SUMMARY  

• Please refer to local prescribing information for storage and stability information.
• Janssen cannot recommend any practices, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.

STABILITY AND TEMPERATURE EXCURSION DATA

• For shelf-life of unopened DARZALEX FASPRO vials see expiry date on the outer pack.¹
• Stability studies support specified expiration dating period for DARZALEX FASPRO vials when stored at 2°C to 8°C (36°F to 46°F) and protected from direct sunlight, with excursions permitted between -20°C to 1°C (-4°F to 34°F) for up to 9 days cumulative excursions, in no more than 3 excursions (3 days each).^1,2
• This data was collected in a strictly controlled environment. The response above provides information on a specific scenario for which we have data. If there is no tracking of time and temperature, Janssen cannot provide recommendations.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 18 September 2025.