Dosing & Uses
Dosage Forms & Strengths
powder for reconstitution; bladder instillation
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
Safety and efficacy not established
Gross hematuria BCG immunotherapy or intravesical chemotherapy within last 3 months
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 & Lactation
Pregnancy Category: C
Lactation: Unknown whether distributed in breast milk, caution advised
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.
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
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)
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)
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.