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Cysview
(hexaminolevulinate hydrochloride), for Intravesical Solution
For bladder instillation only
Cysview contains hexaminolevulinate hydrochloride, an optical imaging drug that in solution form is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy.
The chemical formula for hexaminolevulinate hydrochloride is C11H21NO3•HCl. Its molecular weight is 251.76 and it has the following structural formula:
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Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution is intended for intravesical administration only after reconstitution with the supplied 50 mL DILUENT. Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution and DILUENT for Cysview are supplied together as a kit.
Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution is supplied as a sterile, non-pyrogenic, freeze-dried, white to off-white or pale yellow, powder containing 100 mg of hexaminolevulinate hydrochloride (equivalent of 85 mg of hexaminolevulinate) in a 10 mL clear glass vials. The DILUENT for Cysview (hexaminolevulinate hydrochloride intravesical solution) is a sterile, non-pyrogenic solution (pH 6) containing 0.61 mg/ mL disodium hydrogen phosphate, 0.58 mg/mL of potassium dihydrogen phosphate, 7.02 mg/mL of sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection. It is a clear, colorless solution, free from visible particles, and is provided in a 50 mL polypropylene vial.
The reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) 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.
Cysview (hexaminolevulinate hydrochloride intravesical solution) is indicated 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. Cysview (hexaminolevulinate hydrochloride intravesical solution) is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).
Cysview (hexaminolevulinate hydrochloride intravesical solution) is not:
The recommended dose for adults is 50 mL of reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) (2.2), instilled into the bladder via a urinary catheter (2.3).
Cysview (hexaminolevulinate hydrochloride intravesical solution) is supplied as a kit containing two vials: a clear glass vial labeled as Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, containing 100 mg hexaminolevulinate hydrochloride as a powder, and a vial labeled as DILUENT for Cysview (hexaminolevulinate hydrochloride intravesical solution) , containing 50 mL of the diluent in a polypropylene vial.
Perform all steps under aseptic conditions. Use gloves during the reconstitution procedure; skin exposure to hexaminolevulinate hydrochloride may increase the risk for sensitization to the drug.
Use a 50 mL syringe with a Luer Lock tip throughout the reconstitution procedure to ensure that the correct concentration (2mg/mL) of the drug is obtained and that a stable syringe-catheter connection is made for the bladder instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) .
Figure1
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1. Remove the cap from the sterile 50 mL syringe and carefully retain it for subsequent reattachment to the syringe (step 4). Attach a needle to the syringe and withdraw 50 mL of the diluent (Figure 1).
Figure 2
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2. Penetrate the stopper of the Cysview (hexaminolevulinate hydrochloride intravesical solution) powder vial with the needle and inject 10 mL of the diluent from the syringe into the powder vial (Figure 2).
3. Without withdrawing the needle from the vial, hold the powder vial and syringe in a firm grip (Figure 3) and gently shake to dissolve of the powder in the diluent. The powder normally dissolves almost immediately.
Figure 3
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4. Withdraw all of the dissolved solution from the powder vial (10 mL) into the 50 mL syringe (Figure 4).
Figure 4
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5. Remove the needle from the powder vial, disconnect the needle from the syringe tip and discard it. Plug the syringe with the syringe cap (Figure 5). Gently mix the contents of the syringe. The reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) is colorless to pale yellow and clear to slightly opalescent, and free from visible particles.
Figure 5
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Figure 6
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6. Peel off the detachable portion of the label (starting at the corner marked with a black triangle) from the Cysview (hexaminolevulinate hydrochloride intravesical solution) powder vial and affix it to the syringe containing the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) (Figure 6). Add two hours to the present time and write the resulting expiration time and date on the syringe label.
Cysview (hexaminolevulinate hydrochloride intravesical solution) is now reconstituted and ready for use. Instill the reconstituted solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder. If unable to administer the solution shortly after reconstitution, the solution may be stored for up to 2 hours in a refrigerator at 2°-8°C (36°- 46°F) in the labeled syringe. If not used within 2 hours, discard the solution.
For bladder instillation of the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) , 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 to instill the reconstituted Cysview (hexaminolevulinate hydrochloride intravesical solution) . Do not use catheters coated or embedded with silver or antibiotics. In-dwelling bladder catheters (Foley catheters) may be used if the catheters are inserted shortly prior to Cysview (hexaminolevulinate hydrochloride intravesical solution) administration and are removed following the Cysview (hexaminolevulinate hydrochloride intravesical solution) instillation.
Use the following steps for bladder instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) :
1. Using standard sterile catheterization technique, first insert the urethral catheter into the bladder of the patient and use the catheter to completely empty the patient's bladder before instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) .
Figure 7
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2. To attach the syringe containing the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) to the catheter, do the following:
3. Slowly instill the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder through the catheter (Figure 7), ensuring that the complete volume of the syringe (50 mL) is administered.
4. After the solution is instilled, remove the catheter and instruct the patient to retain the solution within the bladder for at least 1 hour; do not exceed 3 hours. Patients may stand, sit and move about during the time period between instillation and start of the cystoscopic procedure.
5. Evacuate the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) from the bladder as part of routine emptying of the bladder immediately prior to the initiation of the cystoscopic procedure (refer to the Karl Storz PDD Telescope Instruction manual). Also, the patient may void and completely empty the bladder prior to the procedure.
Avoid skin contact with Cysview (hexaminolevulinate hydrochloride intravesical solution) . If skin does come in contact with Cysview (hexaminolevulinate hydrochloride intravesical solution) , wash immediately with soap and water and dry off. After voiding the bladder of Cysview (hexaminolevulinate hydrochloride intravesical solution) , routinely wash the patient's perineal skin region with soap and water and dry.
Cysview (hexaminolevulinate hydrochloride intravesical solution) imaging requires the use of the Karl Storz D-Light C PDD system, which consists of a light source, a camera and a telescope. The light source enables both white light cystoscopy and blue light (wavelength 360 – 450 nm) fluorescence cystoscopy. Familiarity with this system is essential before beginning the procedure and before instilling Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder. For system set up and general information for the safe use of the PDD system, refer to the Karl Storz instruction manual for the PDD system and the instruction manuals for each of the system components. The PDD System is not for use by healthcare providers with green-red color blindness.
Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview (hexaminolevulinate hydrochloride intravesical solution) . Carefully review the instruction manuals provided with the Karl Storz D-Light C Photodynamic Diagnosis (PDD) System. For additional training in the use of the PDD System, contact the manufacturer's representative.
Initiate the cystoscopic examination within 30 minutes after evacuation of Cysview (hexaminolevulinate hydrochloride intravesical solution) from the bladder, but no less than 1 or more than 3 hours after Cysview (hexaminolevulinate hydrochloride intravesical solution) is instilled in the bladder. If the patient did not retain Cysview (hexaminolevulinate hydrochloride intravesical solution) in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) into the bladder to the start of the cystoscopic examination. The efficacy of Cysview (hexaminolevulinate hydrochloride intravesical solution) has not been established when the solution was retained for less than 1 hour.
Empty the patient's bladder and then fill the bladder with a clear fluid (standard bladder irrigation fluid) in order to distend the bladder wall for cystoscopic visibility. Ensure adequate irrigation during examination of the bladder; blood, urine or floating particles in the bladder may interfere with visualization under both white light and blue light.
First perform a complete cystoscopic examination of the entire bladder under white light (Mode 1) and then repeat the examination of the entire bladder surface under blue light (Mode 2) unless the white light cystoscopy reveals extensive mucosal inflammation. Do not perform the blue light cystoscopy if the white light cystoscopy reveals wide-spread mucosal inflammation. Abnormalities of the bladder mucosa during blue light cystoscopy are characterized by the detection of red, homogenous and intense fluorescence. The margins of the abnormal lesions are typically well-demarcated and in contrast to the normal urothelium, which appears blue. Register and document (map) the location and appearance (e.g. papillary) of suspicious lesions and abnormalities seen under either white or blue light.
During the cystoscopic examination, be aware that:
Perform biopsy and/or resection of suspicious lesions by transurethral resection of the bladder (TURB) only after completing white and blue light cystoscopic examinations with bladder mapping. Using standard cystoscopic practices, obtain biopsies of abnormal areas identified during either white or blue light examination and perform resections. Always check for the completeness of the resections under both white light and blue light before finalizing the TURB procedure.
Cysview (hexaminolevulinate hydrochloride) is supplied as a kit containing:
Once reconstituted, the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) contains 2 mg/mL of hexaminolevulinate hydrochloride.
Cysview is supplied as a kit labeled, Cysview (hexaminolevulinate hydrochloride) Kit for Intravesical Solution, 100 mg. The kit contains:
NDC 0407-4085-01
Store Cysview (hexaminolevulinate hydrochloride) Kit for Intravesical Solution at 20°-25°C (68°-77°F); excursions are permitted to 15°-30°C (59°-86°F). Do not use beyond the expiry date printed on the carton.
Use the solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) shortly after reconstitution. If unable to use within this time period, the reconstituted solution can be stored under refrigeration (2°-8°C / 36°-46°F) for up to 2 hours in the 50 mL labeled syringe.
Distributed by GE Healthcare Inc., Princeton, NJ 08540 U.S.A. Licensed from Photocure ASA. Packaged and Labeled by Orifice Medical AB, Ystad, Sweden.
Anaphylaxis has been reported following exposure to Cysview [see WARNINGS AND PRECAUTIONS].
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.
In six clinical trials, safety data were obtained from 1,324 patients, aged 32 to 96 years with a median age of 69 years, all primarily Caucasian and approximately 75% male. All patients were evaluated after a single instillation of 50 mL solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) . Of these patients, 161 (12.2%) patients reported at least one adverse reaction. The most common adverse reaction was bladder spasm (reported in 2.2% of the patients) followed by dysuria, hematuria, and bladder pain. No patients experienced anaphylaxis. In the controlled clinical study, adverse reactions were similar in nature and rate between the study drug group and the control group [see Clinical Studies].
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported during post-marketing use of Cysview (hexaminolevulinate hydrochloride intravesical solution) .
No specific drug interaction studies have been performed.
Included as part of the PRECAUTIONS section.
Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview [see ADVERSE REACTIONS]. Prior to and during use of the Cysview (hexaminolevulinate hydrochloride intravesical solution) , have trained personnel and therapies available for the treatment of anaphylaxis. The safety of repetitive Cysview (hexaminolevulinate hydrochloride intravesical solution) exposures has not been evaluated.
Cysview (hexaminolevulinate hydrochloride intravesical solution) may fail to detect some bladder tumors, including malignant lesions. Cysview (hexaminolevulinate hydrochloride intravesical solution) is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer. In the controlled clinical trial, Cysview (hexaminolevulinate hydrochloride intravesical solution) failed to detect 10% of lesions confirmed as malignant within the study drug group [see Clinical Studies]. 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].
Fluorescent areas detected during blue light cystoscopy may not indicate a bladder mucosal lesion. In the controlled clinical study, biopsies from one of every four fluorescent areas showed neither dysplasia nor carcinoma, if the areas were not also identified during white light cystoscopy [see Clinical Studies]. In addition to these false detections, fluorescent areas within the bladder mucosa may result from inflammation, cystoscopic trauma, scar tissue or bladder mucosal biopsy from a previous cystoscopic examination.
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 (hexaminolevulinate hydrochloride intravesical solution) with the Karl Storz D-Light C PDD System:
No studies in animals have been conducted to evaluate the carcinogenic potential of hexaminolevulinate hydrochloride.
Hexaminolevulinate hydrochloride was not mutagenic in in vitro reverse mutation tests in bacteria, or in chromosome aberration tests in human peripheral blood lymphocytes, and was negative in an in vivo micronucleus test in mice after intravenous injection of doses up to 45 mg/kg in the absence of light activation. Adequate studies have not been performed to evaluate the genetic toxicity of hexaminolevulinate hydrochloride in the presence of light activation.
Adequate reproductive and developmental toxicity studies in animals have not been performed to evaluate the effects of hexaminolevulinate hydrochloride on fertility.
There are no adequate and well-controlled studies in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Cysview (hexaminolevulinate hydrochloride intravesical solution) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when Cysview (hexaminolevulinate hydrochloride intravesical solution) is administered to nursing mothers.
Safety and effectiveness in pediatric patients have not been established.
Of 1823 subjects in clinical studies of Cysview (hexaminolevulinate hydrochloride intravesical solution) , 67% were 65 years and over while 34% were 75 years and over. No clinically important differences in safety or efficacy have been observed between older and younger patients in the controlled study.
No adverse events were reported in a dose-finding study conducted among patients whose bladders were instilled with twice the recommended concentration (dose) of solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) .
Cysview (hexaminolevulinate hydrochloride intravesical solution) is contraindicated in patients with:
Cysview (hexaminolevulinate hydrochloride intravesical solution) is an ester of the heme precursor, aminolevulinic acid. After bladder instillation, Cysview (hexaminolevulinate hydrochloride intravesical solution) enters the bladder mucosa and is proposed to enter the intracellular space of mucosal cells where it is used as a precursor in the formation of the photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are reported to accumulate preferentially in neoplastic cells as compared to normal urothelium, partly due to altered enzymatic activity in the neoplastic cells. After excitation with light at wavelengths between 360 and 450 nm, PpIX and other PAPs return to a lower energy level by fluorescing, which can be detected and used for cystoscopic detection of lesions. The fluorescence from tumor tissue appears bright red and demarcated, whereas the background normal tissue appears dark blue. Similar processes may occur in inflamed cells.
In vitro studies have shown increased porphyrin fluorescence in normal urothelium after exposure to Cysview (hexaminolevulinate hydrochloride intravesical solution) . In the human bladder, a greater accumulation of porphyrins is proposed in neoplastic or inflamed cells, compared to normal urothelium. After bladder instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) for approximately 1 hour and subsequent illumination with blue light at wavelengths 360 – 450nm, the porphyrins will fluoresce red [see DOSAGE AND ADMINISTRATION].
After bladder instillation of [14C]-labeled Cysview (hexaminolevulinate hydrochloride intravesical solution) (100 mg) for approximately 1 hour in healthy volunteers, absolute bioavailability of Cysview (hexaminolevulinate hydrochloride intravesical solution) was 7% (90% confidence interval [CI]: 5%-10%). The [14C]-labeled substance(s) showed biphasic elimination, with an initial elimination half-life of 39 minutes, followed by a terminal half-life of approximately 76 hours. Whole blood analysis showed no evidence of significant binding of Cysview (hexaminolevulinate hydrochloride intravesical solution) to erythrocytes. An in vitro study showed that Cysview (hexaminolevulinate hydrochloride intravesical solution) underwent rapid metabolism in human blood.
Dose dependent neurological effects such as tremor, increased motor activity, and increased startle and touch escape responses were observed immediately after dosing at doses ≥ 30 mg/kg (24 times human systemic exposure based on the body surface area, using 10% as the upper level of 90% confidence interval of bioavailability) in a single dose rat study. The animals recovered to normal status by 60 min after dosing. Adverse neurological effects were also noted in other single or repeat dose toxicity studies.
Hexaminolevulinate hydrochloride had moderate to strong potential to cause skin sensitization based on a local lymph node assay in mouse.
The safety and efficacy of Cysview (hexaminolevulinate hydrochloride intravesical solution) when used with photodynamic cystoscopy were studied in a prospective, multicenter, controlled clinical trial. Adult patients with known or suspected bladder cancer were randomized to either white light (WL) cystoscopy (control group, n = 384) or WL followed by blue light (BL) cystoscopy (study drug group, n = 395). Only the study drug group patients received Cysview (hexaminolevulinate hydrochloride intravesical solution) by bladder instillation prior to cystoscopy. After bladder evacuation of Cysview (hexaminolevulinate hydrochloride intravesical solution) , bladder lesion mapping was performed initially using the Karl Storz PDD system in the WL mode followed by lesion mapping in the BL mode. Control group patients underwent only WL cystoscopy with lesion mapping. The average age of the randomized patients was 69 years (range 24 to 96); 78% were male and 94% were Caucasian. All patients had previously undergone cystoscopy.
The main diagnostic efficacy outcome was assessed within the study drug group. This assessment compared lesions detected during an initial cystoscopic examination to their centralized histologic findings (the standard of truth). Following the initial diagnostic cystoscopy, patients within both study groups who had histologically confirmed Ta and/or T1 lesions underwent follow-up WL cystoscopy at 3, 6 and 9 months; these histologic evaluations were based upon the site assessments at both the initial and follow-up cystoscopy.
Diagnostic efficacy assessed the number of patients within the study drug group who had at least one additional Ta or T1 bladder cancer detected only by BL; the proportion of these patients was compared to a proposed threshold proportion of 10%. Within the study drug group, 286 patients had at least one Ta and/or T1 lesion, including 47 patients who had at least one of the lesions detected only by BL (see Table 1).
Table 1: BL Cystoscopic Ta and/or T1 Lesion Detection within
the Study Drug Group
| Number of patients with any Ta and/or T1 lesion detected with either WL or BL | 286 |
| Number (%) of patients with any Ta and/or T1 lesion detected only with BL | 47 (16%) |
| p-value* | 0.001 |
| *exact test comparison of the proportion to a threshold value of 10% Some malignant lesions were detected only by WL or BL (see Table 2). | |
Table 2: Bladder Tumor Detection within the Study Drug Group
by WL and/or BL Cystoscopy
| Number of lesions | Detected by Both WL & BL |
Detected by WL Only |
Detected by BL Only |
| CIS, n = 66 | 33 | 6 | 27 |
| Ta, n = 580 | 472 | 52 | 56 |
| T1, n = 95 | 76 | 10 | 9 |
| T2 – T4, n = 47 | 38 | 8 | 1 |
Among the lesions detected only by BL, 23% were negative for any carcinoma-related pathology, including dysplasia. Among the lesions detected only by WL, 17% were negative for any carcinoma-related pathology, including dysplasia.
Ask patients if they have:
Inform patients that Cysview (hexaminolevulinate hydrochloride intravesical solution) should be retained in the bladder for 1 hour from instillation of Cysview (hexaminolevulinate hydrochloride intravesical solution) to the start of the cystoscopic procedure. If the patient cannot hold Cysview (hexaminolevulinate hydrochloride intravesical solution) for 1 hour, but needs to void and expel Cysview (hexaminolevulinate hydrochloride intravesical solution) from the bladder, he or she may void and should then inform a health care professional [see DOSAGE AND ADMINISTRATION].
