When This Medicine Should Not Be Used:
You should not use this medicine if your immune system is weak due to other medicines or illness. You should not use this medicine if you have a fever (unless your doctor knows the cause) or if you have a bladder infection. You may not be able to receive this medicine if you have active tuberculosis, or blood in your urine.

How to Use This Medicine:
Liquid

• Do not drink fluids for 4 hours before your treatment. Empty your bladder before you receive this medicine.
• This medicine is given by running the liquid through a tube (catheter) into your bladder. The tube is then taken out, and you will hold the medicine in your bladder for two hours.
• While this medicine is in the bladder, you should lie on your back, stomach, and each side for 15 minutes in each position.
• You can get up after the first hour, but hold the medicine in your bladder for 1 more hour. If you are unable to hold it, tell your doctor or nurse.
• Treatment with BCG may be given once a week for 6 weeks and approximately each month afterward for 6 to 12 months, or as your doctor orders.
• Drink plenty of water during each treatment.
• After each treatment, all patients (men and women) should sit down to urinate.
• Any time you urinate in the first 6 hours after treatment, disinfect the urine by adding an equal amount (usually about 8 ounces, or 1 cup) of household bleach to the toilet bowl and letting it stand for 15 minutes before flushing.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using a medicine to treat an infection or tuberculosis. Some tuberculosis medicines are ethambutol, isoniazid, and rifampin. Medicines to treat an infection (antibiotics) include amoxicillin, azithromycin, penicillin, Augmentin®, Bactrim®, and Cipro®.
• Tell your doctor if you are using any medicine that weakens your immune system, such as steroids or cancer treatments. Some steroids are dexamethasone, prednisolone, prednisone, and Medrol®.

Warnings While Using This Medicine:

• Before you begin your treatment, make sure your doctor knows if you are pregnant or breast feeding. Do not get pregnant while you are being treated with this medicine.
• Tell your doctor if you have any changes in urinary habits after treatment with this medicine. Changes include urinating more or less than usual or having trouble urinating.
• Some people develop infections after receiving this medicine. Call your doctor right away if you start to have flu-like symptoms. These symptoms include chills, weakness, and fever (103 degrees or higher) that lasts longer than 72 hours.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Blood in your urine.
• Burning or pain when you urinate.
• Fever (103 degrees F or higher), chills, or extreme tiredness.
• Severe skin rash.
• Uncontrollable shaking or trembling.
• Urinating more than usual, or feeling like you have to urinate more often.

If you notice these less serious side effects, talk with your doctor:

• Cough.
• Mild skin rash.
• Nausea or vomiting.
• Pain in your joints.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088