Dosing & Uses
Dosage Forms & Strengths
powder for reconstitution; bladder instillation
- 100mg/vial
Bladder Cancer Diagnostic Agent
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
Used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLCTM) as an adjunct to the white light cystoscopy
Instill 50 mL of reconstituted imaging agent via intravesical catheter into emptied bladder
Also see Administration
Safety and efficacy not established
Adverse Effects
1-10%
Dysuria
Hematuria
Headache
Pain
Urinary retention
Spasm
Warnings
Contraindications
Hypersensitivity
Porphyria
Gross hematuria
Cautions
Anaphylaxis, including anaphylactoid shock reported; ensure trained personnel and therapies for anaphylaxis are available before and during administration
Failed detection
- May fail to detect some bladder tumors, including malignant lesions; NOT a replacement for random biopsies or other evaluation procedures
- Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light
False positive fluorescence
- 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
- The presence of urine and/or blood within the bladder may interfere detection of tissue fluorescence; ensure bladder is emptied prior to cystoscopy fluid instillation
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women to inform a drug associated risk of adverse developmental outcomes
Systemic absorption following administration is expected to be minimal
Lactation
There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production
Systemic absorption following administration is expected to be minimal
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
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)
Administration
Bladder Instillation
See prescribing information for full instructions and diagrams
Reconstitute powder with 50 mL diluent (supplied); resulting concentration is 2 mg/mL
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 at least 1 hr (not to exceed 3 hr) before evacuating and performing cystoscopic exam (under white and then blue lights with Karl Storz D-Light C Photodynamic Diagnostic system)
Avoid contact with skin; f skin does come in contact with hexaminolevulinate solution, wash immediately with soap and water and dry off
After voiding the bladder of hexaminolevulinate solution, routinely wash the patient’s perineal skin region with soap and water and dry
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Cysview intravesical - | 100 mg vial | ![]() |
Copyright © 2010 First DataBank, Inc.
Patient Handout
hexaminolevulinate intravesical
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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