How does this medication work? What will it do for me?

Bacillus Calmette-Guérin (BCG) belongs to the group of cancer-fighting medications known as antineoplastics. BCG is thought to treat cancer in the bladder by stimulating the body's own defense system to attack the cancer cells.

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

What form(s) does this medication come in?

Each vial of freeze-dried preparation contains 1 to 8×108 CFU of TICE BCG which is equivalent to approximately 50 mg wet weight.

How should I use this medication?

BCG is always administered under direct supervision of a doctor. It is added to a solution that is instilled into the bladder through a catheter (tube). Before the fluid is instilled into your bladder, you will be asked to empty your bladder completely. The solution containing BCG should be held in your bladder for 2 hours.

Your doctor may ask you to change positions about every 15 minutes in order for the medication to come in contact with as much of the inside of the bladder as possible. When an instillation of BCG is finished, you should be sitting down to empty your bladder. To prevent bladder problems, you will need to drink extra fluids for several hours after each treatment so that more urine is passed. Make sure to empty your bladder as frequently as possible.

Because BCG is a live bacteria, it can cause infection. It is therefore important to disinfect any urine passed in the first 6 hours after treatment with an equal amount of undiluted household bleach. Allow the urine to sit with the bleach for 15 minutes in the toilet before flushing it.

This procedure is usually repeated once a week for 6 weeks, with additional instillations occurring at the 8th and 12th week, and then once a month for a year.

Many things can affect the dose and schedule of medication that a person needs, such as body weight, other medical conditions, and other medications. Your doctor may decide on a schedule different than the one listed here.

It is important to use this medication exactly as prescribed by your doctor.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

You should not use BCG if you:

  • are hypersensitive to one of the ingredients
  • are breast-feeding
  • have a reduced immune response (chemotherapy, radiation)
  • have a urinary tract infection, until the infection has cleared up
  • have an active tuberculosis infection
  • have current active infection
  • have hematuria or blood in urine
  • have tested positive for HIV
  • have had a recent biopsy or traumatic bladder catherization

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • burning upon urination after first treatment

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • blood in urine
  • cough or shortness of breath
  • eye trouble
  • fatigue, fever, and chills that last more than 48 hours or are severe
  • joint pain
  • nausea and vomiting or lack of appetite
  • rash
  • severe and continuing painful urination
  • unexpected frequent urge to urinate
  • unexpected increased frequency of urination
  • yellow eyes or yellowing of skin (sign of liver disease)

It is important to contact your doctor if you develop a cough or fever up to 6 months after treatment with BCG, to rule out the possibility of active tuberculosis.

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Handling of urine: Because BCG contains live mycobacteria urine may also contain the live bacteria. You should use appropriate infection control procedures to protect others from infection. This is especially true if you are living with someone who has reduced immunity (e.g. on chemotherapy).

For up to 6 hours after therapy, you should urinate while sitting to minimize the risk of splashing urine. Also, you should disinfect with equal volume of household bleach for 15 minutes before flushing.

Systemic BCG reaction: Although rare, a systemic granulomatous illness have been reported subsequent to exposure to BCG. Based on past reports, "systemic BCG reaction" may have any of the following signs: fever ≥39.5°C for 12 hours; fever ≥38.5°C for 48 hours; cough/pneumonitis; liver dysfunction; or the classical signs of severe infection such as low blood pressure, difficulty breathing.  Although rare, the reaction is much more likely to occur if BCG  is administered within 14 days of biopsy, TUR, or traumatic bladder catheterization (associated with hematuria).

Pregnancy: BCG has not been studied for use by pregnant women. It is best to use birth control while being treated with this medication. Tell your doctor immediately if you become pregnant during treatment. BCG should be used by pregnant women only if the benefits outweigh the risks.

Breast-feeding: It is not known whether BCG passes into breast milk. Women should not breast-feed while receiving BCG treatment due to risk of potential harm to the infant.

What other drugs could interact with this medication?

There may be an interaction between bacillus Calmette-Guérin and any of the following:

  • azathioprine, 6-mercaptopurine
  • corticosteroids and other immunosuppressants
  • cyclosporine
  • flucytosine
  • ganciclovir
  • interferon
  • plicamycin
  • other cancer medications
  • PPD skin test

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.