Blue Light Cystoscopy® FAQs

Blue Light Cystoscopy (BLC®) with Cysview® FAQs

Patients with bladder cancer have many choices for where to go for their care. There are more diagnostic tools and treatments now than ever before. Today, patients have an additional option when undergoing a biopsy or surgical removal of a suspected or known bladder cancer and for their follow-up, check-up cystoscopies. BLC with Cysview is an important tool that can aid in the diagnosis and management of bladder cancer.(1-4)

Finding a facility that offers this option can make a huge difference in bladder cancer care. The urologists at Kentucky Lake Urologic Associates use BLC with Cysview to better detect and manage patients’ bladder cancer.

Following are the answers to some common questions about BLC with Cysview.

Q: What is Blue Light Cystoscopy (BLC) with Cysview?

A: BLC with Cysview is a state-of-the-art drug/device technology that helps urologists better see non-muscle invasive bladder cancer (NMIBC) tumors when they look into the bladder.

During a standard cystoscopy, urologists visually inspect the inside of the bladder using a cystoscope, which is a long, thin tube that includes a video camera on the end. In the past, there was only one type of cystoscopy available – one that uses regular white light to illuminate inside the bladder. But white light does not always easily show all tumors or cancerous lesions.

BLC with Cysview uses a cystoscope equipped with both white and blue light. Before the procedure, a small amount (less than 2 oz.) of the prescription imaging agent Cysview is placed into the bladder using a catheter. Cysview makes the bladder cancer tumors glow pink in blue light, thus allowing urologists to detect significantly more bladder cancer in more patients.(5)

Q: What is Cysview’s indication?

A: Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC®) as an adjunct to white light cystoscopy.

Q: How is Cysview administered and how does it work?

A: At least one hour before the BLC procedure Cysview is instilled into the bladder through a catheter. Cysview makes tumor cells glow bright pink in blue light, but it is not a dye. It is a variant of a naturally occurring molecule in the body that results in increased production of another natural compound. Unhealthy cells do not process out the compound as quickly as healthy cells; the resulting accumulation creates a pink glow in blue light. Studies have found that, with Cysview, there is a significant increase in the detection of non-muscle invasive bladder cancer.(5)

Q: How many patients have had BLC with Cysview?

A: BLC with Cysview has been used in more than 500,000 patients worldwide.6 It was approved in the US in 2010 and was included in the 2016 American Urological Association (AUA) and Society of Urologic Oncology (SUO) Guideline for Non-Muscle Invasive Bladder Cancer. Over 180 facilities in the US use BLC with Cysview. We at {Facility} have been using it since {Year}, {add if participated in clinical studies or have published}.

Q: Does BLC with Cysview work better than white light? What are the benefits of using Cysview?

A: BLC with Cysview does work better than white light alone. Because Cysview causes bladder cancer cells to glow bright pink in blue light, urologists are better able to see smaller tumors and flat lesions that may not be seen with white light. The urologist can immediately remove diseased tissue, ideally leaving a clean margin of healthy tissue around the resection site. Cysview gives urologists the ability to better evaluate, identify, and remove hard-to-see tumors more accurately.(1-4)

In addition, by detecting and testing more lesions, the stage and grade of a patient’s cancer can be more accurately determined and appropriate management and treatment offered.

Q: Can Cysview be used as a diagnostic tool for all types of bladder cancer?

A: No. It is not suitable for muscle invasive bladder cancer or low-risk non-muscle invasive bladder cancer (NMIBC). It is indicated for use in intermediate and high-risk NMIBC.

Bladder cancer falls into two general categories:

• Non-muscle invasive bladder cancer: About 75% of all bladder cancer is in this category, in which a tumor (also called a lesion) is still in the inner layer of cells of the bladder’s inside wall. Subtypes include Ta, carcinoma in situ (CIS) and T1 lesions.(7)
• Muscle invasive bladder cancer (MIBC): This disease, which is less common than non-muscle invasive, occurs when the cancer has grown into deeper layers of the bladder wall. This disease is more likely to spread to other organs and is more difficult to treat. These cancers include the subtypes T2, T3, and T4.(8)

Cysview detects the first type – NMIBC – which may otherwise be hard to distinguish from healthy tissue. Due to their more advanced nature, MIBC tumors are detected through white light cystoscopy, biopsies, a manual exam, imaging and other diagnostic tests.(1)

Q: What are the limitations of BLC with Cysview?

A: Cysview is not a replacement for random biopsies, which still need to be done to check whether there is any disease that has not been detected during the cystoscopic examination under white or blue light. Cysview is not used for the detection of muscle invasive bladder cancer.

Q: Who is eligible for Cysview?

A: Anyone who is suspected of having or is known (from a previous cystoscopy) to have bladder cancer can have BLC with Cysview. As with all medical situations, the physician will work with each patient to determine if Cysview is right for his/her particular situation.

Q: Is Blue Light Cystoscopy with Cysview safe?

A: Clinical studies have shown that BLC with Cysview is safe and well-tolerated. However, no surgical procedure is free of any risk, so patients should consult their doctors regarding the risks and benefits of this procedure for their individual circumstances.

Most people are ready to go home shortly after a routine procedure. The doctor will advise each patient on how much rest and care will be needed afterward.

Q: What are the side effects associated with Blue Light Cystoscopy with Cysview?

A: Side effects of both blue light and white light cystoscopies are generally the same. They may include: (5)

  • Bladder spasms
  • Discomfort while urinating
  • Blood in urine
  • Bladder pain
  • Frequent urination

A rare side effect of Cysview use may be hypersensitivity reactions to the medication itself.

Patients must consult a physician if they are concerned about any effects they may experience after the procedure.

Q: Do physicians need to special training in this procedure?

A: Yes, urologists require special training to use Cysview and the cystoscope that has both white and blue light.

Q: Is BLC with Cysview covered by insurance?

A: Many insurance plans do cover BLC with Cysview, but coverage can vary widely. Some insurance plans do not cover it at all. Medicare covers it in certain circumstances.

Q: What is the Important Risk & Safety Information for Cysview (hexaminolevulinate HCl)

A: Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.

Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Cysview may fail to detect some malignant lesions. False positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy and recent BCG therapy or intravesical chemotherapy. No specific drug interaction studies have been performed.

Safety and effectiveness have not been established in pediatric patients. There are no available data on Cysview use in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal. 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. 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.

Cysview is approved for use with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the KARL STORZ instruction manuals for each of the components. Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and reconstitution instructions.

References: 1.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):1907-1914.Cancer Recurrence with Hexaminolevulinate Enabled Fluorescence Cystoscopy. J Urol. 2012;188(1) Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018;199(5):1158-1165.2018:1-14. 4.Data on file. Photocure ASA. 7. American Cancer Society. Bladder Cancer.2.Grossman HB, Stenzl A, Fradet Y, et al. Long-Term Decrease in Bladder Daneshmand S, Bazargani ST, Bivalacqua TJ, et al. Blue Light Cystoscopy for the Diagnosis of Bladder Cancer: Results from the US Prospective Multicenter Registry. Urol Oncol. 2018;36(8):361.e1-361.e6. 6. Accessed on July 26, 2018. F. Bladder Cancer: A Patient-Friendly Guide to Understanding Your Diagnosis and Treatment Options. Patient-Friendly Publishing; 2017.