FDA Approves Cysview

The US Food and Drug Administration (FDA) has approved Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer. Cysview is an optical imaging agent 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 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).

Highlights of Prescribing Information

These highlights do not include all the information needed to use Cysview safely and effectively. See full prescribing information for Cysview.

Cysview Indications and Usage

Cysview is an optical imaging agent 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 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).

Important Limitations of Use:

• Not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
• Not for repetitive use.

Dosage and Administration

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 hour 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.

Dosage Forms and Strengths

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

Contraindications

Do not use Cysview in patients with:

• porphyria,
• gross hematuria,
• BCG immunotherapy or intravesical chemotherapy within the past 90 days, or
• known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives.

• 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.

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 hour 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.

Dosage Forms and Strengths

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

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 GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.