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
• Verify the pregnancy status of patients of reproductive potential prior to initiating LAZCLUZE.¹
• Based on findings from animal studies and its mechanism of action, LAZCLUZE can cause fetal harm when administered to pregnant patients. Advise pregnant patients of the potential risk to a fetus.¹
  • Advise patients of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose. Refer to the RYBREVANT Prescribing Information for recommended duration of contraception during treatment with RYBREVANT.
• Because of the potential for serious adverse reactions in breastfed children, advise patients not to breastfeed during treatment with LAZCLUZE and for 3 weeks after the last dose.¹
• Based on findings in animals, LAZCLUZE may impair fertility in patients of reproductive potential.¹
• Please refer to LAZCLUZE product labeling for additional 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.

USE IN PATIENTS OF REPRODUCTIVE POTENTIAL

Pregnancy Testing

• Based on animal data and its mechanism of action, LAZCLUZE can cause fetal harm when administered to pregnant patients.¹
• Verify the pregnancy status of patients of reproductive potential prior to initiating LAZCLUZE.¹

Contraception

Females

• Advise females of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose. Refer to the RYBREVANT Prescribing Information for recommended duration of contraception during treatment with RYBREVANT.¹

Males

• Advise male patients with female partners of reproductive potential to use effective contraception during treatment with LAZCLUZE and for 3 weeks after the last dose.¹

Infertility

• Based on findings in animals, LAZCLUZE may impair fertility in patients of reproductive potential.¹
  • The effects on female fertility were reversible.
  • The effects on male testes in animal studies were not reversible within a 2-week recovery period.

Use in Pregnant Patients

• Based on findings from animal studies and its mechanism of action, LAZCLUZE can cause fetal harm when administered to pregnant patients. There are no available data on the use of LAZCLUZE in pregnant patients to inform a drug-associated risk. Advise pregnant patients of the potential risk to a fetus.¹
  • Oral administration of LAZCLUZE to pregnant animals during the period of organogenesis resulted in reduced embryo-fetal survival and fetal body weight (in rats), and malformations (in rabbits) at exposures that were approximately 4 and 0.5 times, respectively, the human exposure (based on data from the area under the concentration-time curve [AUC] at the recommended dose of 240 mg/day).

Use in Lactating Patients

• There are no data on the presence of LAZCLUZE or its metabolites in human milk or their effects on the breastfed child or on milk production.¹
• Because of the potential for serious adverse reactions in breastfed children, advise patients not to breastfeed during treatment with LAZCLUZE and for 3 weeks after the last dose.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 16 August 2024.