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Storage and Stability of DARZALEX Vials at Freezing Temperatures

Last Updated: 08/26/2025

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

  • DARZALEX (100 mg/5 mL and 400 mg/20 mL) vials without sorbitol1:
    • Stability studies support a 24-month expiration-dating period for DARZALEX vials when stored at 2°C to 8°C (36°F to 46°F) and protected from light, with excursions permitted between -20°C to -1ºC (-4°F to 30.2°F) for up to 6 days cumulative exposure with a maximum of 3 excursions.
  • DARZALEX (100 mg/5 mL and 400 mg/20 mL) vials containing sorbitol2:
    • Stability studies support a 24-month expiration-dating period for DARZALEX vials when stored at 2°C to 8°C (36°F to 46°F) and protected from light, with excursions permitted between -20°C to 1ºC (-4°F to 33.8°F) for up to 9 days cumulative excursions in no more than 3 excursions (3 days each).
  • 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 20 August 2025.

 

References

1 Data on File. Technical Document Recommended Expiry, Storage Conditions, and Temperature excursion Guidelines. Janssen Research and Development, LLC. TV-TEC-51910; 2025.  
2 Data on File. Technical Document Darzalex (JNJ-54767414) Gen 2 IV Drug Product Expiry Memo. TV-TEC-206952; 2025.