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 vials¹:
  • 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.

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 10 September 2024.