CYSVIEW® WITH BLUE-LIGHT CYSTOSCOPY (BLC)

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Cysview® (hexaminolevulinate HCl) is an optical imaging agent used with Blue Light Cystoscopy (BLC) as an adjunct to standard White Light Cystoscopy (WLC), which is approved and recommended for the detection of non-muscle invasive papillary bladder cancer (NMIBC).1

By enhancing the visual contrast between normal and malignant cells, Cysview significantly increases the detection of Ta/T1 tumours that are not detected by standard WLC alone.1 Better detection may improve resection of tumours compared to when using only WLC.2,3*

Cysview drives increased production of porphyrins inside cells. Unhealthy cells do not process out the compound as quickly as healthy cells. The resulting accumulation creates a red/pink glow in blue light. Visualization of the tumour cells is possible 1-3 hours after instillation.1



Indications and Clinical Use1

Cysview is indicated as an adjunct to White Light Cystoscopy in the detection of non-muscle invasive papillary bladder cancer in patients with known or suspected bladder cancer.

Cysview should be used only with approved cystoscopic equipment that has the necessary filters to allow both White Light Cystoscopy and Blue Light (wavelength 360–450nm) fluorescence Cystoscopy (BLC®). Training in Blue Light Cystoscopy with an approved Photodynamic Diagnosis (PDD) System is essential prior to the use of Cysview.



How Does it Work?

Cysview mechanism of action:1

  • After instillation of the reconstituted Cysview solution into the bladder, Cysview is proposed to enter cancer cells via the intracellular space of mucosal cells.
  • In the cells, Cysview is used as a precursor in the formation of photoactive porphyrins (PAPs).
  • PAPs preferentially accumulate in rapidly dividing neoplastic cells.
  • After one hour, sufficient PAPs have accumulated.
  • When viewed with light at wavelengths between 360 and 450 nm, the PAPs fluoresce as red/pink tissue against a dark blue background of normal tissue.
  • This bright red/pink fluorescence allows more accurate visualization of tumours and their borders with considerable contrast between normal and malignant urothelial cells.


The Need

Cysview is the only approved diagnostic agent for the detection of NMIBC in Canada, the US, and the EU (where marketed as Hexvix®). It is recommended by the Canadian Urology Association4, AUA/SUO Guideline on NMIBC5, and a number of expert panels.3,6,7

“That we need something of therapeutic value for the diagnosis and treatment of non-muscle invasive bladder cancer (NMIBC) is obvious.” 7

Worldwide, bladder cancer is the seventh most common cancer. In Canada, bladder cancer is the tenth most common cancer and is estimated to be the fourth most common in men. Every year, there are more than 10,000 new cases of bladder cancer in Canada.8

NMIBC is one of the most expensive cancers to manage, from diagnosis to death, due to the costs related to long-term surveillance, monitoring and treatment.7,9 TURBT is considered, by far, the largest bladder cancer expense in the UK and other countries. “The quality and result of the initial TURBT strongly determines the patient’s prognosis and overall bladder cancer treatment costs.”9


The Benefits

Compared to standard WLC alone

BLC with Cysview improves:

  • Detection of NMIBC because more lesions are visualized.1
  • Resection of tumours due to more complete visualization of lesions.2,3

…which may result in

  • Fewer residual tumours.10
  • Improved patient management during and after TURBT.3

BLC with Cysview has demonstrated clear benefits over WLC alone in terms of clinical practice and patients’ experiences from diagnosis through management of cancer. Cysview improves the detection of papillary tumours, which likely leads to improved risk categorization that can result in better management of bladder cancer.3

Benefits in clinical practice:

Detect more lesions: Cysview significantly improves the detection of Ta/T1 non-muscle invasive bladder cancer compared to WLC alone.1

Enhance tumour visualization: Cysview enables a more complete resection* which reduces residual tumours and the rate of tumour recurrence. 2,3

Improve long-term management: Use of Cysview can improve the identification of papillary NMIBC tumours leading to improved patient care and potentiallyy reduced costs.11

Contraindications:1

  • Cysview is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container
  • Cysview is contraindicated in patients with porphyria

*Resection should be done under white light cystoscopy



Indication for Cysview® (hexaminolevulinate HCl)

Cysview is indicated as an adjunct to White Light Cystoscopy in the detection of non-muscle invasive papillary bladder cancer in patients with known or suspected bladder cancer. Only approved cystoscopic equipment should be used, equipped with necessary filters to allow both White Light Cystoscopy (WLC) and Blue Light (wavelength 360–450nm) fluorescence Cystoscopy (BLC®). Training in Blue Light Cystoscopy with an approved Photodynamic Diagnosis (PDD) System is essential prior to the use of Cysview.

Important Risk & Safety Information

Limitations of Use Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

Contraindications Cysview is contraindicated in patients with porphyria and/or hypersensitivity to the active substance or to any ingredient in the formulation or component of the container. False-positive fluorescence may result from tangential light, scope trauma from a previous cystoscopic examination, and/or bladder inflammation particularly from intravesical Bacillus Calmette–Guérin (BCG) or chemotherapy treatments. No specific drug interaction studies have been performed.

Warnings and Precautions Do not use in patients with gross hematuria. Do not use in patients at high risk of bladder inflammation, e.g., less than 90 days after intravesical BCG or chemotherapy. Do not use for retrograde uretero-renoscopy. Cysview has not been studied in pregnant women or pediatric populations. Cysview may not detect all malignant lesions. Very rare instances of hypersensitivity, including anaphylactic shock, have been reported during post-marketing use of Cysview. Advance life support facilities should be readily available. Biopsy/resect bladder mucosal lesions only following completion of both White Light and Blue Light Cystoscopy.

Adverse Reactions Most of the reported adverse reactions in clinical studies were transient and mild or moderate in intensity: bladder spasm 2.4%; dysuria 1.8%; bladder pain 1.7%; and hematuria 1.7%. The adverse reactions observed were expected based on previous experience with standard cystoscopy and TURBT procedures.

For additional information about Cysview, please refer to the product monograph.

Note: Cysview (hexaminolevulinate (HAL) HCl) is used with Blue Light Cystoscopy (BLC) as an adjunct to White Light Cystoscopy (WLC) and not separately. Cysview with BLC may be referred to in a number of ways, such as Cysview, Cysview with BLC, Cysview with Photodynamic Diagnosis (PDD) System, HAL with BLC and HAL with PDD.

  1. Cysview® Canada Product Monograph, Jan 11, 2022.
  2. Hermann GG, Mogensen K, Carlsson S, et al. Fluorescence-Guided Transurethral Resection of Bladder Tumours Reduces Bladder Tumour Recurrence Due to Less Residual Tumour Tissue in Ta/T1 Patients: A Randomized Two-Centre Study. BJU Int. 2011;108(8b):E297-E303.
  3. Daneshmand S, Schuckman AK, Bochner BH, et al. Hexaminolevulinate Blue-Light Cystoscopy in Non-Muscle Invasive Bladder Cancer: Review of the Clinical Evidence and Consensus Statement on Appropriate Use in the USA. Nat Rev Urol. 2014;11(10):589-596.
  4. Bhindi B, Kool R, Kulkarni GS, et al. Canadian Urological Association Guideline on the Management of Non-Muscle-Invasive Bladder Cancer – Full-Text. Can Urol Assoc J 2021;15(8):E424-457.
  5. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016;196(4):1021-1029.
  6. Lotan Y, Bivalacqua TJ, Downs T, et al. Blue Light Flexible Cystoscopy with Hexaminolevulinate in Non-Muscle Invasive Bladder Cancer: Review of the Clinical Evidence and Consensus Statement on Optimal Use in the USA—Update 2018. Nat Rev Urol. 2019;16(6):377-386.
  7. Witjes JA, Redorta JP, Jacqmin D, et al. Hexaminolevulinate-Guided Fluorescence Cystoscopy in the Diagnosis and Follow-Up of Patients with Non-Muscle Invasive Bladder Cancer: Review of the Evidence and Recommendations. Eur Urol. 2010;57(4):607-614.
  8. Globocan. 5-year Prevalence by Population. Available at: https://gco.iarc.fr/today, accessed April 2022.
  9. Sievert KD, Amend B, Nagele U, et al. Economic Aspects of Bladder Cancer: What Are the Benefits and Costs? World J Urol. 2009; 27(3):295.
  10. Stenzl A, Burger M, Fradet Y, et al. Hexaminolevulinate Guided Fluorescence Cystoscopy reduces Recurrence in Patients with Nonmuscle Invasive Bladder Cancer. J Urol. 2010;184(5):1907-1913.
  11. Witjes JA, Babjuk M, Gontero P, et al. Clinical and Cost Effectiveness of Hexaminolevulinate-Guided Blue-Light Cystoscopy: Evidence Review and Updated Expert Recommendations. Eur Urol. 2014;66(5):863-871.