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RYBREVANT FASPRO™

(amivantamab and hyaluronidase-lpuj)

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RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)

Medical Information

RYBREVANT FASPRO - Dosage and Administration - Every 4 Weeks Dosing

Last Updated: 12/17/2025

SUMMARY

  • RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) 
    administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).1
  • The safety and pharmacokinetics (PK) of RYBREVANT FASPRO every 4 weeks (Q4W) is being evaluated in the PALOMA and PALOMA-2 studies.2-5 
  • PALOMA (NCT04606381) is an ongoing, phase 1, open-label, multicenter, 2-part study evaluating the safety, PK, and efficacy of amivantamab SC as low- and high-concentration formulations with and without rHuPH20 in patients with advanced solid malignancies.2,3
    • Cohort 6a of the study is assessing the safety and PK of RYBREVANT FASPRO administered Q4W.6 
    • Dosing regimen for cohort 6a: RYBREVANT FASPRO was administered weekly (QW) for the first 4 weeks (1600 mg; 2240 mg if body weight ≥80 kg) in cycle 1, followed by Q4W (3200 mg; 4320 mg if body weight ≥80 kg).6
    • PK simulation was used to select RYBREVANT FASPRO SC doses for Q4W administration that match the steady-state trough concentration (Ctrough) of the approved RYBREVANT intravenous (IV) every 2 weeks (Q2W) dosing regimen, with the predicted steady-state maximum concentration (Cmax) of the SC Q4W dose not exceeding 125% of the Cmax of the approved IV Q2W dose. Based on PK evaluations, the Q4W dose for RYBREVANT FASPRO was identified as 3520 mg, or 4640 mg if body weight ≥80 kg.6
    • Administration time of RYBREVANT FASRPO Q4W was between 7 and 11 minutes.6
  • 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).4,5
    • Cohort 5 of the study is assessing the efficacy and safety of RYBREVANT FASPRO administered Q4W in combination with LAZCLUZE.7
    • Population PK modeling and simulation were used to select RYBREVANT FASPRO SC doses for Q4W administration that match the steady-state Ctrough of the approved RYBREVANT IV Q2W dosing regimen, with the predicted steady-state Cmax of the SC Q4W dose not exceeding 125% of the Cmax of the approved IV Q2W dose. Based on PK evaluations, the Q4W dose for RYBREVANT FASPRO was identified as 3520 mg, or 4640 mg if body weight ≥80 kg.8
    • Dosing regimen for cohort 5: RYBREVANT FASPRO was administered QW for the first 4 weeks (1600 mg; 2240 mg if body weight ≥80 kg) in cycle 1, followed by Q4W (3520 mg; 4640 mg if body weight ≥80 kg).7,8
  • Based on PK noninferiority data from the phase 3 PALOMA-3 (NCT05388669) study, IV to SC transition evaluated for Q2W in the PALOMA-2 study, and PK modeling for Q4W, patients treated with RYBREVANT IV may transition to SC administration with RYBREVANT FASPRO.1,9-11
  • The identified RYBREVANT FASPRO Q4W dosage being evaluated in PALOMA-2 study is provided below.

Dosage for RYBREVANT IV Q2W and RYBREVANT FASPRO SC Q4Wa for <80 kg6,8,12
RYBREVANT IV Q2W
RYBREVANT FASPRO SC Q4Wa
Dosage Schedule
Recommended Dosage for <80 kg
Dosage Schedule
Recommended Dosage for <80 kg
Week 1 Day 1
350 mg
Week 1 Day 1
1600 mg
Week 1 Day 2
700 mg
Week 1 Day 2
No dose
Week 2
1050 mg
Week 2
1600 mg
Week 3
1050 mg
Week 3
1600 mg
Week 4
1050 mg
Week 4
1600 mg
Week 5
1050 mg
Week 5
3520 mg
Week 6
No dose
Week 6
No dose
Week 7
1050 mg
Week 7
No dose
Week 8
No dose
Week 8
No dose
Week 9 and Q2W thereafter
1050 mg
Week 9 and Q4W thereafter
3520 mg
Abbreviations: FDA, Food and Drug Administration; IV, intravenous; Q2W, every 2 weeks; Q4W, every 4 weeks; SC, subcutaneous.
aThe administration of RYBREVANT FASPRO SC Q4W is not an FDA approved dosage and dosing frequency. The Q4W dosing schedule is currently under FDA review.

Dosage for RYBREVANT IV Q2W and RYBREVANT FASPRO SC Q4Wa for ≥80 kg6,8,12
RYBREVANT IV Q2W
RYBREVANT FASPRO SC Q4Wa
Dosage Schedule
Recommended Dosage for ≥80 kg
Dosage Schedule
Recommended Dosage for ≥80 kg
Week 1 Day 1
350 mg
Week 1 Day 1
2240 mg
Week 1 Day 2
1050 mg
Week 1 Day 2
No dose
Week 2
1400 mg
Week 2
2240 mg
Week 3
1400 mg
Week 3
2240 mg
Week 4
1400 mg
Week 4
2240 mg
Week 5
1400 mg
Week 5
4640 mg
Week 6
No dose
Week 6
No dose
Week 7
1400 mg
Week 7
No dose
Week 8
No dose
Week 8
No dose
Week 9 and Q2W thereafter
1400 mg
Week 9 and Q4W thereafter
4640 mg
Abbreviations: FDA, Food and Drug Administration; IV, intravenous; Q2W, every 2 weeks; Q4W, every 4 weeks; SC, subcutaneous.
aThe administration of RYBREVANT FASPRO SC Q4W is not an FDA approved dosage and dosing frequency. The Q4W dosing schedule is currently under FDA review.

RYBREVANT FASPRO Dose Reductions for Q4W Doses8
Dosea
1st Dose Reduction
2nd Dose Reduction
3rd Dose Reduction
3520 mg
2400 mg
1600 mg
Discontinue RYBREVANT FASPRO
4640 mg
3360 mg
2240 mg
Abbreviations: AR, adverse reaction; Q4W, every 4 weeks.
aDose at which the AR occurred.
  • 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.13

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 Krebs MG, Johnson M, Cho B, et al. Subcutaneous delivery of amivantamab in patients with advanced solid malignancies: PALOMA, an open-label, multicenter, dose-escalation phase 1b study. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 4-8, 2021; Virtual.  
3 Janssen Research & Development, LLC. An open-label, multicenter, dose escalation phase 1b study to assess the safety and pharmacokinetics of subcutaneous delivery of amivantamab, a human bispecific EGFR and cMet antibody for the treatment of advanced solid malignancies. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 December 09]. Available from: https://clinicaltrials.gov/study/NCT04606381 NLM Identifier: NCT04606381.  
4 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.  
5 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.  
6 Leighl NB, Minchom AR, Lee KH, et al. Subcutaneous amivantamab administered every 4 weeks (Q4W) in patients with advanced solid malignancies: the phase 1b PALOMA study. Oral Presentation presented at: European Lung Cancer Congress (ELCC); March 20-23, 2024; Prague, Czech Republic.  
7 Scott SC, Dias JM, Liu B, et al. PALOMA-2: subcutaneous amivantamab administered every 4 weeks plus lazertinib in first-line EGFR-mutated advanced NSCLC. Oral Presentation presented at: International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC); September 6-9, 2025; Barcelona, Spain.  
8 Data on File. Amivantamab and Lazertinib. PALOMA-2 Clinical Protocol. Janssen Research & Development, LLC. EDMS-RIM-1165532; 2023.  
9 Data on File. Amivantamab Subcutaneous Administration (Q4W Dose Regimen). Summary of Clinical Pharmacology Studies. Janssen Research & Development, LLC. EDMS-RIM-1472423; 2025.  
10 Data on File. Erratum: Population Pharmacokinetics and Exposure-Response Safety Analysis for Subcutaneously Administered Amivantamab. Erratum 1. Janssen Research & Development, LLC. EDMS-RIM-1747840; 2025.  
11 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.  
12 RYBREVANT (amivantamab-vmjw) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT-pi.pdf
13 RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc; https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/RYBREVANT+Faspro-pi.pdf