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Hexaminolevulinate HydrochloridePronunciation: hex-a-MEE-noe-LEV-ue-lin-ate/HYE-droe-KLOR-ide
Class: In vivo diagnostic aid
- Intravesical powder for solution 100 mg
Enters the intracellular space of bladder mucosal cells and is used as a precursor in the formation of photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs), which accumulate preferentially in neoplastic cells. After excitation with light at wavelengths between 360 and 450 nm, PpIX and other PAPs fluoresce, which can be detected and used for cystoscopic detection of lesions.
Absolute bioavailability after bladder instillation is 7%.
Initial elimination half-life is 39 min; terminal half-life is 76 h.
Indications and Usage
For use in the 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.
Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 90 days; gross hematuria; porphyria; hypersensitivity to the product or any derivative of aminolevulinic acid.
Dosage and AdministrationDetection of bladder cancer
Intravesically 50 mL instilled into the bladder via a urinary catheter. After instillation of the solution, it should be retained in the bladder for at least 1 h and not more than 3 h. Evacuate the solution from the bladder immediately prior to initiation of the cystoscopic procedure. Initiate the cystoscopic examination within 30 min after evacuation.
- For intravesical administration only.
- Hexaminolevulinate imaging requires the use of the Karl Storz D-Light C Photodynamic Diagnostic system.
- Use gloves during reconstitution procedure; skin exposure may increase the risk of sensitization to the drug.
- To reconstitute, withdraw 50 mL from the diluent vial using a 50 mL syringe with a Luer–lock tip. Inject 10 mL of the diluent into the hexaminolevulinate vial and, without withdrawing the syringe from the vial, gently shake to dissolve the powder. Withdraw all of the dissolved solution from the vial into the 50 mL syringe. Remove the needle from the vial, disconnect the needle from the syringe tip and discard it. Recap the syringe. Gently mix the contents of the syringe and place the detachable label from the hexaminolevulinate vial on the syringe.
- Prior to administration, inspect visually for particulate matter and discoloration.
- Use straight or intermittent urethral catheters with a proximal funnel opening that will accommodate the Luer–lock adapter. Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), and silicone; do not use catheters coated or embedded with silver or antibiotics.
- Avoid skin contact with hexaminolevulinate. If contact does occur, wash skin immediately with soap and water, and dry off. After voiding the bladder of hexaminolevulinate, routinely wash the patient's perineal skin region with soap and water, and dry.
Store between 59° and 86°F and protect from light. Reconstituted solution may be stored under refrigeration (36° to 46°F) for up to 2 h in the 50 mL labeled syringe.
Drug InteractionsBCG immunotherapy or intravesical chemotherapy
Hexaminolevulinate is contraindicated in patients who have received BCG immunotherapy or intravesical chemotherapy within the past 90 days.
Laboratory Test Interactions
Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal session. Biopsies from 1 in every 4 fluorescent areas showed neither dysplasia nor carcinoma if the areas were not also identified during white light cystoscopy.
Bladder spasm (2%); dysuria, hematuria; abnormal urinalysis, bladder pain, cystitis (postmarketing).
Anaphylactoid shock, hypersensitivity reactions (postmarketing).
Category C .
Safety and efficacy not established.
Anaphylaxis, including anaphylactoid shock, has been reported. Trained personnel and therapies for the treatment of anaphylaxis should be available prior to and during use of hexaminolevulinate.
May fail to detect some bladder tumors, including malignant lesions. Hexaminolevulinate is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer.
Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. In addition, fluorescent areas within the bladder mucosa may result from inflammation, cystoscopic trauma, scar tissue, or bladder mucosal biopsy from a previous cystoscopic exam.
- Ask patients if they have a diagnosis or family history of porphyria, allergy to aminolevulinic acid or prior exposure to hexaminolevulinate, gross hematuria, or had BCG immunotherapy or intravesical chemotherapy.
- Inform patients that hexaminolevulinate should be retained in the bladder for at least 1 h from instillation until the start of the cystoscopic procedure. Advise patients to notify health care provider if they cannot hold the solution in the bladder for this time period.
Copyright © 2009 Wolters Kluwer Health.