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Cysview Generic Name & Formulations
Legal Class
Rx
General Description
Hexaminolevulinate HCl 100mg/vial; pwd for intravesical administration after reconstitution.
Pharmacological Class
Optical imaging agent.
How Supplied
Kit—1 (with or without vial adapter options)
Manufacturer
Cysview Indications
Indications
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.
Cysview Dosage and Administration
Adult
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).
Children
Not established.
Cysview Contraindications
Contraindications
Porphyria. Gross hematuria.
Cysview Boxed Warnings
Not Applicable
Cysview Warnings/Precautions
Warnings/Precautions
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.
Cysview Pharmacokinetics
See Literature
Cysview Interactions
Interactions
Recent BCG immunotherapy or intravesical chemotherapy may cause false (+) fluorescence.
Cysview Adverse Reactions
Adverse Reactions
Bladder spasm, dysuria, hematuria, bladder pain; anaphylaxis.
Cysview Clinical Trials
See Literature
Cysview Note
Not Applicable
Cysview Patient Counseling
See Literature
