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
• The recommended dosage of LAZCLUZE is 240 mg orally (PO) once daily (QD), with or without food, given in combination with RYBREVANT.¹
  • LAZCLUZE is available as 80 mg and 240 mg tablets.
  • Swallow LAZCLUZE tablets whole. Do not crush, split, or chew tablets.
  • Continue treatment until disease progression or unacceptable toxicity.
  • Administer LAZCLUZE any time prior to RYBREVANT when given on the same day.
  • Refer to the RYBREVANT Prescribing Information for recommended RYBREVANT dosing information.
• Administer prophylactic and concomitant medications to reduce the risk of dermatologic adverse reactions (ARs).
• Administer anticoagulant prophylaxis to reduce the risk of venous thromboembolic (VTE) events for the first 4 months of treatment.
• Please refer to the DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, WARNINGS AND PRECAUTIONS, HOW SUPPLIED/STORAGE AND HANDLING, and CLINICAL STUDIES sections of the full Prescribing Information for complete information.¹

PRODUCT LABELING

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

DOSAGE AND ADMINISTRATION

Patient Selection

• Select patients for the first-line treatment of NSCLC with LAZCLUZE, in combination with RYBREVANT, based on the presence of EGFR Exon19del or Exon 21 L858R substitution mutations in tumor or plasma specimens.¹
  • If these mutations are not detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage and Administration

• The recommended dosage of LAZCLUZE is 240 mg PO QD administered in combination with RYBREVANT, with or without food.¹
  • Swallow LAZCLUZE tablets whole. Do not crush, split, or chew tablets.
  • Continue treatment until disease progression or unacceptable toxicity.
  • Administer LAZCLUZE any time prior to RYBREVANT when given on the same day.
  • Refer to the RYBREVANT Prescribing Information for recommended RYBREVANT dosing information.

Missed Dose

• If a patient misses a dose of LAZCLUZE within 12 hours, instruct the patient to take the missed dose.¹
• If more than 12 hours have passed since the dose was to be given, instruct the patient to take the next dose at its scheduled time.¹

Vomiting

• If vomiting occurs any time after taking LAZCLUZE, instruct the patient to take the next dose at its next regularly scheduled time.¹

Prophylactic and Concomitant Medications

Venous Thromboembolic Events

• When initiating treatment with LAZCLUZE in combination with RYBREVANT, administer anticoagulant prophylaxis to reduce the risk of VTE events for the first 4 months of treatment.¹
  • If there are no signs or symptoms of VTE events during the first 4 months of treatment, consider discontinuation of anticoagulant prophylaxis at the discretion of the healthcare provider.

Dermatologic ARs

• When initiating treatment with LAZCLUZE in combination with RYBREVANT, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic ARs.¹
  • Administer an oral antibiotic (doxycycline or minocycline, 100 mg PO twice daily) starting on Day 1 for the first 12 weeks of treatment.
  • After completion of oral antibiotic treatment, administer antibiotic lotion to the scalp (clindamycin 1% topical QD) for the next 9 months of treatment.
  • Administer non-comedogenic skin moisturizer (ceramide-based or other formulations that provide long-lasting skin hydration and exclude drying agents) on the face and whole body (except scalp).
  • Wash hands and feet with 4% chlorhexidine solution QD.
  • Limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen to reduce the risk of dermatologic ARs.

Dosage Modifications for ARs

The recommended LAZCLUZE dose reductions for ARs are provided in Table: Recommended Dose Reductions for ARs for LAZCLUZE.

The recommended management and dosage modifications of LAZCLUZE for specific ARs are provided in Table: Recommended Management and Dosage Modifications for ARs for LAZCLUZE. Refer to the RYBREVANT Prescribing Information for information about dosage modifications for RYBREVANT.

Dosage Forms and Strengths

Tablets

• 80 mg tablets: yellow, oval film-coated tablet, debossed with “LZ” on one side and “80” on the other side. Each tablet contains 80 mg of lazertinib.¹
• 240 mg tablets: reddish-purple, oval film-coated tablet, debossed with “LZ” on one side and “240” on the other side. Each tablet contains 240 mg of lazertinib.¹

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 12 November 2025.