Overview
11 DESCRIPTION Cysview contains hexaminolevulinate hydrochloride, an optical imaging drug that in solution form is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. The chemical formula for hexaminolevulinate hydrochloride is C 11 H 21 NO 3 ∙HCl. Its molecular weight is 251.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Cysview is an ester of the heme precursor, aminolevulinic acid. After bladder instillation, Cysview 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 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.
Indications
- 1 INDICATIONS AND USAGE Cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC ® ) as an adjunct to the white light cystoscopy.
Common Doses
- 50 mL
- 100 mg
- 10 mL
- 2 mg
Dosage
2 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. ( 2.5 ) Reconstitute Cysview powder with the supplied 50 mL DILUENT under aseptic conditions. ( 2.2 ) 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 the labeled syringe. Discard after 2 hours. ( 2.2 , 16 ) Instill 50 mL of reconstituted solution of Cysview into the emptied bladder via an intravesical catheter.
Contraindications
- 4 CONTRAINDICATIONS 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 )
Side Effects
- 6 ADVERSE REACTIONS 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.
Interactions
- 7 DRUG INTERACTIONS No specific drug interaction studies have been performed.