FAQs
What is TICEŽ BCG and how does it work?
What occurs during TICEŽ BCG treatment?
What is the treatment schedule for TICEŽ BCG?
What should I do before TICEŽ BCG treatment?
What are the common side effects of treatment with TICEŽ BCG?
I just had treatment with TICEŽ BCG. What precautions do I need to follow?
Is it safe for me to be around my family after TICEŽ BCG treatment?
How will I pay for TICEŽ BCG treatment?
This section contains frequently asked questions by consumers regarding their TICEŽ BCG treatment. View the answer to a question by clicking on the question in the list at the top of the page.
>What is TICEŽ BCG and how does it work?
TICEŽ BCG is a bacterial preparation of a strain called Bacillus Calmette-Guerin (BCG). It contains live, attenuated bacteria. The medication was developed as a vaccine against tuberculosis but has been found to be useful in treating certain bladder cancers. Doctors have been using TICEŽ BCG for many years to treat and help prevent recurrence of tumors in patients with bladder CIS. It is also used following TUR to help prevent recurrence of Ta and T1 papillary tumors.
How BCG works to treat bladder cancer is not completely understood. A partial explanation may be that it appears to produce an inflammation in the lining of the bladder but the precise mechanism is not known.
In order to work, BCG must be in direct contact with the tumor cells. Thats why it is instilled -- administered directly into the bladder -- instead of being given by injection.
BCG can be effective in treating and helping to prevent the return of bladder CIS. It also can be considered to be effective in helping prevent papillary tumors from coming back following TUR. For BCG to work most successfully, you must actively cooperate with your doctor. This Web site describes TICEŽ BCG treatment in general; however, if you need more specific information about your treatment or side effects, please speak with your doctor.
The instillation -- pouring the medicine into your bladder -- takes only a few minutes. However, the medicine must stay in your bladder for 2 hours. The process itself is simple.
- Your genital area is cleaned with a sterile solution and you are draped with a sterile sheet.
- A tube (a catheter) is passed through your urethra and into your bladder. Any urine that remains in your bladder can then be removed so that the BCG can easily touch all of the bladder lining.
- The TICEŽ BCG mixture is administered into your bladder through the catheter.
- The medication stays in your bladder for 2 hours. During that time, you will be lying down. Your position will be changed from time to time to make sure that the BCG is in contact with all parts of the lining of the bladder long enough to be effective.
- Lying down and changing position may also help to reduce the urge to urinate during the treatment period.
The exact scheduling of treatment depends on the individual to be treated. These are the steps that are commonly followed:
Initial treatment: Once a week for 6 weeks (if necessary, this schedule may be repeated once)
Follow-up treatment: Once a month for at least 6 to 12 months
You will be given specific information about the use of TICEŽ BCG in your medical facility. The four points given here are important for treatment no matter where it is given.
- Be on time for your appointments. Your TICEŽ BCG is mixed for you just before your appointment and can only be kept for a short time.
- Do not drink any liquids for 4 hours before your appointment time.
- Just before your treatment time, urinate to empty your bladder.
- Tell your doctor how you have felt between treatments, especially if you have had a fever, been unusually tired, had chills, or if your urine has contained bright red blood or there have been any blood clots in your urine.
You should talk to your doctor about possible side effects associated with TICEŽ BCG treatment. Some reactions such as painful or frequent urination can be related to irritation of the bladder. These symptoms typically begin 4 to 6 hours after instillation and last 24-72 hours. They are usually seen after the third treatment and tend to increase in severity after each administration. Other symptoms, such as flu-like symptoms, fever, fatigue, and chills may affect your whole body. These symptoms also may get more frequent or worse with subsequent treatments.
>Report Side Effects
Notify your doctor at once if you experience any problems, particularly severe urinary symptoms such as burning or painful urination, an urgent or frequent need to urinate, or blood in the urine. Also report joint pain, coughing, or rash. It is especially important to report these symptoms to your doctor before you receive the next treatment of BCG. They may be a sign that you have an infection requiring immediate attention. You should be aware that infections associated with TICEŽ BCG treatment have led to death on rare occasions. Symptoms lasting longer than 48 hours or a fever of 101.3°F (or higher) should be reported to your physician immediately.
Once outside your body, the TICEŽ BCG fluid may be unsafe for you or others to touch. With proper and simple precautions, the bacteria are not likely to be passed along to other people. After treatment, there are some important steps you must follow. After the TICEŽ BCG treatment, drink plenty of fluids to wash out your bladder as instructed by your doctor. For the 6 hours after each treatment, follow all the steps below each time you urinate.
- To get the medicine out of your bladder and avoid splashing, sit down on the toilet to pass your urine. Touching the medicine outside the bladder may be unsafe for you and others.
- After you urinate, add two cups of chlorine bleach to the toilet, close the lid, and wait 15 minutes before flushing.
- Wash your genital area and your hands carefully with soap each time you urinate.
Once outside your body, the TICEŽ BCG fluid may be unsafe for you or others to touch. With proper and simple precautions, the bacteria are not likely to be passed along to other people. After treatment, there are some important steps you must follow. After the TICEŽ BCG treatment, drink plenty of fluids to wash out your bladder as instructed by your doctor. For the 6 hours after each treatment, follow all the steps below each time you urinate.
- To get the medicine out of your bladder and avoid splashing, sit down on the toilet to pass your urine. Touching the medicine outside the bladder may be unsafe for you and others.
- After you urinate, add two cups of chlorine bleach to the toilet, close the lid, and wait 15 minutes before flushing.
- Wash your genital area and your hands carefully with soap each time you urinate.
For patients with financial need, Schering Corporation has developed Schering's COMMITMENT TO CAREŽ program. This service can help eligible patients find alternative sources of reimbursement, and may be contacted by calling 1-800-521-7157 (Weekdays, 9 am to 8 pm EST).
TICEŽ BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). TICEŽ BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. |
TICEŽ BCG is not indicated for papillary tumors of stages higher than T1. |
WARNING
TICEŽ BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material.
BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG.
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TICEŽ BCG is contraindicated in immunocompromised patients. Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization. TICEŽ BCG should not be administered to persons with active tuberculosis.
BCG LIVE (TICEŽ BCG) is not a vaccine for the prevention of cancer.
TICEŽ BCG is an infectious agent. Physicians using it should be familiar with the prevention and treatment of BCG-related complications. Deaths have been reported as a result of BCG infection and sepsis.
There is a ≤1% incidence of life-threatening reactions such as BCG sepsis, coagulopathy, leukopenia, thrombocytopenia, hepatic granuloma, hepatitis, disseminated sepsis with associated mortality, and M. bovis infections of several organs.
Many patients (60%) experience symptoms of bladder irritability beginning 4 to 6 hours after instillation and lasting for 24 to 72 hours. Adverse reactions tend to progress in frequency and severity with subsequent instillations.
Adverse reactions (frequency ≥5%) reported during clinical trials in patients with superficial bladder cancer, including carcinoma in situ, were dysuria (60%), urinary frequency (40%), flu-like syndrome (33%), hematuria (26%), fever (20%), malaise/fatigue (7%), cystitis (6%), urgency (6%), and nocturia (5%).
Adverse reactions (frequency ≥5%) reported during clinical trials in patients with TaT1 bladder cancer following transurethral resection were dysuria (52%), urgency/frequency (50%), hematuria (38%), flu-like symptoms (24%), fever (17%), pain (17%), hemorrhagic cystitis (9%), chills (9%), bladder cramps (8%), and nausea (7%).
You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For additional important product information please click the Prescribing Info link below.
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