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DARZALEX - Storage and Stability of Diluted Solution at Room Temperature

Last Updated: 01/30/2025

SUMMARY  

  • Please refer to the 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

Excursion data shows, a holding time of 15 hours for DARZALEX diluted in 0.9% sodium chloride at room temperature following 24 hours of refrigerated storage is supported by a microbial challenge study.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.

 

References

1 Data on File. Technical document Microbial Challenge Study for Daratumumab. Janssen Research and Development, LLC. TV-TEC-78212; 2015.