Hexaminolevulinate

What is hexaminolevulinate used for?

Hexaminolevulinate is a prescription medicine that is used with a light test to check for bladder cancer.

Description

Cysview contains hexaminolevulinate hydrochloride, an optical imaging drug that in solution form is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy.

The chemical formula for hexaminolevulinate hydrochloride is C 11H 21NO 3∙HCl. Its molecular weight is 251.76 and it has the following structural formula:

Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution is intended for intravesical administration only after reconstitution with the supplied 50 mL DILUENT. Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution and DILUENT for Cysview are supplied together as a kit.

Cysview (hexaminolevulinate hydrochloride) for Intravesical Solution is supplied as a sterile, non-pyrogenic, freeze-dried, white to off-white or pale yellow, powder containing 100 mg of hexaminolevulinate hydrochloride (equivalent of 85 mg of hexaminolevulinate) in a 10 mL clear glass vial. The DILUENT for Cysview is a sterile, non-pyrogenic solution (pH 6) containing 0.61 mg/ mL disodium hydrogen phosphate, 0.58 mg/mL of potassium dihydrogen phosphate, 7.02 mg/mL of sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection. It is a clear, colorless solution, free from visible particles, and is provided in a 50 mL plastic prefilled syringe.

The reconstituted solution of Cysview contains 2 mg/ml of hexaminolevulinate hydrochloride and is colorless to pale yellow. It is free from visible particles and has a pH between 5.7 and 6.2.

Mechanism of Action

Cysview is an ester of the heme precursor, aminolevulinic acid. After bladder instillation, Cysview enters the bladder mucosa and is proposed to enter the intracellular space of mucosal cells where it is used as a precursor in the formation of the photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are reported to accumulate preferentially in neoplastic cells as compared to normal urothelium, partly due to altered enzymatic activity in the neoplastic cells. After excitation with light at wavelengths between 360 and 450 nm, PpIX and other PAPs return to a lower energy level by fluorescing, which can be detected and used for cystoscopic detection of lesions. The fluorescence from tumor tissue appears bright red and demarcated, whereas the background normal tissue appears dark blue. Similar processes may occur in inflamed cells.

Before taking hexaminolevulinate, tell your doctor:

• If you are allergic to hexaminolevulinate; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Blood in the urine or porphyria.
• If you have ever been given BCG or a cancer drug in the bladder.

This is not a list of all drugs or health problems that interact with hexaminolevulinate.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take hexaminolevulinate with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take hexaminolevulinate?

• Tell all of your health care providers that you take hexaminolevulinate. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may not help in finding all bladder tumors. If you have questions, talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using hexaminolevulinate while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is hexaminolevulinate best taken?

Use hexaminolevulinate as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given through a catheter into the bladder.
• You will need to keep hexaminolevulinate in your bladder for at least 1 hour, but not more than 3 hours.
• If you cannot keep hexaminolevulinate in your bladder for at least 1 hour, talk with your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of hexaminolevulinate that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Blood in the urine.
• Trouble passing urine.
• Very bad bladder irritation.

What are some other side effects of hexaminolevulinate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Bladder irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out hexaminolevulinate?

• If you need to store hexaminolevulinate at home, talk with your doctor, nurse, or pharmacist about how to store it.