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Bacillus of Calmette and Guérin (BCG) infections have been reported in health care workers and in patients because of exposure to the vaccine during preparation and administration. Serious and fatal disseminated BCG infections have occurred and the risk is increased with intravesical administration. THERACYS(R) and TICE(R) BCG contain live attenuated mycobacteria and because of the potential risk for transmission, it should be prepared, handled, and disposed of as a biohazard material .
Bacillus Calmette-Guérin (BCG) is used as a solution that is run through a tube (instilled through a catheter) into the bladder to treat bladder cancer. The exact way it works against cancer is not known, but it may work by stimulating the body's immune system.
BCG is to be administered only by or under the immediate supervision of your doctor.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
There is no specific information comparing use of BCG for treatment of cancer in children with use in other age groups.
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Your doctor will ask you to empty your bladder completely before the solution is instilled into it.
Follow your doctor's instructions carefully about how long to hold the solution in your bladder:
It is important that you drink extra fluids for several hours after each treatment with BCG so that you will pass more urine. Also, empty your bladder frequently. This will help prevent bladder problems.
BCG is a live product. In other words, it contains active bacteria that can cause infection. Some bacteria will be present for several hours in urine that you pass after each treatment with BCG. Any urine that you pass during the first 6 hours after each treatment should be disinfected with an equal amount (usually about 1 cup) of undiluted household bleach. After the bleach is added to the urine, it should be allowed to sit for 15 minutes before it is flushed. If you have any questions about this, check with your doctor.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
While you are being treated with BCG, and for 6 to 12 weeks after you stop treatment with it, avoid contact with people who have tuberculosis. If you think you have been exposed to someone with tuberculosis, tell your doctor.
While you are being treated with BCG and for a few weeks after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.