Tice BCG Live (for intravesical use)

BCG (Bacillus Calmette and Guérin) is a freeze-dried product made from bacteria. BCG helps increase specific white blood cells that attack tumor cells in the bladder.

BCG is used to treat bladder cancer that is localized (has not spread to other parts of the body).

BCG may also be used for reasons not mentioned in this medication guide.

You should not receive BCG if you have tuberculosis, a fever, a bladder infection, blood in your urine, or a weak immune system (caused by disease or by using certain medicines).

You should also not receive BCG if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

Serious and sometimes fatal infections may occur during treatment with BCG. Call your doctor right away if you have signs of infection (fever, chills, body aches).

You should not receive Tice BCG Live (for intravesical use) if you are allergic to BCG, or if you have:

• tuberculosis;
• a weak immune system from diseases such as AIDS, leukemia, or lymphoma;
• a fever, a bladder infection, or blood in your urine;
• if you are using steroids or receiving chemotherapy or radiation treatments; or
• if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

Tell your doctor if you have any type of bacterial, fungal, or viral infection (including HIV).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while being treated with BCG.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes deadly infections may happen during treatment with BCG.

Tice BCG Live (for intravesical use) can cause serious side effects. Contact your doctor immediately if you experience:

• fever, chills, aches, weakness, flu-like symptoms;
• cough or difficulty breathing;
• pain or burning while urinating;
• a weak urine stream, difficulty emptying your bladder;
• blood in your urine, dark urine;
• vomiting, upper stomach pain;
• jaundice (yellowing of your skin or eyes); or
• signs of a penis infection—burning, itching, odor, discharge, pain, tenderness, redness or swelling in the genital or rectal area, fever, feeling unwell.

About 4 to 6 hours after treatment, you may experience bladder symptoms such as sudden urges to urinate, frequent urination, stomach discomfort, bloating, and possibly loss of bladder control. Inform your doctor right away if these side effects last longer than 2 or 3 days.

Common side effects of Tice BCG Live (for intravesical use) may include:

• increased urination;
• painful urination;
• fever; or
• flu-like symptoms.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice regarding side effects. You may report side effects to the FDA at 1-800-FDA-1088.

BCG is injected directly into the bladder using a catheter inserted into the urethra (the tube for passing urine out of your bladder). You will receive this medicine in a clinic or hospital setting.

BCG is usually given once every week for 6 weeks, and then given every 3 to 6 months for up to 2 years. Follow your doctor's instructions about your specific dosing schedule.

You will need hold the medicine in your bladder as long as possible up to 2 hours. During that time you may be encouraged to lie down or stay relaxed.

For at least 6 hours after you are treated with BCG, your urine will still contain some of the medication and the bacteria it is made from. To prevent the spread of this bacteria, use a toilet rather than a urinal, and sit on the toilet while urinating.

Before you flush the toilet, disinfect the urine with household bleach in an amount that is approximately equal to how much you have urinated. Pour the bleach into the toilet in which you urinated, let it stand for 15 minutes and then flush.

Your doctor may ask you to drink extra fluids for several hours after your BCG treatment to help flush out your bladder. Follow all instructions.

Call your doctor right away if you have a fever after receiving BCG, especially if the fever lasts for several hours or longer.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using BCG.

Call your doctor for instructions if you miss an appointment for your BCG intravesical treatment.

Since this medication is given by a healthcare professional in a medical setting, it is unlikely that an overdose will happen.

Follow your doctor's instructions about any limits on food, drinks, or activities.

If you have an infection that needs an antibiotic, you may have to temporarily stop BCG. Antibiotics can reduce the effectiveness of BCG and should be avoided while you are being treated with BCG. Follow your doctor's instructions and make sure to inform any other doctor treating you that you are receiving BCG.

Tell your doctor about all other medicines you are taking, especially

• an antibiotic;
• chemotherapy or radiation;
• medicine to prevent organ transplant rejection; or
• medicines for multiple sclerosis, psoriasis, rheumatoid arthritis, or other autoimmune disorders.

This list is not complete. Other medications may affect BCG, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are mentioned here.

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