Why is it prescribed?
BCG vaccine contains attenuated tubercle bacillus.
This injection is indicated for the prevention of tuberculosis in people who are at a high risk of exposure and who are not already infected by the tubercle bacillus as indicated by a negative Mantoux test.
Side Effects
BCG vaccine contains attenuated tubercle bacillus.
Generally, vaccination with attenuated tubercle bacillus is well tolerated. The frequency and
severity of unwanted effects depend on the dosage and method of administration, the age of the person receiving the vaccine, and the substrain of the bacillus used by the manufacturer. Unwanted effects are usually mild and infrequent but can be severe and sometimes occur a year or more following administration of the vaccine. Possible unwanted effects include:
- a small, hardened, blister-like formation at the injection site
- ulceration (inflamed open lesion at the injection site)
Uncommon:
- enlargement of lymph nodes (may last for several months)
Rare:
- life threatening allergic reaction
Precautions and Warnings for BCG vaccine
BCG vaccine contains attenuated tubercle bacillus
Immunity can not be determined until a positive Mantoux result is seen. A vaccinated person may be susceptible to TB before sensitivity has been confirmed. Vaccinated people should avoid contact with all known or suspected persons that have been infected with the tubercle bacillus until sensitivity to tuberculin is verified (usually within 3 months).
Drug Interactions: It is important to tell your doctor and pharmacist of any prescription or over-the-counter medications you are taking. In some cases, the dose of one or both drugs may need to be altered or another drug may be prescribed. The following drugs or drug classes have been known to interact with vaccine:
- immunosuppressive agents (e.g. corticosteroids)
- antituberculosis drugs (e.g. isoniazid, rifampin)
Use is not recommended in the following situations:
- allergy to any component of the vaccine
- fever or other signs of acute infection
- extensive skin disease or burns
- positive tuberculin test (Mantoux)
- suppressed immune system (e.g. HIV)
Use in pregnancy: This vaccine is not recommended during pregnancy unless there is an excessive or unavoidable exposure to infective TB. Vaccination of pregnant women is usually delayed until after delivery, although no harmful effects on the fetus have been observed. Consult your doctor or pharmacist if you suspect you are pregnant.
Use in breastfeeding: It is not known whether this vaccine is excreted in human milk. Because live vaccines may be excreted in human milk, caution should be exercised when administered to a nursing woman. Consult your doctor or pharmacist is you are breastfeeding.
Patient Information
BCG vaccine is to be administered by a qualified health professional only.
The injection is given intracutaneously (into the skin) into the outer surface of the upper arm.
Directions for Use
The recommended dose for newborns and infants <12 months of age is 0.05 mL (0.05 mg). Children over 12 months of age and adults should be given a 0.1 mL (0.1 mg) dose. The recommended dosage for age should not be exceeded, as this may result in more extensive local reactions.
Lung Diseases Treated with this Drug
Need More Information?
For more information contact your physician, pharmacist, other health care professional or for general questions call your local lung association.
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