This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)

Medical Information

DARZALEX FASPRO - Density and Fill Volume

Last Updated: 05/23/2024

SUMMARY  

  • Janssen cannot recommend any practices, procedures, or storage conditions that deviate from product labeling and are not approved by the regulatory agencies.
  • DARZALEX FASPRO solution for subcutaneous (SC) injection is for single use only.1
  • Each single-use vial contains 15 mL nominal fill volume plus overfill to allow for delivery of 1800 mg daratumumab (120 mg/mL).1,2
  • The content in the co-formulated DARZALEX FASPRO product solution is presented in the table: Density and Fill Volume of Co-Formulated DARZALEX FASPRO Product Solution.2,3

Density and Fill Volume of Co-Formulated DARZALEX FASPRO Product Solution2,3
DARZALEX FASPRO Solution
Density
Approximate overfill volume
120 mg/ml co-formulated
1.048 g/mL
1 mL

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 21 May 2024.

 

References

1 Data on File. Daratumumab SC Company Core Data Sheet (CCDS). Janssen Research & Development, LLC. EDMS-ERI-184804517; 2024.  
2 Data on File. Technical Document Daratumumab 2nd Generation Product Physical Property Summary Memo. Janssen Research & Development, LLC. TV-TEC-146505; 2017.  
3 Data on File. Janssen Scientific Affairs, LLC. Correspondence from Janssen Research and Development, LLC. (Communication dated 25 June 2021).