cysview kit
Cysview Kit (Hexaminolevulinate Hydrochloride) is a medication supplied as a kit.
Hexaminolevulinate Hydrochloride · by Photocure Asa
Key facts
- Active ingredient
- Hexaminolevulinate Hydrochloride
- Form
- Kit
- Strength
- Hexaminolevulinate Hydrochloride 100MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Photocure Asa
- FDA application
- NDA022555
What is Cysview Kit?
From the FDA label:CYSVIEW (hexaminolevulinate hydrochloride) for intravesical solution is an optical imaging agent. The chemical name of hexaminolevulinate hydrochloride is hexyl 5-amino-4-oxopentanoate hydrochloride, and it has a molecular formula of C 11 H 21 NO 3 ∙HCl. Its molecular weight is 251.76, and it has the following structural formula: CYSVIEW and DILUENT for CYSVIEW are supplied together as a kit: CYSVIEW is a sterile, non-pyrogenic, freeze-dried, white to off-white or pale yellow powder provided in a clear glass vial. Each vial contains 100 mg hexaminolevulinate hydrochloride (equivalent to 85 mg hexaminolevulinate). The DILUENT for CYSVIEW is a sterile, non-pyrogenic, clear, colorless solution (pH 6) free from visible particles provided in a 50 mL plastic prefilled syringe. Each mL contains 0.61 mg disodium hydrogen phosphate, 0.58 mg potassium dihydrogen phosphate, 7.02 mg sodium chloride, hydrochloric acid and sodium hydroxide for pH adjustment, and water for injection. The reconstituted solution of CYSVIEW contains 2 mg/mL of hexaminolevulinate hydrochloride and is colorless to pale yellow. It is free from visible particles and has a pH between 5.7 and 6.2. Chemical Structure
How to use
The recommended adult dose is 100 mg reconstituted in 50 mL of the supplied diluent instilled into the bladder via a urinary catheter and retained for 1 hour to 3 hours before evacuation. ( 2.1 ) Use an FDA-authorized blue light imaging device intended to perform blue light cystoscopy with hexaminolevulinate hydrochloride. ( 2.4 ) Perform cystosopic examination of the entire bladder first under white light and then under blue light. ( 2.5 ) For reconstitution, administration, and cystoscopic examination see full prescribing information. ( 2.2 , 2.3 , 2.5 ) 2.1 Recommended Dose The recommended dose for adults is 100 mg of CYSVIEW administered by bladder instillation. Reconstitute the CYSVIEW 100 mg powder in the vial with the supplied diluent to a final volume of 50 mL. Administer the entire 50 mL dose via a urinary catheter. The solution should be retained in the bladder for 1 hour to 3 hours following instillation. [see Dosage and Administration (2.2 , 2.3) ] . 2.2 Reconstitution of CYSVIEW General Instructions CYSVIEW is supplied as a kit with diluent for reconstitution, with or without a vial adapter for use during reconstitution [see How Supplied/Storage and Handling (16) ] . Perform all steps using aseptic technique. Wear gloves during the reconstitution procedure; skin exposure to CYSVIEW may increase the risk of sensitization to the drug. Reconstituted CYSVIEW has a…
Side effects
The following clinically significant adverse reaction is discussed elsewhere in the Prescribing Information: Anaphylaxis [see Warnings and Precautions (5.1) ] . The most common adverse reaction was bladder spasm followed by dysuria, hematuria, and bladder pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Photocure Inc. at 1-855-297-8439 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CYSVIEW was evaluated in 1,628 patients in seven clinical trials. Patients were aged 32 to 96 years with a median age of 70 years, 77% male, 88% White, 3% Black or African American, and 9% of unspecified racial group. All patients were evaluated after a single instillation of 100 mg of CYSVIEW, and 103 patients received a repeat administration of CYSVIEW [see Clinical Studies (14) ] . The most common adverse reaction was bladder spasm (reported in 2% of the patients) followed by dysuria, hematuria, and bladder pain. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of CYSVIEW. Because these reactions are reported voluntarily…
Warnings
Important safety information
Anaphylaxis: Have trained personnel and therapies available. ( 5.1 ). Failed Detection: CYSVIEW may not detect all malignant lesions. Always perform white light cystoscopy followed by blue light cystoscopy. Do not biopsy with blue light only. ( 5.2 ) False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy, or chemotherapy. ( 5.3 ) 5.1 Anaphylaxis Anaphylaxis, including anaphylactic shock, has been reported following administration of CYSVIEW [see Adverse Reactions (6.2) ] . Prior to and during use of CYSVIEW, have trained personnel and therapies available for the treatment of anaphylaxis. 5.2 Failed Detection CYSVIEW may fail to detect some bladder tumors, including malignant lesions. CYSVIEW is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer. Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light [see Dosage and Administration (2.5) and Clinical Studies (14) ] . The presence of urine and/or blood within the bladder may interfere with the detection of tissue fluorescence. To enhance the diagnostic utility of CYSVIEW: Ensure the bladder is emptied of urine prior to the instillation of fluids at cystoscopy. Rinse the bladder as needed during cystoscopy to optimize visualisation. Biopsy/resect bladder mucosal lesions only following completion of both white light and blue light rigid cystoscopy. 5.3 False Positive Fluorescence Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. In clinical studies, approximately 20% of the lesions detected only by blue light cystoscopy showed neither dysplasia nor carcinoma [see Clinical Studies (14) ] . False positive fluorescence may result from inflammation, cystoscopic trauma, and scar tissue from bladder mucosal biopsy from a previous cystoscopic examination, or following intravesical treatment such as recent BCG immunotherapy or intravesical chemotherapy. In a study of patients treated with recent BCG immunotherapy or intravesical chemotherapy, the rate of false positives with blue light was 55% between 6 weeks to 90 days and 41% after 90 days; the false positive rate was 53% and 33% at the respective time intervals with white light.
Who should not take Cysview Kit
CYSVIEW is contraindicated in patients with: Porphyria Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid Porphyria Known hypersensitivity to hexaminolevulinate or aminolevulinate derivatives ( 4 )
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- Is there a coupon or discount for Cysview Kit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cysview Kit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cysview Kit?
- Cysview Kit is marketed by Photocure Asa. You can see Photocure Asa's full profile, rating, and other products on pharmaranks.
- Is Cysview Kit a brand-name or generic drug?
- Cysview Kit is a brand-name product with the active ingredient Hexaminolevulinate Hydrochloride.
- Is Cysview Kit available over the counter?
- No. Cysview Kit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cysview Kit come in?
- Cysview Kit is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Cysview Kit FDA-registered?
- Cysview Kit is on record with the U.S. FDA under application number NDA022555. You can verify this on its official FDA label.
- Is Cysview Kit safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cysview Kit. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cysview Kit?
- Cysview Kit's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reaction is discussed elsewhere in the Prescribing Information: Anaphylaxis [see Warnings and Precautions (5.1) ] . The most common adverse reaction was bladder spasm followed by dysuria, hematuria, and bladder pain.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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