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Important safety information about Cysview® (hexaminolevulinate HCI)

Important safety information about Cysview® (hexaminolevulinate HCI)

Cysview is an optical imaging agent used to detect non-muscle invasive bladder cancer in patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer. Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

Important Risk & Safety Information for Cysview® (hexaminolevulinate HCl)

Cysview is an optical imaging agent used to detect non-muscle invasive bladder cancer in patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for bladder cancer. Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. False-positive fluorescence may occur due to inflammation, trauma from past cystoscopies, scar tissue, previous bladder biopsy, and recent Bacillus Calmette-Guérin (BCG) therapy or intravesical chemotherapy.

Anaphylactoid shock, hypersensitivity reactions, bladder pain, bladder inflammation (cystitis), and abnormal urine tests have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, trouble urinating, discomfort when urinating, frequent urination, blood in the urine, and bladder pain.

Cysview should not be used in patients with large amounts of blood in their urine, any known allergy to Cysview or any derivative of aminolevulinic acid, or porphyria, a condition that means you already have high levels of porphyrins in your body. No specific drug interaction studies have been performed.

There are no available data on Cysview use in pediatric patients, pregnant women, or nursing mothers.

BLC® and Cysview® are
registered trademarks of Photocure ASA

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©2025 Photocure/Cysview. All Rights Reserved.

The information on this website is intended for U.S audiences only.
Residents of Canada, please visit Cysview.ca.

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Photocure offers links to third-party websites that may be of interest to our website visitors. If you continue, you will leave the Cysview.com website and be directed to another site. These third-party sites are not under the control of Photocure, and Photocure is not responsible for and has no control over the content of linked third-party websites. Photocure makes no warranties or representations of any kind as to the accuracy, currency, or completeness of any information contained in such websites. Photocure shall not be liable for any damages or injuries of any kind arising from such content or information or reliance thereon. Inclusion of any third-party link on the websites, the content, and/or the services does not imply an endorsement or recommendation by Photocure. You should take precautions when downloading files from all websites to protect your computer from viruses and other destructive programs. If you decide to access linked third-party websites, you do so at your own risk.

 

Please be aware that the security and privacy policies on the third-party sites may be different than Photocure’s policies, so please read third-party privacy and security policies closely. When you visit a third-party site, you will be subject to its terms and policies and no longer be protected by the Cysview.com privacy policy or security practices.

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Photocure offers links to third-party websites that may be of interest to our website visitors. If you continue, you will leave the Cysview.com website and be directed to another site. These third-party sites are not under the control of Photocure, and Photocure is not responsible for and has no control over the content of linked third-party websites. Photocure makes no warranties or representations of any kind as to the accuracy, currency, or completeness of any information contained in such websites. Photocure shall not be liable for any damages or injuries of any kind arising from such content or information or reliance thereon. Inclusion of any third-party link on the websites, the content, and/or the services does not imply an endorsement or recommendation by Photocure. You should take precautions when downloading files from all websites to protect your computer from viruses and other destructive programs. If you decide to access linked third-party websites, you do so at your own risk.

 

Please be aware that the security and privacy policies on the third-party sites may be different than Photocure’s policies, so please read third-party privacy and security policies closely. When you visit a third-party site, you will be subject to its terms and policies and no longer be protected by the Cysview.com privacy policy or security practices.

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Bacillus Calmette-Guérin (BCG) is an immunotherapy that is put into the bladder directly to treat early-stage bladder cancer (NMIBC).1

Immunotherapies work by causing the body’s immune system to attack the cancer cells.1

Reference: 1. American Cancer Society. Intravesical Therapy for Bladder Cancer. 2022. Available online. Accessed March 2024.

Not all bladder cancer is the same so to help identify it and decide the best treatment option, it is classified according to stage and grade.1

Stage is determined by how far the cancer has gone into the bladder wall and spread, with the stages as follows:1

T0: No tumor     
Ta: Papillary tumor without invading the bladder wall     
TIS (CIS): Carcinoma in situ (non-invasive flat high-grade (G3) cancer)     
T1: Tumor invades the connective tissue under the surface lining     
T2: Tumor invades the muscle layer     
T3: Tumor penetrates the bladder wall and invades the surrounding fat layer   
T4: Tumor invades other organs (i.e., prostate, uterus, vagina, pelvic wall)

Grade is expressed as a number between 1 (low) and 3 (high, i.e., G3); the higher the number, the more the tumor is abnormal. Your urologist, however, may refer to the tumor as either low grade or high grade instead of using a number.1

Reference: 1. Bladder Cancer Advocacy Network. Bladder Cancer Types, Stages and Grades. Available online. Accessed March 2024.

Bladder cancer is classified into two types, depending on the depth of invasion in the bladder wall:1
  • Non-muscle invasive bladder cancer (NMIBC) is in the inner layer of cells and has not gone deeper.1 These cancers are the most common (around 75% of all bladder cancer cases).2
  • Muscle-invasive bladder cancer is when the cancer has penetrated deeper layers of the bladder wall. These cancers are harder to treat and are more likely to spread to other organs.1

    • References: 1. American Cancer Society. What is Bladder Cancer? 2022. Available online. Accessed March 2024. 2. Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-Muscle-Invasive Bladder Cancer (Ta, T1, and Carcinoma in Situ). Eur Urol. 2022;81(1):75–94.

    TURBT is a surgical procedure where a urologic oncologist removes tumors from the bladder wall. The procedure is performed under general anesthesia in the operating room.1

    Reference: 1. American Cancer Society. Bladder Cancer Surgery. 2019. Available online. Accessed March 2024.