SUMMARY

• DARZALEX should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur.¹
• Infusion bags/containers must be made of either polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE).¹
• Polyurethane (PU), polybutadiene (PBD), PVC, PP or PE administration sets must be used.¹
  • The in-line filter is required to ensure patient safety by protecting against any proteinaceous particulate matter that may be present in the product or introduced during the dosage preparation process.²
• Although diethylhexyl phthalate (DEHP) is not specified in the prescribing information as one of the materials that the infusion bags can be made of, daratumumab was shown to be stable when tested with DEHP‐containing PVC intravenous (IV) bags.³

BACKGROUND

• Janssen Biotech, Inc. does not have a recommendation for a specific manufacturer of infusion bags or administration sets to be used. Infusion bag and administration set materials tested for compatibility include those listed as acceptable in the summary section.
  • Examples of acceptable IV bags containing 0.9% Normal Saline made from compatible material include the following³:
    • Polypropylene-polyethylene blend (PP-PE) (aka Polyolefin (PO) (eg, 500 mL, B.Braun EXCEL^® Part# L8002). Source: USA
    • Polypropylene-polyethylene blend (PP-PE) (aka Polyolefin (PO) (eg, 1000 mL, B.Braun EXCEL^® Part# L8000). Source: USA
    • Polyvinyl chloride (PVC) with DEHP (eg, 500 mL, Macopharma Macoflex^® Part# 14I09D). Source: USA
    • Polyvinyl chloride (PVC) with DEHP (eg, 1000 mL, Macopharma Macoflex^® Part# 14J20D). Source: USA
  • Examples of acceptable administration sets with 0.2 micron inline polyethersulfone (PES) filters and tubing made from compatible material include the following³:
    • PVC tubing with silicone segments (eg, Alaris Carefusion Part# 10807851 with 0.2 µm PES filter). Source: USA
    • Polyethylene (PE) (eg, Alaris Carefusion Part# 10015104 with 0.2 µm PES filter). Source: USA
• Other manufacturers and part numbers not described herein may also be appropriate to use when made of the approved materials. As always, confirm that the specific administration equipment you are using for DARZALEX meets the requirements per the DARZALEX product labeling.
• Contact your supplier or manufacturer directly to obtain appropriate infusion bags and administration sets.

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 01 August 2024.