PRODUCT LABELING

• Please refer to the following section of the DARZALEX FASPRO Full Prescribing Information which is relevant to your inquiry: DOSAGE AND ADMINISTRATION.

DOSAGE AND ADMINISTRATION

• DARZALEX FASPRO is administered as a SC injection.¹
• The recommended dose of DARZALEX FASPRO is 1,800 mg daratumumab and 30,000 units hyaluronidase administered SC into the abdomen over approximately 3 to 5 minutes according to the recommended schedule.¹

Recommended Dosage for Multiple Myeloma

• DARZALEX FASPRO dosing schedule for in combination with lenalidomide or pomalidomide or carfilzomib and dexamethasone ([Rd or Pd or Kd]; 4-week cycle) and for monotherapy¹:
  • Weeks 1 to 8: weekly (total of 8 doses)
  • Weeks 9 to 24: every two weeks (total of 8 doses; first dose of the every-2-week dosing schedule is given at Week 9)
  • Week 25 onwards until disease progression: every four weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• DARZALEX FASPRO dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle)¹:
  • Weeks 1 to 6: weekly (total of 6 doses)
  • Weeks 7 to 54: every three weeks (total of 16 doses; first dose of the every-3-week dosing schedule is given at Week 7)
  • Weeks 55 onwards until disease progression: every four weeks (first dose of the every-4-week dosing schedule is given at Week 55)
• DARZALEX FASPRO dosing schedule for combination therapy with bortezomib, thalidomide and dexamethasone ([VTd]; 4-week cycle)¹:
  • Induction Phase:
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 16: every two weeks (total of 4 doses; first dose of the every-2-week dosing schedule is given at Week 9)
  • Stop for high dose chemotherapy and autologous stem cell transplant (ASCT)
  • Consolidation Phase:
    • Weeks 1 to 8: every two weeks (total of 4 doses; first dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT)
• DARZALEX FASPRO dosing schedule for combination therapy with bortezomib, lenalidomide, and dexamethasone ([VRd]; 4-week cycle)¹:
  • Induction Phase:
    • Weeks 1 to 8: weekly (total of 8 doses)
    • Weeks 9 to 16: every two weeks (total of 4 doses; first dose of the every-2-week dosing schedule is given at Week 9)
  • Stop for high dose chemotherapy and ASCT
  • Consolidation Phase:
    • Weeks 1 to 8: every two weeks (total of 4 doses; first dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT)
• DARZALEX FASPRO dosing schedule for combination therapy with bortezomib and dexamethasone ([Vd]; 3-week cycle)¹:
  • Weeks 1 to 9: weekly (total of 9 doses)
  • Weeks 10 to 24: every three weeks (total of 5 doses; first dose of the every-3 week-dosing schedule is given at Week 10)
  • Week 25 onwards until disease progression: every four weeks (first dose of the every-4 week-dosing schedule is given at Week 25)
• When DARZALEX FASPRO is administered as part of a combination therapy, see the prescribing information for dosage recommendations for the other drugs.¹

Recommended Dosage for Light Chain Amyloidosis

• DARZALEX FASPRO dosing schedule for combination therapy with bortezomib, cyclophosphamide and dexamethasone ([VCd]; 4-week cycle):
  • Weeks 1 to 8: weekly (total of 8 doses)
  • Weeks 9 to 24: every two weeks (total of 8 doses; first dose of the every-2-week dosing schedule is given at Week 9)
  • Week 25 onwards until disease progression or a maximum of 2 years: every four weeks (first dose of the every-4-week dosing schedule is given at Week 25)¹

Missed DARZALEX FASPRO Doses

• If a dose of DARZALEX FASPRO is missed, administer the dose as soon as possible and adjust the dosing schedule to maintain the dosing interval.¹

Recommended Concomitant Medications

Pre-Medication

• Administer the following pre-medications 1-3 hours before each dose of DARZALEX FASPRO¹:
  • Acetaminophen 650 mg to 1,000 mg orally (PO)
  • Diphenhydramine 25 mg to 50 mg (or equivalent) PO or IV
  • Corticosteroid (long- or intermediate-acting)
    • Monotherapy: Administer methylprednisolone 100 mg (equivalent) PO or IV. Consider reducing the dose to 60 mg (or equivalent) following the second dose of DARZALEX FASPRO.
    • In Combination: Administer dexamethasone 20 mg (or equivalent) PO or IV prior to every DARZALEX FASPRO 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 FASPRO administration days. Do not administer background regimen-specific corticosteroids (e.g. prednisone) on DARZALEX FASPRO administration days when patients have received dexamethasone (or equivalent) as a pre-medication.

Post-Medication

• Administer the following post-medications¹:
  • Monotherapy: Administer methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) PO for 2 days starting the day after the administration of DARZALEX FASPRO.
  • In Combination: Consider administering methylprednisolone PO at a dose of less than or equal to 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) on the day after administration of DARZALEX FASPRO. If a background regimen-specific corticosteroid (e.g., dexamethasone, prednisone) is administered the day after the administration of DARZALEX FASPRO, additional corticosteroids may not be needed.
• If the patient does not experience a major systemic administration-related reaction after the first 3 doses of DARZALEX FASPRO, 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 FASPRO, consider discontinuing these additional post-medications, if the patient does not experience a major systemic administration-related reaction.

Prophylaxis for Varicella Zoster Virus Reactivation

• Initiate antiviral prophylaxis to prevent varicella zoster virus reactivation within 1 week after starting DARZALEX FASPRO and continue for 3 months following the end of treatment.¹

Dosage Modifications for Adverse Reactions

• No dose reductions of DARZALEX FASPRO are recommended. Consider withholding DARZALEX FASPRO to allow recovery of blood cell counts in the event of myelosuppression.¹

Preparation and Administration

• DARZALEX FASPRO 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 FASPRO for SC use. Do not administer DARZALEX FASPRO IV.¹
• DARZALEX FASPRO is a sterile, preservative-free, colorless to yellow, and clear to opalescent solution for SC use supplied as individually packaged single-dose vials providing 1,800 mg of daratumumab and 30,000 units of hyaluronidase per 15 mL.¹
• DARZALEX FASPRO is ready to use.¹

Preparation

• Prepare DARZALEX FASPRO as follows¹:
  • Remove the DARZALEX FASPRO 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 FASPRO 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 FASPRO is withdrawn into the syringe, replace the transfer needle with a syringe closing cap. Label the syringe DARZALEX FASPRO 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.

Administration

• Administer DARZALEX FASPRO as follows¹:
  • Inject 15 mL DARZALEX FASPRO 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 FASPRO 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 FASPRO, do not administer other medications for subcutaneous use at the same site as DARZALEX FASPRO.

First Dose

• For new patients, DARZALEX FASPRO may be administered starting from the first dose.¹
• There is no requirement to provide an DARZALEX IV dose prior to transitioning patients to the DARZALEX FASPRO SC formulation.¹
• For patients on DARZALEX IV, they may transition to DARZALEX FASPRO at their next dose in accordance with their current treatment regimen and dosing schedule.¹

ALTERNATIVE INJECTION SITE/DOSING INTERVALS/ADMINISTRATION ROUTES

• There are no systematically collected data to support DARZALEX FASPRO injections at alternative injection sites, intervals, or routes to those described in the DARZALEX FASPRO Prescribing Information.  
• Clinical judgment should be exercised when considering any alternative injection sites or dosing intervals outside of those listed in the DARZALEX FASPRO Prescribing Information.
• Janssen cannot recommend any practices, procedures, or dosing modifications that deviate from product labeling and are not approved by the Food and Drug Administration.

Injection Set Materials

DARZALEX FASPRO is compatible with polypropylene or polyethylene syringe material; polypropylene, polyethylene, or polyvinyl chloride (PVC) subcutaneous infusion sets; and stainless steel transfer and injection needles.1 Janssen Biotech, Inc. does not have a recommendation for a specific manufacturer of injection set materials to be used. Injection set materials tested for compatibility include those listed as acceptable in the product labeling.

• In DARZALEX FASPRO clinical studies, the following injection set materials were utilized as shown in: Injection Set Materials Used in DARZALEX FASPRO Clinical Studies.²
• In DARZALEX FASPRO clinical studies, the winged infusion set was administered either unprimed or primed with DARZALEX FASPRO. The winged infusion set was not flushed once the 15 mL of DARZALEX FASPRO was administered. The fill volume per DARZALEX FASPRO vial was 16.6 mL.³
• There are no systematically collected data to support the use of 0.9% sodium chloride with DARZALEX FASPRO.³

• In the DARZALEX FASPRO clinical studies, 23-25 G 3/8"-1" delivery needles and 23-25 G winged infusion set (PVC material construction, ≤0.5 mL hold up volume, 12" tubing) was used. Clinical judgement should be exercised to choose the most appropriately sized needle as needed depending on patient presentation.⁴

Use of a Filter

• Use of a filter is not required for appropriate administration of DARZALEX FASPRO commercial product. However, a filter was utilized in the DARZALEX FASPRO clinical studies for all dose preparations per the investigational product preparation instructions.² The types of filter supplies permitted and utilized in DARZALEX FASPRO clinical studies are summarized in Table: Filter Supplies Used in DARZALEX FASPRO Clinical Studies.

Partial or Incomplete Administration

• There are no systematically collected data to support the safety and efficacy of DARZALEX FASPRO when considering partial or incomplete dose administration.
• Clinical judgment should be exercised when considering any dosing intervals outside of those listed in the DARZALEX FASPRO Prescribing Information.
• Janssen cannot recommend any practices, procedures, or dosing modifications that deviate from product labeling and are not approved by the regulatory agencies.

Test Dose

There are no systematically collected data to support the administration of a test dose for DARZALEX FASPRO.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 31 July 2024.