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Administer medications before and after administration of DARZALEX SC to minimize administration-related reactions [see Recommended Concomitant Medications as follows].
Type and screen patients prior to starting DARZALEX SC.
Recommended Dosage for Multiple Myeloma: The recommended dose of DARZALEX SC is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over approximately 3-5 minutes. Tables 8, 9, 10 and 11 provide the recommended dosing schedule when DARZALEX SC is administered as monotherapy or as part of a combination therapy.
Monotherapy and In Combination with Lenalidomide and Dexamethasone (DARZALEX SC-Rd) or Pomalidomide and Dexamethasone (DARZALEX SC-Pd) or Carfilzomib and Dexamethasone (Darzalex SC-Kd): Use the dosing schedule provided in Table 8 when DARZALEX SC is administered: in combination with lenalidomide and dexamethasone (4-week cycle) OR; in combination with pomalidomide and dexamethasone (4-week cycle) OR; in combination with carfilzomib and dexamethasone (4-week cycle) OR; as monotherapy. (See Table 8.)
Click on icon to see table/diagram/imageWhen DARZALEX SC is administered as part of a combination therapy, see Pharmacology: Pharmacodynamics: Clinical Studies: Relapsed/Refractory Multiple Myeloma under Actions and the prescribing information for dosage recommendations for the other drugs.
In Combination with Bortezomib, Melphalan and Prednisone (DARZALEX SC-VMP): Use the dosing schedule provided in Table 9 when DARZALEX SC is administered in combination with bortezomib, melphalan and prednisone (6-week cycle). (See Table 9.)
Click on icon to see table/diagram/imageWhen DARZALEX SC is administered as part of a combination therapy, see Pharmacology: Pharmacodynamics: Clinical Studies: Newly Diagnosed Multiple Myeloma under Actions and the prescribing information for dosage recommendations for the other drugs.
In Combination with Bortezomib, Thalidomide, and Dexamethasone (DARZALEX SC-VTd): Use the dosing schedule in Table 10 when DARZALEX SC is administered in combination with bortezomib, thalidomide, and dexamethasone (4‑week cycle). (See Table 10.)
Click on icon to see table/diagram/imageWhen DARZALEX SC is administered as part of a combination therapy, see the prescribing information for dosage recommendations for the other drugs.
In Combination with Bortezomib and Dexamethasone (DARZALEX SC-Vd): Use the dosing schedule in Table 11 when DARZALEX SC is administered in combination with bortezomib and dexamethasone (3-week cycle). (See Table 11.)
Click on icon to see table/diagram/imageWhen DARZALEX SC is administered as part of a combination therapy, see the prescribing information for dosage recommendations for the other drugs.
Recommended Dosage for Light Chain Amyloidosis: In Combination with Bortezomib, Cyclophosphamide and Dexamethasone (DARZALEX SC-VCd): Use the dosing schedule provided in Table 12 when DARZALEX SC is administered in combination with bortezomib, cyclophosphamide and dexamethasone (4-week cycle). (See Table 12.)
Click on icon to see table/diagram/imageWhen DARZALEX SC is administered as part of a combination therapy, see Pharmacology: Pharmacodynamics: Clinical Studies: Relapsed/Refractory Multiple Myeloma under Actions and the prescribing information for dosage recommendations for the other drugs.
Administration: If a dose of DARZALEX SC is missed, administer the dose as soon as possible and adjust the dosing schedule to maintain the dosing interval.
Recommended Concomitant Medications: Pre-medication: Administer the following pre-medications 1-3 hours before each dose of DARZALEX SC: Acetaminophen 650 to 1,000 mg orally; Diphenhydramine 25 to 50 mg (or equivalent) orally or intravenously; Corticosteroid (long- or intermediate-acting).
Monotherapy: Administer methylprednisolone 100 mg (or equivalent) orally or intravenously. Consider reducing the dose of methylprednisolone to 60 mg (or equivalent) following the second dose of DARZALEX SC.
In Combination: Administer dexamethasone 20 mg (or equivalent) orally or intravenously prior to every DARZALEX SC administration.
When dexamethasone is the background regimen-specific corticosteroid, the dexamethasone dose that is part of the background regimen will serve as pre-medication on DARZALEX SC administration days [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Do not administer background regimen-specific corticosteroids (e.g. prednisone) on DARZALEX SC administration days when patients have received dexamethasone (or equivalent) as a pre-medication.
Post-medication: Administer the following post-medications: Monotherapy: Administer methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of DARZALEX SC.
In Combination: Consider administering oral methylprednisolone at a dose of less than or equal to 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) beginning the day after administration of DARZALEX SC.
If a background regimen-specific corticosteroid (e.g. dexamethasone, prednisone) is administered the day after the administration of DARZALEX SC, additional corticosteroids may not be needed [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
If the patient does not experience a major systemic administration-related reaction after the first 3 doses of DARZALEX SC, consider discontinuing the administration of corticosteroids (excluding any background regimen-specific corticosteroid).
For patients with a history of chronic obstructive pulmonary disease, consider prescribing short and long-acting bronchodilators and inhaled corticosteroids. Following the first 4 doses of DARZALEX SC, consider discontinuing these additional post-medications, if the patient does not experience a major systemic administration-related reaction.
Prophylaxis for Herpes Zoster Reactivation: Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting DARZALEX SC and continue for 3 months following the end of treatment [see Clinical Trials Experience under Adverse Reactions].
Dosage Modifications for Adverse Reactions: No dose reductions of DARZALEX SC are recommended. Consider withholding DARZALEX SC to allow recovery of blood cell counts in the event of myelosuppression [see Neutropenia and Thrombocytopenia under Precautions].
Preparation and Administration: DARZALEX SC should be administered by a healthcare provider.
To prevent medication errors, check the vial labels to ensure that the drug being prepared and administered is DARZALEX SC for subcutaneous use. Do not administer DARZALEX SC intravenously.
DARZALEX SC is ready to use.
Preparation: Remove the DARZALEX SC vial from refrigerated storage [2°C to 8°C (36°F to 46°F)] and equilibrate to ambient temperature [15°C to 30°C (59°F to 86°F)]. Store the unpunctured vial at ambient temperature and ambient light for a maximum of 24 hours. Keep out of direct sunlight. Do not shake.
Withdraw 15 mL from the vial into a syringe.
DARZALEX SC is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles. Use the product immediately.
After the solution of DARZALEX SC is withdrawn into the syringe, replace the transfer needle with a syringe closing cap. Label the syringe appropriately to include the route of administration per institutional standards. Label the syringe with the peel-off label.
To avoid needle clogging, attach the hypodermic injection needle or subcutaneous infusion set to the syringe immediately prior to injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if opaque particles, discoloration or other foreign particles are present.
Storage: If the syringe containing DARZALEX SC is not used immediately, store refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 hours and/or at room temperature at 15°C to 30°C (59°F to 86°F) for up to 7 hours under ambient light.
Discard if storage time exceeds these limits.
If stored in the refrigerator, allow the solution to come to room temperature before administration.
Administration: Inject 15 mL DARZALEX SC into the subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3‑5 minutes. No data are available on performing the injection at other sites of the body.
Rotate injection sites for successive injections.
Never inject DARZALEX SC into areas where the skin is red, bruised, tender, hard or areas where there are scars.
Pause or slow down delivery rate if the patient experiences pain. In the event pain is not alleviated by pausing or slowing down delivery rate, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose.
During treatment with DARZALEX SC, do not administer other medications for subcutaneous use at the same site as DARZALEX SC.
Use in Specific Populations: Pediatric Use: Safety and effectiveness of DARZALEX SC in pediatric patients have not been established.
Geriatric Use: Of the 291 patients who received DARZALEX SC as monotherapy for relapsed and refractory multiple myeloma, 37% were 65 to <75 years of age, and 19% were 75 years of age or older. No overall differences in effectiveness of DARZALEX SC have been observed between patients ≥65 years of age and younger patients. Adverse reactions that occurred at a higher frequency (≥5% difference) in patients ≥65 years of age included upper respiratory tract infection, urinary tract infection, dizziness, cough, dyspnea, diarrhea, nausea, fatigue, and peripheral edema. Serious adverse reactions that occurred at a higher frequency (≥2% difference) in patients ≥65 years of age included pneumonia.
Of the 214 patients who received DARZALEX SC as combination therapy with pomalidomide and dexamethasone or DARZALEX SC as combination therapy with lenalidomide and low-dose dexamethasone for relapsed and refractory multiple myeloma, 43% were 65 to <75 years of age, and 18% were 75 years of age or older. No overall differences in effectiveness were observed between patients ≥65 years (n=131) and <65 years (n=85). Adverse reactions occurring at a higher frequency (≥5% difference) in patients ≥65 years of age included fatigue, pyrexia, peripheral edema, urinary tract infection, diarrhea, constipation, vomiting, dyspnea, cough, and hyperglycemia. Serious adverse reactions occurring at a higher frequency (≥2% difference) in patients ≥65 years of age included neutropenia, thrombocytopenia, diarrhea, anemia, COVID-19, ischemic colitis, deep vein thrombosis, general physical health deterioration, pulmonary embolism, and urinary tract infection.
Of the 193 patients who received DARZALEX SC as part of a combination therapy for light chain (AL) amyloidosis, 35% were 65 to <75 years of age, and 10% were 75 years of age or older. Clinical studies of DARZALEX SC as part of a combination therapy for patients with light chain (AL) amyloidosis did not include sufficient numbers of patients aged 65 and older to determine whether effectiveness differs from that of younger patients. Adverse reactions that occurred at a higher frequency in patients ≥65 years of age were peripheral edema, asthenia, pneumonia and hypotension.
No clinically meaningful differences in the pharmacokinetics of daratumumab were observed in geriatric patients compared to younger adult patients [see Pharmacology: Pharmacokinetics under Actions].
