DARZALEX

DARZALEX- daratumumab injection, solution, concentrate
Janssen Biotech, Inc.

1 INDICATIONS AND USAGE

DARZALEX is indicated for the treatment of adult patients with multiple myeloma:

  • in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
  • in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant.
  • in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
  • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy.
  • in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.
  • in combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
  • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosing Information

2.2 Recommended Dosage

Monotherapy and In Combination with Lenalidomide (D-Rd) or Pomalidomide (D-Pd) and Dexamethasone

The DARZALEX dosing schedule in Table 1 is for combination therapy (4-week cycle regimens) and monotherapy as follows:

combination therapy with lenalidomide and low-dose dexamethasone for newly diagnosed patients ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed/refractory multiple myeloma
combination therapy with pomalidomide and low-dose dexamethasone for patients with relapsed/refractory multiple myeloma
monotherapy for patients with relapsed/refractory multiple myeloma.

The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an intravenous infusion according to the following dosing schedule:

Table 1: DARZALEX Dosing Schedule in Combination With Lenalidomide or Pomalidomide (4-Week Cycle) and Low-Dose Dexamethasone and for Monotherapy
Weeks Schedule
*
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
Weeks 1 to 8 weekly (total of 8 doses)
Weeks 9 to 24* every two weeks (total of 8 doses)
Week 25 onwards until disease progression every four weeks

For dosing instructions of combination agents administered with DARZALEX, see Clinical Studies (14) and manufacturer’s prescribing information.

In Combination with Bortezomib, Melphalan and Prednisone (D-VMP)

The DARZALEX dosing schedule in Table 2 is for combination therapy with bortezomib, melphalan and prednisone (6-week cycle regimen) for patients with newly diagnosed multiple myeloma ineligible for ASCT.

The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an intravenous infusion according to the following dosing schedule:

Table 2: DARZALEX Dosing Schedule in Combination With Bortezomib, Melphalan and Prednisone ([VMP], 6-Week Cycle)
Weeks Schedule
*
First dose of the every-3-week dosing schedule is given at Week 7
First dose of the every-4-week dosing schedule is given at Week 55
Weeks 1 to 6 weekly (total of 6 doses)
Weeks 7 to 54* every three weeks (total of 16 doses)
Week 55 onwards until disease progression every four weeks

For dosing instructions of combination agents administered with DARZALEX see Clinical Studies (14.1).

In Combination with Bortezomib, Thalidomide and Dexamethasone (D-VTd)

The DARZALEX dosing schedule in Table 3 is for combination therapy with bortezomib, thalidomide, and dexamethasone (4-week cycle regimen) for patients with newly diagnosed multiple myeloma eligible for ASCT.

The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an intravenous infusion according to the following dosing schedule:

Table 3: DARZALEX Dosing Schedule in Combination With Bortezomib, Thalidomide and Dexamethasone ([VTd]; 4-Week Cycle)
Treatment phase Weeks Schedule
*
First dose of the every-2-week dosing schedule is given at Week 9
First dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT
Induction Weeks 1 to 8 weekly (total of 8 doses)
Weeks 9 to 16* every two weeks (total of 4 doses)
Stop for high dose chemotherapy and ASCT
Consolidation Weeks 1 to 8 every two weeks (total of 4 doses)

For dosing instructions of combination agents administered with DARZALEX, see Clinical Studies (14.1) and the manufacturer’s prescribing information.

In Combination with Bortezomib and Dexamethasone (D-Vd)

The DARZALEX dosing schedule in Table 4 is for combination therapy with bortezomib and dexamethasone (3-week cycle) for patients with relapsed/refractory multiple myeloma.

The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an intravenous infusion according to the following dosing schedule:

Table 4: DARZALEX Dosing Schedule With Bortezomib and Dexamethasone (3-Week Cycle)
Weeks Schedule
*
First dose of the every-3-week dosing schedule is given at Week 10
First dose of the every-4-week dosing schedule is given at Week 25
Weeks 1 to 9 weekly (total of 9 doses)
Weeks 10 to 24* every three weeks (total of 5 doses)
Week 25 onwards until disease progression every four weeks

For dosing instructions of combination agents administered with DARZALEX see Clinical Studies (14.2) and manufacturer’s prescribing information.

In Combination with Carfilzomib and Dexamethasone (DKd)

The recommended dosage for DARZALEX when administered in combination with carfilzomib and dexamethasone (4-week cycle) for patients with relapsed/refractory multiple myeloma is provided in Table 5.

Table 5: DARZALEX Dosing Schedule With Carfilzomib and Dexamethasone (4-Week Cycle)
Weeks DARZALEX Dose * Schedule
*
Based on actual body weight
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
Week 1 8 mg/kg 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)
Week 25 onwards until disease progression 16 mg/kg every four weeks

For dosing instructions of combination agents administered with DARZALEX see Clinical Studies (14.1) and manufacturer’s prescribing information.

Infusion Rates

Administer DARZALEX intravenously at the infusion rate described below in Table 6. Consider incremental escalation of the infusion rate only in the absence of infusion-related reactions.

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 dose is administered on Day 1 and Day 2, respectively.

Table 6: Infusion Rates for DARZALEX (16 mg/kg) Administration
Dilution volume Initial rate (first hour) Rate increment * Maximum rate
*
Consider incremental escalation of the infusion rate only in the absence of infusion-related reactions.
Use a dilution volume of 500 mL for the 16 mg/kg dose only if there were no infusion-related reactions the previous week. Otherwise, use a dilution volume of 1,000 mL.
Use a modified initial rate (100 mL/hour) for subsequent infusions (i.e. Week 3 onwards) only if there were no infusion-related reactions during the previous infusion. Otherwise, continue to use instructions indicated in the table for the Week 2 infusion rate.
Week 1 Infusion
Option 1 (Single dose infusion)
Week 1 Day 1 (16 mg/kg) 1,000 mL 50 mL/hour 50 mL/hour every hour 200 mL/hour
Option 2 (Split dose infusion)
Week 1 Day 1 (8 mg/kg) 500 mL 50 mL/hour 50 mL/hour every hour 200 mL/hour
Week 1 Day 2 (8 mg/kg) 500 mL 50 mL/hour 50 mL/hour every hour 200 mL/hour
Week 2 (16 mg/kg) 500 mL 50 mL/hour 50 mL/hour every hour 200 mL/hour
Week 3 onwards (16 mg/kg) 500 mL 100 mL/hour 50 mL/hour every hour 200 mL/hour

Missed DARZALEX Doses

If a dose of DARZALEX is missed, administer the dose as soon as possible and adjust the dosing schedule to maintain the dosing interval.

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