Anaphylaxis has been reported following exposure to Cysview [see WARNINGS AND PRECAUTIONS].
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 six clinical trials, safety data were obtained from 1,324 patients, aged 32 to 96 years with a median age of 69 years, all primarily Caucasian and approximately 75% male. All patients were evaluated after a single instillation of 50 mL solution of Cysview (hexaminolevulinate hydrochloride intravesical solution) . Of these patients, 161 (12.2%) patients reported at least one adverse reaction. The most common adverse reaction was bladder spasm (reported in 2.2% of the patients) followed by dysuria, hematuria, and bladder pain. No patients experienced anaphylaxis. In the controlled clinical study, adverse reactions were similar in nature and rate between the study drug group and the control group [see Clinical Studies].
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 (hexaminolevulinate hydrochloride intravesical solution) .