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USP DI Vol. II - BACILLUSCALMETTE-GU?RIN (BCG) LIVE for Cancer (Mucosal-Local)

BACILLUSCALMETTE-GU?RIN (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-Gu?rin (Ba-SIL-es Kal-met Geh-rin) (BCG) is used as a solution thatis run through a tube (instilled through a catheter) into the bladder to treatbladder cancer. The exact way it works against cancer is not known, but itmay work by stimulating the body's immune system.

BCG is to be administered only by or under the immediate supervision ofyour 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 beweighed against the good it will do. This is a decision you and your doctorwill make. For BCG, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic 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 pregnantbefore receiving BCG.

Breast-feeding?It is not known whether BCG passes into the breastmilk.

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

Older adults?This medicine has been tested and has not been shownto cause different side effects or problems in older people than it does inyounger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When receiving BCGit is especially important that your health care professional know if youare 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 reducethe body's natural immunity, they may prevent BCG from stimulating the immunesystem and will cause it to be less effective. In addition, the risk of infectionmay be increased

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

  • Fever?Infection may be present and could cause problems
  • Immunity problems?BCG treatment is less effective and thereis a risk of infection
  • Urinary tract infection?Infection and irritation of the bladdermay occur

Proper Use of This Medicine

Your doctorwill ask you to empty your bladder completely before the solution is instilledinto it.

Follow your doctor's instructions carefully about howlong to hold the solution in your bladder:

  • The solution should be held in your bladder for 2 hours. If you thinkyou cannot hold it, tell your health care professional.
  • During the first hour, your doctor may have you lie for 15 minuteseach 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 severalhours 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 thatcan cause infection. Some bacteria will be present for several hours in urinethat you pass after each treatment with BCG. Any urine that you pass duringthe first 6 hours after each treatment should be disinfected with an equalamount (usually about 1 cup) of undiluted household bleach. After the bleachis added to the urine, it should be allowed to sit for 15 minutes before itis flushed. If you have any questions about this, check with your doctor.

Dosing?The dose of BCG will be different for differentpatients. 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 directionson the label. If you have any questions about the proper dose of BCG,ask your doctor.


Precautions While Using This Medicine

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

While you are being treated with BCG and for a few weeks after you stoptreatment with it, do not have any immunizations (vaccinations) without yourdoctor'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 mayneed medical attention.

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

      More common

        Blood in urine; fever and chills; frequent urge to urinate; increasedfrequency of urination; joint pain; nausea and vomiting; painful urination(severe or continuing)

      Rare

        Cough; skin rash

Other sideeffects may occur that usually do not need medical attention. These side effectsmay 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 arebothersome or if you have any questions about them:

    More common

      Burning during first urination after treatment

After youstop using this medicine, your body may need time to adjust. The length oftime this takes depends on the amount of medicine you were using and how longyou used it. During this period of time (up to 6 months after treatment withBCG) 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. Ifyou notice any other effects, check with your doctor.


Revised: 08/17/2000