Summary

Important Dosing Information

• DARZALEX is administered as an intravenous (IV) infusion following dilution in 0.9% Sodium Chloride Injection.¹
• DARZALEX should be administered by a healthcare provider, with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur.¹
• Type and screen patients prior to starting treatment. Inform blood banks that a patient has received DARZALEX.¹

Recommended Dosage

• The recommended dose of DARZALEX is 16 mg/kg actual body weight administered as an IV infusion.¹
• The recommended dose of 16 mg/kg to be administered on Day 1 when DARZALEX is administered as monotherapy or in combination may be split over 2 consecutive days, such that an 8 mg/kg dose is administered on Day 1 and Day 2, respectively.¹
• DARZALEX dosing schedule for monotherapy and in combination therapy with lenalidomide or pomalidomide and low-dose dexamethasone ([Rd or Pd]; 4-week cycle)¹:
  • Weeks 1 to 8: weekly (total of 8 doses)
  • Weeks 9 to 24: every 2 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 4 weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• DARZALEX 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 3 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 4 weeks (first dose of the every-4-week dosing schedule is given at Week 55)
• DARZALEX dosing schedule in combination 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 2 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 2 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 dosing schedule in combination with bortezomib and dexamethasone ([Vd]; 3-week cycle)¹:
  • Weeks 1 to 9: weekly (total of 9 doses)
  • Weeks 10 to 24: every 3 weeks (total of 5 doses; first dose of the every3week dosing schedule is given at Week 10)
  • Week 25 onwards until disease progression: every 4 weeks (first dose of the every-4-week dosing schedule is given at Week 25)
• DARZALEX dosing schedule in combination with carfilzomib and dexamethasone ([Kd]; 4-week cycle)¹:
  • Week 1: 8 mg/kg on days 1 and 2 (total of 2 doses)
  • Weeks 2 to 8: 16 mg/kg weekly (total of 7 doses)
  • Weeks 9 to 24: 16 mg/kg every 2 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: 16 mg/kg every 4 weeks; first dose of the every-4-week dosing schedule is given at Week 25)
• If a dose of DARZALEX is missed, administer the dose as soon as possible and adjust the dosing schedule to maintain the dosing interval.¹
• A quantitative pharmacologic analysis of pivotal studies has been referenced for your convenience.²

Recommended Concomitant Medications

• Administer the following pre-infusion medications 1 hour to 3 hours before every DARZALEX infusion¹:
  • Corticosteroid (long- or intermediate-acting)
    • Monotherapy: Administer methylprednisolone 100 mg (or equivalent) IV. Following the second infusion, consider reducing the dose to 60 mg (or equivalent) administered either orally or IV.
    • In Combination: Administer dexamethasone 20 mg (or equivalent) orally or IV. 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 infusion days. Do not administer background regimen-specific corticosteroids (e.g. prednisone) on DARZALEX infusion days when patients have received dexamethasone (or equivalent) as a pre-medication.
  • Acetaminophen 650 to 1000 mg orally.  
  • Diphenhydramine 25 to 50 mg (or equivalent) orally or IV.
• Administer the following post-infusion medications¹:
  • 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.
  • 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 the DARZALEX infusion. If a background regimen-specific corticosteroid (e.g. dexamethasone, prednisone) is administered the day after the DARZALEX infusion, additional corticosteroids may not be needed.
• For patients with a history of chronic obstructive pulmonary disease, consider prescribing short and long-acting bronchodilators and inhaled corticosteroids. Following the first 4 DARZALEX infusions, consider discontinuing these additional post-infusion medications, if the patient does not experience a major infusion-related reaction.¹
• Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting DARZALEX and continue for 3 months following the end of treatment.¹

Dosage Modifications for Adverse Reactions

• For infusion-related reactions of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms. Management of infusion-related reactions may further require reduction in the rate of infusion, or treatment discontinuation of DARZALEX.¹
• No dose reductions of DARZALEX are recommended. Consider withholding DARZALEX to allow recovery of blood cell counts in the event of myelosuppression.¹
• For information concerning drugs given in combination with DARZALEX, see manufacturer’s prescribing information.¹

Preparation and Administration

• DARZALEX is a colorless to pale yellow, preservative-free solution for IV infusion available as 100 mg/5 mL (NDC 57894-502-05 and NDC 57894-505-05) or 400 mg/20 mL (NDC 57894-502-20 and NDC 57894-505-20) in a single-dose vials.¹

Preparation

• DARZALEX is for single dose only.¹ 
• Prepare the solution for infusion using aseptic technique as follows¹:
  • Calculate the dose (mg), total volume (mL) of DARZALEX solution required and the number of DARZALEX vials needed based on patient actual body weight.
  • DARZALEX vials of the same strength with different NDCs are available and can be admixed in the same infusion bag.
  • Check that the DARZALEX solution is colorless pale yellow. Do not use if opaque particles, discoloration or other foreign particles are present.
  • Remove a volume of 0.9% Sodium Chloride Injection from the infusion bag/container that is equal to the required volume of DARZALEX solution.
  • Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to the infusion bag/container containing 0.9% Sodium Chloride Injection. Infusion bags/containers must be made of either polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE). Dilute under appropriate aseptic conditions. Discard any unused portion left in the vial.
  • Gently invert the bag/container to mix the solution. Do not shake. DARZALEX is an immunoglobulin G1 kappa (IgG1κ) human monoclonal antibody (mAb).¹ Protein solutions of IgG1 mAbs are susceptible to degradation in the form of particle formation when agitated.³
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted solution may develop very small, translucent to white proteinaceous particles, as daratumumab is a protein. Do not use if visibly opaque particles, discoloration or foreign particles are observed.  

Administration

• If stored in the refrigerator, allow the solution to come to room temperature. Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 micrometer or 0.2 micrometer). Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP or PE.¹
• Do not store any unused portion of the infusion solution for reuse. Any unused product or waste material should be disposed of in accordance with local requirements.¹
• Do not infuse DARZALEX concomitantly in the same intravenous line with other agents.¹

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 23 September 2025.