Hexaminolevulinate hydrochloride

What is Hexaminolevulinate hydrochloride?

• Hexaminolevulinate hydrochloride (Cysview) is an optical imaging agent that lights up under blue light during a blue light cystoscopy.
• It is used to help detection of carcinoma of the bladder, including carcinoma in situ (CIS).

Hexaminolevulinate hydrochloride

What are the uses of this medicine?

Cysview is indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the Karl Storz D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLC ®) as an supplement to the white light cystoscopy.

Limitations of Use:

• Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.

How does this medicine work?

• The hydrochloride salt form of hexaminolevulinate, a hexyl ester of the heme precursor 5-aminolevulinic acid (ALA) with potential photosensitizing activity.
• Hexaminolevulinate serves as a precursor of photoactive porphyrins (PAPs), particularly protoporphyrin IX (PpIX), which selectively accumulate in rapidly proliferating cells, such as those seen in tumor tissue.
• When exposed to blue light, PAPs are activated and emit red light thereby allowing tumor imaging.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• porphyria
• gross hematuria
• known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid.

What drug interactions can this medicine cause?

• No specific drug interaction studies have been performed.

Is this medicine FDA approved?

• Initial U.S. Approval: 2010

How should this medicine be used?

• Training in blue light cystoscopy with the Karl Storz D-Light C PDD system is essential prior to the use of Cysview.

Recommended dosage:

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

Administration:

• Reconstitute Cysview powder with the supplied 50 mL DILUENT under aseptic conditions.
• Use solution of Cysview shortly after reconstitution.
• If unable to use, the solution may be stored for up to 2 hours in a refrigerator at 2°-8°C (36°-46°F) in the labeled syringe.
• Discard after 2 hours.
• Instill 50 mL of reconstituted solution of Cysview into the emptied bladder via an intravesical catheter.
• Retain in the bladder for 1 hour before evacuating and performing cystoscopic examination.
• First perform a complete cystoscopic examination of the entire bladder under white light and then repeat the examination of the entire bladder under blue light.
• Record and document information about location and appearance of suspicious lesions and areas seen under both white and blue light.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cysview (hexaminolevulinate hydrochloride), for Intravesical Solution For bladder instillation only

This medicine is available in fallowing brand namesː

• Cysview

What side effects can this medication cause?

The most common side effects of this medicine include:

• bladder spasm
• dysuria
• hematuria
• bladder pain

What special precautions should I follow?

• Anaphylaxis, including anaphylactoid shock, has been reported following administration of Cysview. Prior to and during use of the Cysview, have trained personnel and therapies available for the treatment of anaphylaxis.
• Cysview may fail to detect some bladder tumors, including malignant lesions. Cysview is not a replacement for random biopsies or any other procedure usually performed in the cystoscopic evaluation for cancer. Always perform white light cystoscopy followed by blue light cystoscopy. Do not biopsy with blue light only.
• False fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG therapy or chemotherapy.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No adverse events were reported.

Can this medicine be used in pregnancy?

• There are no available data on Cysview use in pregnant women to inform a drug associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredient: HEXAMINOLEVULINATE HYDROCHLORIDE

Inactive Ingredients: SODIUM PHOSPHATE, DIBASIC, DIHYDRATE MONOBASIC POTASSIUM PHOSPHATE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE WATER

Who manufactures and distributes this medicine?

• Distributed by Photocure Inc. Princeton, NJ U.S.A.
• Cysview and BLC are registered trademarks of Photocure.

What should I know about storage and disposal of this medication?

• Store Cysview (hexaminolevulinate hydrochloride) Kit for Intravesical Solution at 20°-25°C (68°-77°F); excursions are permitted to 15°-30°C (59°-86°F).
• Do not use beyond the expiry date printed on the carton.
• Use the solution of Cysview shortly after reconstitution.
• If unable to use within this time period, the reconstituted solution can be stored under refrigeration at 2°-8°C (36°-46°F) for up to 2 hours in the labeled syringe.

• Dailymed label info on Hexaminolevulinate hydrochloride
• FDA Hexaminolevulinate hydrochloride

Hexaminolevulinate hydrochloride Resources
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