- For US Patients
Administration options include subcutaneous DARZALEX FASPRO® and intravenous DARZALEX®1,2
DARZALEX FASPRO®—subcutaneous administration starting with the first dose1
With an ~3 to 5 minute subcutaneous injection, patients receive DARZALEX FASPRO® treatment substantially faster than intravenous daratumumab1,2
DARZALEX FASPRO® contains 1,800 mg of daratumumab and 30,000 units of hyaluronidase in a 15 mL solution. Recombinant hyaluronidase increases permeability of subcutaneous tissue, enabling 1,800 mg of daratumumab to be absorbed into the subcutaneous tissue of the abdomen.1
DARZALEX FASPRO® is for subcutaneous use only.1
Pre-medicate patients 1 to 3 hours before each dose with a histamine-1 receptor antagonist, acetaminophen, and a corticosteroid.
~3 to 5 minute injection1
Consider administering corticosteroids and other medications after the administration of DARZALEX FASPRO® depending on dosing regimen and medical history to minimize the risk of delayed (defined as occurring the day after administration) systemic administration-related reactions* (ARRs).
Monitor patients for systemic ARRs, especially following the first and second injections. For anaphylactic reaction or life-threatening (Grade 4) ARRs, immediately and permanently discontinue DARZALEX FASPRO®.1
Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with daratumumab-containing products. If ocular symptoms occur, interrupt DARZALEX FASPRO® and seek immediate ophthalmologic evaluation prior to restarting DARZALEX FASPRO®.1
DARZALEX FASPRO® benefits1,2
Fixed dose; no weight-based calculations
Ready-to-use, single-dose vial
Same dosing schedules as DARZALEX® for approved indications†
†Split first dose option for DARZALEX® is not applicable to DARZALEX FASPRO®.
Formulated with hyaluronidase for subcutaneous administration
DARZALEX® is given as an intravenous (IV) infusion after dilution at 16 mg/kg of actual body weight2
Median duration of 16 mg/kg infusion decreased after the first infusion2
- To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over 2 consecutive days. See full Prescribing Information to learn more about split first dose2
- DARZALEX® should be administered by a healthcare professional with immediate access to emergency equipment and appropriate medical support to manage infusion reactions if they occur2
- If a planned dose of DARZALEX® is missed, administer the dose as soon as possible and adjust the dosing schedule accordingly, maintaining the treatment interval2
Dosing and administration guide for DARZALEX®
A slower rate of infusion for the first DARZALEX® dose is recommended, as infusion reactions are more likely to occur during the first infusion2
§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 onward) only if there were no infusion reactions during the previous infusion. Otherwise, use instructions indicated in the table for the Week 2 infusion rate.
Infusion-related recommendations to keep in mind
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. Thirty seven percent of patients experienced an infusion reaction during the first infusion. For 2% of patients, infusion reactions occurred with the second infusion; and cumulatively, for 6% with subsequent infusions.2
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: 0-73 hours).2
Signs and symptoms that may be indicative of an infusion reaction include2:
- Shortness of breath or trouble breathing
- Dizziness or lightheadedness (hypotension)
- Heart beating faster than usual
- Low oxygen in the blood (hypoxia)
- Throat tightness or irritation
- Runny or stuffy nose
- High blood pressure
- Chest discomfort
- Blurred vision
Severe infusion reactions included bronchospasm, hypoxia, dyspnea, hypertension, tachycardia, headache, laryngeal edema, pulmonary edema, and ocular adverse reactions, including choroidal effusion, acute myopia, and acute angle closure glaucoma. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common signs and symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, hypotension, and blurred vision.2
Ocular adverse reactions, including acute myopia and narrowing of the anterior chamber angle due to ciliochoroidal effusions with potential for increased intraocular pressure or glaucoma, have occurred with DARZALEX® infusion. If ocular symptoms occur, interrupt DARZALEX® infusion and seek immediate ophthalmologic evaluation prior to restarting DARZALEX®.2
Pre- and post-administration/infusion medications and dose modifications1,2
To reduce the risk of ARRs/IRRs, administration of pre- and post-administration/infusion medications is recommended. No dose reductions of DARZALEX FASPRO® or 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 ARRs/IRRs, administer approximately 1 to 3 hours prior to every administration/infusion as follows:
- Dexamethasone 20 mg prior to every DARZALEX FASPRO® or DARZALEX® infusion orally or intravenously. When dexamethasone is the background regimen-specific corticosteroid, the dexamethasone treatment dose will also serve as pre-medication on days DARZALEX FASPRO® or DARZALEX® is given
- During monotherapy, methylprednisolone 100 mg, or equivalent, administered orally or intravenously. Following the second administration/infusion of DARZALEX FASPRO® or DARZALEX®, respectively, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg)
- Oral antipyretics (acetaminophen 650 to 1000 mg)
- Oral or IV antihistamine (diphenhydramine 25 to 50 mg or equivalent)
To reduce the risk of ARRs/IRRs, administer the day after every administration/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 FASPRO® or DARZALEX® administration/infusion, additional post-administration/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 FASPRO® or DARZALEX® administrations/infusions (beginning the day after the administration/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 administrations/infusions, if the patient experiences no major administration/infusion reactions, these additional inhaled post-administration/infusion medications may be discontinued.
ARR=administration-related reaction; IRR=infustion-related reaction.
Other administration/infusion-related considerations
Interference with serological testing2
- 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
- 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®
Brochure on daratumumab and serological testing
ID card to give to patients taking daratumumab
Prophylaxis for herpes zoster reactivation2
Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting DARZALEX® and continue for 3 months following treatment.
Hepatitis B reactivation2
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.
Interference with determination of complete response (CR)2
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.
*In clinical trials of DARZALEX FASPRO® and DARZALEX®, and in the Prescribing Information for DARZALEX®, the terms “infusion reactions” and “infusion-related reactions” were used instead of “systemic administration-related reactions.”
‡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 6 of the DARZALEX® Prescribing Information.2
DARZALEX® and DARZALEX FASPRO® studied in wide range of clinical trials for multiple myeloma