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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

Medical Information

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Storage and Stability of DARZALEX FASPRO Vials at Room Temperature

Last Updated: 09/24/2024

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

The expiration dating period and storage conditions are presented in the figure: Storage and Stability of DARZALEX FASPRO at Room Temperature.

Storage and Stability of DARZALEX FASPRO at Room Temperature¹^,²

^aThe data shown above was collected in a strictly controlled environment and 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 23 September 2024.

References

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1	Data on File. Daratumumab Subcutaneous Formulation Company Core Data Sheet (CCDS). Janssen Research & Development, LLC. EDMS-ERI-184804517; 2024.
2	Data on File. Proven Temperature Ranges for JSC Drug Products. TV-TEC-102593; 2024.