Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Zanubrutinib
Drug ID BADD_D02609
Description Zanubrutinib is a novel Bruton's tyrosine kinase (BTK) inhibitor used for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.[L10163] Mantle cell lymphoma is an aggressive mature B-cell non-Hodgkin lymphoma that is associated with early relapse, poor clinical outcomes, and long-term survival.[A187967] BTK is an enzyme that plays a role in oncogenic signalling pathways, where it promotes the survival and proliferation of malignant B cells.[A187985] Compared to the first-generation BTK inhibitor [ibrutinib], zanubrutinib displays higher potency and selectivity for BTK with fewer off-target effects.[A187958] Due to this enhanced selectivity towards BTK, zanubrutinib belongs to the second-generation BTK inhibitor drug group that also includes [acalabrutinib], which was approved by the FDA in 2017. Zanubrutinib was granted accelerated approval by the FDA in November 2019 based on clinical trial results that demonstrated an 84% overall response rate from zanubrutinib therapy in patients with MCL,[L10166] which measures the proportion of patients in a trial whose tumour is entirely or partially destroyed by a drug.[L10169] It is currently marketed under the trade name BRUKINSA™ and is available as oral capsules. In August 2021, the FDA granted accelerated approval to zanubrutinib for the treatment of adults with Waldenström’s macroglobulinemia.[L39030] This indication is valid in the US, Europe, and Canada.[L39367] In September 2021, zanubrutinib was granted another accelerated approval for the treatment of relapsed or refractory marginal zone lymphoma who have received at least one anti-CD20-based regimen.[L39025]
Indications and Usage Zanubrutinib is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. It is used to treat Waldenström’s macroglobulinemia in adults. Zanubrutinib is also indicated for the treatment of relapsed or refractory marginal zone lymphoma (MZL) in adults who have received at least one anti-CD20-based regimen.[L10163]
Marketing Status approved; investigational
ATC Code L01EL03
DrugBank ID DB15035
KEGG ID D11422
MeSH ID C000629551
PubChem ID 135565884
TTD Drug ID D0UT4W
NDC Product Code 72579-011; 17205-628; 24538-311; 11014-0472; 11014-0395
UNII AG9MHG098Z
Synonyms zanubrutinib | (7S)-2-(4-phenoxyphenyl)-7-(1-(prop-2-enoyl)piperidin-4-yl)-4,5,6,7-tetrahydropyrazolo(1,5-a)pyrimidine-3-carboxamide | Brukinsa | 7-(1-acryloyl-4-piperidinyl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo(1,5-a)pyrimidine-3-carboxamide | BGB-3111
Chemical Information
Molecular Formula C27H29N5O3
CAS Registry Number 1691249-45-2
SMILES C=CC(=O)N1CCC(CC1)C2CCNC3=C(C(=NN23)C4=CC=C(C=C4)OC5=CC=CC=C5)C(=O)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)
Malaise08.01.01.003--
Myalgia15.05.02.0010.000302%
Neoplasm malignant16.16.01.001---
Neuropathy peripheral17.09.03.0030.000112%-
Neutropenia01.02.03.0040.000112%-
Oedema08.01.07.006; 14.05.06.0100.000627%-
Pain in extremity15.03.04.0100.000571%
Pancytopenia01.03.03.003---
Pericardial effusion02.06.01.0020.000168%
Petechiae01.01.03.002; 23.06.01.003; 24.07.06.0040.000112%-
Pleural effusion22.05.02.0020.000224%
Pneumonitis22.01.01.0060.000112%
Pruritus23.03.12.0010.000358%
Pyrexia08.05.02.0030.000414%
Rash23.03.13.0010.002071%-
Rectal haemorrhage07.12.03.001; 24.07.02.0180.000112%
Skin discolouration23.03.03.0050.000246%-
Thrombocytopenia01.08.01.002---
Tremor17.01.06.0020.000112%
Urticaria10.01.06.001; 23.04.02.0010.000381%
Onychoclasis23.02.05.005---
Peripheral swelling02.05.04.015; 08.01.03.0530.000246%-
Haemorrhage24.07.01.0020.000224%-
Metastases to central nervous system16.22.02.004; 17.02.10.013---
Erectile dysfunction19.08.04.001; 21.03.01.0070.000112%
Disease progression08.01.03.0380.000280%
Drug intolerance08.06.01.0130.000168%-
Renal impairment20.01.03.0100.000112%-
Acute kidney injury20.01.03.0160.000224%
Myelosuppression01.03.03.0150.000224%-
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