DARZALEX® in combination with bortezomib, cyclophosphamide and dexamethasone (VCd) is the first and only targeted therapy to significantly transform clinical outcomes in AL amyloidosis*[1]
ANDROMEDA is a randomised, open-label, active-controlled, multicentre, phase 3 study comparing DARZALEX® + VCd (DVCd) vs. VCd (N=388).[1]
* DVCd vs. VCd alone.
NEW DATA │ANDROMEDA study presented at ASH 2021
DVCd provided consistent benefit across the majority of patient subgroups in a pre-specified analysis of haematologic CR, including:*[1][2]
* DVCd vs. VCd alone.
* DVCd vs. VCd alone.
Treatment | Dose | Dosing schedule |
DARZALEX® (daratumumab) | 1800 mg SC | Cycles 1–2: Weekly (total of 8 doses) Cycles 3–6: Every 2 weeks (total of 8 doses) Cycles 7+: Every 4 weeks until disease progression |
Bortezomib | 1.3 mg/m2 SC body surface area | Weekly on Days 1, 8, 15, and 22 of repeated 28-day/4-week cycles |
Cyclophosphamide | 300 mg/m2 PO/IV* | Weekly on Days 1, 8, 15, and 22 of repeated 28-day/4-week cycles |
Dexamethasone | 40 mg PO/IV* | Weekly on Days 1, 8, 15, and 22 of repeated 28-day/4-week cycles |
* On DARZALEX® SC injection days, 20 mg of the dexamethasone was given as a pre-injection medication and the remainder given the day after the injection.[1] In the phase 3 clinical trial, dexamethasone was administered at a reduced dose of 20 mg/week for patients >70 years, BMI <18.5 kg/m2, or those who have hypervolemia, poorly controlled diabetes mellitus, or prior intolerance to steroid therapy.
In clinical trials with DARZALEX® SC formulation (monotherapy and combination treatments; N=683), 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.
Adapted from DARZALEX® (daratumumab) EU SmPC[3]
Patients should receive appropriate pre-injection and post-injection medications to reduce the risk of IRRs (see treatment schedules).[3]
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 3.2 hours (range: 0.15–83.00 hours). Most IRRs occurred on the day of treatment. Delayed IRRs have occurred in 1% of patients.[3]
The most common IRRs include:[3]
Severe IRRs include:[3]
DARZALEX® solution for subcutaneous injection is for subcutanous use, and the recommended dose is 1800 mg administered over approximately 3–5 minutes.[3]
DARZALEX® should be administered by a healthcare professional, and the first dose should be administered in an environment where resuscitation facilities are available.[3]
Pre- and post-injection medications should be administered to reduce the risk of IRRs (see treatment schedules).[3]
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”.[3]
DARZALEX® SC 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.[3]
Before use, remove the vial from refrigerated storage (2°C–8°C) and equilibrate to ambient temperature (15°C–30°C).[3]
The unpunctured vial may be stored at ambient temperature and ambient light for a maximum of 24 hours in the original carton to protect from light. Keep out of direct sunlight. Do not shake.[3]
Once transferred from the vial into the syringe, DARZALEX® solution for injection can be stored for a maximum of 12 hours at ambient temperature (a 15 ºC-25ºC ) and ambient light.[3]
Includes a first use checklist of Darzalex® SC.
Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more
AL: amyloid light chain
ARR: administration-related reaction
CR: complete response
DVCd: DARZALEX® + Velcade® + cyclophosphamide + dexamethasone
IRR: infusion-related reaction
ISR: injection-site reactions
IV: intravenous
PO: oral
SC: subcutaneous
VCd: Velcade® + cyclophosphamide + dexamethasone
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