SUMMARY  

• A formulation of DARZALEX single-dose vials (100 mg/5 mL [NDC 57894-505-05] and 400 mg/20 mL [NDC 57894-505-20]) containing sorbitol are available.¹
• DARZALEX vials of the same strength with different NDCs are available and can be admixed in the same infusion bag.¹
• DARZALEX is administered as an intravenous (IV) infusion following dilution in 0.9% Sodium Chloride Injection, USP.¹
• DARZALEX is a colorless to pale yellow, preservative-free solution for IV infusion available as 100 mg/5 mL (NDC 57894-502-05 and NDC 57894-505-05) or 400 mg/20 mL (NDC 57894-502-20 and NDC 57894-505-20) single-dose vials.¹
  • 100 mg/5mL (NDC 57894-502-05)¹:
    • Each DARZALEX 5 mL singledose vial contains 100 mg daratumumab, glacial acetic acid (0.9 mg), mannitol (127.5 mg), polysorbate 20 (2 mg), sodium acetate trihydrate (14.8 mg), sodium chloride (17.5 mg), and Water for Injection, USP.
  • 100 mg/5mL (NDC 57894-505-05)¹:
    • Each DARZALEX 5 mL singledose vial contains 100 mg daratumumab, L-histidine (1.8 mg), L-histidine hydrochloride monohydrate (8.2 mg), L-methionine (5 mg), polysorbate 20 (2 mg), sorbitol (273.3 mg), and Water for Injection, USP.
  • 400 mg/20 mL (NDC 57894-502-20)¹:
    • Each DARZALEX 20 mL singledose vial contains 400 mg daratumumab, glacial acetic acid (3.7 mg), mannitol (510 mg), polysorbate 20 (8 mg), sodium acetate trihydrate (59.3 mg), sodium chloride (70.1 mg), and Water for Injection, USP.
  • 400 mg/20 mL (NDC 57894-505-20)¹:
    • Each DARZALEX 20 mL singledose vial contains 400 mg daratumumab, L-histidine (7 mg), L-histidine hydrochloride monohydrate (32.6 mg), L-methionine (20 mg), polysorbate 20 (8 mg), sorbitol (1093 mg), and Water for Injection, USP.

PRODUCT LABELING

Please note the following as stated in the DOSAGE AND ADMINISTRATION Section of the DARZALEX Prescribing Information:

2.5 Preparation and Administration

• DARZALEX is for single dose only.¹
• Prepare the solution for infusion using aseptic technique as follows¹:
  • Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient actual body weight.
  • DARZALEX vials of the same strength with different NDCs are available and can be admixed in the same infusion bag.
  • Check that the DARZALEX solution is colorless pale yellow. Do not use if opaque particles, discoloration or other foreign particles are present.
  • Remove a volume of 0.9% Sodium Chloride Injection, USP from the infusion bag/container that is equal to the required volume of DARZALEX solution.
  • Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to the infusion bag/container containing 0.9% Sodium Chloride Injection, USP. Infusion bags/containers must be made of either polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE). Dilute under appropriate aseptic conditions. Discard any unused portion left in the vial.
  • Gently invert the bag/container to mix the solution. Do not shake.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein. Do not use if visibly opaque particles, discoloration or foreign particles are observed.
• Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 micrometer or 0.2 micrometer). Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP or PE.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
• Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.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 16 September 2024.