Hexaminolevulinate

Reconstitution of CYSVIEW General Instructions CYSVIEW is supplied as a kit with diluent for reconstitution, with or without a vial adapter for use during reconstitution [see How Supplied/Storage and Handling ] . Perform all steps using aseptic technique. Wear gloves during the reconstitution procedure; skin exposure to CYSVIEW may increase the risk of sensitization to the drug.

Reconstituted CYSVIEW has a concentration of 2 mg/mL hexaminolevulinate hydrochloride and appears as a colorless to pale yellow, clear to slightly opalescent solution free from visible particles. If not immediately used, store the reconstituted solution in the labeled syringe under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 2 hours.

The solution should be discarded if not used within 2 hours. Reconstitution Using a Vial Adapter [See table below.] 1. Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (see Figure A ). Figure B. Connection of Vial Adapter to CYSVIEW Vial 2. Remove the plastic cap from the vial.

Remove the TyveK® cover from the vial adapter blister package. Do not remove the vial adapter from the package. Place the CYSVIEW vial on a flat surface. Using the blister package to hold the vial adapter, connect to the vial with a downward vertical motion. The vial adapter snaps onto the vial as the spike penetrates the rubber stopper of the vial.

Remove the plastic blister package and discard it. Take care not to touch the exposed end of the vial adapter (see Figure B ). Figure C. Injection of Diluent into CYSVIEW Vial 3. Remove the cap from the prefilled syringe and carefully retain it for subsequent reattachment to the syringe. Hold the prefilled syringe upright and carefully press the plunger rod upward to remove air.

Connect the syringe to the vial adapter. Inject about 10 mL of the diluent from the prefilled syringe down into the vial. The vial should be about ¾ full (see Figure C ). Figure D. Dissolution of CYSVIEW Powder in Diluent 4. Without disconnecting the vial adapter from the vial, hold the vial and syringe in a firm grip and gently shake to dissolve the powder in the diluent.

The powder normally dissolves almost immediately (see Figure D ). Figure E. Withdrawal of Reconstituted CYSVIEW from Vial 5. Turn the vial upside down and withdraw all of the dissolved solution from the vial back into the syringe (see Figure E ). Do not inject large amounts of air or diluent when vial is inverted as it may block the venting action of the vial adapter.

If this occurs, turn the vial upright and pull back on the plunger rod in the syringe. Figure F. Final Preparation of Reconstituted CYSVIEW Solution 6. Disconnect the empty vial with the vial adapter from the syringe tip and discard it. Plug the syringe with the syringe cap. Gently mix the contents of the syringe (see Figure F ). 7.

Peel off the detachable portion of the syringe label. On the syringe label, add 2 hours to the present time and write the resulting expiration time and date. Reconstitution Without Using a Vial Adapter CYSVIEW Powder Diluent Plunger Rod Figure G. Components of CYSVIEW and Attachment of Plunger Rod to Diluent Syringe 1. Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (see Figure G ).

Figure H. Injection of Diluent into CYSVIEW Vial 2. Remove the plastic cap from the vial. Remove the cap from the prefilled syringe and carefully retain it for subsequent reattachment to the syringe. Attach a needle to the prefilled syringe. Hold the prefilled syringe upright and carefully press the plunger rod upward to remove air.

Penetrate the stopper of the CYSVIEW vial with the needle and inject about 10 mL of the diluent from the prefilled syringe down into the vial. The vial should be about ¾ full (see Figure H ). Figure I. Dissolution of CYSVIEW Powder in Diluent 3. Without withdrawing the needle from the vial, hold the vial and syringe in a firm grip and gently shake to dissolve of the powder in the diluent.

The powder normally dissolves almost immediately (see Figure I ). Figure J. Withdrawal of Reconstituted CYSVIEW from Vial 4. Turn the vial upside down and withdraw all of the dissolved solution from the vial back into the syringe (see Figure J ). Figure K. Final Preparation of Reconstituted CYSVIEW Solution 5. Remove the needle from the vial, disconnect the needle from the syringe tip and discard it.

Plug the syringe with the syringe cap. Gently mix the contents of the syringe (see Figure K ). 6. Peel off the detachable portion of the syringe label. On the syringe label, add two hours to the present time and write the resulting expiration time and date. Figure A - Powder Figure A - Diluent Figure A - Plunger Rod Figure A - Vial Adapter Figure A - Complete Figure B Figure C Figure D Figure E Figure F Figure G - Powder Figure G - Diluent Figure G - Plunger Rod Figure G Figure H Figure I Figure J Figure K

Administration Instructions Catheter Requirements For bladder instillation of the solution of CYSVIEW, use straight or intermittent, urethral catheters with a proximal funnel opening that will accommodate the Luer Lock adapter. Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), and silicone to instill the reconstituted CYSVIEW.

Do not use catheters coated or embedded with silver or antibiotics. In-dwelling bladder catheters (Foley catheters) may be used if the catheters are inserted shortly prior to CYSVIEW administration and are removed following the CYSVIEW instillation. Instructions for Bladder Instillation of CYSVIEW 1. Using standard sterile catheterization technique, first insert the urethral catheter into the bladder of the patient and use the catheter to completely empty the patient's bladder before instillation of CYSVIEW.

Figure L. Connection of Catheter Adapter and Instillation of CYSVIEW 2. To attach the syringe containing the solution of CYSVIEW to the catheter, do the following: Remove the syringe cap from the syringe that contains the reconstituted solution of CYSVIEW. Attach the Luer Lock end of the (provided) catheter adapter to the syringe.

Insert the tapered end of the catheter adapter into the funnel opening of the catheter (see Figure L ). 3. Slowly instill the solution of CYSVIEW into the bladder through the catheter, ensuring that the complete volume of the syringe (50 mL) is administered (see Figure L ). 4. After the solution is instilled, remove the catheter and instruct the patient to retain the solution within the bladder for at least 1 hour; do not exceed 3 hours [see Dosage and Administration ] .

Patients may stand, sit and move about during the time period between instillation and start of the cystoscopic procedure. 5. Evacuate the solution of CYSVIEW from the bladder as part of routine emptying of the bladder immediately prior to the initiation of the cystoscopic procedure. Also, the patient may void and completely empty the bladder prior to the procedure. 6.

Avoid skin contact with CYSVIEW. If skin does come in contact with CYSVIEW, wash immediately with soap and water and dry off. After voiding the bladder of CYSVIEW, routinely wash the patient's perineal skin region with soap and water and dry. Figure 1