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.
SUMMARY
- Please refer to local prescribing information for storage and stability information.
- Johnson & Johnson 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 storage 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 20 January 2026.
| 1 | Data on File. Daratumumab Intravenous Formulation Company Core Data Sheet (CCDS). Janssen Research & Development, LLC. EDMS-ERI-78724630; 2025. |