Cysview

Cysview Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cysview (hexaminolevulinate hydrochloride) is an imaging drug used in the cystoscopic detection of non-muscle invasive papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy. It is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1). Common side effects include bladder spasm, pain during urination, difficulty urinating, blood in the urine, or bladder pain.

The recommended dose for adults is 50 mL of reconstituted solution of Cysview instilled into the bladder via a urinary catheter. Cysview may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Cysview should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cysview (hexaminolevulinate hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cysview FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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].

Postmarketing Experience

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) .

Read the entire FDA prescribing information for Cysview (Hexaminolevulinate Hydrochloride Intravesical Solution) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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