CYSVIEW KIT

After bladder instillation of [ 14 C]-labeled Cysview (100 mg) for approximately 1 hour in healthy volunteers, absolute bioavailability of Cysview was 7% (90% confidence interval [CI]: 5%-10%). The [ 14 C]-labeled substance(s) showed biphasic elimination, with an initial elimination half-life of 39 minutes, followed by a terminal half-life of approximately 76 hours. Whole blood analysis showed no evidence of significant binding of Cysview to erythrocytes. An in vitro study showed that Cysview un...

The safety and efficacy of Cysview when used with photodynamic cystoscopy were studied in two controlled clinical trials.

Study 1A prospective, multicenter, controlled clinical trial in adult patients with known or suspected bladder cancer who were randomized to either white light (WL) cystoscopy (control group, n = 384) or WL followed by blue light (BL) cystoscopy (study drug group, n = 395). Only the study drug group patients received Cysview by bladder instillation prior to cystoscopy. After bladder evacuation of Cysview, bladder lesion mapping was performed initially using the Karl Stor...

Anaphylaxis has been reported following exposure to Cysview [see Warnings and Precautions (5.1) ]. The most common adverse reaction reported in patients who received Cysview was bladder spasm, occurring in 2% of patients, followed by dysuria, hematuria and bladder pain. ( 6.1 ) 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. 6.1 Clinical Study Experience Because clinical trials are conducted under widely varying c...

Cysview is contraindicated in patients with: porphyria, gross hematuria, known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Do not use Cysview in patients with: porphyria, gross hematuria, known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives. ( 4 )

Anaphylaxis: have trained personnel and therapies available. ( 5.1 ). Failed Detection: Cysview may not detect all malignant lesions. Always perform white light cystoscopy followed by blue light cystoscopy. Do not biopsy with blue light only. ( 5.2 ) False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy or chemotherapy. ( 5.3 ) 5.1 Anaphylaxis Anaphylaxis, including anaphylactoid shock, has been reported following administr...

7 DRUG INTERACTIONS No specific drug interaction studies have been performed.