This medication is used to treat or prevent certain types of bladder cancer. This medication works by causing the body's defense system (immune system) to become more active.

This form of the medication is not used to prevent tuberculosis.

This medication is given into the bladder through a tube (catheter) by a health care professional as directed by your doctor. This medication is usually given weekly for the first 6 weeks and then less often thereafter as directed by your doctor.

Do not drink any fluids for 4 hours before treatment. The medication is left in the bladder for up to 2 hours and then released by urinating. Follow your doctor's instructions carefully. There may be some burning pain when you first urinate. Since the urine contains live bacteria that may infect you or others, you must sit down to urinate for 6 hours after treatment to avoid splashing of the urine. After each time you urinate during this 6-hour period, pour household bleach (about the same amount of bleach as the amount of urine) into the toilet, then wait 15 minutes before flushing. Always wash your hands afterward. Talk to your doctor about other important things you must do to prevent infection.

Drink plenty of fluids after your first urination unless otherwise directed by your doctor. Doing so helps clear the medication from your body.

See also Warning section.

Nausea, vomiting, loss of appetite, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of bladder irritation (such as difficult/painful/frequent/bloody urination)
• muscle/joint pain
• pain/swelling of the testes
• unusual tiredness
• fast/pounding heartbeat
• shortness of breath
• vision changes
• redness/swelling/pain in the eye
• eye sensitivity to light
• severe stomach/abdominal pain
• yellowing skin/eyes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• immune system problems (including HIV, certain cancers such as leukemia/lymphoma)
• radiation treatment
• current infection/fever (such as bladder infection, active tuberculosis)
• certain blood vessel disease (aneurysm)
• injury/procedure in the bladder within the last 7 days (such as catheterization, biopsy, signs of bloody urine)
• man-made medical devices/parts in the body (such as pacemakers, artificial joints, arterial grafts)

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is recommended that women receiving this medication avoid pregnancy. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• antibiotics (including isoniazid, rifampin, penicillins such as amoxicillin, macrolides such as erythromycin)
• drugs that weaken the immune system (including abatacept, corticosteroids such as prednisone, cancer chemotherapy)
• mefloquine

This medication may interfere with the tuberculosis (TB) skin test, possibly causing false test results. If a skin test is needed, it is recommended that patients finish it before treatment.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule.

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