Leadership in multiple myeloma treatment

More FDA-approved regimens for DARZALEX FASPRO® and DARZALEX® than any other monoclonal antibody in multiple myeloma1-5

Newly diagnosed
Transplant ineligible
DARZALEX® + Rd/
DARZALEX FASPRO® + Rd
Transplant eligible
Relapsed or refractory
After ≥1 prior therapy
DARZALEX FASPRO® + Pd
Prior line of therapy including lenalidomide and a proteasome inhibitor (PI).
After 1-3 prior lines of therapy
After ≥2 prior therapies
DARZALEX® + Pd
Prior therapies included lenalidomide and a PI.
After ≥3 prior therapies
DARZALEX® monotherapy/
DARZALEX FASPRO® monotherapy
Prior therapies included a PI and an immunomodulatory agent, or patients were double refractory to a PI and an immunomodulatory agent.

Non-inferiority of DARZALEX FASPRO® vs DARZALEX® IV was established in COLUMBA trial1

DKd=DARZALEX FASPRO®/DARZALEX® (D) + carfilzomib (K) + dexamethasone (d); DPd=DARZALEX FASPRO®/DARZALEX® (D) + pomalidomide (P) + dexamethasone (d); DRd=DARZALEX FASPRO®/DARZALEX® (D) + lenalidomide (R) + dexamethasone (d); DVd=DARZALEX FASPRO®/DARZALEX® (D) + bortezomib (V) + dexamethasone (d); DVMP=DARZALEX FASPRO®/DARZALEX® (D) + bortezomib (V) + melphalan (M) + prednisone (P); DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d); DVTd=DARZALEX FASPRO®/DARZALEX® (D) + bortezomib (V) + thalidomide (T) + dexamethasone (d); IV=intravenous; Kd=carfilzomib (K) + dexamethasone (d); Pd=pomalidomide (P) + dexamethasone (d); Rd=lenalidomide (R) + dexamethasone (d); Vd=bortezomib (V) + dexamethasone (d); VMP=bortezomib (V) + melphalan (M) + prednisone (P); VTd=bortezomib (V) + thalidomide (T) + dexamethasone (d).

National Comprehensive Cancer Network® (NCCN®) Guidelines recommendations for daratumumab-containing regimens

Dosing schedules for DARZALEX FASPRO® and DARZALEX®

Dosing and administration guide for DARZALEX FASPRO® and DARZALEX®
For more detailed information on dosing and administration, including management of infusion-related
reactions (IRRs) and administration-related reactions (ARRs), please click the link below.

Once-monthly dosing over time—a key milestone for patients to reach in newly diagnosed, transplant-ineligible multiple myeloma1,2*
Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
DARZALEX® dosing schedule: newly diagnosed DRd regimenDARZALEX® dosing schedule with the newly diagnosed DRd regimen
Continue DRd until disease progression or unacceptable toxicity
DRd=DARZALEX FASPRO®/DARZALEX® (D) + lenalidomide (R) + dexamethasone (d).
DARZALEX FASPRO® in combination with lenalidomide and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX® in combination with lenalidomide and dexamethasone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Once-monthly dosing over time—a key milestone for patients to reach in newly diagnosed, transplant-ineligible multiple myeloma1,2*
Starting at Cycle 10, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
Dosing schedule with the DVMP regimenDosing schedule with the DVMP regimen
Continue DVMP until disease progression or unacceptable toxicity
DVMP=DARZALEX FASPRO®/DARZALEX® (D) + bortezomib (V) + melphalan (M) + prednisone (P).
DARZALEX FASPRO® in combination with bortezomib + melphalan + prednisone (6-week cycle) has the same dosing schedule as DARZALEX® in combination with bortezomib + melphalan + prednisone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Fixed-cycle dosing for patients in newly diagnosed,
transplant-eligible multiple myeloma1,2*
Dosing schedule with DVRd regimenChart showing dosing schedule with the DVRd regimen
DARZALEX FASPRO® is the only anti-CD38 monoclonal antibody
that can be delivered subcutaneously in ~3 to 5 minutes.1-3
ASCT=autologous stem cell transplant; d=dexamethasone (d); D=DARZALEX FASPRO® (D); DR=DARZALEX FASPRO® (D) + lenalidomide (R); DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d).
DARZALEX FASPRO® in combination with bortezomib + lenalidomide and dexamethasone(4-week cycle) has the same dosing schedule as DARZALEX® in combination with bortezomib + lenalidomide and dexamethasone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2 See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Fixed-cycle dosing for patients in newly diagnosed, transplant-eligible multiple myeloma1,2*
Dosing schedule with DVTd regimenChart showing dosing schedule with the DVTd regimen
ASCT=autologous stem cell transplant; d=dexamethasone (d); D=DARZALEX FASPRO® (D); DR=DARZALEX FASPRO® (D) + lenalidomide (R); DVRd=DARZALEX FASPRO® (D) + bortezomib (V) + lenalidomide (R) + dexamethasone (d).
DARZALEX FASPRO® in combination with bortezomib + thalidomide + dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX® in combination with bortezomib + thalidomide + dexamethasone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma1,2*
Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
Dosing schedule with the DRd regimenChart showing relapsed DRd dosing schedule
Continue DRd until disease progression or unacceptable toxicity
DRd=DARZALEX FASPRO®/DARZALEX® (D) + lenalidomide (R) + dexamethasone (d).
DARZALEX FASPRO® in combination with lenalidomide and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX® in combination with lenalidomide and dexamethasone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma1,2*
Starting at Cycle 9, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
Chart showing DVd dosing regimenDosing schedule with the DVd regimen
Continue DVd until disease progression or unacceptable toxicity
DVd=DARZALEX FASPRO®/DARZALEX® (D) + bortezomib (V) + dexamethasone (d).
DARZALEX FASPRO® in combination with bortezomib and dexamethasone (3-week cycle) has the same dosing schedule as DARZALEX® in combination with bortezomib and dexamethasone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma1,2*
Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
Chart showing dosing schedule on the DPd regimenDosing schedule with the DPd regimen
Continue DPd until disease progression or unacceptable toxicity
ASCT:=autologous stem cell transplant; DPd=DARZALEX FASPRO®/DARZALEX® (D) + pomalidomide (P) + dexamethasone (d).
DARZALEX FASPRO® in combination with pomalidomide and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX® in combination with pomalidomide and dexamethasone.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma1,2*
Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
Dosing schedule with the DKd regimenDosing schedule with the DKd regimen
Continue DKd until disease progression or unacceptable toxicity
DKd=DARZALEX FASPRO®/DARZALEX® (D) + carfilzomib (K) + dexamethasone (d).
DARZALEX FASPRO® in combination with carfilzomib and dexamethasone (4-week cycle) has the same dosing schedule as DARZALEX® in combination with carfilzomib and dexamethasone, with the exception of Week 1.1,2
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

Once-monthly dosing over time—a key milestone for patients to reach in relapsed or refractory multiple myeloma1,2*
Starting at Cycle 7, patients will transition to approximately once-monthly dosing for DARZALEX FASPRO® or DARZALEX®
Dosing schedule for monotherapy regimenDosing schedule for monotherapy regimen
Continue monotherapy treatment until disease progression or unacceptable toxicity
DARZALEX FASPRO® monotherapy (4-week cycle) has the same dosing schedule as DARZALEX® monotherapy.1,2‡
*The first dose of the every-2-week dosing schedule is given at Week 9. First dose of the every-4-week dosing schedule is given at Week 25.1,2
See the Dosage and Administration section of the full Prescribing Information for more details. When DARZALEX FASPRO® or DARZALEX® is administered as part of a combination therapy, see the Prescribing Information for dosage recommendations for the other drugs.
Cycle=28 days.
The option of splitting the first dose for DARZALEX® is not applicable to DARZALEX FASPRO®.1,2

References:

  1. DARZALEX FASPRO® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  2. DARZALEX® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
  3. Mateos M-V, Nahi H, Legiec W, et al. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020;7(5):e370-e380.
  4. Sarclisa® (isatuximab-irfc) [Prescribing Information]. Bridgewater, NJ: Sanofi-Aventis US LLC.
  5. Empliciti® (elotuzumab) [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb Company.