LAZCLUZE - Open Bottle Stability

SUMMARY  

• The company cannot support any practices, procedures, or storage conditions that deviate from the approved product labeling.
• Stability data indicate that the 240 mg film-coated tablets remain stable for 2 months at 25°C/60% relative humidity (RH) and 30°C/75% RH during the in-use studies at the end of the shelf life when packed as 30-count in 75 mL high-density polyethylene (HDPE) bottle.¹  
• Stability data indicate that the 80 mg film-coated tablets remain stable for 3 months at 25°C/60% RH and 30°C/75% RH during the in-use studies at the end of the shelf life when packed as 90-count in 160 mL HDPE bottle.² 
• Please refer to LAZCLUZE product labeling for complete information.³ 

PRODUCT LABELING

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

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 05 March 2026.