Hexaminolevulinate

CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

Hexaminolevulinate is an ester of the heme precursor, aminolevulinic acid. After bladder instillation, hexaminolevulinate enters the bladder mucosa and is proposed to enter the intracellular space of mucosal cells where it is used as a precursor in the formation of the photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are reported to accumulate preferentially in neoplastic cells as compared to normal urothelium, partly due to altered enzymatic activity in the neoplastic cells. After excitation with light at wavelengths between 360 nm and 450 nm, PpIX and other PAPs return to a lower energy level by fluorescing, which can be detected and used for cystoscopic detection of lesions. The fluorescence from tumor tissue appears bright red and demarcated, whereas the background normal tissue appears dark blue.

The recommended adult dose is 100 mg reconstituted in 50 mL of the supplied diluent instilled into the bladder via a urinary catheter and retained for 1 hour to 3 hours before evacuation. Use an FDA-authorized blue light imaging device intended to perform blue light cystoscopy with hexaminolevulinate hydrochloride. Perform cystosopic examination of the entire bladder first under white light and then under blue light. For reconstitution, administration, and cystoscopic examination see full prescribing information.

CYSVIEW is contraindicated in patients with: Porphyria Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid Porphyria 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 followed by blue light cystoscopy. Do not biopsy with blue light only. False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy, or chemotherapy.

The following clinically significant adverse reaction is discussed elsewhere in the Prescribing Information: Anaphylaxis. The most common adverse reaction was bladder spasm followed by dysuria, hematuria, and bladder pain.

Store the CYSVIEW kit at 20°C to 25°C (68°F to 77°F), excursions are permitted to 15°C to 30°C (59°F to 86°F). Alternatively, the solution may be stored in the labeled syringe under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 2 hours.