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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

Medical Information

RYBREVANT FASPRO - Vial Overfill

Last Updated: 02/13/2026

SUMMARY

  • RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).1
  • Each RYBREVANT FASPRO 10 mL single-dose (preservative-free) vial contains 1600 mg of amivantamab and 20,000 units of hyaluronidase (160 mg/mL and 2000 units/mL) solution with an overfill volume of 1.2 mL (for the current commercial manufacturing site).2,3
  • Each RYBREVANT FASPRO 14 mL single-dose (preservative-free) vial contains 2240 mg of amivantamab and 28,000 units of hyaluronidase (160 mg/mL and 2000 units/mL) solution with an overfill volume of 1.3 mL (for the current commercial manufacturing site).2,3
  • Each RYBREVANT FASPRO 15 mL single-dose (preservative-free) vial contains 2400 mg of amivantamab and 30,000 units of hyaluronidase (160 mg/mL and 2000 units/mL) solution with an overfill volume of 1.3 mL (for the current commercial manufacturing site).3,4
  • Each RYBREVANT FASPRO 22 mL single-dose (preservative-free) vial contains 3520 mg of amivantamab and 44,000 units of hyaluronidase (160 mg/mL and 2000 units/mL) solution with an overfill volume of 1.4 mL (for the current commercial manufacturing site).3,5
  • Discard unused portion.3
  • Please refer to the DOSAGE AND ADMINISTRATION and HOW SUPPLIED/STORAGE AND HANDLING sections of the full Prescribing Information for RYBREVANT FASPRO for complete information.3

LITERATURE SEARCH

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 04 February 2026.

 

References

1 Leighl NB, Akamatsu H, Lim SM, et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: primary results from the phase III PALOMA-3 study. J Clin Oncol. 2024;42(30):3593-3605.  
2 Data on File. Overfill verification report for amivantamab (JNJ-61186372, CNTO 4424) 1600 mg and 2240 mg FVP. Janssen Research & Development, LLC. TV-TEC-249411 v1.0; 2022.  
3 RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf
4 Data on File. Overfill verification report for amivantamab SC (JNJ-61186372) 2400 and 3360 mg/vial FVP. Janssen Research & Development, LLC. TV-TEC-265705 v1.0; 2023.  
5 Data on File. Overfill verification report for amivantamab SC (JNJ-61186372) 3520 mg/vial FVP. Janssen Research & Development, LLC. TV-TEC-289694 v1.0; 2024.