Cysview
Generic: HEXAMINOLEVULINATE HYDROCHLORIDE
Basic Information
Manufacturer
Photocure Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
5aeed40d-6841-4adf-8940-f51d439fdfa3
Indications & Usage
1 INDICATIONS AND USAGE Cysview is 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 the white light cystoscopy.
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 the white light cystoscopy.
Important Limitations of Use: Not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
( 1.1 , 5.2 ) 1.1 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 used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC ® ) as an adjunct to the white light cystoscopy.
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 the white light cystoscopy.
Important Limitations of Use: Not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.
( 1.1 , 5.2 ) 1.1 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) ].
Adverse Reactions
6 ADVERSE REACTIONS Anaphylaxis has been reported following exposure to Cysview [ see Warnings and Precautions (5.1) ].
The most common adverse reaction reported in patients who received Cysview was bladder spasm, occurring in 2% of patients, 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 Study 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.
In seven clinical trials, safety data were obtained from 1,628 patients, aged 32 to 96 years with a median age of 70 years, all primarily Caucasian and approximately 75% male.
All patients were evaluated after a single instillation of 50 mL solution of Cysview, and 103 patients received a repeat administration of Cysview.
Of these patients, 170 (10.4%) patients reported at least one adverse reaction.
The most common adverse reaction was bladder spasm (reported in 2.0% of the patients) followed by dysuria, hematuria, and bladder pain.
No patients experienced anaphylaxis.
In the randomized controlled clinical study, adverse reactions were similar in nature and rate between the study drug group and the control group.
In a controlled study using Cysview in the surveillance setting, adverse reaction types were similar [ see Clinical Studies (14) ].
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.
Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported during post-marketing use of Cysview.
The most common adverse reaction reported in patients who received Cysview was bladder spasm, occurring in 2% of patients, 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 Study 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.
In seven clinical trials, safety data were obtained from 1,628 patients, aged 32 to 96 years with a median age of 70 years, all primarily Caucasian and approximately 75% male.
All patients were evaluated after a single instillation of 50 mL solution of Cysview, and 103 patients received a repeat administration of Cysview.
Of these patients, 170 (10.4%) patients reported at least one adverse reaction.
The most common adverse reaction was bladder spasm (reported in 2.0% of the patients) followed by dysuria, hematuria, and bladder pain.
No patients experienced anaphylaxis.
In the randomized controlled clinical study, adverse reactions were similar in nature and rate between the study drug group and the control group.
In a controlled study using Cysview in the surveillance setting, adverse reaction types were similar [ see Clinical Studies (14) ].
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.
Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis and abnormal urinalysis have been reported during post-marketing use of Cysview.