Cysview is supplied as a kit containing: a clear glass vial labeled as Cysview (hexaminolevulinate HCl) for Intravesical Solution containing 100 mg hexaminolevulinate hydrochloride as a powder, a prefilled syringe labeled as DILUENT for Cysview containing 50 mL of the diluent, and a catheter adapter. The kit may be supplied as two options; with or without a vial adapter for use during reconstitution.

Perform all steps under aseptic conditions. Wear gloves during the reconstitution procedure; skin exposure to hexaminolevulinate hydrochloride may increase the risk for sensitization to the drug.

Figure 1.

Reconstitution Using a Vial Adapter

  * Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (Figure 1). 



Figure 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 (Figure 2). 



Figure 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 (Figure 3). 



Figure 4.

  * Without disconnecting the vial adapter from the vial, hold the vial and syringe in a firm grip (Figure 4) and gently shake to dissolve the powder in the diluent. The powder normally dissolves almost immediately. 



Figure 5.

  * Turn the vial upside down and withdraw all of the dissolved solution from the vial back into the syringe (Figure 5). 

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 6.

  * Disconnect the empty vial with the vial adapter from the syringe tip and discard it. Plug the syringe with the syringe cap (Figure 6). Gently mix the contents of the syringe. The reconstituted solution of Cysview is colorless to pale yellow and clear to slightly opalescent, and free from visible particles. 
  * 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. 



Cysview is now reconstituted and ready for use. The solution of Cysview contains 2 mg/mL of hexaminolevulinate hydrochloride. Instill the reconstituted solution of Cysview into the bladder [ see Bladder instillation of Cysview (2.3)]. If unable to administer the solution shortly after reconstitution, store the solution for up to 2 hours in a refrigerator at 2°-8°C (36°- 46°F) in the labeled syringe. If not used within 2 hours, discard the solution [ see How Supplied/Storage and Handling (16)]. 

Reconstitution Without the Use of a Vial Adapter

  * Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (Figure 1). 

Figure 7.

  * 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 (Figure 7). 

Figure 8.

  * Without withdrawing the needle from the vial, hold the vial and syringe in a firm grip (Figure 8) and gently shake to dissolve of the powder in the diluent. The powder normally dissolves almost immediately. 



Figure 9.

  * Turn the vial upside down and withdraw all of the dissolved solution from the vial back into the syringe (Figure 9). 



Figure 10.

  * Remove the needle from the vial, disconnect the needle from the syringe tip and discard it. Plug the syringe with the syringe cap (Figure 10). Gently mix the contents of the syringe. The reconstituted solution of Cysview is colorless to pale yellow and clear to slightly opalescent, and free from visible particles. 
  * 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. 



Cysview is now reconstituted and ready for use. The solution of Cysview contains 2 mg/mL of hexaminolevulinate hydrochloride. Instill the reconstituted solution of Cysview into the bladder [ see Bladder instillation of Cysview (2.3)]. If unable to administer the solution shortly after reconstitution, store the solution for up to 2 hours in a refrigerator at 2°-8°C (36°- 46°F) in the labeled syringe. If not used within 2 hours, discard the solution [ see How Supplied/Storage and Handling (16)].