Hexaminolevulinate Hydrochloride (1 brand name, 1 dosage form, 1 route)
Available dosage forms: FOR SOLUTION.
Routes of administration: INTRAVESICAL.
Brand Names
- CYSVIEW KIT
Indications and Usage
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 [see Warnings and Precautions (5.2)].
Contraindications
CYSVIEW is contraindicated in patients with: Porphyria Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid
Adverse Reactions
The following clinically significant adverse reaction is discussed elsewhere in the Prescribing Information: Anaphylaxis [see Warnings and Precautions (5.1)].
Mechanism of Action
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. Similar processes may occur in inflamed cells.