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DARZALEX FASPRO®

(daratumumab and hyaluronidase-fihj)

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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, Specific Gravity, and Overfill Volume

Last Updated: 03/20/2026

SUMMARY  

  • Johnson & Johnson 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, Specific Gravity, and Overfill Volume of Co-Formulated DARZALEX FASPRO Product Solution.2-4

Density, Specific Gravity, and Overfill Volume of Co-Formulated DARZALEX FASPRO Product Solution2-4
DARZALEX FASPRO Solution
Density
Specific Gravity
Approximate Overfill Volume
120 mg/mL co-formulated
1.048 g/mL
1.0432 relative to normal saline
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 20 March 2026.

 

References

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1 Data on File. Daratumumab Subcutaneous Formulation Company Core Data Sheet (CCDS). Janssen Research & Development, LLC. EDMS-ERI-184804517; 2026.  
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); 2021.  
4 Data on File. Janssen Scientific Affairs, LLC. Correspondence from Janssen Research and Development, LLC. (Communication dated 20 March 2026); 2026.