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DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

Medical Information

DARZALEX + DARZALEX FASPRO - Adverse Event - Extravasation

Last Updated: 04/17/2024

SUMMARY  

  • Currently, there are no published reports of extravasation with DARZALEX or DARZALEX FASPRO.
  • The Safety Data Sheets for DARZALEX/DARZALEX FASPRO state that the product is non-hazardous based on chemical classification rules. Large protein biotherapeutics in the dry or reconstituted (solution in buffer) forms are not expected to elicit skin corrosion/irritation or skin sensitization.1,2
  • Daratumumab is neither a vesicant nor an irritant.3
  • Consult with your institutional guidelines for management of extravasation.

PRODUCT LABELING

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) conducted on
02 April 2024 did not identify any relevant citations pertaining to this topic.

 

References

1 Data on File. DARZALEX FASPRO (daratumumab and hyaluronidase) injection for subcutaneous use - Safety Data Sheet (SDS). Janssen Research & Development, LLC.; 2023.  
2 Data on File. DARZALEX (daratumumab) Injection - Safety Data Sheet (SDS). Janssen Research & Development, LLC. 2023.  
3 Data on File. Janssen Scientific Affairs, LLC. Correspondence from Janssen Research and Development, LLC. (Communication dated 05 April 2024).