SUMMARY  

• The recommended dose of DARZALEX FASPRO is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3-5 minutes.¹
• If a dose of DARZALEX FASPRO is missed, administer the dose as soon as possible and adjust the dosing schedule to maintain the dosing interval.¹
• When DARZALEX FASPRO is administered as part of a combination therapy, see Clinical Studies (Section 14) and the prescribing information for dosage recommendations for the other drugs.¹

PRODUCT LABELING

Recommended Dosage for Multiple Myeloma

• DARZALEX FASPRO dosing schedule for monotherapy and in combination therapy with lenalidomide or pomalidomide or carfilzomib and dexamethasone ([Rd or Pd or Kd]; 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 FASPRO 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 FASPRO 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 two 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 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 FASPRO dosing schedule for combination therapy with bortezomib, lenalidomide, and dexamethasone ([VRd]; 4-week cycle)¹:
  • Induction Phase:
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 16: every two 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 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 FASPRO 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)
• When DARZALEX FASPRO is administered as part of a combination therapy, see the prescribing information for dosage recommendations for the other drugs.¹

Recommended Dosage for Light Chain Amyloidosis

• DARZALEX FASPRO dosing schedule for combination therapy with bortezomib, cyclophosphamide and dexamethasone ([VCd]; 4-week cycle)¹:
  • 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 or a maximum of 2 years: every 4 weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• When DARZALEX FASPRO is administered as part of a combination therapy, see Clinical Studies (Section 14) and the prescribing information for dosage recommendations for the other drugs.¹

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 31 July 2024.