Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS Anaphylaxis: have trained personnel and therapies available.
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.
Like all medications, Cysview can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: