DARZALEX + DARZALEX FASPRO - Concomitant Use with Vaccines

SUMMARY

• Johnson & Johnson does not recommend the use of DARZALEX/DARZALEX FASPRO in a manner inconsistent with the approved labeling.
• Please refer to local labeling and guidelines for relevant information regarding vaccinations with DARZALEX/DARZALEX FASPRO.
• Per the PERSEUS study clinical protocol, vaccination was allowed per local guidelines (including annual influenza and inactivated SARS-CoV-2 vaccines, including mRNA-based vaccines), but vaccines should not be administered on the same day as study treatment administration. Some types of vaccines (e.g., live, attenuated or with suspected replication capabilities) were not permitted. Note that antibody responses to vaccines may be suboptimal during study treatment.¹ 
  • Administration of investigational, live attenuated, or replication-competent viral vector vaccines <4 weeks prior to the start of study treatment, during study treatment, or initiated <90 days after last dose of study treatment were prohibited.

PRODUCT LABELING

• DARZALEX (daratumumab) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf.
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf.

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 07 May 2026.