Summary

• Janssen 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
• No DARZALEX dose modifications (increase or decrease) were permitted per the clinical trial protocols for the GEN501, MMY2002 (SIRIUS), MMY1001 (EQUULEUS), MMY3003 (POLLUX), MMY3004 (CASTOR), MMY3007 (ALCYONE), MMY3006 (CASSIOPEIA), and MMY3008 (MAIA) studies.^2-9
• 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.
• For information concerning medicinal products given in combination with DARZALEX, see manufacturer’s prescribing information.¹

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 07 October 2024.