Version May 2024
Detection of bladder cancer: Intravesical instillation: 100 mg (50 mL) instilled into empty bladder via urinary catheter.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Central nervous system: Headache, procedural pain
Genitourinary: Bladder spasm (2%), bladder pain, dysuria, hematuria
<1%, postmarketing, and/or case reports: Abnormal urinalysis, anaphylaxis (including anaphylactoid shock), cystitis, hypersensitivity reaction
Known hypersensitivity to hexaminolevulinate, any derivative of aminolevulinic acid, or any component of the formulation; porphyria; gross hematuria
Concerns related to adverse events:
• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis and anaphylactoid shock, have been reported following administration. Immediate treatment for anaphylaxis and/or hypersensitivity reactions and trained personnel should be available during use.
Other warnings/precautions:
• Appropriate use: Bladder must be emptied of urine prior to instillation of fluids for cystoscopy. Biopsy/resect bladder mucosal lesions only following completion of both white and blue light rigid cystoscopy. Do not use in patients with gross hematuria.
• Failed detection: May fail to detect some bladder tumors (including malignant tumors). Cystoscopic examination with hexaminolevulinate is not a replacement for random biopsies or other procedures usually performed in the cystoscopic evaluation for cancer. Both light settings of the PDD system (white before blue) must be used for the most accurate detection of malignancies.
• False fluorescence: Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. False positive fluorescent areas may result from inflammation, cystoscopic trauma, scar tissue, or bladder mucosal biopsy from prior cystoscopic examinations, as well as recent BCG immunotherapy or intravesical chemotherapy. The presence of urine and/or blood in the bladder may interfere with detection.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravesical, as hydrochloride:
Cysview: 100 mg (1 ea)
No
Solution (reconstituted) (Cysview Intravesical)
100 mg (per each): $1,522.80
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravesical, as hydrochloride:
Cysview: 100 mg (1 ea)
Intravesical instillation: Slowly instill solution (50 mL) via intravesical catheter into emptied bladder; catheter may be a straight or intermittent urethral catheter with a proximal funnel opening to accommodate a luer lock adapter. Use only catheters which are vinyl (uncoated or coated in hydrogel), latex (amber or red), and silicone for instillation; do not use catheters coated or embedded with silver or antibiotics. Indwelling catheters (eg, Foley catheters) may only be used if inserted shortly before and removed following instillation of hexaminolevulinate. Following instillation, remove catheter and instruct the patient to retain the solution for at least 1 hour (maximum: 3 hours); patient may stand, sit, and move around while retaining instillation; solution should be evacuated immediately prior to the initiation of the cystoscopic procedure. After voiding of the bladder, the perineal skin region should be washed with soap and water and dried (avoid skin contact with hexaminolevulinate solution). Begin cystoscopic exam within 30 minutes of evacuation (but not less than 1 and no more than 3 hours after instillation into bladder); if the patient retained the solution for <1 hour, allow 1 hour to pass from the instillation to the initiation of cystoscopic examination. Refer to manufacturer's instructions for details on cystoscopic examination procedure.
Detection of bladder cancer: Imaging agent for cystoscopic detection of bladder cancer (including carcinoma in situ), in patients with known or suspected lesion(s) based on prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer. Hexaminolevulinate is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC) as an adjunct to the white light cystoscopy.
Limitations of use: Not a replacement for random bladder biopsies or other procedures used to detect bladder cancer.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
BCG (Intravesical): May diminish the diagnostic effect of Hexaminolevulinate. Risk X: Avoid combination
Adequate animal reproduction studies have not been conducted. Systemic absorption is expected to be minimal.
It is not known if hexaminolevulinate is present in breast milk. Systemic absorption is expected to be minimal. According to the manufacturer, the decision to continue or discontinue breastfeeding following administration should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of diagnostic imaging to the mother.
Monitor for signs/symptoms of hypersensitivity
Upon intravesical administration, hexaminolevulinate, an ester of aminolevulinic acid and a porphyrin precursor, enters urinary epithelial cells and is used in the formation of photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are thought to preferentially accumulate in neoplastic cells. Following photoexcitation with the Karl Storz D-Light Photodynamic Diagnostic (PDD) system (white and blue light), PpIX and PAPs fluoresce and can be used to detect malignant lesions on cystoscopy; fluorescence from tumor tissue appears bright red and demarcated.
Bioavailability: Intravesical: 7%
Half-life elimination: Biphasic; Initial: 39 minutes; Terminal: ~76 hours
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