Generic Name and Formulations:
Hexaminolevulinate HCl 100mg/vial; pwd for intravesical administration after reconstitution.
Indications for CYSVIEW:
For use in the cystoscopic detection of bladder carcinoma, including carcinoma in situ, among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder carcinoma. Use with Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC) as an adjunct to the white light cystoscopy.
Limitations Of use:
Not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
See full labeling. Instill 50mL into emptied bladder via a urinary catheter. Retain in bladder for at least 1hr (max 3hrs) before evacuating and performing cystoscopic examination. First perform complete cystoscopic exam of entire bladder under white light, then repeat exam under blue light (unless white light reveals extensive mucosal inflammation).
Porphyria. Gross hematuria.
Have trained personnel and emergency treatment readily available. Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light. False (+) fluorescence may result due to inflammation, cystoscopic trauma, scar tissue, or bladder mucosal biopsy from previous cystoscopy. Presence of urine and/or blood within the bladder may interfere with detection of tissue fluorescence. Pregnancy. Nursing mothers.
Optical imaging agent.
Recent BCG immunotherapy or intravesical chemotherapy may cause false (+) fluorescence.
Bladder spasm, dysuria, hematuria, bladder pain; anaphylaxis.
Kit—1 (with or without vial adapter options)
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