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Hexaminolevulinate (Urinary Bladder Route)

US Brand Names

Description

Hexaminolevulinate is an imaging agent that is used in a procedure for the bladder called cystoscopy. Imaging agents help create an image or picture of body parts, such as 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.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hexaminolevulinate in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hexaminolevulinate in the elderly.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bladder cancer that was treated with BCG (Bacillus Calmette-Guerin) solution in the past 90 days or
• Blood in the urine or
• Porphyria (an enzyme problem)—Should not be used in patients with these conditions.

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

Proper Use

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 in 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.

Precautions

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash; itching; hoarseness; swelling of your hands, face, or mouth; trouble with breathing or swallowing; or chest pain after you receive the medicine.

Side Effects

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:

• Blood in the urine
• Burning while urinating
• Difficult or painful urination
• Frequent urge to urinate
• Lower stomach pain or spasm

• Bloody or cloudy urine
• Cough
• Difficulty with breathing or swallowing
• Dizziness
• Fast heartbeat
• Fever
• Hives
• Itching
• Nausea
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Reddening of the skin, especially around the ears
• Shortness of breath
• Skin rash
• Tightness in the chest
• Unusual tiredness or weakness
• Wheezing

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.

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