Hexaminolevulinate (Urinary)

Overview

Bladder cancer patients are at a high risk of a more aggressive form of cancer if their tumors are not spotted early or are not properly removed during surgery.

Hexaminolevulinate is used in a procedure known as blue light cystoscopy (BLC), where it produces a clear image of the bladder. From this image, a doctor is able to examine the bladder and detect the presence of cancer cells or tumors. When the blue light technology is applied during the procedure, the cancer cells glow. Physicians are then able to clearly see and remove cancer tumors from the bladder if necessary.

BLC using Hexaminolevulinate is not for repetitive use. It is also not for use in place of random bladder biopsies or other methods used for detecting bladder cancer.

The medicine is supplied in the US under the brand name, Cysview. It is administered to patients at a hospital or clinic, usually under direct supervision of a doctor.

Condition treated:

  • Bladder cancer

Type Of Medicine

  • Optical imaging agent

Side Effects

Most, if not all, prescription medicines cause side effects. Hexaminolevulinate may cause side effects that are expected and required as the medicine works in the body.

Other side effects are unwanted and may or may not require medical attention.

Serious allergic reaction

This medicine may cause anaphylaxis, a serious type of allergic reaction. This condition may be fatal if the patient experiencing the symptoms does not seek urgent medical care.

Let your nurse or doctor know right away if you notice the following symptoms after receiving Hexaminolevulinate:

  • Chest pain
  • Itching
  • Rash
  • Trouble breathing
  • Swelling of the face, mouth or hands
  • Trouble swallowing
  • Hoarseness

The following symptoms were found to be the most common adverse effects in patients treated with this medicine:

  • Bladder spasm
  • Reduction in urine output
  • Pain in the bladder
  • Dysuria (pain, burning or discomfort while urinating)
  • Pain from the procedure
  • Headache
  • Hematuria (blood in urine)

Tell your doctor or nurse right away if you experience any of the following side effects:

More commonly occur

  • Pain or difficulty urinating
  • Bloody urine
  • Increase in the urge to urinate
  • Pain or spasm in the lower stomach
  • Burning sensation during urination

Some side effects that may occur are grouped as 'incidence unknown'. This is because there is no adequate information to determine the frequency or severity in which they occur. They are as follows:

Incidence unknown

  • Fever
  • Urine that appears cloudy or bloody
  • Fast heartbeat
  • Cough
  • Skin rash
  • Tightness in the chest
  • Dizziness
  • Wheezing
  • Fever
  • Itching
  • Nausea
  • Hives
  • Skin that appears red, especially around the ears
  • Difficulty breathing or swallowing
  • Feeling unusually tired or weak
  • Shortness of breath
  • Puffiness or swelling of the face, tongue, lips, eyelids or area around the eyes

Some patients may experience other side effects not listed here. Tell your doctor if you notice any unusual symptom that bothers you, becomes worse or does not go away.

You can ask your doctor or health care professional about ways to prevent or reduce side effects.

You may also call the FDA at 1-800-FDA-1088 to report side effects.

Dosage

This medicine is supplied to hospitals and clinics as a kit containing a 10 ml glass vial of 100 mg powder of Cysview (hexaminolevulinate) for solution. It also contains a liquid for diluting the powder and a catheter adapter. 50 ml of reconstituted solution of Cysview is the recommended dose for adults.

After mixing the powder and the liquid to form a solution, a nurse or healthcare professional will administer the medicine into your bladder through a catheter (tube). It will be done under direct supervision of a doctor. The solution is usually placed into the bladder an hour before the examination.

Some patients may not be able to hold the medicine in their bladder for the entire hour. If this happens to you, tell your nurse or doctor right away.

During the one hour timeframe, the medicine accumulates the cancer cells. This is followed by an examination of the bladder under the standard white-light procedure. The doctor or technician will then use the blue light to perform the cystoscopy of the bladder. Under blue light, the cancer cells and tumors become more visible and can be effectively removed through surgery.

Missed dose

This medicine is not taken at home by the patient. It is given at a hospital or clinic by a nurse or healthcare professional.

Overdose

The risk of overdose is unlikely, since the medicine is given by a nurse or healthcare professional under the direct supervision of a doctor.

Interactions

Food, alcohol, tobacco or other medicines or medical problems may interact with this medicine.

Food, alcohol, and tobacco

Your doctor, nurse, or healthcare professional at the hospital may advise you about any restrictions on the use of food, alcohol or tobacco when taking this medicine.

Other medicines

It is not known whether this medicine interacts with other medicines being used by a patient taking hexaminolevulinate. The lack of data is due inadequate studies done on the drug. This does not mean that there is no medicine that may cause interaction. You should still give your doctor a list of all prescription and over the counter medicines you are taking, as well as any herbal or vitamin supplements.

Other medical problems

The presence of other medical problems may affect or be affected by the medicine. Tell your doctor if you have any other medical problems.

This medicine should not be used in patients with any of the following conditions:

  • Hematuria (blood in the urine)
  • Porphyria (enzyme problem)
  • Bladder cancer that was treated within the last 90 days with Bacillus Calmette-Guerin (BCG)

The medicine should be used with caution in patients with any of the following conditions, because it may make the condition worse:

  • Bladder spasm
  • Bladder pain

Warnings

Use Hexaminolevulinate only if it was prescribed for your bladder cystoscopy procedure and the potential risks and benefits were considered.

Do not use Hexaminolevulinate if you are allergic to it or any of its inactive ingredients. Tell your doctor if you are allergic to this or other medicines. The medicine is known to cause anaphylaxis in some patients, which is a serious type of allergic reaction to the medicine. Urgent medical attention is needed as anaphylaxis can become life-threatening. Call your doctor or nurse right away if you experience symptoms of anaphylaxis, such as hoarseness, itching, rash, trouble swallowing or breathing, chest pain, or swelling of the face, mouth, or hands.

Do not use Hexaminolevulinate to treat children. Appropriate studies have not been done to determine its safety and efficacy in this group of patients.

Do not use this medicine if you are pregnant or may become pregnant, unless your doctor determines it is safe for you. There is a potential risk of harm to an unborn baby. Do not use the medicine if you are breastfeeding. It is not known if it can pass through breastmilk and harm a breastfeeding infant.

Do not do a cystoscopy with blue light only. For a more effective cystoscopy procedure and a better chance for detecting all malignant cancer cells, your doctor should perform a white light, followed by a blue light, cystoscopy.

Do not use BLC with Hexaminolevulinate as a replacement for random bladder biopsies and do not use it as a replacement for other procedures used for detecting bladder cancer.

Take necessary precautions when using this medicine as it may produce false fluorescence. Inflammation, scar tissues, previous bladder biopsy or cystoscopic trauma may cause this to happen.

Do not use it repetitively in the same patient.

Storage

The medicine is usually stored at the hospital or clinic.

Summary

Hexaminolevulinate is an effective medicine that represented a breakthrough in the technology for detection of cancer cells and removal of tumors from the bladder.

Blue light cystoscopy (BLC), the detection procedure, is especially important, because bladder cancer patients are at high a risk of a more aggressive form of cancer if their tumors are not spotted early or are not properly removed during surgery.

Prior to the BLC technology using Hexaminolevulinate, standard white-light cystoscopy was used, but it was not as effective in detecting cancer cells and tumors. Incomplete detection of cancerous tumors is reported as the main reason bladder cancer has one of the highest rates of recurrence.

BLC using Hexaminolevulinate is not for repetitive use. The procedure should also not be used as a replacement for random bladder biopsies or other methods used for detecting bladder cancer.