Rybrevant Caution For Usage

Preparation for administration: RYBREVANT solution must be diluted and prepared for intravenous infusion by a healthcare professional using aseptic technique.
1. Determine the dose required (either 1050 mg or 1400 mg) and number of RYBREVANT vials needed based on patient’s baseline weight (see Dosage under Dosage & Administration). Each vial of RYBREVANT contains 350 mg of amivantamab.
2. Check that the RYBREVANT solution is colorless to pale yellow. Do not use if discoloration or visible particles are present.
3. Withdraw and then discard a volume of either 5% dextrose [glucose] solution or 0.9% sodium chloride solution from the 250 mL infusion bag equal to the volume of RYBREVANT to be added (i.e., discard 7 mL diluent from the infusion bag for each RYBREVANT vial). Infusion bags must be made of polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE), or polyolefin blend (PP+PE).
4. Withdraw 7 mL of RYBREVANT from each vial and add it to the infusion bag. The final volume in the infusion bag should be 250 mL. Each vial contains a 0.5 mL overfill to ensure sufficient extractable volume. Discard any unused portion left in the vial.
5. Gently invert the bag to mix the solution. Do not shake.
6. Visually inspect the diluted solution before administration. Do not use if discoloration or visible particles are observed.
7. Diluted solutions should be administered within 10 hours (including infusion time) at room temperature (15°C to 25°C) and in room light.
Administration: 1. Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.2 micrometer). Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE.
2. Do not infuse RYBREVANT concomitantly in the same intravenous line with other agents.
3. This medicinal product is for single use only. Any unused medicinal product should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Dosage & Administration.
Instructions for Use and Handling and Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.