Rybrevant Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: Prepare the solution for intravenous infusion using aseptic technique as follows: Preparation: Determine the dose required and the number of Rybrevant vials needed based on patient's baseline weight (see Dosage & Administration). Each vial contains 350 mg of amivantamab.
For every 2-week dosing, patients <80 kg receive 1,050 mg and for patients ≥80 kg, 1,400 mg once weekly for a total of 4 doses, then every 2 weeks starting at Week 5.
For every 3-week dosing, patients <80 kg receive 1,400 mg once weekly for a total of 4 doses, then 1,750 mg every 3 weeks starting at Week 7, and for patients ≥80 kg, 1,750 mg once weekly for a total of 4 doses, then 2,100 mg every 3 weeks starting at Week 7.
Check that the Rybrevant solution is colourless to pale yellow. Do not use if discolouration or visible particles are present.
Withdraw and then discard a volume of either 5% glucose solution or sodium chloride 9 mg/mL (0.9%) solution for injection from the 250 mL infusion bag that is equal to the required volume of Rybrevant solution to be added (discard 7 mL diluent from the infusion bag for each vial). Infusion bags must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE), or polyolefin blend (PP+PE).
Withdraw 7 mL of Rybrevant from each vial needed then add it to the infusion bag.
Each vial contains a 0.5 mL overfill to ensure sufficient extractable volume. The final volume in the infusion bag should be 250 mL. Discard any unused portion left in the vial.
Gently invert the bag to mix the solution. Do not shake.
Visually inspect for particulate matter and discolouration prior to administration. Do not use if discolouration or visible particles are observed.
Administration: 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 0.22 or 0.2 micrometer). Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE.
The administration set with filter must be primed with either 5% glucose solution or 0.9% sodium chloride solution prior to the initiation of each Rybrevant infusion.
Do not infuse Rybrevant concomitantly in the same intravenous line with other agents.
The diluted solution should be administered within 10 hours (including infusion time) at room temperature (15°C to 25°C) and in room light.
Due to the frequency of IRRs at the first dose, amivantamab should be infused via a peripheral vein at Week 1 and Week 2; infusion via a central line may be administered for subsequent weeks when the risk of IRR is lower. See infusion rates in Dosage & Administration.
Disposal: This medicinal product is for single use only and any unused medicinal product that is not administered within 10 hours should be disposed of in accordance with local requirements.