Hexaminolevulinate (Urinary bladder)

Hexaminolevulinate is an imaging agent used during a procedure for the bladder called cystoscopy. Imaging agents help create an image or picture of body parts, like the bladder. Hexaminolevulinate is used to check for cancer cells in the bladder.

This medicine is to be used only by or under the direct supervision of a doctor.

It is very important for your doctor to closely monitor your progress while you are taking this medicine. This will help your doctor determine if the medicine is effective and if you should keep using it.

This medicine may cause a serious allergic reaction known as anaphylaxis, which can be life-threatening and requires immediate medical help. Inform your doctor or nurse right away if you experience a rash, itching, hoarseness, difficulty breathing or swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it will provide. This decision will be made by you and your doctor. Additionally, other factors may affect the test results. For this test, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on the effects of hexaminolevulinate in children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the effectiveness of hexaminolevulinate.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may adjust the dose or take other precautions. When receiving this diagnostic test, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Receiving this diagnostic test along with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Bacillus of Calmette and Guerin Vaccine, Live
• Docetaxel
• Gemcitabine
• Mitomycin
• Thiotepa
• Valrubicin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact the use of this diagnostic test. Make sure to inform your doctor if you have any other medical conditions, especially:

• Bladder cancer that was treated with BCG (Bacillus Calmette-Guerin) or cancer medications, or
• Swelling, trauma, or scarring from a previous bladder examination—May cause a false positive result when using hexaminolevulinate.

• Bladder pain or
• Bladder spasm—Use with caution. May worsen these conditions.

• Hematuria (blood in the urine) or
• Porphyria (an enzyme problem)—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blood in the urine
• burning sensation while urinating
• difficult or painful urination
• frequent urge to urinate
• lower stomach pain or spasm

Incidence not known

• Bloody or cloudy urine
• cough
• difficulty with breathing or swallowing
• dizziness
• fast heartbeat
• fever
• hives, itching, skin rash
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• reddening of the skin, especially around the ears
• tightness in the chest
• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cysview

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given through a tube (catheter) that is placed into your bladder.

The tube will be taken out and the medicine must be held in the bladder for at least 1 hour. You may stand, sit, or move during this time. If you feel you cannot hold the medicine in the bladder for 1 hour, tell your doctor or nurse right away.