Nadofaragene firadenovec

Preparation and Handling ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy. Follow universal biosafety precautions for handling. Individuals who are immunosuppressed or immune-deficient, should not prepare, administer, or come into contact with ADSTILADRIN [ see Warnings and Precautions ]. ADSTILADRIN is provided as a sterile frozen suspension.

All four vials of ADSTILADRIN must be thawed and brought to room temperature (20°C to 25°C [68°F to 77°F]) prior to use. Do not expose the vials to higher temperatures (>25°C [77°F]). Protect from light. DO NOT refreeze. ADSTILADRIN may be moved between refrigerator and room temperature if the total storage time at each condition is not exceeded (24 hours at room temperature and 7 days refrigerated including thawing time). [ see How Supplied/Storage and Handling ] WHEN THAWING IN WATER BATH Frozen ADSTILADRIN vials will thaw in approximately 25 minutes outside the cardboard nest when placed directly in a water bath maintained at 25°C [77ºF].

Place the vials in the water bath, ensuring that the water level is sufficient to cover the product within the vials. Following thawing, remove vials from the water bath and dry with a clean paper towel to remove any residual moisture prior to further handling. WHEN THAWING AT ROOM TEMPERATURE Frozen ADSTILADRIN vials will thaw in approximately 3 to 5 hours outside the cardboard nest when placed at room temperature (up to 25°C [77ºF]) (8 to 10 hours inside the nest).

WHEN THAWING IN REFRIGERATOR Frozen ADSTILADRIN vials will thaw in approximately 4 to 5 hours outside the cardboard nest when placed in the refrigerator (up to 8°C [46ºF]) (11 to 13 hours inside the nest). Subsequent time for bringing thawed ADSTILADRIN to room temperature is approximately 2 hours 30 minutes outside of the cardboard nest (6 hours inside the nest).

Inspection and Preparing ADSTILADRIN for instillation Visually inspect all 4 vials for visible particles and discoloration. The suspension is clear to slightly opalescent and may contain opalescent flecks. Do not use if visible particles or discoloration are observed. Mix gently. Do not shake. Items required for instillation: 70% isopropyl ethanol pads Four thawed vials of ADSTILADRIN Four vented vial adapters suitable for a standard 20 mL vial Two standard 50 or 60 mL polypropylene Luer lock syringes or one Luer lock syringe equal to or greater than 75 mL (max 100 mL) Two Luer lock adapters One straight, or intermittent, urethral catheter with a proximal funnel opening that will accommodate the Luer lock adapter.

Use only catheters made of vinyl/PVC (uncoated or coated with hydrogel), red rubber latex or silicone to instill ADSTILADRIN. Do not use catheters coated or embedded with silver or antibiotics. Using aseptic technique, remove the cap from an ADSTILADRIN vial. Prior to vial access, wipe the access diaphragm with 70% isopropyl alcohol pad, allowing it to air dry before proceeding.

Attach a vented vial adapter according to manufacturer’s instructions. Connect the syringe to the vial adapter and withdraw the contents of the vial into the syringe. Repeat steps 1-2 for the remaining three vials until 75 mL has been withdrawn into one or two syringes. The volumes in the syringes do not have to be equal.

Discard any remaining volume according to universal precautions. If unable to administer the suspension shortly after withdrawal, the solution may be stored in syringes for up to 6 hours at room temperature (20°C to 25°C [68°F to 77°F]) protected from light. Treat any ADSTILADRIN spills or unused portion with a virucidal agent (such as sodium hypochlorite with 0.5% active chlorine or 6% hydrogen peroxide solution) for 15 minutes.

Disposable materials that have come into contact with ADSTILADRIN should be placed in biohazard containers for destruction. Non-disposable equipment may be decontaminated according to the facility’s standard operating procedures. [ see Patient Counseling Information ]. Inspection and Preparing ADSTILADRIN for instillation Visually inspect all 4 vials for visible particles and discoloration.

The suspension is clear to slightly opalescent and may contain opalescent flecks. Do not use if visible particles or discoloration are observed. Mix gently. Do not shake. Items required for instillation:

Four thawed vials of ADSTILADRIN

Four vented vial adapters suitable for a standard 20 mLvial

Two standard 50 or 60 mL polypropylene Luer lock syringes or one Luer lock syringe equal to or greater than 75 mL (max 100 mL)

Two Luer lock adapters - One straight, or intermittent, urethral catheter with a proximal funnel opening that will accommodate the Luer lock adapter. - Use only catheters made of vinyl/PVC (uncoated or coated with hydrogel), red rubber latex or silicone to instill ADSTILADRIN. Do not use catheters coated or embedded with silver or antibiotics. 1.

Using aseptic technique, remove the cap from an ADSTILADRIN vial and attach a vented vial adapter according to manufacturer's instructions. 2. Connect the syringe to the vial adapter and withdraw the contents of the vial into the syringe. Repeat steps 1-2 for the remaining three vials until 75 mL has been withdrawn into one or two syringes.

The volumes in the syringes do not have to be equal. 3. Discard any remaining volume according to universal precautions. If unable to administer the suspension shortly after withdrawal, the solution may be stored in syringes for up to 6 hours at room temperature (20°C to 25°C [68°F to 77°F]) protected from light. Treat any ADSTILADRIN spills or unused portion with a virucidal agent (such as sodium hypochlorite with 0.5% active chlorine or 6% hydrogen peroxide solution) for 15 minutes.

Disposable materials that have come into contact with ADSTILADRIN should be placed in biohazard containers for destruction. Non-disposable equipment may be decontaminated according to the facility's standard operating procedures. [ see Patient Counseling Information ].