Active Ingredient: Daratumumab
Daratumumab is indicated:
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
16 - 16 mg per kg of body weight
From 16 To 16 mg per kg of body weight once every 7 day(s) for 56 day(s)
The recommended dose is daratumumab 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 1.
Table 1. daratumumab dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy:
| Weeks | Schedule |
|---|---|
| Weeks 1 to 8 | weekly (total of 8 doses) |
| Weeks 9 to 24a | every two weeks (total of 8 doses) |
| Week 25 onwards until disease progressionb | every four weeks |
a First dose of the every-2-week dosing schedule is given at Week 9
b First dose of the every-4-week dosing schedule is given at Week 25
The recommended dose is daratumumab 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 2.
Table 2. daratumumab dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen):
| Weeks | Σχήμα |
|---|---|
| Weeks 1 to 6 | weekly (total of 6 doses) |
| Weeks 7 to 54a | every three weeks (total of 16 doses) |
| Week 55 onwards until disease progressionb | every four weeks |
a First dose of the every-3-week dosing schedule is given at Week 7
b First dose of the every-4-week dosing schedule is given at Week 55
Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
The recommended dose is daratumumab 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 3.
Table 3. daratumumab dosing schedule in combination with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle dosing regimen):
| Treatment phase | Weeks | Schedule |
|---|---|---|
| Induction | Weeks 1 to 8 | weekly (total of 8 doses) |
| Weeks 9 to 16a | every two weeks (total of 4 doses) | |
| Stop for high dose chemotherapy and ASCT | ||
| Consolidation | Weeks 1 to 8β | every two weeks (total of 4 doses) |
a First dose of the every-2-week dosing schedule is given at Week 9
b First dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT
For dose and schedule of medicinal products administered with daratumumab, see section 5.1 and the corresponding Summary of Product Characteristics.
The recommended dose is daratumumab 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 4.
Table 4. daratumumab dosing schedule in combination with bortezomib (3-week cycle dosing regimen):
| Weeks | Schedule |
|---|---|
| Weeks 1 to 9 | weekly (total of 9 doses) |
| Weeks 10 to 24a | every three weeks (total of 5 doses) |
| Week 25 onwards until disease progressionb | every four weeks |
a First dose of the every-3-week dosing schedule is given at Week 10
b First dose of the every-4-week dosing schedule is given at Week 25
If a planned dose of daratumumab is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
No dose reductions of daratumumab are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity.
Following dilution the daratumumab infusion should be intravenously administered at the initial infusion rate presented in Table 5 below. Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.
To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over two consecutive days i.e. 8 mg/kg on Day 1 and Day 2 respectively, see Table 5 below.
Table 5. Infusion rates for daratumumab (16 mg/kg) administration:
| Dilution volume | Initial rate (first hour) | Rate Incrementa | Maximum 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)infusionb | 500 ml | 50 ml/ώρα | 50 mL/hour every hour | 200 ml/ώρα |
| Subsequent (Week 3 onwards, 16 mg/kg) infusionsc | 500 ml | 100 mL/hour | 50 mL/hour every hour | 200 mL/hour |
a Incremental escalation of the infusion rate should be considered only in the absence of infusion reactions.
b A dilution volume of 500 mL for the 16 mg/kg dose should be used only if there were no IRRs the previous week. Otherwise, use a dilution volume of 1,000 mL.
c A modified initial rate (100 mL/hour) for subsequent infusions (i.e. Week 3 onwards) should only be used only if there were no IRRs during the previous infusion. Otherwise, continue to use instructions indicated in the table for the Week 2 infusion rate.
Pre-infusion medications should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every infusion of daratumumab as follows:
Post-infusion medications should be administered to reduce the risk of delayed infusion-related reactions as follows:
Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-infusion medications including short and long acting bronchodilators, and inhaled corticosteroids should be considered. Following the first four infusions, if the patient experiences no major IRRs, these inhaled post-infusion medications may be discontinued at the discretion of the physician.
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