Cysview

Generic name:hexaminolevulinate hydrochloride
Drug class:Malignancy photosensitizers
Approval date: May 28, 2010
Company: Photocure ASA
Treatment for: Detection of Papillary Bladder Cancer

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...