Product Risk Information:
Safety and effectiveness have not been established in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue light cystoscopy, nor in pediatric patients.
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 possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of anaphylactoid shock, bladder pain, cystitis and abnormal urinalysis have uncommonly been reported.
Cysview should not be used in patients with porphyria or with known hypersensitivity to hexaminolevulinate. There are no known drug interactions with hexaminolevulinate; however, no specific drug interaction studies have been performed.
Cysview must be used 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.