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zanubrutinib (Brukinsa)

Indications: - mantle cell lymphoma - Waldenstrom's macroglobulinemia [3] - first line treatment of chronic lymphocytic leukemia & small lymphocytic lymphoma in older patients (> 65 years) [4] Dosage: - 160 mg PO BID or 320 mg PO QD Capsule: 80 mg Pharmacokinetics: - metabolized by CYP3A - eliminated in feces (38% unchanged) & 8% in urine (< 1% unchanged) Adverse effects: - leukopenia, neutropenia, thrombocytopenia, anemia - rash, bruising, diarrhea, cough - serious: pneumonia (11%), hemorrhage (5%) Drug interactions: - CYP3A inhibitors: modify dose - avoid with moderate or strong CYP3A inducers Mechanism of action: - selective Bruton tyrosine kinase inhibitor [4]

General

small inhibitory antineoplastic agent (ib drug)

Database Correlations

PUBCHEM cid=135565884

References

  1. RxNorm
  2. FDA Drug Approval, Nov 14, 2019 FDA grants accelerated approval to zanubrutinib for mantle cell lymphoma. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-mantle-cell-lymphoma
  3. FDA Drug Approval. Aug 31, 2021 FDA approves zanubrutinib for Waldenstrom's macroglobulinemia. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanubrutinib-waldenstroms-macroglobulinemia
  4. Bassett M Zanubrutinib Wins in First-Line CLL for Older Patients. The BTK inhibitor proves superior to bendamustine-rituximab in phase III trial. MedPage Today July 8, 2022 https://www.medpagetoday.com/hematologyoncology/leukemia/99653 - Tam CS, Brown JR, Kahl BS et al Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncology. 2022. July 7. PMID: 35810754 https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00293-5/fulltext
  5. Highlights of Prescribing Information. BRUKINSA (zanubrutinib) capsules, for oral use https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s000lbl.pdf