hexaminolevulinate (Rx)

Brand and Other Names:Cysview

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for reconstitution; bladder instillation

  • 100mg/vial

Bladder Cancer Diagnostic Agent

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

Used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLCTM) as an adjunct to the white light cystoscopy

Instill 50 mL of reconstituted imaging agent via intravesical catheter into emptied bladder

Also see Administration

Safety and efficacy not established

Next:

Adverse Effects

1-10%

Dysuria

Hematuria

Headache

Pain

Urinary retention

Spasm

Previous
Next:

Warnings

Contraindications

Hypersensitivity

Porphyria

Gross hematuria

Cautions

Anaphylaxis, including anaphylactoid shock reported; ensure trained personnel and therapies for anaphylaxis are available before and during administration

Failed detection

  • May fail to detect some bladder tumors, including malignant lesions; NOT a replacement for random biopsies or other evaluation procedures
  • Do not perform cystoscopy with blue light alone as malignant lesions can be missed unless the bladder is initially examined under white light

False positive fluorescence

  • False fluorescence may occur during blue light cystoscopy and be unable to detect either dysplasia or carcinoma
  • Fluorescent areas in bladder mucosa may result from inflammation, cystoscopic trauma, scar tissue, or bladder mucosal biopsy from previous cystoscopic examination
  • Use only catheters made of vinyl (uncoated or coated with hydrogel), latex (amber or red), or silicone for bladder instillation; do not use catheters coated or embedded with silver or antibiotics
  • The presence of urine and/or blood within the bladder may interfere detection of tissue fluorescence; ensure bladder is emptied prior to cystoscopy fluid instillation
Previous
Next:

Pregnancy & Lactation

Pregnancy

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

Systemic absorption following administration is expected to be minimal

Lactation

There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production

Systemic absorption following administration is expected to be minimal

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Previous
Next:

Pharmacology

Mechanism of Action

Hexaminolevulinate is an ester of aminolevulinic acid, a heme precursor; used as photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs); PpIX and PAPs referentially accumulate in neoplastic cells and are detected at light wavelengths of 360-450 to distinguish between cancerous and normal tissue

Pharmacokinetics

Half-Life: Biphasic; 39 minutes initial half-life, 76 hr terminal half-life

Absorption: 7% following 1 hr instillation

Metabolism: Rapidly by human blood

Bioavailability: 7% (intravesical)

Previous
Next:

Administration

Bladder Instillation

See prescribing information for full instructions and diagrams

Reconstitute powder with 50 mL diluent (supplied); resulting concentration is 2 mg/mL

Use solution immediately after reconstitution; otherwise store in refrigerator at 2-8 degrees C (36-46 degrees F) for up to 2 hr

After bladder instillation, retain for at least 1 hr (not to exceed 3 hr) before evacuating and performing cystoscopic exam (under white and then blue lights with Karl Storz D-Light C Photodynamic Diagnostic system)

Avoid contact with skin; f skin does come in contact with hexaminolevulinate solution, wash immediately with soap and water and dry off

After voiding the bladder of hexaminolevulinate solution, routinely wash the patient’s perineal skin region with soap and water and dry

Previous
Next:

Images

BRAND FORM. UNIT PRICE PILL IMAGE
Cysview intravesical
-
100 mg vial

Copyright © 2010 First DataBank, Inc.

Previous
Next:

Patient Handout

Patient Education
hexaminolevulinate intravesical

NO MONOGRAPH AVAILABLE AT THIS TIME

USES: Consult your pharmacist.

HOW TO USE: Consult your pharmacist.

SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Consult your pharmacist.

DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: No monograph available at this time.

MISSED DOSE: Consult your pharmacist.

STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2023 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.