BCG Live, Intravesical

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KEY POINTS

• This medicine is given through a tube into your bladder to treat or prevent cancer of the bladder in adults. Follow your healthcare provider’s instructions carefully after you have received this medicine.
• This medicine may cause severe or life-threatening infections. This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: BCG live, intravesical; Bacillus of Calmette and Guérin Live; TICE BCG; TheraCys

What is this medicine used for?

This medicine is used to treat or prevent cancer of the bladder in adults.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine, or to rubber latex
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• An organ transplant
• Heart valve or joint replacements
• Tuberculosis (TB)

Before taking this medicine, tell your healthcare provider if you have had a fever, a bladder or kidney infection, or blood in your urine (orange-red color) in the past 2 weeks. Also tell your provider if you are taking any cancer medicines.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Your healthcare provider will give you this medicine. Do not drink any liquids for 4 hours before treatment, and empty your bladder before treatment.

A catheter (tube) is inserted into your bladder to drain any urine that is present. Then this medicine is put into your bladder through the same tube.

After you receive this medicine, you will need to lie for 15 minutes each on your back, stomach, and then on each side for a total of 1 hour. You will then be able to sit up, but you should try to keep the medicine in your bladder for another hour. At the end of 2 hours, you will empty your bladder. If you cannot hold the medicine for the full 2 hours, you will be allowed to urinate sooner. Drink plenty of liquid after you urinate.

This medicine contains live bacteria and must be handled carefully. Your urine must be disposed of carefully. You will sit on the toilet when you empty your bladder (to prevent splashing) for several hours after you receive the medicine. You may be asked to add bleach to the toilet when you urinate for 6 hours after treatment. Follow all instructions your healthcare provider gives you.

What should I watch out for?

This medicine may cause severe or life-threatening infections. Talk with your healthcare provider about this.

Drink plenty of water after each treatment. Follow your healthcare provider's instruction carefully.

You may have burning the first time you urinate after using this medicine. Tell your healthcare provider if this continues or becomes severe.

Contact your healthcare provider right away if your symptoms get worse or if they continue after you receive several treatments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine. This medicine may cause a positive test result for a tuberculin (TB) skin test.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Blood in your urine, fever and chills, severe burning or painful urination, more frequent urination, fast heartbeat, joint pain, eye pain or redness, vomiting, cough, rash, yellowing of your skin or eyes, breathing problems.

Other: Headache, dizziness, nausea, diarrhea, constipation, tiredness, weakness, weight loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antibiotics such as amoxicillin (Amoxil, Moxatag), ampicillin, azithromycin (Zithromax, Zmax), cefaclor, cefadroxil (Duricef), cefixime (Suprax), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), ciprofloxacin (Cipro), clarithromycin (Biaxin), doxycycline (Doryx, Monodox, Vibramycin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gatifloxacin (Zymaxid), levofloxacin (Levaquin), and tetracycline
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), and tacrolimus (Astagraf, Prograf, Protopic)
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), belimumab (Benlysta), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), and leflunomide (Arava)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Other cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Radiation therapy

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.