Dosing and uses of Cysview (hexaminolevulinate)
Adult dosage forms and strengths
powder for reconstitution; bladder instillation
- 100mg
Bladder Cancer Diagnostic Agent
Indicated for detecting recurrent nonmuscle invasive papillary bladder cancer (based on prior cystoscopy)
Instill 50 mL of reconstituted imaging agent via intravesical catheter into emptied bladder
Administration
Reconstitute powder with 40 mL diluent (supplied)
Use solution immediately after reconstitution; otherwise store in refrigerator at 2-8 degrees C (36-46 degrees F) for up to 2 hr
After bladder instillation, retain for 1 hr before evacuating and performing cystoscopic exam (under white and then blue lights with Karl Storz D-Light C Photodynamic Diagnostic system)
Pediatric dosage forms and strengths
Safety and efficacy not established
Cysview (hexaminolevulinate) adverse (side) effects
1-10%
Dysuria
Hematuria
Headache
Pain
Urinary retention
Spasm
Warnings
Contraindications
Hypersensitivity
Porphyria
Gross hematuria BCG immunotherapy or intravesical chemotherapy within last 3 months
Cautions
May fail to detect some bladder tumors, including malignant lesions; NOT a replacement for random biopsies or other evaluation procedures
False fluorescence may occur during blue light cystoscopy and be unable to detect either dysplasia or carcinoma
Fluorescent areas in bladder mucosa may result from inflammation, cystoscopic trauma, scar tissue, or bladder mucosal biopsy from previous cystoscopic examination
Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), or silicone for bladder instillation; do not use catheters coated or embedded with silver or antibiotics
Avoid contact with skin
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk, caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Cysview (hexaminolevulinate)
Mechanism of action
Hexaminolevulinate is an ester of aminolevulinic acid, a heme precursor; used as photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs); PpIX and PAPs referentially accumulate in neoplastic cells and are detected at light wavelengths of 360-450 to distinguish between cancerous and normal tissue
Pharmacokinetics
Half-Life: Biphasic; 39 minutes initial half-life, 76 hr terminal half-life
Absorption: 7% following 1 hr instillation
Metabolism: Rapidly by human blood
Bioavailability: 7% (intravesical)
