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Photocure Inc. Drugs
2.1 Recommended Dose
The recommended dose for adults is 50 mL of reconstituted solution of Cysview [see Dosage and Administration (2.2)], instilled into the bladder via a urinary catheter [see Dosage and Administration (2.3)].
2.2 Reconstitution of Cysview
Cysview 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, 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 (2 mg/mL) of the drug is obtained and that a stable syringe-catheter connection is made for the bladder instillation of Cysview.
Figure 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. Penetrate the stopper of the Cysview powder vial with the needle and inject 10 mL of the diluent from the syringe into the powder vial (Figure 2). Figure 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 4. Withdraw all of the dissolved solution from the powder vial (10 mL) into the 50 mL syringe (Figure 4). Figure 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 is colorless to pale yellow and clear to slightly opalescent, and free from visible particles. Figure 6. Peel off the detachable portion of the label (starting at the corner marked with a black triangle) from the Cysview powder vial and affix it to the syringe containing the solution of Cysview (Figure 6). Add two hours to the present time and write the resulting expiration time and date on the syringe label.
Cysview is now reconstituted and ready for use. Instill the reconstituted solution of Cysview 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. [see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16)]
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 7. To attach the syringe containing the solution of Cysview to the catheter, do the following: Remove the syringe cap from the 50 mL syringe that contains the 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 7, with the connection enlarged in the inset. Slowly instill the solution of Cysview into the bladder through the catheter (Figure 7), 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 Dosage and Administration (2.4)]. 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 PDD Telescope Instruction manual). 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.
2.4 Use of the Karl Storz D-Light C Photodynamic Diagnostic (PDD) System
Cysview 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 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.
2.5 Cystoscopic Examination
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.
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 (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 T2 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 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 (14)].
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.
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