Cysview

Hexaminolevulinate hydrochloride · Kit

Prescription (Rx)

Uses

1 INDICATIONS AND USAGE CYSVIEW is indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) based on a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see Warnings and Precautions (5.2) ] . CYSVIEW is an optical imaging agent indicated for the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), in adult patients: With suspected or known lesion(s) on the basis of a prior cystoscopy Undergoing surveillance cystoscopy for bladder cancer Limitations of Use CYSVIEW is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. ( 1 , 5.2 )

Dosage and administration

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 concentration of 2 mg/mL hexaminolevulinate hydrochloride and appears as a colorless to pale yellow, clear to slightly opalescent solution free from visible particles. If not immediately used, store the reconstituted solution in the labeled syringe under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 2 hours. The solution should be discarded if not used within 2 hours. Reconstitution Using a Vial Adapter CYSVIEW Powder Diluent Plunger Rod Vial Adapter Figure A. Components of CYSVIEW and Attachment of Plunger Rod to Diluent Syringe 1. Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (see Figure A ). Figure B. Connection of Vial Adapter to CYSVIEW Vial 2. Remove the plastic cap from the vial. Remove the TyveK® cover from the vial adapter blister package. Do not remove the vial adapter from the package. Place the CYSVIEW vial on a flat surface. Using the blister package to hold the vial adapter, connect to the vial with a downward vertical motion. The vial adapter snaps onto the vial as the spike penetrates the rubber stopper of the vial. Remove the plastic blister package and discard it. Take care not to touch the exposed end of the vial adapter (see Figure B ). Figure C. Injection of Diluent into CYSVIEW Vial 3. Remove the cap from the prefilled syringe and carefully retain it for subsequent reattachment to the syringe. Hold the prefilled syringe upright and carefully press the plunger rod upward to remove air. Connect the syringe to the vial adapter. Inject about 10 mL of the diluent from the prefilled syringe down into the vial. The vial should be about ¾ full (see Figure C ). Figure D. Dissolution of CYSVIEW Powder in Diluent 4. Without disconnecting the vial adapter from the vial, hold the vial and syringe in a firm grip and gently shake to dissolve the powder in the diluent. The powder normally dissolves almost immediately (see Figure D ). Figure E. Withdrawal of Reconstituted CYSVIEW from Vial 5. Turn the vial upside down and withdraw all of the dissolved solution from the vial back into the syringe (see Figure E ). Do not inject large amounts of air or diluent when vial is inverted as it may block the venting action of the vial adapter. If this occurs, turn the vial upright and pull back on the plunger rod in the syringe. Figure F. Final Preparation of Reconstituted CYSVIEW Solution 6. Disconnect the empty vial with the vial adapter from the syringe tip and discard it. Plug the syringe with the syringe cap. Gently mix the contents of the syringe (see Figure F ). 7. Peel off the detachable portion of the syringe label. On the syringe label, add 2 hours to the present time and write the resulting expiration time and date. Reconstitution Without Using a Vial Adapter CYSVIEW Powder Diluent Plunger Rod Figure G. Components of CYSVIEW and Attachment of Plunger Rod to Diluent Syringe 1. Fasten the plunger rod into the rubber stopper of the prefilled syringe by turning the plunger rod clockwise until it stops (see Figure G ). Figure H. Injection of Diluent into CYSVIEW Vial 2. Remove the plastic cap from the vial. Remove the cap from the prefilled syringe and carefully retain it for subsequent reattachment to the syringe. Attach a needle to the prefilled syringe. Hold the prefilled syringe upright and carefully press the plunger rod upward to remove air. Penetrate the stopper of the CYSVIEW vial with the needle and inject about 10 mL of the diluent from the prefilled syringe down into the vial. The vial should be about ¾ full (see Figure H ). Figure I. Dissolution of CYSVIEW Powder in Diluent 3. Without withdrawing the needle from the vial, hold the vial and syringe in a firm grip and gently shake to dissolve of the powder in the diluent. The powder normally dissolves almost immediately (see Figure I ). Figure J. Withdrawal of Reconstituted CYSVIEW from Vial 4. Turn the vial upside down and withdraw all of the dissolved solution from the vial back into the syringe (see Figure J ). Figure K. Final Preparation of Reconstituted CYSVIEW Solution 5. Remove the needle from the vial, disconnect the needle from the syringe tip and discard it. Plug the syringe with the syringe cap. Gently mix the contents of the syringe (see Figure K ). 6. Peel off the detachable portion of the syringe label. On the syringe label, add two hours to the present time and write the resulting expiration time and date.

Dosage forms and strengths

For intravesical solution: 100 mg of hexaminolevulinate hydrochloride as a white to off-white or pale yellow freeze-dried powder for reconstitution with the supplied diluent. For intravesical solution: 100 mg of hexaminolevulinate hydrochloride for reconstitution with the supplied diluent

Contraindications

4 CONTRAINDICATIONS 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 )

Warnings and precautions

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.

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 from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Anaphylactic shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis.

Use in specific populations

8.1 Pregnancy Risk Summary There are no available data on CYSVIEW use in pregnant women to inform a drug associated risk of adverse developmental outcomes. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of CYSVIEW is expected to be minimal [see Clinical Pharmacology (12.3) ]. The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production. Systemic absorption following administration of CYSVIEW is expected to be minimal [see Clinical Pharmacology (12.3) ]. The lack of clinical data during lactation precludes a clear determination of the risk of CYSVIEW to an infant during lactation; therefore, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for CYSVIEW and any potential adverse effects on the breastfed infant from CYSVIEW or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Of 2,127 subjects in clinical studies of CYSVIEW, 67% were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Pregnancy

Pediatric use

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric use

8.5 Geriatric Use Of 2,127 subjects in clinical studies of CYSVIEW, 67% were 65 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Description

(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

Mechanism of action

12.1 Mechanism of Action Hexaminolevulinate is an ester of the heme precursor, aminolevulinic acid. After bladder instillation, hexaminolevulinate 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 nm 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.

How supplied

How Supplied CYSVIEW (hexaminolevulinate hydrochloride) for intravesical solution is supplied as a kit. It is available in the following two configurations: CYSVIEW Kit with Vial Adapter (NDC 10511-3001-2): This kit contains: One vial of CYSVIEW: 100 mg of hexaminolevulinate hydrochloride as a white to off-white or pale yellow freeze-dried powder in a 10 mL clear glass vial One DILUENT for CYSVIEW: 50 mL as a clear, colorless solution in plastic prefilled syringe One Luer Lock catheter adapter One vial adapter (either West Vented Vial Adapter or West Mixject Dispensing Pin) CYSVIEW Kit without Vial Adapter (NDC 10511-3001-3): This kit contains: One vial of CYSVIEW: 100 mg of hexaminolevulinate hydrochloride as a white to off-white or pale yellow freeze-dried powder in a 10 mL clear glass vial One DILUENT for CYSVIEW: 50 mL as a clear, colorless solution in plastic prefilled syringe One Luer Lock catheter adapter Storage and Handling Store the CYSVIEW kit at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). After reconstitution, use the CYSVIEW solution immediately. Alternatively, the solution may be stored in the labeled syringe under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 2 hours.

Storage

Storage and Handling Store the CYSVIEW kit at 20°C to 25°C (68°F to 77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). After reconstitution, use the CYSVIEW solution immediately. Alternatively, the solution may be stored in the labeled syringe under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 2 hours.

Patient information

Anaphylaxis Inform patients that CYSVIEW may cause severe hypersensitivity reactions including anaphylactic shock. Instruct patients to seek immediate medical attention if they experience any symptoms of hypersensitivity reactions [see Warnings and Precautions (5.1) ]. Administration Instructions Inform patients that CYSVIEW should be retained in the bladder for at least 1 hour from instillation of CYSVIEW to the start of the cystoscopic procedure. If the patient cannot hold CYSVIEW for 1 hour and needs to void and expel CYSVIEW from the bladder, they may void and should then inform a healthcare professional [see Dosage and Administration (2.5) ] .

Label text from the FDA structured product label by Photocure Inc. (revised Jun 3, 2026). Long sections are shortened; the complete label is on DailyMed.

Cysview NDC products (1)

NDC	Strength & form	Labeler	Type
10511-3001	Kit	Photocure Inc.	NDA

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Cysview is listed by 1 labeler in the FDA NDC directory, including Photocure Inc..