Posted on April 28th, 2009 by
Class: Biologic therapy
Generic Name: Bacillus Calmette-Guerin, BCG
Trade Name: TheraCys®, TICE®
For which conditions is this drug approved? BCG is FDA approved for the treatment of superficial bladder cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? BCG is classified as a biologic response modifier and is comprised of an inactivated form of the bacteria Mycobacterium bovis which is responsible for causing tuberculosis. BCG produces its anti-cancer effects by being recognized as “foreign” by the immune system. This stimulates the immune system to mount an inflammatory response in the bladder where the BCG is administered. The immune responses that occur produce anti-cancer activity within the bladder.
How is BCG typically given (administered)? BCG is administered directly into the bladder and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used and the overall health of the patient. It is typically given on an outpatient basis, during which time it is delivered through a catheter. Once inserted, the catheter is clamped so that the solution remains in the bladder, and the patient is often asked to move from side to side so that the solution comes in contact with the entire bladder. Following a pre-determined time, the catheter is unclamped and the solution is allowed to drain.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with BCG. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. Due to the uncommon side effect of a patient experiencing a systemic infection of tuberculosis, physicians will monitor for signs indicative of an active infection. These signs may include fever that persists for 2-3 days, chills, weakness or flu-like symptoms that increase following therapy, joint pain, cough, skin rash, and/or urinary symptoms including burning, pain, urgency, frequency or blood in the urine that increases or persists, and/or confusion, lightheadedness, dizziness, and/or swelling of the testicles. Patients experiencing any of these symptoms should contact their healthcare provider immediately.
What are the common (occur in 30% or more of patients) side effects of treatment with BCG?
• Increased frequency in urination
• Painful urination
• Blood in the urine
• Generalized weakness
• Generalized aches and pains
What are the less common (occur in 10% to 29% of patients) side effects of treatment with BCG?
• Bladder irritation/inflammation
• Urinary tract infection
• Urinary urgency
• Kidney damage
• Nausea or vomiting
• Lack of appetite
• Genital pain
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Avoid caffeine or alcohol on the day of treatment.
• Avoid drinking large quantities of liquid 6-10 hours prior to treatment and approximately 2 hours following treatment, to allow maximum exposure to BCG.
Are there any special precautions patients should be aware of before starting treatment?
• Since BCG is a live bacterium, it is possible to transmit the infection. To help avoid transmission of infection to others, patients should be seated while urinating to reduce splashing.
• Urine should be disinfected with 2 cups of household bleach (let bleach sit in toilet water for 15-20 minutes) after voiding.
• Men should avoid sexual intercourse for 48 hours following treatment, as sex can transmit infection of BCG to a partner.
• Men should wear a condom if engaging in sexual activity during the treatment course (after 48 hours following treatment with BCG) and for 6 weeks following the completion of treatment.
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician if they are at high risk of HIV infection or tuberculosis, are known to be immunocompromised, or have an active infection.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Fever lasting 2 days or more
• Joint pain
• Increase in urinary frequency, pain on urination, blood in the urine, difficulty in urinating, or sense of urgency to urinate
• Lightheadedness, confusion, dizziness
• Swelling of testicle(s)
• Yellowing of skin or eyes
• Difficulty breathing
• Extreme, persistent fatigue
• Increase in flu-like symptoms
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug.
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