SUMMARY

• There are no systematically collected data to support alternative dosing intervals of DARZALEX. Clinical judgment should be exercised when considering any dosing interval adjustments outside of those listed in the DARZALEX Prescribing Information. Janssen cannot recommend any practices, procedures, or dosing modifications that deviate from product labeling and are not approved by the Food and Drug Administration.
• The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an intravenous infusion according to the following schedule for the regimens listed below.¹
  • DARZALEX dosing schedule for monotherapy and in combination therapy with lenalidomide or pomalidomide and low-dose dexamethasone ([Rd or Pd]; 4-week cycle)¹:
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 24: every 2 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 4 weeks (first dose of the every-4-week dosing schedule is given at Week 25)
  • DARZALEX dosing schedule for combination therapy with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle)¹:
    • Weeks 1 to 6: weekly (total of 6 doses)
    • Weeks 7 to 54: every 3 weeks (total of 16 doses; first dose of the every-3-week dosing schedule is given at Week 7)
    • Week 55 onwards until disease progression: every 4 weeks (first dose of the every-4-week dosing schedule is given at Week 55)
  • DARZALEX dosing schedule for combination therapy with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle)¹:
    • 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 autologous stem cell transplant (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)
  • DARZALEX dosing schedule for combination therapy with bortezomib and dexamethasone ([Vd]; 3-week cycle)¹:
    • Weeks 1 to 9: weekly (total of 9 doses)
    • Weeks 10 to 24: every 3 weeks (total of 5 doses; first dose of the every-3-week dosing schedule is given at Week 10)
    • Week 25 onwards until disease progression: every 4 weeks (first dose of the every-4-week dosing schedule is given at Week 25)
  • DARZALEX dosing schedule in combination with carfilzomib and dexamethasone ([Kd]; 4-week cycle)¹:
    • Week 1: 8 mg/kg on days 1 and 2 (total 2 doses)
    • Weeks 2 to 8: 16 mg/kg weekly (total of 7 doses)
    • Weeks 9 to 24: 16 mg/kg every 2 weeks (total of 8 doses; first dose of the every2week dosing schedule is given at Week 9)
    • Week 25 onwards until disease progression: 16 mg/kg every 4 weeks (first dose of the every4-week dosing schedule is given at Week 25)
• The recommended dose of 16 mg/kg to be administered on Day 1 when DARZALEX is administered as monotherapy or in combination may be split over two consecutive days, such that an 8 mg/kg on Day 1 and Day 2, respectively. Refer to Table 6 in the DARZALEX Prescribing Information.¹
• If you would like to discuss your specific situation further, please contact the Medical Information at 1-800-526-7736.

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
03 October 2024.