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The reconstituted product contains no preservative and is intended for single-dose only. Proper aseptic technique throughout the handling of this medicinal product should be followed.
Polivy must be reconstituted using sterile water for injection and diluted into an intravenous infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or sodium chloride 4.5 mg/mL (0.45%) solution for injection, or 5% glucose prior to administration.
The reconstituted solution and solution for infusion should not be frozen or exposed to direct sunlight.
Instructions for reconstitution: Polivy 30 mg: Using a sterile syringe, slowly inject 1.8 mL of sterile water for injection into the 30 mg Polivy vial to yield a single-dose solution containing 20 mg/mL polatuzumab vedotin. Direct the stream toward the wall of the vial and not directly on the lyophilized cake.
Polivy 140mg: Using a sterile syringe, slowly inject 7.2 mL of sterile water for injection into the 140 mg Polivy vial to yield a single-dose solution containing 20 mg/mL polatuzumab vedotin. Direct the stream toward the wall of the vial and not directly on the lyophilized cake.
Swirl the vial gently until completely dissolved. Do not shake.
Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution should appear colourless to slightly brown, clear to slightly opalescent, and free of visible particulates. Do not use if the reconstituted solution is discoloured, is cloudy, or contains visible particulates.
Instructions for dilution: 1. Polivy must be diluted to a final concentration of 0.72 - 2.7 mg/mL in an intravenous infusion bag, with a minimum volume of 50 mL, containing 9 mg/mL sodium chloride solution for injection, or 4.5 mg/mL sodium chloride solution for injection, or 5% glucose.
2. Determine the volume of 20 mg/mL reconstituted solution needed based on the required dose (see as follows): See equation.
Click on icon to see table/diagram/image3. Withdraw the required volume of reconstituted solution from the Polivy vial using a sterile syringe and dilute into the intravenous infusion bag. Discard any unused portion left in the vial.
4. Gently mix the intravenous bag by slowly inverting the bag. Do not shake.
5. Inspect the intravenous bag for particulates and discard if present.
Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation. If the prepared infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes room temperature (9°C - 25°C) or 24 hours refrigerated (2°C - 8°C). If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion. The total storage plus transportation times of the diluted product should not exceed the storage duration specified in Table 6 (see Shelf life under Storage).
Polivy must be administered using a dedicated infusion line equipped with sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 micrometer pore size) and catheter.
Polivy is compatible with intravenous infusion bags with product contacting materials of polyvinyl chloride (PVC) or polyolefins such as polyethylene (PE) and polypropylene. In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane, polybutadiene, acrylonitrile butadiene styrene, polycarbonate, polyetherurethane, fluorinated ethylene propylene, or polytetrafluorethylene and with filter membranes composed of polyether sulfone or polysulfone.
Disposal: Polivy is for single-use only.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed or diluted with other medicinal products except those previously mentioned in Special precautions for disposal and other handling.
