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|Bacillus Calmette-Gu?rin

BACILLUS CALMETTE-GUéRIN (BCG) LIVE for Cancer (Mucosal-Local)

Some commonly used brand names are:

In the U.S.—

• Pacis
• TheraCys
• TICE BCG

In Canada—

• ImmuCyst
• Pacis

Category

• Antineoplastic

Description

Bacillus Calmette-Guérin (Ba-SIL-es Kal-met Geh-rin) (BCG) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer. The exact way it works against cancer is not known, but it may work by stimulating the body"s immune system.

BCG is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:

• Mucosal-Local
• Bladder instillation (U.S. and Canada)

Before Receiving This Medicine

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 BCG, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to BCG.

Pregnancy—BCG has not been studied in pregnant women or animals. Make sure your doctor knows if you are pregnant or if you may become pregnant before receiving BCG.

Breast-feeding—It is not known whether BCG passes into the breast milk.

Children—There is no specific information comparing use of BCG for treatment of cancer in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—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 receiving BCG it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chlorambucil (e.g., Leukeran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Corticosteroids (cortisone-like medicine) or
• Cyclophosphamide (e.g., Cytoxan) or
• Cyclosporine (e.g., Sandimmune) or
• Flucytosine (e.g., Ancobon) or
• Ganciclovir (e.g., Cytovene) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Muromonab-CD3 (e.g., Orthoclone OKT3) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir)—Because these medicines reduce the body"s natural immunity, they may prevent BCG from stimulating the immune system and will cause it to be less effective. In addition, the risk of infection may be increased

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

• Fever—Infection may be present and could cause problems

• Immunity problems—BCG treatment is less effective and there is a risk of infection

• Urinary tract infection—Infection and irritation of the bladder may occur

Proper Use of This Medicine

Your doctor will ask you to empty your bladder completely before the solution is instilled into it.

Follow your doctor"s instructions carefully about how long to hold the solution in your bladder :

• The solution should be held in your bladder for 2 hours. If you think you cannot hold it, tell your health care professional.
• During the first hour, your doctor may have you lie for 15 minutes each on your stomach, back, and each side.
• When you do empty your bladder, you should be sitting down.

It is important that you drink extra fluids for several hours after each treatment with BCG so that you will pass more urine. Also, empty your bladder frequently. This will help prevent bladder problems.

BCG is a live product. In other words, it contains active bacteria that can cause infection. Some bacteria will be present for several hours in urine that you pass after each treatment with BCG. Any urine that you pass during the first 6 hours after each treatment should be disinfected with an equal amount (usually about 1 cup) of undiluted household bleach. After the bleach is added to the urine, it should be allowed to sit for 15 minutes before it is flushed. If you have any questions about this, check with your doctor.

Dosing—The dose of BCG will be different for different patients. The dose that is used may depend on a number of things. If you are receiving BCG at home, follow your doctor"s orders or the directions on the label . If you have any questions about the proper dose of BCG, ask your doctor.

Precautions While Using This Medicine

While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.

While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor"s approval.

Side Effects of This 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.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome or if you have any questions about them:

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time (up to 6 months after treatment with BCG) check with your doctor if you notice any of the following side effects:

Cough; fever

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

Revised: 08/17/2000

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