SUMMARY  

• 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.
• The recommended dose of DARZALEX FASPRO is 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously, over approximately 3-5 minutes.¹
• 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
• 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

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 17 July 2024.