Cysview

• Anaphylaxis: have trained personnel and therapies available.
• Failed Detection: Cysview may not detect all malignant lesions. Always perform white light cystoscopy (Mode 1) followed by blue light cystoscopy (Mode 2). Do not biopsy with blue light only.
• False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue or previous bladder biopsy.

The most common adverse reaction reported in patients who received Cysview was bladder spasm, occurring in < 3% of patients, followed by dysuria, hematuria, bladder pain, procedural pain, urinary retention and headache, all occurring in ≤ 2% of patients.

To report SUSPECTED ADVERSE REACTIONS, contact Photocure Inc. at 1-855-297-8439 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Pregnancy Category C: No human or animal data. Use only if clearly needed.
• Nursing mothers: No human or animal data. Exercise caution when Cysview is administered to nursing mothers.
• Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Ask patients if they have:

• a diagnosis or a family history of porphyria
• allergy to aminolevulinic acid or prior exposure to Cysview

Inform patients that Cysview should be retained in the bladder for at least 1 hour from instillation of Cysview to the start of the cystoscopic procedure. If the patient cannot hold Cysview for 1 hour, but needs to void and expel Cysview from the bladder, he or she may void and should then inform a health care professional.

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

• Reconstitute Cysview powder with all 50 mL of supplied diluent under aseptic conditions.
• 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 labeled syringe. Discard after 2 hours.
• Instill 50 mL of reconstituted solution of Cysview into the emptied bladder via an intravesical catheter. Retain in the bladder for 1 to 3 hours before evacuating and performing cystoscopic examination.
• 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.

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

• A 10 mL glass vial containing 100 mg powder of Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution.
• A polypropylene vial containing 50 mL diluent for Cysview.
• One Luer Lock catheter adapter. Once reconstituted, the solution contains 2 mg/mL (8mmol/L) of hexaminolevulinate hydrochloride

Do not use Cysview in patients with:

• porphyria,
• known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives.