Treatment Name: BCG (Bacillus Calmette-Guérin, Theracys®, TICE®)
BCG (Bacillus Calmette-Guérin, Theracys®, TICE®) is a Treatment Regimen for Bladder Cancer
How does BCG work?
BCG is designed to promote an inflammatory response in the lining of the bladder where the cancer is located. This inflammatory response recruits white blood cells of the immune system causing them to migrate to the location of the cancer and kill the cancer cells within the lining of the bladder.
B - Bacillus
C - Calmette
G - Guérin
Goals of therapy:
BCG is given to shrink and rid the bladder of cancerous cells. BCG is commonly given with the goal of cure.
Usual BCG starting dose:
- Induction: One dose (81 mg), diluted in preservative-free saline, is given via intravesical instillation Once Weekly for 6 weeks in a row
- Maintenance (if needed): One dose (81 mg), diluted in preservative-free saline, is given via intravesical instillation at month 3, 6, 12, 18 and 24 months, after the initial dose is given during induction
- Once the medication has been administered into the bladder, patients should try to retain the medication for a full two hours, if possible
- During the first 15 minutes, patients should lie down on their stomach. After the first 15 minutes, patients may then sit or stand in an upright position
- After a total of 2 hours, patients should urinate in a seated position for safety reasons (to avoid splashing BCG medication outside of a toilet)
- Patients should drink plenty of water or fluids for up to 3 days to help flush BCG out of the bladder
- Patients should properly decontaminate all urine voided during the 6-hour period after each and every dose using a household bleach solution (also known as hypochlorite) as recommended by your health care team. An equal volume of bleach is often added to the toilet after voiding (urinating) and then allowed to stand for 15 minutes before flushing. This disinfectant process helps avoid the risk of someone who uses the toilet afterwards from becoming infected with BCG
Estimated total clinic time needed for this treatment:
- Up to 4 hours for each dose, including preparation time by the pharmacy
- Clinic times are based on clinical studies, but may vary depending on doctor preference, patient tolerability, and the time it takes to prepare the medication in the pharmacy
- BCG is usually given in an outpatient infusion center, allowing the person to go home afterwards
In clinical studies, the most commonly reported side effects with BCG are shown here. Side effects sometimes have percentage ranges because they differed between doses or clinical studies:
- Bladder irritation/inflammation (28 - 35%)
- Bladder infection (21 - 24%)
- Blood in urine (23%)
- Voiding (having to urinate) more than once per hour (19 - 23%)
- General feeling of illness [malaise] (13 - 16%)
- Fever (5 - 9%)
- Unable to hold urine [Urinary incontinence] (2%)
- Skin rash (2%)
- Severe infection requiring hospitalization [sepsis] (0.3%)
Symptoms of bladder irritation are experienced by roughly 35 - 50% of patients receiving BCG, and are usually seen after the third dose. After a dose, irritation begins typically 4 – 6 hours after the dose is given, and lasts for 24 – 72 hours. The inflammatory response and irritation in the bladder may increase in severity after each dose. Dose reduction does not usually reduce these symptoms.
Roughly 8% of patients stop receiving BCG during the first year due to unacceptable side effects.
How often is monitoring needed?
Labs (blood tests) may be checked before each treatment, and periodically throughout treatment as needed. Labs may include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), urinalysis, urine culture, or any others your doctor may order.
How often is imaging needed?
Imaging may be checked before treatment, then as indicated should certain side effects occur. Imaging may include: ultrasound or chest x-ray
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue BCG as planned, interrupt or delay therapy, or stop treatment with BCG and switch therapy
If a patient develops a fever, or illness consistent with BCG infection, no further doses should be given, and 2 or more antibiotics aimed at treating tuberculosis-like infections should be given in addition to appropriate diagnostic tests and cultures. Infection from BCG is more likely to occur if BCG is given within 2 weeks of a bladder surgery or biopsy, or if the bladder catheter causes excessive damage to the bladder leading to bleeding during its insertion
- Tell your doctor if you experience flu-like symptoms (fever, chills, weakness, fatigue, increasing pain or burning with urination), especially if they last for more than 48 hours
- Immunosuppressant medications given with BCG may increase the risk of infection and decrease the effectiveness of BCG. A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Tell your doctor and pharmacist if you have an allergy to latex as the rubber stopper of the BCG vial contains natural rubber latex and could cause an allergic reaction
- Treatment with BCG could cause a tuberculin skin test (TB skin test; used to diagnose tuberculosis) to test positive, even if an active tuberculosis infection is not present. If your job requires you to take a TB skin test, tell your employer the dates that you have received or are receiving BCG
- If a urinary tract infection (known as a “UTI”) occurs during treatment, future doses of BCG should not be given until the infection is gone
- Clinical trials may exist for bladder cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications.
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for BCG (Bacillus Calmette-Guérin, Theracys®, TICE®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for BCG (Bacillus Calmette-Guérin, Theracys®, TICE®). Depending upon your income, they may be able to help cover the cost of:
- BCG (Bacillus Calmette-Guérin)
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as BCG (Bacillus Calmette-Guérin, Theracys®, TICE®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with BCG (Bacillus Calmette-Guérin, Theracys®, TICE®)
What is Bladder Cancer?
A disease of the cells that line the inside of the bladder. Bladder cancer is a rare disease that is most commonly seen in older adults. It is known to cause blood in the urine in up to 90% of patients at diagnosis. Causes of bladder cancer include smoking, exposure to certain chemicals (arylamines), and chronic bladder infections.
Treatment includes surgery (full or partial removal of the bladder), chemotherapy, immunotherapy (giving certain vaccines into the bladder), or thermotherapy (heating the lining of the bladder combined with chemotherapy). The stage of bladder cancer can vary at diagnosis and throughout treatment. Bladder cancer is staged using the Tumor, Node, Metastasis (TNM) system, as well as Stage Grouping 0, I, II, III, or IV. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. The effectiveness of the treatment may depend upon the stage at diagnosis.
NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.
What does "Cure" mean?
The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.
Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.
What is "Intravesical Instillation"?
This means that a catheter is first placed into the bladder allowing it to drain any urine that may be inside. When the bladder is empty, diluted BCG medication is then allowed to flow through the catheter into the bladder using gravity.
If you are interested in reading the clinical trials results, please click on references below:
Brausi M, Oddens J, Sylvester R, et al. Side Effects of Bacillus Calmette-Guérin (BCG) in the Treatment of Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Bladder: Results of the EORTC Genito-Urinary Cancers Group Randomised Phase 3 Study Comparing One-third Dose with Full Dose and 1 Year with 3 Years of Maintenance BCG. Eur Urol. 2014;65:69-76.
What is a CBC?
A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.
2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.
3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.
What is a CMP?
A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status, 2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.
Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein
13) Serum glucose
14) Serum calcium