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Some commonly used brand names are:

In the U.S.—

• TICE BCG

Category

• Immunizing agent, active

Description

Bacillus Calmette-Guérin (Ba-SIL'es Kal-met Geh-rin) (BCG) vaccine is given by injection to help prevent tuberculosis (TB). TB is a serious disease that can cause severe illness. It is spread by close contact with people who already have TB, such as people living in the same house. Some infected people do not appear to be sick, but they can still spread TB to others. BCG vaccine does not provide 100% protection. Therefore it is important to avoid people with TB, even if you have received the vaccine.

BCG vaccine is to be administered only by or under the direct supervision of a doctor. It is available in the following dosage forms:

• Parenteral
• Multiple-puncture device (U.S.)
• Injection (Canada)

Before Receiving This Vaccine

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 vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to BCG vaccine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals. Before you receive BCG vaccine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether BCG vaccine passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who will receive or have received BCG vaccine and who wish to breast-feed should discuss this with their doctor.

Children—BCG vaccine has been used widely in children, and it has not been reported to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of BCG vaccine in the elderly with use in other age groups.

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 you are going to receive BCG vaccine, it is especially important that your health care professional know if you are taking any of the following:

• Antituberculosis medicines (rifampin [e.g., Rifadin], isoniazid [e.g., Nydrazid])—These medicines may prevent BCG vaccine from working properly

• Corticosteroids (e.g., cortisone-like medicine)—Concurrent administration may result in increased risk of systemic infection

• Immunosuppressants (e.g., Sandimmune, Imuran)—Because these medicines reduce the body's natural immunity, they may prevent BCG from working properly. Also, the risk of infection may be increased

• Virus vaccines (e.g., Poliovax)—Concurrent administration with BCG is not recommended

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

• Fever—If an infection is present, the chance of side effects from BCG vaccine may be increased

• Immunity problems—BCG vaccine may not work properly in persons with decreased natural immunity; also, the risk of side effects from BCG vaccine may be increased.

• Widespread skin infections

Proper Use of This Vaccine

Dosing—The dose of BCG vaccine may be different for different patients.

Side Effects of This Vaccine

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.

More common

Accumulation of pus; peeling or scaling of the skin; sores at place of injection; sores at different sites of the skin; swollen lymph glands

Rare

Cough; fever; increase in bone pain; skin rash

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

Revised: 07/20/1995

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