Description and Brand Names
US Brand Name
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.
This product is available in the following dosage forms:
In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hexaminolevulinate in the elderly.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Bacillus of Calmette and Guerin Vaccine, Live
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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
Bladder cancer that was treated with BCG (Bacillus Calmette-Guerin) or cancer medicines or
Swelling, trauma, or scarring from a previous bladder examination—May cause a false positive result when used with hexaminolevulinate.
Bladder pain or
Bladder spasm—Use with caution. May make these conditions worse.
Hematuria (blood in the urine) or
Porphyria (an enzyme problem)—Should not be used in patients with these conditions.
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.
It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.
This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a rash, itching, hoarseness, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth after you receive the medicine.
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 sensation while urinating
difficult or painful urination
frequent urge to urinate
lower stomach pain or spasm
Incidence not known
Bloody or cloudy urine
difficulty with breathing or swallowing
hives, itching, skin rash
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.