Cysview Side Effects Center

Last updated on RxList: 12/6/2022
Cysview Side Effects Center

What Is Cysview?

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. Cysview 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).

What Are Side Effects of Cysview?

Cysview may cause serious side effects including:

  • hives,
  • difficulty breathing, and
  • swelling of your face, lips, tongue, or throat

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Cysview include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Cysview

The recommended dose for adults is 50 mL of reconstituted solution of Cysview instilled into the bladder via a urinary catheter.

What Drugs, Substances, or Supplements Interact with Cysview?

Cysview may interact with other drugs. Tell your doctor all medications and supplements you use.

Cysview During Pregnancy and Breastfeeding

During pregnancy, Cysview should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

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Cysview Professional Information

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 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].

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.

DRUG INTERACTIONS

No specific drug interaction studies have been performed.

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

© Cysview Patient Information is supplied by Cerner Multum, Inc. and Cysview Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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