Cysview

INDICATIONS

Cysview (hexaminolevulinate hydrochloride intravesical solution) is indicated for use in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. Cysview (hexaminolevulinate hydrochloride intravesical solution) is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).

Limitations of Use

Cysview (hexaminolevulinate hydrochloride intravesical solution) is not:

  • a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see WARNINGS AND PRECAUTIONS].
  • for repetitive use. The potential risks associated with repetitive exposure, including sensitization and adverse effects of blue light have not been evaluated [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Recommended Dose

The recommended dose for adults is 50 mL of reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) (2.2), instilled into the bladder via a urinary catheter (2.3).

Reconstitution of Cysview (hexaminolevulinate hydrochloride intravesical solution)

Cysview (hexaminolevulinate hydrochloride intravesical solution) is supplied as a kit containing two vials: a clear glass vial labeled as Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, containing 100 mg hexaminolevulinate hydrochloride as a powder, and a vial labeled as DILUENT for Cysview (hexaminolevulinate hydrochloride intravesical solution) , containing 50 mL of the diluent in a polypropylene vial.

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

Use a 50 mL syringe with a Luer Lock tip throughout the reconstitution procedure to ensure that the correct concentration (2mg/mL) of the drug is obtained and that a stable syringe-catheter connection is made for the bladder instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) .

Figure1

Attach a needle to the syringe and withdraw 50 mL of the diluent - Illustration

1. Remove the cap from the sterile 50 mL syringe and carefully retain it for subsequent reattachment to the syringe (step 4). Attach a needle to the syringe and withdraw 50 mL of the diluent (Figure 1).

Figure 2

inject 10 mL of the diluent from the syringe into the powder vial - Illustration

2. Penetrate the stopper of the Cysview (hexaminolevulinate hydrochloride intravesical solution) powder vial with the needle and inject 10 mL of the diluent from the syringe into the powder vial (Figure 2).

3. Without withdrawing the needle from the vial, hold the powder vial and syringe in a firm grip (Figure 3) and gently shake to dissolve of the powder in the diluent. The powder normally dissolves almost immediately.

Figure 3

Hold the powder vial and syringe in a firm grip - Illustration

4. Withdraw all of the dissolved solution from the powder vial (10 mL) into the 50 mL syringe (Figure 4).

Figure 4

Withdraw all of the dissolved solution from the powder vial (10 mL) into the 50 mL syringe - Illustration

5. Remove the needle from the powder vial, disconnect the needle from the syringe tip and discard it. Plug the syringe with the syringe cap (Figure 5). Gently mix the contents of the syringe. The reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) is colorless to pale yellow and clear to slightly opalescent, and free from visible particles.

Figure 5

Plug the syringe with the syringe cap - Illustration

Figure 6

Peel off the detachable portion of the label - Illustration

6. Peel off the detachable portion of the label (starting at the corner marked with a black triangle) from the Cysview (hexaminolevulinate hydrochloride intravesical solution) powder vial and affix it to the syringe containing the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) (Figure 6). Add two hours to the present time and write the resulting expiration time and date on the syringe label.

Cysview (hexaminolevulinate hydrochloride intravesical solution) is now reconstituted and ready for use. Instill the reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder. If unable to administer the solution shortly after reconstitution, the solution may be stored 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.

Bladder Instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution)

For bladder instillation of the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) , 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 (hexaminolevulinate hydrochloride intravesical solution) . 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 (hexaminolevulinate hydrochloride intravesical solution) administration and are removed following the Cysview (hexaminolevulinate hydrochloride intravesical solution) instillation.

Use the following steps for bladder instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) :

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 (hexaminolevulinate hydrochloride intravesical solution) .

Figure 7

Insert the tapered end of the catheter adapter into the funnel opening of the catheter - Illustration

2. To attach the syringe containing the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) to the catheter, do the following:

  • Remove the syringe cap from the 50 mL syringe that contains the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) .
  • 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 7, with the connection enlarged in the inset.

3. Slowly instill the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder through the catheter (Figure 7), ensuring that the complete volume of the syringe (50 mL) is administered.

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. 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 (hexaminolevulinate hydrochloride intravesical solution) from the bladder as part of routine emptying of the bladder immediately prior to the initiation of the cystoscopic procedure (refer to the Karl Storz PDD Telescope Instruction manual). Also, the patient may void and completely empty the bladder prior to the procedure.

Avoid skin contact with Cysview (hexaminolevulinate hydrochloride intravesical solution) . If skin does come in contact with Cysview (hexaminolevulinate hydrochloride intravesical solution) , wash immediately with soap and water and dry off. After voiding the bladder of Cysview (hexaminolevulinate hydrochloride intravesical solution) , routinely wash the patient's perineal skin region with soap and water and dry.

Use of the Karl Storz D-Light C Photodynamic Diagnostic (PDD) System

Cysview (hexaminolevulinate hydrochloride intravesical solution) imaging requires the use of the Karl Storz D-Light C PDD system, which consists of a light source, a camera and a telescope. The light source enables both white light cystoscopy and blue light (wavelength 360 – 450 nm) fluorescence cystoscopy. Familiarity with this system is essential before beginning the procedure and before instilling Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder. For system set up and general information for the safe use of the PDD system, refer to the Karl Storz instruction manual for the PDD system and the instruction manuals for each of the system components. The PDD System is not for use by healthcare providers with green-red color blindness.

Cystoscopic Examination

Training

Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview (hexaminolevulinate hydrochloride intravesical solution) . Carefully review the instruction manuals provided with the Karl Storz D-Light C Photodynamic Diagnosis (PDD) System. For additional training in the use of the PDD System, contact the manufacturer's representative.

Preparation for Cystoscopy

Initiate the cystoscopic examination within 30 minutes after evacuation of Cysview (hexaminolevulinate hydrochloride intravesical solution) from the bladder, but no less than 1 or more than 3 hours after Cysview (hexaminolevulinate hydrochloride intravesical solution) is instilled in the bladder. If the patient did not retain Cysview (hexaminolevulinate hydrochloride intravesical solution) in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder to the start of the cystoscopic examination. The efficacy of Cysview (hexaminolevulinate hydrochloride intravesical solution) has not been established when the solution was retained for less than 1 hour.

Cystoscopic Examination

Empty the patient's bladder and then fill the bladder with a clear fluid (standard bladder irrigation fluid) in order to distend the bladder wall for cystoscopic visibility. Ensure adequate irrigation during examination of the bladder; blood, urine or floating particles in the bladder may interfere with visualization under both white light and blue light.

First perform a complete cystoscopic examination of the entire bladder under white light (Mode 1) and then repeat the examination of the entire bladder surface under blue light (Mode 2) unless the white light cystoscopy reveals extensive mucosal inflammation. Do not perform the blue light cystoscopy if the white light cystoscopy reveals wide-spread mucosal inflammation. Abnormalities of the bladder mucosa during blue light cystoscopy are characterized by the detection of red, homogenous and intense fluorescence. The margins of the abnormal lesions are typically well-demarcated and in contrast to the normal urothelium, which appears blue. Register and document (map) the location and appearance (e.g. papillary) of suspicious lesions and abnormalities seen under either white or blue light.

During the cystoscopic examination, be aware that:

  • a red fluorescence is expected at the bladder outlet and the prostatic urethra; this fluorescence occurs in normal tissue and is usually less intense and more diffuse than the bladder mucosal fluorescence associated with malignant lesions.
  • tangential light may give false fluorescence. To help avoid false fluorescence, hold the endoscope perpendicular and close to the bladder wall with the bladder distended.
  • false positive fluorescence may result from scope trauma from a previous cystoscopic examination and/or bladder inflammation [see WARNINGS AND PRECAUTIONS].
  • malignant lesions may not fluoresce following Cysview (hexaminolevulinate hydrochloride intravesical solution) administration, particularly if the lesions are coated with necrotic tissue. Blue light may fail to detect T2 tumors which have a tendency to be necrotic on the surface, and necrotic cells generally do not fluoresce [see WARNINGS AND PRECAUTIONS].
  • when performing the blue light cystocopy, avoid prolonged blue light exposure. Studies have not evaluated the potential for adverse effects from blue light. In the controlled clinical trial, the cumulative blue light exposure from bladder mapping did not exceed 12 minutes and checking for complete tumor resection under blue light did not exceed 8 minutes for any patient [see Clinical Studies].

Perform biopsy and/or resection of suspicious lesions by transurethral resection of the bladder (TURB) only after completing white and blue light cystoscopic examinations with bladder mapping. Using standard cystoscopic practices, obtain biopsies of abnormal areas identified during either white or blue light examination and perform resections. Always check for the completeness of the resections under both white light and blue light before finalizing the TURB procedure.

HOW SUPPLIED

Dosage Forms And Strengths

Cysview (hexaminolevulinate hydrochloride) is supplied as a kit containing:

  • Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, 100 mg, as a powder in a 10 mL clear glass vial.
  • DILUENT for Cysview (hexaminolevulinate hydrochloride intravesical solution) , 50 mL, in a polypropylene vial.
  • One Luer Lock catheter adapter (to connect the syringe containing the reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) to the urethral catheter for bladder instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) ).

Once reconstituted, the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) contains 2 mg/mL of hexaminolevulinate hydrochloride.

Storage And Handling

Cysview is supplied as a kit labeled, Cysview (hexaminolevulinate hydrochloride) Kit for Intravesical Solution, 100 mg. The kit contains:

  • One vial of Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, 100 mg, as a powder in a 10 mL clear glass vial.
  • One vial of DILUENT for Cysview (hexaminolevulinate hydrochloride intravesical solution) , 50 mL, in a polypropylene vial.
  • One Luer Lock catheter adapter (to connect the syringe containing Cysview (hexaminolevulinate hydrochloride intravesical solution) solution to the urethral catheter during instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) )

NDC 0407-4085-01

Storage

Store Cysview (hexaminolevulinate hydrochloride) Kit for Intravesical Solution at 20°-25°C (68°-77°F); excursions are permitted to 15°-30°C (59°-86°F). Do not use beyond the expiry date printed on the carton.

Use the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) shortly after reconstitution. If unable to use within this time period, the reconstituted solution can be stored under refrigeration (2°-8°C / 36°-46°F) for up to 2 hours in the 50 mL labeled syringe.

Distributed by GE Healthcare Inc., Princeton, NJ 08540 U.S.A. Licensed from Photocure ASA. Packaged and Labeled by Orifice Medical AB, Ystad, Sweden.

Last reviewed on RxList: 6/29/2010
This monograph has been modified to include the generic and brand name in many instances.

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