Hexaminolevulinate

Hexaminolevulinate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Hexaminolevulinate is a Diagnostic Agent that is FDA approved for the diagnosis of cystoscopic detection of non-muscle invasive papillary cancer of the bladder. Common adverse reactions include Bladder pain, Dysuria, Hematuria, Spasm of bladder.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Cysview is an optical imaging agent indicated for use 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).

1.1 Limitations of Use Cysview is not:

a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer [see WARNINGS AND PRECAUTIONS (5.2)]. for repetitive use. The potential risks associated with repetitive exposure, including sensitization and adverse effects of blue light have not been evaluated

Dosage

2.1 Recommended Dose The recommended dose for adults is 50 mL of reconstituted solution of Cysview [see DOSAGE AND ADMINISTRATION (2.2)], instilled into the bladder via a urinary catheter [see DOSAGE AND ADMINISTRATION (2.3)].

2.2 Reconstitution of Cysview Cysview is supplied as a kit containing two vials: a clear glass vial labeled as Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution, containing 100 mg hexaminolevulinate hydrochloride as a powder, and a vial labeled as DILUENT for Cysview, containing 50 mL of the diluent in a polypropylene vial.

Perform all steps under aseptic conditions. Use gloves during the reconstitution procedure; skin exposure to hexaminolevulinate hydrochloride may increase the risk for sensitization to the drug.

Use a 50 mL syringe with a Luer Lock tip throughout the reconstitution procedure to ensure that the correct concentration (2mg/mL) of the drug is obtained and that a stable syringe-catheter connection is made for the bladder instillation of Cysview.

2.3 Bladder Instillation of Cysview For bladder instillation of the solution of Cysview, use straight, or intermittent, urethral catheters with a proximal funnel opening that will accommodate the Luer Lock adapter. Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), and silicone to instill the reconstituted Cysview. Do not use catheters coated or embedded with silver or antibiotics. In-dwelling bladder catheters (Foley catheters) may be used if the catheters are inserted shortly prior to Cysview administration and are removed following the Cysview instillation.

Use the following steps for bladder instillation of Cysview:

Using standard sterile catheterization technique, first insert the urethral catheter into the bladder of the patient and use the catheter to completely empty the patient's bladder before instillation of Cysview.

Avoid skin contact with Cysview. If skin does come in contact with Cysview, wash immediately with soap and water and dry off. After voiding the bladder of Cysview, routinely wash the patient's perineal skin region with soap and water and dry.

2.4 Use of the Karl Storz D-Light C Photodynamic Diagnostic (PDD) System Cysview imaging requires the use of the Karl Storz D-Light C PDD system, which consists of a light source, a camera and a telescope. The light source enables both white light cystoscopy and blue light (wavelength 360 – 450 nm) fluorescence cystoscopy. Familiarity with this system is essential before beginning the procedure and before instilling Cysview into the bladder. For system set up and general information for the safe use of the PDD system, refer to the Karl Storz instruction manual for the PDD system and the instruction manuals for each of the system components. The PDD System is not for use by healthcare providers with green-red color blindness.

2.5 Cystoscopic Examination Training

Training and proficiency in cystoscopic procedures are essential prior to the use of Cysview. Carefully review the instruction manuals provided with the Karl Storz D-Light C Photodynamic Diagnosis (PDD) System. For additional training in the use of the PDD System, contact the manufacturer's representative.

Preparation for Cystoscopy

Initiate the cystoscopic examination within 30 minutes after evacuation of Cysview from the bladder, but no less than 1 or more than 3 hours after Cysview is instilled in the bladder. If the patient did not retain Cysview in the bladder for 1 hour, allow 1 hour to pass from the instillation of Cysview into the bladder to the start of the cystoscopic examination. The efficacy of Cysview has not been established when the solution was retained for less than 1 hour.

Cystoscopic Examination

Empty the patient's bladder and then fill the bladder with a clear fluid (standard bladder irrigation fluid) in order to distend the bladder wall for cystoscopic visibility. Ensure adequate irrigation during examination of the bladder; blood, urine or floating particles in the bladder may interfere with visualization under both white light and blue light.

First perform a complete cystoscopic examination of the entire bladder under white light (Mode 1) and then repeat the examination of the entire bladder surface under blue light (Mode 2) unless the white light cystoscopy reveals extensive mucosal inflammation. Do not perform the blue light cystoscopy if the white light cystoscopy reveals wide-spread mucosal inflammation. Abnormalities of the bladder mucosa during blue light cystoscopy are characterized by the detection of red, homogenous and intense fluorescence. The margins of the abnormal lesions are typically well-demarcated and in contrast to the normal urothelium, which appears blue. Register and document (map) the location and appearance (e.g. papillary) of suspicious lesions and abnormalities seen under either white or blue light.

During the cystoscopic examination, be aware that:

a red fluorescence is expected at the bladder outlet and the prostatic urethra; this fluorescence occurs in normal tissue and is usually less intense and more diffuse than the bladder mucosal fluorescence associated with malignant lesions. tangential light may give false fluorescence. To help avoid false fluorescence, hold the endoscope perpendicular and close to the bladder wall with the bladder distended. false positive fluorescence may result from scope trauma from a previous cystoscopic examination and/or bladder inflammation [see WARNINGS AND PRECAUTIONS (5.3)]. malignant lesions may not fluoresce following Cysview administration, particularly if the lesions are coated with necrotic tissue. Blue light may fail to detect T2 tumors which have a tendency to be necrotic on the surface, and necrotic cells generally do not fluoresce [see WARNINGS AND PRECAUTIONS (5.3)]. when performing the blue light cystocopy, avoid prolonged blue light exposure. Studies have not evaluated the potential for adverse effects from blue light. In the controlled clinical trial, the cumulative blue light exposure from bladder mapping did not exceed 12 minutes and checking for complete tumor resection under blue light did not exceed 8 minutes for any patient [see CLINICAL STUDIES (14)]. Perform biopsy and/or resection of suspicious lesions by transurethral resection of the bladder (TURB) only after completing white and blue light cystoscopic examinations with bladder mapping. Using standard cystoscopic practices, obtain biopsies of abnormal areas identified during either white or blue light examination and perform resections. Always check for the completeness of the resections under both white light and blue light before finalizing the TURB procedure.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hexaminolevulinate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hexaminolevulinate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

safety and effectiveness in pediatric patients have not been established

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hexaminolevulinate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hexaminolevulinate in pediatric patients.

Contraindications

• Condition1

Warnings

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Hexaminolevulinate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Hexaminolevulinate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hexaminolevulinate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hexaminolevulinate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hexaminolevulinate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Hexaminolevulinate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Hexaminolevulinate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Hexaminolevulinate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hexaminolevulinate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hexaminolevulinate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hexaminolevulinate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hexaminolevulinate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hexaminolevulinate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Hexaminolevulinate in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Hexaminolevulinate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Hexaminolevulinate in the drug label.

Pharmacology

There is limited information regarding Hexaminolevulinate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Hexaminolevulinate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Hexaminolevulinate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Hexaminolevulinate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Hexaminolevulinate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Hexaminolevulinate in the drug label.

How Supplied

Storage

There is limited information regarding Hexaminolevulinate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Hexaminolevulinate in the drug label.

Precautions with Alcohol

• Alcohol-Hexaminolevulinate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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