Dose DARZALEX® at 16 mg/kg of actual body weight as an intravenous (IV) infusion1
DARZALEX® dosing frequency decreases throughout the course of therapy1
- Administer DARZALEX® only as an IV infusion after dilution1
- 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 Testing
- 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®
Interference with determination of complete response1
- Daratumumab is a human immunoglobulin G (IgG) kappa 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
DARZALEX® 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 only if there were no Grade 1 (mild) or greater 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 Grade 1 (mild) or greater 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 3.5 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
- DARZALEX® can cause severe infusion reactions
- Approximately half of all patients experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent infusions
- Nearly all reactions occurred during infusion or within 4 hours of completing an infusion. Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion
- Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, and throat irritation, as well as chills, vomiting and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension
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. 46% of patients experienced an infusion reaction during the first infusion. For 2% of patients, infusion reactions occurred with the second infusion and for 3% 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: 0.02 to 72.8 hours).1 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
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.2 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