ALCYONE | DARZALEX® + VMP
DARZALEX® + Velcade® (bortezomib) + melphalan + prednisone
DARZALEX® dosing frequency decreases over time1
In newly diagnosed multiple myeloma (NDMM) transplant-ineligible patients
- DARZALEX® is given as an intravenous (IV) infusion after dilution at 16 mg/kg of actual body weight
Bortezomib 1.3 mg/m2 is administered by subcutaneous injection twice weekly at Weeks 1, 2, 4, and 5 (Cycle 1) followed by once weekly at Weeks 1, 2, 4, and 5 (Cycles 2 to 9)
- Melphalan and prednisone are orally administered on Days 1 through 4 for each of the first 9 cycles
- VMP administration should be stopped after 9 cycles
On DARZALEX® infusion days, 20 mg of dexamethasone was given orally or IV as a pre-infusion medication and was continued as a pre-medication after VMP discontinuation
- Additional background regimen-specific corticosteroids (eg, prednisone) should not be taken on DARZALEX® infusion days
*Until disease progression or unacceptable toxicity.
†To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over 2 consecutive days. (Please see full Prescribing Information to learn more about split first dose.)
Velcade® is a registered trademark of Millenium Pharmaceuticals, Inc.
Starting at Cycle 10 (Week 55+), administration frequency for DARZALEX® is once every 4 weeks and requires a median duration of 3.4 hours1
Median duration of 16 mg/kg infusion decreased after the first infusion1
‡Median infusion length for subsequent infusions (Week 2+ in aggregate). Administer the Week 2 (16 mg/kg) infusion according to the infusion rates outlined in Table 4 of the DARZALEX® Prescribing Information.1
- DARZALEX® should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur1
- If a planned dose of DARZALEX® is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval1
Interference with serological testing1
- Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test)
- Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion
- Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type is not impacted
- Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®
- Type and screen patients prior to starting DARZALEX®
DARZALEX® + VMP Interactive Calendar
DARZALEX<sup>®</sup> + VMP Interactive Calendar
§Please note that dates provided are recommendations for infusion visits only. These dates do not account for additional follow-up/care visits. Infusion dates may change depending on patient and office availability.
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A slower rate of infusion for the first DARZALEX® dose is recommended, as infusion reactions are more likely to occur during the first infusion1
|Infusion rates for DARZALEX® administration1|
|First Infusion||1000 mL||50 mL/hour||
|Second infusion‡||500 mL||50 mL/hour||
|Subsequent infusion‡||500 mL||100 mL/hour||
‖Consider incremental escalation of the infusion rate only in the absence of infusion reactions.
†Use a dilution volume of 500 mL only if there were no infusion reactions during the first 3 hours of the first infusion. Otherwise, continue to use a dilution volume of 1000 mL and instructions for the first infusion.
‡Use a modified initial rate for subsequent infusions (ie, third infusion onwards) only if there were no infusion reactions during a final infusion rate of ≥100 mL/hour in the first 2 infusions. Otherwise, continue to use instructions for the second infusion.
Median infusion duration decreased considerably after the first infusion1
- 1st infusion was 7.0 hours
- 2nd infusion was 4.3 hours
- Subsequent infusions were 3.4 hours
Prophylaxis for herpes zoster reactivation1
- Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week of starting DARZALEX® and continue for 3 months following treatment
Pre- and post-infusion medications and dose modifications1
- To reduce the risk of infusion reactions, administration of pre- and post-infusion medications is recommended
- No dose reductions of DARZALEX® are recommended. Dose delay may be required to allow recovery of blood cell counts in the event of hematological toxicity
To reduce the risk of infusion reactions, administer approximately 1 to 3 hours prior to every infusion as follows:
- IV dexamethasone 20 mg prior to the first infusion and IV or oral dexamethasone 20 mg prior to subsequent infusions§
- oral antipyretics (acetaminophen 650 to 1000 mg), plus
- oral or IV antihistamine (diphenhydramine 25 to 50 mg or equivalent)
§Additional background regimen-specific corticosteroids (eg, prednisone) should not be taken on DARZALEX® infusion days when patients receive dexamethasone (or equivalent) as pre-medication.
To reduce the risk of infusion reactions, administer the day after every infusion as follows:
- Oral corticosteroid (≤20 mg methylprednisolone or equivalent); however, if a background regimen-specific corticosteroid (eg, dexamethasone, prednisone) is administered the day after the DARZALEX® infusion, additional post-infusion medications may not be needed
Note: For patients with a history of chronic obstructive pulmonary disease, consider including short- and long-acting bronchodilators and inhaled corticosteroids. Following the first 4 infusions, if the patient experiences no major infusion reactions, these additional inhaled post-infusion medications may be discontinued.
Interference with serological testing1
- DARZALEX® binds to CD38 found on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test) that may persist for up to 6 months after the last DARZALEX® infusion
- Type and screen patients before starting DARZALEX®
- Inform blood banks when a patient is on DARZALEX®
- Identify any DARZALEX®-treated blood samples
- Ask patients to tell other healthcare professionals that they've taken DARZALEX®
Interference with determination of complete response (CR)1
- Daratumumab is a human immunoglobulin G (IgG) kappa monoclonal antibody (mAb) that can be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays, which can impact the determination of a CR and of disease progression in some patients with IgG kappa myeloma protein
Be prepared: The first infusion of DARZALEX® may take about 7 hours. Future infusions will take less time but may still take 3 to 5 hours. 40% of patients experienced an infusion reaction during the first infusion. For 2% of patients, infusion reactions occurred with the second infusion; and for 4% with subsequent infusions.1
Keep an eye on patients as infusion reactions may occur: Ask them to tell you right away about any concerns or discomfort. In clinical trials, median time to onset of an infusion reaction was 1.4 hours (range: 0 to 72.8 hours). Signs and symptoms that may be indicative of an infusion reaction include1:
- shortness of breath or trouble breathing
- dizziness or lightheadedness (hypotension)
- throat tightness
- runny or stuffy nose
Infusion reaction includes terms determined by investigators to be related to infusion. Severe infusion reactions included bronchospasm, dyspnea, laryngeal edema, pulmonary edema, hypoxia, and hypertension. Other adverse infusion reactions included nasal congestion, cough, chills, throat irritation, vomiting, and nausea.1
Be vigilant: Remind patients to tell you right away about any side effect that bothers them or that does not go away.1
Remind patients to stay hydrated: Make sure they have enough fluids before and throughout their infusion. Let them know that they should avoid alcohol and caffeine.
Before they come in for each infusion, remind patients to:
- Wear comfortable, loose-fitting, and layered clothing
- Bring headphones, a music player, a tablet, crossword puzzles, or a book to help pass the time
- Bring a blanket and pillow, or anything else that will help them get comfortable
- If permitted by your office or hospital, bring something to eat and drink throughout the day