Redefining approaches in early lines of multiple myeloma
MAIA and POLLUX | DARZALEX® + Rd
DARZALEX® + Revlimid® (lenalidomide) + dexamethasone
DARZALEX® dosing frequency decreases over time1
In newly diagnosed multiple myeloma (NDMM) transplant-ineligible patients OR after 1 prior therapy
- DARZALEX® is given as an intravenous (IV) infusion after dilution at 16 mg/kg of actual body weight
- Lenalidomide is given orally on days 1–21 of each cycle*
Dexamethasone is given orally or IV once a week†
In newly diagnosed, transplant-ineligible multiple myeloma:
- On DARZALEX® infusion days, the entire dexamethasone dose was given as a pre-infusion medication
After 1 prior therapy:
- 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
- In newly diagnosed, transplant-ineligible multiple myeloma:
*Please refer to the lenalidomide Prescribing Information for more detailed information about lenalidomide dosing.
†Dexamethasone may be modified for various patient populations. Please see the DARZALEX® Prescribing Information for more information.
‡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.)
Revlimid® is a registered trademark of Celgene Corporation.
Starting at Week 25, administration frequency for DARZALEX® regimens is once every 4 weeks and median duration averages 3 hours.1
Median duration of 16 mg/kg infusion decreased after the first infusion1
- 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® + Rd 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
#Consider incremental escalation of the infusion rate only in the absence of infusion reactions.
**Use a dilution volume of 500 mL for the 16 mg/kg dose only if there were no infusion reactions the previous week. Otherwise, use a dilution volume of 1000 mL.
††Use a modified initial rate (100 mL/hour) for subsequent infusions (ie, Week 3 onwards) only if there were no infusion reactions during the previous infusion. Otherwise, use instructions indicated in the table for the Week 2 infusion rate.
Median infusion duration decreased considerably after the first infusion1
- 1st infusion was 7.0 hours
- 2nd infusion was 4.0 hours
- Subsequent infusions were 3.0 hours
Prophylaxis for herpes zoster reactivation1
- Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting DARZALEX® and continue for 3 months following treatment
Hepatitis B reactivation1
- Hepatitis B Reactivation: Hepatitis B virus reactivation has been reported in less than 1% of patients (including fatal cases) treated with DARZALEX® in clinical trials. Advise patients to inform healthcare providers if they have ever had or might have a hepatitis B infection and that DARZALEX® could cause hepatitis B virus to become active again
- 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:
- Dexamethasone 20 mg prior to every DARZALEX® infusion. When dexamethasone is the background regimen-specific corticosteroid, the dexamethasone treatment dose will also serve as pre-medication on DARZALEX® infusion days‡‡
- During monotherapy, methylprednisolone 100 mg, or equivalent, administered intravenously. Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg)
- Oral antipyretics (acetaminophen 650 to 1000 mg), plus
- Oral or IV antihistamine (diphenhydramine 25 to 50 mg or equivalent)
‡‡Dexamethasone is given intravenously prior to the first DARZALEX® infusion and oral administration may be considered prior to subsequent infusions. 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
- During monotherapy, administer oral corticosteroid (20 mg methylprednisolone or equivalent dose of an intermediate-acting or long-acting corticosteroid in accordance with local standards) on each of the 2 days following all DARZALEX® infusions (beginning the day after the infusion)
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 4 hours. 40% of patients experienced an infusion reaction during the first infusion. For 2% of patients, infusion reactions occurred with the second infusion; and cumulatively, 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 1.5 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
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