BACILLUSCALMETTE-GU?RIN (BCG) LIVE (Systemic)

Some commonly used brand names are:

In the U.S.?

• TICE BCG

Category

• Immunizing agent, active

Description

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

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

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

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

Breast-feeding?It is not known whether BCG vaccine passes intothe 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 receiveor have received BCG vaccine and who wish to breast-feed should discuss thiswith their doctor.

Children?BCG vaccine has been used widely in children, andit has not been reported to cause different side effects or problems in childrenthan it does in adults.

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

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 you are goingto receive BCG vaccine, it is especially important that your health care professionalknow 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)?Concurrentadministration may result in increased risk of systemic infection

• Immunosuppressants (e.g., Sandimmune, Imuran)?Because thesemedicines reduce the body's natural immunity, they may prevent BCG from workingproperly. Also, the risk of infection may be increased

• Virus vaccines (e.g., Poliovax)?Concurrent administration withBCG is not recommended

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

• Fever?If an infection is present, the chance of side effectsfrom BCG vaccine may be increased

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

• Widespread skin infections

Proper Use of This Vaccine

Dosing?The dose of BCG vaccine may be different fordifferent 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 mayneed medical attention.

More common

Rare

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