SUMMARY  

• DARZALEX dosing schedule for monotherapy and in combination with lenalidomide or pomalidomide (4-week cycle regimens) and low-dose dexamethasone¹:
  • 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 4 weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• DARZALEX dosing schedule in combination with bortezomib, melphalan, and prednisone (6-week cycle regimen)¹:
  • 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)
• DARZALEX dosing schedule in combination with bortezomib, thalidomide and dexamethasone (4-week cycle regimen)¹:
  • Induction Phase
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 16: every two weeks (total of 4doses; 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 two 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 in combination with bortezomib and dexamethasone (3-week cycle regimen)¹:
  • 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)
  • Week 25 onwards until disease progression: every four weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• DARZALEX dosing schedule in combination with carfilzomib and dexamethasone (4-week cycle regimen)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 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: 16 mg/kg every four weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• The recommended dose of 16 mg/kg (based on actual body weight) 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 dose is administered on Day 1 and Day 2, respectively.¹
• If a dose of DARZALEX is missed, administer the dose as soon as possible and adjust the dosing schedule to maintain the dosing interval.¹
  
  
  

product labeling

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.;  www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf

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 12 July 2024.