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.

BACKGROUND

• Dietz et al (1993)¹ has classified countries according to climatic zone groups 1 (temperature climate), 2 (Mediterranean and subtropical climate), 3 (hot and dry climate, arid zones), and 4 (hot and humid climate, tropics). The US falls under climatic zone 2. Please see the below reference for the list of specific countries in climatic zone groups 1 & 2 and 3 & 4.

STORAGE AND STABILITY EXCURSION DATA

Climatic Zone 1 and 2²:

• Excursion data shows, if the syringe containing DARZALEX FASPRO is not used immediately, store the DARZALEX FASPRO solution for up to 24 hours refrigerated followed by up to 12 hours at 59°F to 77°F (15°C to 25°C) and ambient light. Discard if stored more than 24 hours of being refrigerated or more than 12 hours of being at 59°F to 77°F (15°C to 25°C), if not used. If stored in the refrigerator, allow the DARZALEX FASPRO solution to come to ambient temperature before administration.

Climatic Zone 3 and 4²:

• Excursion data shows if the syringe containing DARZALEX FASPRO is not used immediately, store the DARZALEX FASPRO solution for up to 24 hours refrigerated followed by up to 7 hours at 59°F to 86°F (15°C to 30°C) and ambient light. Discard if stored more than 24 hours of being refrigerated or more than 7 hours of being at 59°F to 86°F (15°C to 30°C), if not used. If stored in the refrigerator, allow the DARZALEX FASPRO solution to come to ambient temperature before administration.

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 November 2024.