What is this medication?

BACILLUS CALMETTE-GUERIN LIVE, BCG (ba SIL us KAL met gay RAYN) is a bacteria solution. This medicine stimulates the immune system to ward off cancer cells. It is used to treat bladder cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Theracys, TICE BCG

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

•aneurysm

•blood in the urine

•bladder biopsy within 2 weeks

•fever or infection

•immune system problems

•leukemia

•lymphoma

•myasthenia gravis

•need organ transplant

•prosthetic device like arterial graft, artificial joint, prosthetic heart valve

•recent or ongoing radiation therapy

•tuberculosis

•an unusual or allergic reaction to Bacillus Calmette-Guerin Live, BCG, latex, other medicines, foods, dyes, or preservatives

•pregnant or trying to get pregnant

•breast-feeding

How should I use this medication?

This drug is given as a catheter infusion into the bladder. It is administered in a hospital or clinic by a specially trained health care provider. You will be given directions to follow before the treatment. Follow your health care provider's directions carefully.

This medicine contains live bacteria. It is very important to follow these directions closely after treatment to prevent others from coming in contact with your urine. Your health care provider may give you additional directions to follow. Try to hold this medicine in your bladder for 1 to 2 hours. Follow these directions the first time you go to the bathroom and for 6 hours after the first void.

• Wash your hands before using the restroom. After voiding, wash your hands and genital area.
• Use a toilet and sit when going to the bathroom. This helps to prevent the urine from splashing. Do not use public toilets or void outside.
• After each void, add 2 cups of undiluted bleach to the toilet. Close the lid. Wait 15 to 20 minutes and then flush the toilet.
• After the first void, drink more fluids to help dilute your urine.
• If you have urinary incontinence, wash the clothes you were wearing in the washer immediately. Do not wash other clothes at the same time.
• If you are wearing an incontinence pad, pour bleach on the pad and allow it to soak into the pad before throwing it away. Put the pad in a plastic bag and put it in the trash.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

•antibiotics

•medicines to suppress your immune system like chemotherapy agents or corticosteroids

•medicine to treat tuberculosis

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for checks on your progress. This medicine may make you feel generally unwell. Contact your health care provider if your symptoms last more than 2 days or if they get worse. Call your health care provider right away if you have a severe or unusual symptom.

Infection can be spread to others through contact with this medicine. To prevent the spread of infection, follow your health care provider's directions carefully after treatment.

Do not become pregnant while taking this medicine. There is a potential for serious side effects to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine.

If you have sex while on this medicine, use a condom. Ask your health care provider how long you should use a condom.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

•signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

•signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

•blood in urine

•breathing problems

•cough

•eye pain, redness

•flu-like symptoms

•joint pain

•bladder-area pain for more than 2 days after treatment

•trouble passing urine or change in the amount of urine

•vomiting

•yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

•bladder spasm

•burning when passing urine within 2 days of treatment

•feel need to pass urine often or wake up at night to pass urine

•loss of appetite

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.