What is BCG?

BCG (Bacillus Calmette and Guérin) is made using the organisms of a bacteria.

This medication is injected directly into the bladder, where it causes inflammation and increases certain white blood cells known as natural killer cells. These killer cells act to destroy invading cells such as tumor cells in the bladder.

BCG is used to treat bladder cancer that is localized (has not spread to other parts of the body).

BCG may also be used for other purposes not listed in this medication guide.

Precautions

You should not receive this medication if you are allergic to BCG, or if you have:

  • tuberculosis;
  • a weak immune system from diseases such as AIDS, leukemia, or lymphoma;
  • fever, a bladder infection, or blood in your urine;
  • if you are using steroids or receiving chemotherapy or radiation treatments; or
  • if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

Before you receive BCG, tell your doctor if you are allergic to latex rubber, or if you have:

  • any type of bacterial, fungal, or viral infection (including HIV);
  • myasthenia gravis;
  • a pacemaker or other artificial heart device;
  • an artificial joint or other prosthetic;
  • a history of aneurysm (dilated blood vessel);
  • if you have ever had bypass surgery;
  • if you have ever had tuberculosis; or
  • if you need to have an organ transplant (kidney, liver, heart, etc).

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive BCG.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Before you receive BCG, tell your doctor if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether BCG passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Antibiotics can make BCG less effective and should be avoided during your treatment with BCG. If you have an infection that must be treated with an antibiotic, you may need to stop receiving BCG for a short time. Follow your doctor’s instructions and be sure to tell any other doctor who treats you that you are receiving BCG.

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Instructions

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include signs of an infection, such as fever, chills, body aches, weakness, or other flu symptoms.

Call your doctor for instructions if you miss an appointment for your BCG treatment.

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Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any side effects to your doctor. Some side effects may be serious, including:

  • fever, chills, cough, body aches, joint pain, weakness, vomiting, or other flu symptoms;
  • nausea, vomiting, stomach pain, jaundice (yellowing of your skin or eyes);
  • pain or burning when you urinate;
  • difficult urination;
  • more frequent or urgent urinating;
  • blood in your urine, lower back pain;
  • pain or swelling in your testicles;
  • easy bruising or bleeding;
  • eye pain, redness, watering, severe burning or itching; or
  • vision changes, increased sensitivity to light.

Less serious side effects may include:

  • mild nausea, stomach pain, or loss of appetite;
  • mild bladder or groin pain;
  • urine leakage or incontinence;
  • diarrhea, constipation;
  • headache;
  • mild skin rash;
  • dizziness, tired feeling; or
  • tissue particles in your urine (not blood).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before you receive BCG, tell your doctor if you are taking an antibiotic, or if you are using any drugs that weaken your immune system, such as:

  • cancer medicine or radiation;
  • cyclosporine (Neoral, Sandimmune, Gengraf);
  • sirolimus (Rapamune), tacrolimus (Prograf);
  • basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
  • mycophenolate mofetil (CellCept);
  • azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or
  • steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there may be other drugs that can interact with BCG. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Other Names

BCG, TheraCys, and Tice BCG Vaccine

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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