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.

PRODUCT LABELING

• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf

BACKGROUND

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

STORAGE AND STABILITY EXCURSION DATA

• Remove DARZALEX FASPRO vials from refrigerated storage [2°C-8°C (36°F-46°F)] and equilibrate to ambient temperature [15°C-30°C (59°F-86°F)]. The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours. Keep out of direct sunlight. Do not shake.¹
• Climatic Zone 1 and 2¹:
  • 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 15°C-25°C (59°F-77°F) and ambient light. Discard if stored more than 24 hours of being refrigerated or more than 12 hours of being at 15°C-25°C (59°F-77°F), if not used. If stored in the refrigerator, allow the DARZALEX FASPRO solution to come to ambient temperature before administration.
• Climatic Zone 3 and 4¹:
  • 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 15°C-30°C (59°F-86°F) and ambient light. Discard if stored more than 24 hours of being refrigerated or more than 7 hours of being at 15°C-30°C (59°F-86°F), 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^®, Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 05 March 2024.