Pronunciation:

ba-SILL-us of KAL-met and GARE-in vak-SEEN, lyve

Brand Names:

• BCG Vaccine
• Bcg Vaccine Freeze Dried

Dosage Forms:

• Powder for Solution

Warnings:

Bacillus of calmette and guerin infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of bacillus of calmette and guerin for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which bacillus of calmette and guerin was reconstituted. Bacillus of calmette and guerin is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical bacillus of calmette and guerin.

• TICE® BCG
  • TICE® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material .

Bacillus of calmette and guerin infections have been reported in health care workers and patients due to exposure to the vaccine during preparation and administration. Bacillus of calmette and guerin is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical bacillus of calmette and guerin. THERACYS(R) and TICE(R) BCG contains live, attenuated mycobacteria and because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material .

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Bacillus Calmette-Guérin (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.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin
• Adalimumab
• Aldesleukin
• Altretamine
• Amonafide
• Amsacrine
• Asparaginase
• Azacitidine
• Azathioprine
• Bleomycin
• Broxuridine
• Busulfan
• Capecitabine
• Carboplatin
• Carmustine
• Certolizumab Pegol
• Chlorambucil
• Cisplatin
• Cladribine
• Cyclophosphamide
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dactinomycin
• Daunorubicin
• Daunorubicin Citrate Liposome
• Decitabine
• Docetaxel
• Doxifluridine
• Doxorubicin Hydrochloride
• Doxorubicin Hydrochloride Liposome
• Edatrexate
• Eflornithine
• Epirubicin
• Estramustine
• Etanercept
• Etoposide
• Floxuridine
• Fludarabine
• Fluorouracil
• Fotemustine
• Gallium Nitrate
• Gemcitabine
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Interferon Alfa
• Interferon Alfacon-1
• Interferon Beta
• Interferon Beta-1a
• Interferon Beta-1b
• Interferon Gamma
• Irinotecan
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitolactol
• Mitomycin
• Mitotane
• Mitoxantrone
• Mycophenolic Acid
• Oxaliplatin
• Paclitaxel
• Pegaspargase
• Pentostatin
• Pipobroman
• Pirarubicin
• Plicamycin
• Procarbazine
• Raltitrexed
• Rilonacept
• Rituximab
• Sirolimus
• Streptozocin
• Tacrolimus
• Teceleukin
• Tegafur
• Temsirolimus
• Teniposide
• Thioguanine
• Thiotepa
• Topotecan
• Treosulfan
• Trimetrexate
• Trofosfamide
• Uracil Mustard
• Vinblastine
• Vincristine
• Vincristine Liposome
• Vindesine
• Vinorelbine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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 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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.