DARZALEX® is now available as a solution for injection.
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) SC | 1800 mg SC | Cycles 1–2: Weekly Cycles 3–4: Every 2 weeks During ASCT: None Cycles 5–6: Every 2 weeks |
Velcade® (bortezomib) | 1.3 mg/m2 SC | Cycles 1–6: Twice weekly during Weeks 1 and 2 |
Thalidomide | 100 mg PO | Cycle 1–6: Once daily |
Dexamethasone | 40 mg PO | Cycle 1–2: Twice weekly during Weeks 1–3 Cycles 3–4: Day 1 and 2 of each cycle |
Dexamethasone | 20 mg PO | Cycle 3–4: Twice weekly during Weeks 2 and 3 Cycles 5–6: Twice weekly during Weeks 1–3 |
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) SC | 1800 mg SC | Cycles 1–2: Weekly Cycles 3–6: Every 2 weeks Cycles 7+: Every 4 weeks until disease progression |
Lenalidomide | 25 mg PO | Once daily on Days 1–21 of each cycle until disease progression |
Dexamethasone | 40 mg PO/IV | Every week until disease progression |
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) SC | 1800 mg SC | Cycles 1: Weekly Cycles 2–9: Every 3 weeks Cycles 10+: Every 4 weeks until disease progression |
Velcade® (bortezomib) | 1.3 mg/m2 SC | Cycle 1: Twice weekly on Weeks 1, 2, 4 and 5 Cycles 2–9: Once weekly on Weeks 1, 2, 4 and 5 |
Melphalan | 9 mg/m2 PO | Once daily on Days 1–4 of each cycle until disease progression |
Prednisone* | 60 mg/m2 PO | Once daily on Days 1–4 of each cycle until disease progression |
* Dexamethasone at a dose of 20 mg was substituted for prednisone on Day 1 of each cycle.
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) SC | 1800 mg SC | Cycles 1–2: Weekly Cycles 3–6: Every 2 weeks Cycles 7+: Every 4 weeks until disease progression |
Lenalidomide | 25 mg PO | Once daily on days 1–21 of each cycle until disease progression |
Dexamethasone | 40 mg PO/IV* | Every week until disease progression |
* On DARZALEX® infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) SC | 1800 mg SC | Cycles 1–3: Weekly Cycles 4–8: Every 3 weeks Cycles 9+: Every 4 weeks until disease progression |
Velcade® (bortezomib) | 1.3 mg/m2 SC/IV | Cycles 1–8: Days 1, 4, 8 and 11 |
Dexamethasone | 20 mg PO* | Cycle 1–8: Days 1, 2, 4, 5, 8, 9, 11 and 12 |
* On DARZALEX® dosing days, the pre-administration medication replaces the daily dose of dexamethasone.
Medications should be administered to reduce the risk of IRRs to all patients 1–3 hours prior to every infusion of DARZALEX® as follows:
Medications should be administered to reduce the risk of delayed infusion-related reactions as follows:
If a planned dose of DARZALEX® 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 DARZALEX® are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity.[1]
In clinical trials with DARZALEX® SC formulation (monotherapy and combination treatments; N=639), the incidence of any grade IRRs was 8.2% with the first injection of DARZALEX® (1,800 mg, Week 1), 0.4% with the Week 2 injection, and 1.1% with subsequent injections. Grade 3 IRRs were seen in 0.8% of patients. No patients had Grade 4 IRRs.[1]
Adapted from DARZALEX® (daratumumab) EU SmPC[1]
Patients should receive appropriate pre-injection and post-injection medications to reduce the risk of IRRs (see treatment schedules).[1]
In clinical trials, no modification to rate or dose of DARZALEX® SC was required to manage IRRs. The median time to onset of IRRs following DARZALEX® injection was 3.7 hours (range: 00.15–83.00 hours). Most IRRs occurred on the day of treatment. Delayed IRRs have occurred in 1% of patients.[1]
The most common IRRs include:[1]
Severe IRRs include:[1]
DARZALEX® solution for subcutaneous injection is for subcutanous use, and the recommended dose is 1800 mg administered over approximately 3–5 minutes.[1]
DARZALEX® should be administered by a healthcare professional, and the first dose should be administered in an environment where resuscitation facilities are available.[1]
Pre- and post-injection medications should be administered to reduce the risk of infusion-related IRRs (see treatment schedules).[1]
Either an injection needle
OR
a winged/butterfly infusion set
1. Inspect the solution
2. Attach transfer needle and fill syringe
3. Attach injection needle and set dose
4. Choose the injection site
5. Insert needle
6. Inject dose
7. After injection
8. Dispose of used syringe
9. Check injection site
1. Inspect the solution
2. Choose the injection site
3. Prime infusion set
4. Attach transfer needle and fill syringe
* Vials are overfilled to allow for infusion set administration
5. Attach infusion set and set dose
6. Insert needle
7. Inject dose
Optional: After completion of administration, flush the syringe with saline to ensure the patient receives the full dose.
8. After injection
9. Check injection site
Unopened vials have a shelf life of 18 months. Do not use this medicine after the expiry date, which is stated on the carton after “EXP”.[1]
DARZALEX® should be stored in a refrigerator (2°C–8°C) and never frozen. It should be stored in the original package in order to protect from light.[1]
Before use, remove the vial from refrigerated storage (2°C–8°C) and equilibrate to ambient temperature (15°C–30°C).[1]
The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours out of direct sunlight and must not be shaken.[1]
Once transferred from the vial into the syringe, DARZALEX® solution for injection can be stored for a maximum of 12 hours at ambient temperature (15ºC-25ºC) and ambient light.[1]
Includes a first use checklist of Darzalex® SC.
Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more
ASCT: autologous stem cell transplant
COPD: chronic obstructive pulmonary disease
DRd: DARZALEX®, lenalidomide, dexamethasone
DVd: DARZALEX®, Velcade®, dexamethasone
DVMP: DARZALEX®, Velcade®, melphalan, prednisone
DVTd: DARZALEX®, Velcade®, thalidomide, dexamethasone
IV: intravenous
IRR: infusion-related reaction
NDMM: newly-diagnosed multiple myeloma
PO: oral
RRMM: relapsed/refractory multiple myeloma
SC: subcutaneous
Titular da Autorização de Introdução no Mercado: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Bélgica.
Para mais informações deverá contactar o Representante do Titular da Autorização de Introdução no Mercado: Janssen-Cilag Farmacêutica, Lda.
Medicamento de receita médica restrita, de utilização reservada a certos meios especializados.
Antes de prescrever consulte o RCM completo.
RCM de Darzalex®, veja aqui