SUMMARY  

DARZALEX

Pre-infusion Medication

Administer the following pre-infusion medications 1 hour to 3 hours prior to every DARZALEX infusion:¹

• Corticosteroid (long-acting or intermediate-acting)
  • Monotherapy: Administer methylprednisolone 100 mg (or equivalent) intravenously. Following the second infusion, consider reducing the dose to 60 mg (or equivalent) administered either orally or intravenously.
  • In Combination: Administer dexamethasone 20 mg (or equivalent) orally or intravenously.
    • 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 (eg, 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 intravenously.

Post-infusion Medication

Administer the following post-infusion medications:¹

• 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 administration of a DARZALEX infusion.
  • If a background regimen-specific corticosteroid (eg, 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 (COPD), 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

DARZALEX FASPRO

Pre-medication

Administer the following pre-medications 1-3 hours before each dose of DARZALEX FASPRO:²

• Corticosteroid (long-acting 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 FASPRO.
  • In Combination: Administer dexamethasone 20 mg (or equivalent) orally or intravenously 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 (eg, prednisone) on DARZALEX FASPRO administration 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 intravenously.

Post-medication

• Administer the following post-medications:²
  • 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 FASPRO.
  • 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 FASPRO.
    • If a background regimen-specific corticosteroid (eg, 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).²
• For patients with a history of COPD, 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.²
• Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting DARZALEX FASPRO and continue for 3 months following the end of treatment.²

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 12 July 2024.