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Use of LAZCLUZE in Patients with Hepatic Impairment

Last Updated: 08/20/2024

SUMMARY

  • LAZCLUZE (lazertinib) is a kinase inhibitor indicated in combination with RYBREVANT (amivantamab-vmjw) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions (Exon19del) or Exon 21 L858R substitution mutations, as detected by a United States Food and Drug Administration (FDA)-approved test.1
  • No dose adjustment is recommended in patients with1:
    • Mild hepatic impairment defined as:
      • Total bilirubin ≤upper limit of normal [ULN] and aspartate transaminase [AST] >ULN, or
      • Total bilirubin ≤1.5×ULN and any AST
    • Moderate hepatic impairment defined by total bilirubin ≤1.5 to 3×ULN and any AST
  • LAZCLUZE has not been studied in patients with severe hepatic impairment (total bilirubin >3×ULN and any AST).1
  • Please refer to LAZCLUZE product labeling for additional information.1

PRODUCT LABELING

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 16 August 2024.

References

1 LAZCLUZE (lazertinib) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/LAZCLUZE-pi.pdf.