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Practical help and advice when prescribing DARZALEX®
Daratumumab SC handling and administration
DARZALEX® is now available as a solution for injection.
Dosing schedules
NDMM: DARZALEX® + Velcade® + thalidomide + dexamethasone (DVTd)[1]
DVTd dosing schedule: 4-week cycle regimen
DVTd dosing schedule: 4-week cycle regimen[1]
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 |
NDMM: DARZALEX® + lenalidomide + dexamethasone (DRd)[1]
DRd dosing schedule: 4-week cycle regimen
DRd dosing schedule: 4-week cycle regimen[1]
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 |
NDMM: DARZALEX® + Velcade® + melphalan + prednisone (DVMP)[1]
DVMP dosing schedule: 6-week cycle regimen
DVMP dosing schedule: 6-week cycle regimen[1]
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.
RR: DARZALEX® + lenalidomide + dexamethasone (DRd)[1]
DRd dosing schedule: 4-week cycle regimen
DRd dosing schedule: 4-week cycle regimen[1]
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.
RR: DARZALEX® + Velcade® + dexamethasone (DVd)[1]
DVd dosing schedule: 3-week cycle regimen
DVd dosing schedule: 3-week cycle regimen[1]
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.
RR: DARZALEX® monotherapy[1]
Recommended concomitant medications & missed dose information
Pre-injection[1]
Medications should be administered to reduce the risk of IRRs to all patients 1–3 hours prior to every infusion of DARZALEX® as follows:
- Corticosteroid (long-acting or intermediate-acting) – dexamethasone 20 mg or equivalent administered before every DARZALEX® injection. When dexamethasone is the background regimen-specific corticosteroid, the dexamethasone treatment dose will instead serve as pre-injection medicinal product on DARZALEX® administration days. Additional background regimen–specific corticosteroids (e.g., prednisone) should not be taken on DARZALEX® administration days when patients have received dexamethasone (or equivalent) as a pre-injection medication
- Antipyretic – paracetamol 650–1000 mg
- Antihistamine – diphenhydramine 25–50 mg PO/IV or equivalent
Post-injection[1]
Medications should be administered to reduce the risk of delayed infusion-related reactions as follows:
- Consider administering low-dose methylprednisolone PO (≤20 mg) or equivalent the day after the DARZALEX® injection. However, if a background regimen–specific corticosteroid (e.g., dexamethasone, prednisone) is administered the day after the DARZALEX® injection, additional post-injection medications may not be needed
- If the patient experiences no major IRRs after the first three injections, post-injection corticosteroids (excluding any background regimen corticosteroids) may be discontinued
Additional concomitant medications[1]
Patients with a history of COPD[1]
- For patients with a history of chronic obstructive pulmonary disease, the use of post-injection medications, including short- and long-acting bronchodilators, and inhaled corticosteroids, should be considered. Following the first four injections, if the patient experiences no major IRRs, these inhaled post-injection medications may be discontinued at the discretion of the physician
Herpes zoster prophylaxis[1]
- Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation
Missed dose[1]
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
Dose modifications[1]
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]
IRR management
Rate of IRRs[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]
- Nasal congestion
- Cough
- Throat irritation
- Allergic rhinitis
- Wheezing
- Pyrexia
- Chest pain
- Pruritis
- Chills
- Vomiting
- Nausea
- Hypotension
Severe IRRs include:[1]
- Bronchospasm
- Hypoxia
- Dyspnoea
- Hypertension
- Tachycardia
Administration
How to administer DARZALEX SC®
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]
Supplies you will need:[1]
- Vial of DARZALEX® SC (1800 mg/15 ml)
- Syringe – 20 mL recommended
- Transfer needle – 18G x 38 mm recommended
- Alcohol swabs
- Cotton ball or gauze pad
- Adhesive bandage
- Sharps bin
Either an injection needle
- 23G x 38 mm recommended
OR
a winged/butterfly infusion set
- 23G x 19 mm recommended
Primary method — Injection needle[1][2]
.png?width=391&height=216&format=webp&quality=50 "Inspect the solution")
1. Inspect the solution
- Remove one DARZALEX® SC vial from the refrigerator and warm to room temperature
- Check that the DARZALEX® SC solution is clear to opalescent and colourless-to-yellow
- Do not use if opaque particles, discolouration or other foreign particles are present
.png?width=392&height=216&format=webp&quality=50 "Fill syringe")
2. Attach transfer needle and fill syringe
- Prepare the dosing syringe in controlled and validated aseptic conditions
- Attach the transfer needle to the syringe. Withdraw the full contents of the vial into the syringe using the transfer needle*
- Administer DARZALEX® SC within 4 hours of puncturing the vial or drawing the dose into the syringe
- If not used immediately, label the syringe with the date and time
.png?width=391&height=216&format=webp&quality=50 "Attach needle")
3. Attach injection needle and set dose
- Remove the transfer needle and attach the injection needle to the syringe
- Prime the syringe and set the dose to 15 ml
.png?width=391&height=216&format=webp&quality=50 "Choose site")
4. Choose the injection site
- Choose a site on the abdomen, about 7,5 cm to the right or left of the navel
- Do not inject into skin that is tender, bruised, red, hard, or has scars
- Wipe your chosen injection site with an alcohol swab and allow it to dry
- Rotate injection sites for each successive injection – note down which side was used each time
.png?width=392&height=216&format=webp&quality=50 "Insert needle")
5. Insert needle
- Pinch skin at the injection site. It is important to pinch enough skin to inject under the skin and not into the muscle
- Inject at a 45° angle
- Release pinched skin
- Check no blood vessel has been punctured
.png?width=391&height=216&format=webp&quality=50 "5 mins")
6. Inject dose
- Press the plunger with a constant rate of delivery for about 3–5 minutes
- Try to limit needle and syringe movement during injection through a two-handed syringe grip
- If the patient feels pain, pause or slow down the rate of delivery. If the patient still feels pain, consider using a different injection site on the opposite side of the abdomen to deliver the remainder of the dose
.png?width=391&height=216&format=webp&quality=50 "After injection")
7. After injection
- Gently remove the needle
- Place a gauze pad or a cotton ball over the entrance site of the needle
.png?width=392&height=216&format=webp&quality=50 "Dispose used syringe")
8. Dispose of used syringe
- Put the used syringe in a sharps disposal container right away after use
.png?width=391&height=216&format=webp&quality=50 "Check injection site")
9. Check injection site
- There may be a small amount of blood or liquid at the injection site.
- Hold pressure over skin with a cotton ball or gauze pad until any bleeding stops
- Do not rub the injection site. If needed, cover the injection site with a bandage
Secondary method — Winged/butterly infusion set[1][2]
1. Inspect the solution
- Remove one DARZALEX® SC vial from the refrigerator and warm to room temperature
- Check that the DARZALEX® SC solution is clear to opalescent and colourless-to-yellow
- Do not use if opaque particles, discolouration or other foreign particles are present
2. Choose the injection site
- Choose a site on the abdomen, about 7,5 cm to the right or left of the navel
- Do not inject into skin that is tender, bruised, red, hard, or has scars
- Wipe your chosen injection site with an alcohol swab and allow it to dry
- Rotate injection sites for each successive injection – note down which side was used each time
.png?width=391&height=216&format=webp&quality=50 "Prime infusion set")
3. Prime infusion set
- Flush the tubing of the infusion set with a small volume of saline solution or with the product itself
- Follow the instructions from your infusion set manufacturer
4. Attach transfer needle and fill syringe
* Vials are overfilled to allow for infusion set administration
5. Attach infusion set and set dose
- Remove the transfer needle and attach the injection needle to the syringe
- Set the dose to 15 ml
- Follow the instructions from your infusion set manufacturer
.png?width=391&height=216&format=webp&quality=50 "insert needle")
6. Insert needle
- Remove needle safety cap
- Pinch skin at the injection site. It is important to pinch enough skin to inject under the skin and not into the muscle
- Inject at a 45° angle
- Release pinched skin. If needed, secure site as per your institutional protocol (e.g., surgical tape)
7. Inject dose
- Press the plunger with a constant rate of delivery for about 3–5 minutes (use phone/watch to track time)
- If the patient feels pain, pause or slow down the rate of delivery. If the patient still feels pain, consider using a different injection site on the opposite side of the abdomen to deliver the remainder of the dose
Optional: After completion of administration, flush the syringe with saline to ensure the patient receives the full dose.
8. After injection
- Remove the surgical tape, if used
- Gently remove the needle
- Place a gauze pad or a cotton ball over the entrance site of the needle
- Put the used syringe in a sharps disposal container right away after use
9. Check injection site
- There may be a small amount of blood or liquid at the injection site. Hold pressure over skin with a cotton ball or gauze pad until any bleeding stops
- Do not rub the injection site. If needed, cover the injection site with a bandage
Storing DARZALEX® SC
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]
Quick downloads
SC Checklist beginning of treatment
Includes a first use checklist of Darzalex® SC.
Darzalex® SC Practical Guide
Includes DARZALEX® SC handling and administration info, pre and post-injection medications, and more
Glossary
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
