Columvi

Instructions for dilution ● Columvi contains no preservative and is intended for single use only. ● Columvi must be diluted by a healthcare professional using aseptic technique, prior to intravenous administration. ● Visually inspect the Columvi vial for particulate matter or discolouration prior to administration.‍‍‍‍‍‍​​​‍​​​​​​ Columvi is a colourless, clear solution. Discard the vial if the solution is cloudy, discoloured or contains visible particles. ● Withdraw the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or sodium chloride 4.5 mg/mL (0.45%) solution for injection, as described in Table 10, from the infusion bag using a sterile needle and syringe and discard. ● Withdraw the required volume of Columvi concentrate for the intended dose from the vial using a sterile needle and syringe and dilute into the infusion bag (see Table 10). Discard any unused portion left in the vial. ● The final glofitamab concentration after dilution must be 0.1 mg/mL to 0.6 mg/mL. ● Gently invert the infusion bag to mix the solution in order to avoid excessive foaming. Do not shake. ● Inspect the infusion bag for particulates and discard if present. ● Prior to the start of the intravenous infusion, the content of the infusion bag should be at room temperature (25°C). Table 10. Dilution of Columvi for infusion Dose of Columvi to be administered Size of infusion bag Volume of sodium chloride 9 mg/mL (0.9%) or 4.5 mg/mL (0.45%) solution for injection to be withdrawn and discarded Volume of Columvi concentrate to be added 2.5 mg 50 mL 27.5 mL 2.5 mL 100 mL 77.5 mL 2.5 mL 10 mg 50 mL 10 mL 10 mL 100 mL 10 mL 10 mL 30 mg 50 mL 30 mL 30 mL 100 mL 30 mL 30 mL Only sodium chloride 9 mg/mL (0.9%) or 4.5 mg/mL (0.45%) solution for injection should be used to dilute Columvi, since other solvents have not been tested. When diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, Columvi is compatible with intravenous infusion bags composed of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP) or non-PVC polyolefin. When diluted with sodium chloride 4.5 mg/mL (0.45%) solution for injection, Columvi is compatible with intravenous infusion bags composed of PVC. No incompatibilities have been observed with infusion sets with product-contacting surfaces of polyurethane (PUR), PVC or PE, and in-line filter membranes composed of polyethersulfone (PES) or polysulfone. The use of in-line filter membranes is optional. Disposal Columvi vial is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.