Polivy Caution For Usage

Incompatibilities: Do not mix Polivy with, or administer through the same infusion line, as other medicinal products.
No incompatibilities have been observed between Polivy and IV infusion bags with product contacting materials of polyvinyl chloride (PVC), or polyolefins (PO) such as polyethylene (PE) and polypropylene (PP). In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane (PU), polybutadiene (PBD), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polyetherurethane (PEU), fluorinated ethylene propylene (FEP), or polytetrafluorethylene (PTFE), or with filter membranes composed of polyether sulfone (PES) or polysulfone (PSU).
Special Instructions for Use, Handling and Disposal: Polivy must be reconstituted using sterile water for injection and diluted into an IV infusion bag containing 0.9% sodium chloride, 0.45% sodium chloride, or 5% dextrose by a healthcare professional prior to administration.
Use aseptic technique for reconstitution and dilution of Polivy. Appropriate procedures for the preparation of antineoplastic products should be used.
The reconstituted product contains no preservative and is intended for single-dose usage only. Discard any unused portion.
A dedicated infusion line equipped with a sterile, non-pyrogenic, low-protein binding in-line or add-on filter (0.2 or 0.22 µm pore size) and catheter must be used to administer diluted Polivy.
Reconstitution: 1. Using a sterile syringe, slowly inject 1.8 mL of sterile water for injection into the 30 mg Polivy vial or 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.
2. Swirl the vial gently until completely dissolved. Do not shake.
3. Inspect the reconstituted solution for discoloration and particulate matter. The reconstituted solution should appear colorless to slightly brown, clear to slightly opalescent, and free of visible particulates. Do not use if the reconstituted solution is discolored, cloudy, or contains visible particulates.
From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for up to 72 hours at 2°C to 8°C and up to 24 hours at room temperature (9°C to 25°C).
Dilution: 1. Polatuzumab vedotin must be diluted to a final concentration of 0.72-2.7 mg/mL in an IV infusion bag with a minimum volume of 50mL containing 0.9% sodium chloride, 0.45% sodium chloride, or 5% dextrose.
2. Determine the volume of 20 mg/mL reconstituted solution needed based on the required dose: (See equation.)

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3. Withdraw the required volume of reconstituted solution from the Polivy vial using a sterile syringe and dilute into the IV infusion bag. Discard any unused portion left in the vial.
4. Gently mix the IV bag by slowly inverting the bag. Do not shake.
5. Inspect the IV bag for particulates and discard if present.
From a microbiological point of view, the prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. Acceptable chemical and physical stability of the prepared solution for infusion has been demonstrated for the durations listed in Table 7. Discard if storage time exceeds these limits. Do not freeze or expose to direct sunlight. (See Table 7.)

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Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation. If the prepared solution for infusion will be transported, remove air from the infusion bag and limit transportation to 30 minutes at 9°C to 25°C or 24 hours at 2°C to 8°C. If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion.
Disposal of unused/expired medicines: The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided.
The following points should be strictly adhered to regarding the use and disposal of syringes and other medicinal sharps: Needles and syringes should never be reused.
Place all used needles and syringes into a sharps container (puncture-proof disposable container).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.