Cysview

(Hexaminolevulinate Hydrochloride)

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Cysview Prescribing Information

Cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC

^®) as an adjunct to the white light cystoscopy.

Training in blue light cystoscopy with the Karl Storz D-Light C PDD system is essential prior to the use of Cysview. (

2.5 Cystoscopic Examination

Training

Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview. 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 from the bladder, but no less than 1 or more than 3 hours after Cysview is instilled in the bladder. If the patient did not retain Cysview in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview into the bladder to the start of the cystoscopic examination

The efficacy of Cysview 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 and then repeat the examination of the entire bladder surface under blue light 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 (as appropriate for the cystoscopy procedure) and appearance (e.g. papillary, flat) 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 (5.3)
].
malignant lesions may not fluoresce following Cysview administration, particularly if the lesions are coated with necrotic tissue. Blue light may fail to detect tumors which have a tendency to be necrotic on the surface, and necrotic cells generally do not fluoresce [
see Warnings and Precautions (5.3)
].
when performing the blue light cystoscopy, avoid prolonged blue light exposure. Studies have not evaluated the potential for adverse effects from blue light. In the controlled clinical trials, the cumulative blue light exposure from bladder evaluation, mapping and resection did not exceed 32 minutes for any procedure [
see Clinical Studies (14)
].

For rigid cystoscopy, 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.

)

Reconstitute Cysview powder with the supplied 50 mL DILUENT under aseptic conditions. (
2.2 Reconstitution of Cysview
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.
Cysview Powder Cysview Diluent Plunger Rod
Figure 1.
Figure 1
Figure 1a
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)
].
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
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)
].
Figure 7
Figure 8
Figure 9
Figure 10
)
Use solution of Cysview shortly after reconstitution. If unable to use, the solution may be stored for up to 2 hours in a refrigerator at 2°-8°C (36°-46°F) in the labeled syringe. Discard after 2 hours. (
2.2 Reconstitution of Cysview
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.
Cysview Powder Cysview Diluent Plunger Rod
Figure 1.
Figure 1
Figure 1a
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)
].
Figure 2
Figure 3
Figure 4
Figure 5
Figure 6
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)
].
Figure 7
Figure 8
Figure 9
Figure 10
,
16 HOW SUPPLIED/STORAGE AND HANDLING
Cysview is supplied as a kit labeled Cysview (hexaminolevulinate HCl) Kit for Intravesical Solution, 100 mg. The kit may be supplied as two options; with or without a vial adapter, and contains:
Cysview kit with a vial adapter
Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, 100 mg, as a powder in a 10 mL clear glass vial.
One plastic prefilled syringe of DILUENT for Cysview, 50 mL.
One vial adapter for use during reconstitution. The vial adapter is either a "West Vented Vial Adapter" or a "West Mixject Dispensing Pin".
One Luer Lock catheter adapter (to connect the syringe containing the reconstituted solution of Cysview to the urethral catheter for bladder instillation of Cysview).
NDC 10511-3001-2
Cysview kit without a vial adapter
Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, 100 mg
,
as a powder in a 10 mL clear glass vial.
One plastic prefilled syringe of DILUENT for Cysview, 50 mL.
One Luer Lock catheter adapter (to connect the syringe containing the reconstituted solution of Cysview to the urethral catheter for bladder instillation of Cysview).
NDC 10511-3001-3
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 shortly after reconstitution. If unable to use within this time period, the reconstituted solution can be stored under refrigeration at 2°-8°C (36°-46°F) for up to 2 hours in the labeled syringe.
)
Instill 50 mL of reconstituted solution of Cysview into the emptied bladder via an intravesical catheter. Retain in the bladder for 1 hour before evacuating and performing cystoscopic examination. (
2.3 Bladder Instillation of Cysview
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.
Use the following steps for bladder instillation of Cysview:
- 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 11.
- 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 11, with the connection enlarged in the inset.
- Slowly instill the solution of Cysview into the bladder through the catheter (Figure 11), ensuring that the complete volume of the syringe (50 mL) is administered.
- 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 Cystoscopic examination (2.5)
  ]. Patients may stand, sit and move about during the time period between instillation and start of the cystoscopic procedure.
- 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 (refer to the Karl Storz D-Light C Photodynamic Diagnostic (PDD) System Manual for further details). Also, the patient may void and completely empty the bladder prior to the procedure.
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 11
,
2.5 Cystoscopic Examination
Training
Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview. 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 from the bladder, but no less than 1 or more than 3 hours after Cysview is instilled in the bladder. If the patient did not retain Cysview in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview into the bladder to the start of the cystoscopic examination
.
The efficacy of Cysview 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 and then repeat the examination of the entire bladder surface under blue light 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 (as appropriate for the cystoscopy procedure) and appearance (e.g. papillary, flat) 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 (5.3)
].
malignant lesions may not fluoresce following Cysview administration, particularly if the lesions are coated with necrotic tissue. Blue light may fail to detect tumors which have a tendency to be necrotic on the surface, and necrotic cells generally do not fluoresce [
see Warnings and Precautions (5.3)
].
when performing the blue light cystoscopy, avoid prolonged blue light exposure. Studies have not evaluated the potential for adverse effects from blue light. In the controlled clinical trials, the cumulative blue light exposure from bladder evaluation, mapping and resection did not exceed 32 minutes for any procedure [
see Clinical Studies (14)
].
For rigid cystoscopy, 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.
)
First perform a complete cystoscopic examination of the entire bladder under white light and then repeat the examination of the entire bladder under blue light. Record and document information about location and appearance of suspicious lesions and areas seen under both white and blue light. (
2.5 Cystoscopic Examination
Training
Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview. 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 from the bladder, but no less than 1 or more than 3 hours after Cysview is instilled in the bladder. If the patient did not retain Cysview in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview into the bladder to the start of the cystoscopic examination
.
The efficacy of Cysview 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 and then repeat the examination of the entire bladder surface under blue light 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 (as appropriate for the cystoscopy procedure) and appearance (e.g. papillary, flat) 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 (5.3)
].
malignant lesions may not fluoresce following Cysview administration, particularly if the lesions are coated with necrotic tissue. Blue light may fail to detect tumors which have a tendency to be necrotic on the surface, and necrotic cells generally do not fluoresce [
see Warnings and Precautions (5.3)
].
when performing the blue light cystoscopy, avoid prolonged blue light exposure. Studies have not evaluated the potential for adverse effects from blue light. In the controlled clinical trials, the cumulative blue light exposure from bladder evaluation, mapping and resection did not exceed 32 minutes for any procedure [
see Clinical Studies (14)
].
For rigid cystoscopy, 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.
)

Anaphylaxis: have trained personnel and therapies available. (

5.1 Anaphylaxis
Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview [
see Adverse Reactions (6.2)
]. Prior to and during use of the Cysview, have trained personnel and therapies available for the treatment of anaphylaxis.
).
Failed Detection: Cysview may not detect all malignant lesions. Always perform white light cystoscopy followed by blue light cystoscopy. Do not biopsy with blue light only. (

5.2 Failed Detection
Cysview may fail to detect some bladder tumors, including malignant lesions. Cysview is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer. Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light [
see Dosage and Administration (2.5)
and
Clinical Studies (14)
].
)
False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy or chemotherapy. (
5.3 False Positive Fluorescence
Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. In the controlled clinical studies, approximately 20% of the lesions detected only by blue light cystoscopy showed neither dysplasia nor carcinoma [
see Clinical Studies (14)
]. False positive fluorescence may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination, and recent BCG immunotherapy or intravesical chemotherapy. In a study of patients treated with recent BCG immunotherapy or intravesical chemotherapy, the rate of false positives with blue light was 55% between 6 weeks to 90 days and 41% after 90 days; the false positive rate was 53% and 33% at the respective time intervals with white light.
The presence of urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. To enhance the diagnostic utility of Cysview with the Karl Storz D-Light C PDD System:
- ensure the bladder is emptied of urine prior to the instillation of fluids at cystoscopy;
- biopsy/resect bladder mucosal lesions only following completion of both white light and blue light rigid cystoscopy;
)

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