DARZALEX - Dose Adjustments

Summary

• Johnson & Johnson does not recommend the use of DARZALEX in a manner that is inconsistent with the approved labeling.
• No dose reductions of DARZALEX are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of hematological toxicity.¹
• For infusion-related reactions (IRRs) of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms. Management of IRRs may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX.¹
• For monotherapy and combination therapy with lenalidomide or pomalidomide or carfilzomib and dexamethasone ([Rd, Pd, or Kd]; 4-week cycle regimens), the recommended dose of DARZALEX is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule¹:
  • Weeks 1 to 8: weekly (total of 8 doses)
  • Weeks 9 to 24: every two weeks (total of 8 doses; first dose of the every-2-week dosing schedule is given at week 9)
  • Week 25 onwards until disease progression: every four weeks (first dose of the every-4-week dosing schedule is given at week 25)
• For combination therapy with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimens) for patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), the recommended dose of DARZALEX is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule¹:
  • Weeks 1 to 6: weekly (total of 6 doses)
  • Weeks 7 to 54: every three weeks (total of 16 doses; first dose of the every-3-week dosing schedule is given at week 7)
  • Weeks 55 onwards until disease progression: every four weeks (first dose of the every-4-week dosing schedule is given at week 55)
• For combination therapy with bortezomib, thalidomide and dexamethasone ([VTd]; 4week cycle regimen) for patients with NDMM eligible for ASCT, the recommended dose of DARZALEX is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule¹:
  • Induction phase:
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 16: every 2 weeks (total of 4 doses; first dose of the every-2-week dosing schedule is given at week 9)
  • Stop for high dose chemotherapy and ASCT
  • Consolidation phase:
    • Weeks 1 to 8: every 2 weeks (total of 4 doses; first dose of the every-2-week dosing schedule is given at week 1 upon re-initiation of treatment following ASCT)
• For combination therapy with bortezomib ([Vd]; 3-week cycle regimen), the recommended dose of DARZALEX is 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule¹:
  • Weeks 1 to 9: weekly (total of 9 doses)
  • Weeks 10 to 24: every three weeks (total of 5 doses; first dose of the every-3-week dosing schedule is given at week 10)
  • Weeks 25 onwards until disease progression: every four weeks (first dose of the every-4-week dosing schedule is given at week 25)
• To facilitate administration, the first prescribed 16 mg/kg dose at week 1 may be split over two consecutive days i.e. 8 mg/kg on day 1 and day 2, respectively.¹
  • For patients receiving DARZALEX in combination with Kd, DARZALEX 16 mg/kg dose at week 1 should be split over 2 days to minimize the risk of volume overload.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 22 September 2026.