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.

STORAGE AND STABILITY

• There is no data to support the storge and stability of DARZALEX after dilution in diluents other than normal saline.
  • DARZALEX is administered as an intravenous infusion following dilution with
    0.9% Sodium Chloride.¹
  • Since DARZALEX does not contain a preservative, diluted solutions should be administered within 15 hours (including infusion time) at room temperature 15°C-25°C (59°F-77°F) and in room light.¹
  • If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions 2°C-8°C (36°F-46°F) and protected from light. Do not freeze.¹
  • Do not store any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of in accordance with local requirements.¹

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 27 January 2025.