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RYBREVANT®

(amivantamab-vmjw)

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RYBREVANT® (amivantamab-vmjw)

Medical Information

RYBREVANT FASPRO, RYBREVANT - Dosage and Administration - Intravenous to Subcutaneous Switch

Last Updated: 12/18/2025

SUMMARY

  • RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).1
  • Adult patients currently receiving RYBREVANT (amivantamab-vmjw) intravenous (IV) at an every 2 week (Q2W) dosing regimen may switch to RYBREVANT FASPRO SC at Q2W dosing regimen at their next scheduled dose on or after Week 5.2 
  • Adult patients currently receiving RYBREVANT IV at an every 3 week (Q3W) dosing regimen may switch to RYBREVANT FASPRO SC at Q3W dosing regimen at their next scheduled dose on or after Week 4.2
  • The feasibility of switching from RYBREVANT IV to RYBREVANT FASPRO SC was evaluated in the PALOMA-2 study.3,4
  • PALOMA-2 (NCT05498428) is an ongoing, phase 2, open-label, international, parallel-cohort study evaluating the efficacy and safety of RYBREVANT FASPRO with chemotherapy and/or LAZCLUZE (lazertinib) in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).3,4
    • Patients must not have had evidence of progressive disease during treatment with RYBREVANT or at the time of study enrollment.5
    • No washout was required between IV and SC administration.5
    • Initial safety and pharmacokinetics (PK) results were reported for patients switching from RYBREVANT IV to RYBREVANT FASPRO SC (cohort 4). Patients in cohort 4 previously received RYBREVANT IV for ≥8 weeks without dose reduction or evidence of progressive disease, as part of standard of care, an expanded access program, or rollover from a long-term extension study.6 
    • At a median follow-up of 9.7 months, the safety profile of RYBREVANT FASPRO SC after switching from RYBREVANT IV was consistent with previous reports of RYBREVANT FASPRO SC monotherapy, with no new safety signals; no administration-related reactions (ARRs) were reported.6
    • The most common adverse events (AEs) associated with EGFR and mesenchymal-epithelial transition (MET) inhibition were paronychia (44%) and hypoalbuminemia (40%), respectively.6
    • The simulated PK exposures of amivantamab IV were noninferior to amivantamab SC for the Q2W dose regimen, including dose reductions, meeting the predefined noninferiority criteria for efficacy and safety.6
  • The recommended dosage of RYBREVANT FASPRO was based on the estimated bioavailability of amivantamab SC from the PALOMA study, supported by compartmental PK modeling. The SC dosage regimens ensure similar exposures to the IV dosages, with no additional safety signals anticipated.5 Please refer to the Clinical Pharmacology section (Section 12.3 Pharmacokinetics) of the Prescribing Information for RYBREVANT FASPRO for complete information.2  

IV to SC Switch

  • Based on PK noninferiority from PK simulations comparing IV to SC systemic exposures from the phase 3 PALOMA-3 (NCT05388669) study, and IV to SC switch evaluated in PALOMA-2, patients treated with RYBREVANT IV may switch to SC administration with RYBREVANT FASPRO.1,6,7 
  • Adult patients currently receiving RYBREVANT IV at Q2W dosing regimen may switch to RYBREVANT FASPRO SC at Q2W dosing regimen at their next scheduled dose on or after Week 5.2
  • Adult patients currently receiving RYBREVANT IV at Q3W dosing regimen may switch to RYBREVANT FASPRO SC at Q3W dosing regimen at their next scheduled dose on or after Week 4.2
  • The tables below outline the recommended IV and SC starting dosages, as well as the corresponding dose reductions, which are provided in the current Prescribing Information for RYBREVANT IV and RYBREVANT FASPRO SC.2,8

Dosage for RYBREVANT IV or RYBREVANT FASPRO SC in Combination with LAZCLUZE or as a Single Agent for Body Weight <80 kg2,8
Recommended Dosage for Q2W Dosing for <80 kg
RYBREVANT IV
RYBREVANT FASPRO SC
Week 1 Day 1
350 mg
1600 mg
Week 1 Day 2
700 mg
No dose
Week 2
1050 mg
1600 mg
Week 3
1050 mg
1600 mg
Week 4
1050 mg
1600 mg
Week 5
1050 mg
1600 mg
Week 6
No dose
No dose
Week 7 and Q2W thereafter
1050 mg
1600 mg
Abbreviations: IV, intravenous; Q2W, every 2 weeks; SC, subcutaneous.

Dosage for RYBREVANT IV or RYBREVANT FASPRO SC in Combination with LAZCLUZE or as a Single Agent for Body Weight ≥80 kg2,8
Recommended Dosage for Q2W Dosing for ≥80 kg
RYBREVANT IV
RYBREVANT FASPRO SC
Week 1 Day 1
350 mg
2240 mg
Week 1 Day 2
1050 mg
No dose
Week 2
1400 mg
2240 mg
Week 3
1400 mg
2240 mg
Week 4
1400 mg
2240 mg
Week 5
1400 mg
2240 mg
Week 6
No dose
No dose
Week 7 and Q2W thereafter
1400 mg
2240 mg
Abbreviations: IV, intravenous; Q2W, every 2 weeks; SC, subcutaneous.

Dosage for RYBREVANT IV or RYBREVANT FASPRO SC in Combination with Carboplatin and Pemetrexed for Body Weight <80 kg2,8
Recommended Dosage for Q3W Dosing for <80 kg
RYBREVANT IV
RYBREVANT FASPRO SC
Week 1 Day 1
350 mg
1600 mg
Week 1 Day 2
1050 mg
No dose
Week 2
1400 mg
2400 mg
Week 3
1400 mg
2400 mg
Week 4
1400 mg
2400 mg
Week 5
No dose
No dose
Week 6
No dose
No dose
Week 7 and Q3W thereafter
1750 mg
2400 mg
Abbreviations: IV, intravenous; Q3W, every 3 weeks; SC, subcutaneous.

Dosage for RYBREVANT IV or RYBREVANT FASPRO SC in Combination with Carboplatin and Pemetrexed for Body Weight ≥80 kg2,8
Recommended Dosage for Q3W Dosing for ≥80 kg
RYBREVANT IV
RYBREVANT FASPRO SC
Week 1 Day 1
350 mg
2240 mg
Week 1 Day 2
1400 mg
No dose
Week 2
1750 mg
3360 mg
Week 3
1750 mg
3360 mg
Week 4
1750 mg
3360 mg
Week 5
No dose
No dose
Week 6
No dose
No dose
Week 7 and Q3W thereafter
2100 mg
3360 mg
Abbreviations: IV, intravenous; Q3W, every 3 weeks; SC, subcutaneous.
  • The following information regarding recommended dose reductions for adverse reactions are available in the current Prescribing Information for RYBREVANT and RYBREVANT FASPRO2,8

RYBREVANT IV Dose Reductions for ARs8 
Dosea
1st Dose Reduction
2nd Dose Reduction
3rd Dose Reduction
1050 mg
700 mg
350 mg
Discontinue RYBREVANT
1400 mg
1050 mg
700 mg
1750 mg
1400 mg
1050 mg
2100 mg
1750 mg
1400 mg
Abbreviations: AR, adverse reaction; IV, intravenous.
aDose at which the AR occurred.

RYBREVANT FASPRO SC Dose Reductions for ARs2
Dosea
1st Dose Reduction
2nd Dose Reduction
3rd Dose Reduction
1600 mg amivantamab and 20,000 units hyaluronidase
1050 mg amivantamab and 13,200 units hyaluronidaseb
700 mg amivantamab and 8800 units hyaluronidasec
Discontinue RYBREVANT FASPRO
2240 mg amivantamab and 28,000 units hyaluronidase
1600 mg amivantamab and 20,000 units hyaluronidased
1050 mg amivantamab and 13,200 units hyaluronidaseb
2400 mg amivantamab and 30,000 units hyaluronidase
1600 mg amivantamab and 20,000 units hyaluronidased
1050 mg amivantamab and 13,200 units hyaluronidaseb
3360 mg amivantamab and 42,000 units hyaluronidase
2240 mg amivantamab and 28,000 units hyaluronidasee
1600 mg amivantamab and 20,000 units hyaluronidased
Abbreviations: AR, adverse reaction; SC, subcutaneous.
aDose at which the AR occurred.
bThe dose volume should be 6.6 mL for 1050 mg amivantamab and 13,200 units hyaluronidase dose.
cThe dose volume should be 4.4 mL for 700 mg amivantamab and 8800 units hyaluronidase dose.
dThe dose volume should be 10 mL for 1600 mg amivantamab and 20,000 units hyaluronidase dose.
eThe dose volume should be 14 mL for 2240 mg amivantamab and 28,000 units hyaluronidase dose.
  • The company cannot support any practices, procedures, or dosage administration techniques that deviate from the approved product labeling.
  • Please refer to the DOSAGE AND ADMINISTRATION, DOSAGE FORMS AND STRENGTHS, CONTRAINDICATIONS (hypersensitivity to hyaluronidase), WARNINGS AND PRECAUTIONS, and CLINICAL STUDIES sections of the full Prescribing Information for RYBREVANT FASPRO for complete information.2

PRODUCT LABELING

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 09 December 2025.

 

References

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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 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
3 Lim SM, Tan JL, Dias JM, et al. Subcutaneous amivantamab and lazertinib as first-line treatment in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC): interim results from the phase 2 PALOMA-2 study. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.  
4 Janssen Research & Development, LLC. A phase 2, open-label, parallel cohort study of subcutaneous amivantamab in multiple regimens in patients with advanced or metastatic solid tumors including EGFR-mutated non-small cell lung cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 09]. Available from: https://clinicaltrials.gov/study/NCT05498428 NLM Identifier: NCT05498428.  
5 Data on File. Amivantamab and Lazertinib. PALOMA-2 Clinical Protocol. Janssen Research & Development, LLC. EDMS-RIM-1165532; 2023.  
6 Lim SM, Han JY, Zhang J, et al. Subcutaneous after intravenous amivantamab in advanced NSCLC: initial results from PALOMA 2. Poster presented at: European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.  
7 Data on File. Amivantamab Subcutaneous. Summary of Clinical Pharmacology Studies. Janssen Research & Development, LLC. EDMS-RIM-1316087; 2024.  
8 RYBREVANT (amivantamab-vmjw) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf