Adult Dosing

Cystoscopic imaging of non-muscle invasive papillary bladder cancer

• Recommended dose: 50 mL of reconstituted solution intravesicular via urinary catheter

• Retain the solution in the bladder for at least 1 hr (Max: 3 hrs) before evacuating and performing cystoscopic examination
• Evacuate the solution and empty the bladder prior to cystoscopy; the patient may void and completely empty the bladder prior to the procedure
• Use catheters made of vinyl, latex or silicone for instillation

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Imaging agent for use in cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy

Note:

• To be used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to any aminolevulinate derivatives
• Porphyria
• Gross hematuria
• BCG immunotherapy within the past 3 months
• Intravesical chemotherapy within the past 3 months

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Anaphylaxis, including anaphylactoid shock, may occur with the use of hexaminolevulinate. Appropriate treatment options and trained health professionals should be readily available for the management of anaphylaxis
• Product not indicated for repetitive use
• Certain bladder tumors and malignant lesions may not be detected by hexaminolevulinate. This agent is not a replacement for random biopsies and other commonly followed cystoscopic procedures for cancer screening
• Do not evaluate with blue light alone as some malignant lesions may be missed unless initially examined under white light
• Blood or urine present within the bladder may interfere with the detection of tissue fluorescence. To enhance the diagnostic utility of this product, ensure complete emptying of the bladder prior to instillation of fluids and perform biopsy/resection of bladder mucosal lesions only after completion of white and blue light cystoscopy
• Detection of fluorescent areas during blue light cystoscopy may not always indicate a bladder mucosal lesion. False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopy
• Avoid use of catheters embedded/coated with antibiotics or silver

Supplemental Patient Information

• Instruct patients to retain the solution in the bladder for at least 1 hr from instillation of the agent to the start of cytoscopic examination

Pregnancy Category:C

Breastfeeding: Safety unknown. Manufacturer advises caution when administering to nursing women.

• CNS: Headache
• GU: Bladder spasm, dysuria, hematuria, bladder pain, procedural pain, urinary retention
• HYPERSENSITIVITY: Anaphylaxis

• Optical imaging agent; acts as a precursor in the formation of photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs), which generally accumulate in neoplastic cells and are detected after excitation with light at wavelengths of 360-450 nm
• Bioavailability: 7%
• Metabolized rapidly in blood
• Excretion: Unknown
• Half-life:
• Initial: 39 minutes
• Terminal: 76 hrs

US Trade Name(s)

• Cysview

US Availability

Cysview

• PWDR for SOLN: 100 mg/vial (10 mL vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Radiologic

Radiocontrast Agents