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.
SUMMARY
- RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) for subcutaneous (SC) administration is a coformulation of amivantamab with recombinant human hyaluronidase PH20 (rHuPH20).1
- The company does not have a recommendation for a specific manufacturer of injection set materials to be used. Injection set materials tested for compatibility include those listed as acceptable in the product labeling.
- The injection set materials utilized in RYBREVANT FASPRO clinical trials are shown in Table: Injection Set Materials Used in RYBREVANT FASPRO Clinical Trials.
- RYBREVANT FASPRO is compatible with polycarbonate (PC), polypropylene (PP), polyvinylchloride (PVC), polyurethane (PU), polyethylene (PE), and stainless steel. During development, RYBREVANT FASPRO was additionally found to be compatible with acrylonitrile butadiene styrene (ABS), acrylic, and silicone rubber.2
Injection Set Materials Used in RYBREVANT FASPRO Clinical Trials2
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Luer lock syringe with 0.1 mL, 0.2 mL, or 1 mL graduations depending on the dose
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Sterile needle for preparation (recommended gauge, 18-23 G)
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Sterile needle for administration (RYBREVANT FASPRO is viscous, thus: recommended gauge, 21-23 G; recommended length, 8-25 mm)
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Optional: Closed system transfer devices/needle-free connectors
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Optional: Syringe tip cap
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Optional: Winged infusion set for subcutaneous administration; total hold-up volume not to exceed 1 mL (recommended gauge, 20-24 G; recommended length, 8-25 mm)
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- For sites using a winged infusion set to administer RYBREVANT FASPRO, a post-injection flush of 0.9% sodium chloride or air is required to complete the administration, clearing remaining RYBREVANT FASPRO dose volume from the entirety of the winged infusion set. Flush volumes must be greater than or equal to the hold-up volume of the winged infusion set. Total hold-up volume of winged infusion set not to exceed 1 mL.2
- If using an optional winged infusion set that requires priming in the administration area, follow the applicable priming step below2:
- If flushing with 0.9% sodium chloride, manually prime winged infusion set tubing with RYBREVANT FASPRO.
- If flushing with air, pull back on the syringe plunger to allow sufficient air into the syringe to flush the entirety of the winged infusion set. Invert syringe to allow air bubble to move behind RYBREVANT FASPRO. Manually prime winged infusion set tubing with RYBREVANT FASPRO.
- Closed system transfer devices (CSTDs) and other needle-free connectors can be used in the preparation and administration of RYBREVANT FASPRO.2
- The proper use of CSTDs, including accounting for hold-up volume and residual transfer volumes of CSTD components, is the responsibility of the preparers and administrators.
- CSTD manufacturer guidance and site practice must be followed to ensure that an accurate dose is prepared and delivered.
Literature Search
A literature search of Ovid MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 04 February 2026.
| 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. Investigational product preparation and administration instructions for JNJ-61186372 co-formulated with rHuPH20 for manual subcutaneous administration. Janssen Research & Development, LLC. TV-TEC-237607 v5.0; 2025. |