Important Risk & Safety Information for Cysview® (hexaminolevulinate HCl)

Cysview is an optical imaging agent used to detect non-muscle invasive bladder cancer in patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer. Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. False-positive fluorescence may occur due to inflammation, trauma from past cystoscopies, scar tissue, previous bladder biopsy, and recent Bacillus Calmette-Guérin (BCG) therapy or intravesical chemotherapy.

Anaphylactoid shock, hypersensitivity reactions, bladder pain, bladder inflammation (cystitis), and abnormal urine tests have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, trouble urinating, discomfort when urinating, frequent urination, blood in the urine, and bladder pain.

Cysview should not be used in patients with large amounts of blood in their urine, any known allergy to Cysview or any derivative of aminolevulinic acid, or porphyria, a condition that means you already have high levels of porphyrins in your body. No specific drug interaction studies have been performed.

There are no available data on Cysview use in pediatric patients, pregnant women, or nursing mothers.