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

• 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
• Compatibility data supports a final concentration of DARZALEX diluted in 0.9% sodium chloride of up to 4.5 mg/mL (range, 0.4‐4.5 mg/mL). The 0.4 mg/mL would be resulting concentration for an 8 mg/kg dose given to a 50 kg patient in a volume of 1000 mL. The 4.5 mg/mL would be resulting concentration for a 16 mg/kg dose given to a 140 kg patient in a volume of 500 mL.²

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 05 March 2024.