partial responder08.06.01.0640.000604%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.067--Not Available
Vein collapse24.03.02.039; 12.02.01.0400.000112%Not Available
Brain fog16.32.03.050; 19.21.02.017; 17.02.05.077--Not Available
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