SUMMARY  

• Please refer to local prescribing information for dosage and administration information.  
• Janssen cannot recommend any practices, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.

CLINiCAL DATA

Description

• DARZALEX FASPRO is a sterile, preservative-free, colorless to yellow, and clear to opalescent solution supplied in a single-dose vial for subcutaneous administration.¹

Preparation

• Withdraw 15 mL from the vial into a syringe using an 18G to 22G transfer needle with a regular bevel. Insert the needle into the vial at a 90° angle within the ring of the stopper.¹
  • An internal study was conducted using DARZALEX FASPRO vials to provide data-based recommendations for preparation. The study demonstrated a reduction in stopper coring under the conditions of an 18G standard bevel needle vs an 18G blunt needle and a 90° angle of insertion vs a 77° angle of insertion.²
  • Dynamic needle insertion techniques understood as clinical best practice were not tested.²
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if opaque particles, discoloration or other foreign particles are present.¹
• After the solution of DARZALEX FASPRO is withdrawn into the syringe, replace the transfer needle with a syringe closing cap. Label the syringe appropriately to include the route of administration per institutional standards. Label the syringe with the peel-off label.¹
• To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.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 04 December 2025.