Generic Name: BCG (bee cee jee)Brand Names: TheraCys, Tice BCG Vaccine
BCG (Bacillus Calmette and Guérin) is made using the organisms of a bacteria.
This medication is injected directly into the bladder, where it causes inflammation and increases certain white blood cells known as natural killer cells. These killer cells act to destroy invading cells such as tumor cells in the bladder.
BCG is used to treat bladder cancer that is localized (has not spread to other parts of the body).
BCG may also be used for other purposes not listed in this medication guide.
You should also not receive BCG if you have had a bladder biopsy, surgery, or catheter within the past 14 days.
Before you receive BCG, tell your doctor if you are allergic to latex rubber, or if you have myasthenia gravis, a pacemaker or other artificial heart device, an artificial joint or other prosthetic, or any type of infection (including HIV).
Also tell your doctor if you have ever had tuberculosis, bypass surgery, or an aneurysm (dilated blood vessel), or if you currently need to have an organ transplant (kidney, liver, heart, etc).
Your doctor may ask you to drink extra fluids for several hours after your BCG treatment to help flush out your bladder. Follow your doctor's instructions about the type and amount of liquids you should drink.Call your doctor right away if you have a fever after receiving BCG, especially if the fever lasts for several hours or longer. Antibiotics can make BCG less effective and should be avoided during your treatment with BCG. If you have an infection that must be treated with an antibiotic, you may need to stop receiving BCG for a short time. Follow your doctor's instructions and be sure to tell any other doctor who treats you that you are receiving BCG.What should I discuss with my health care provider before I receive TheraCys (BCG)?You should not receive this medication if you are allergic to BCG, or if you have:
a weak immune system from diseases such as AIDS, leukemia, or lymphoma;
fever, a bladder infection, or blood in your urine;
if you are using steroids or receiving chemotherapy or radiation treatments; or
if you have had a bladder biopsy, surgery, or catheter within the past 14 days.
Before you receive BCG, tell your doctor if you are allergic to latex rubber, or if you have:
any type of bacterial, fungal, or viral infection (including HIV);
a pacemaker or other artificial heart device;
an artificial joint or other prosthetic;
a history of aneurysm (dilated blood vessel);
if you have ever had bypass surgery;
if you have ever had tuberculosis; or
if you need to have an organ transplant (kidney, liver, heart, etc).
If you have any of these conditions, you may need a dose adjustment or special tests to safely receive BCG.FDA pregnancy category C. This medication may be harmful to an unborn baby. Before you receive BCG, tell your doctor if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether BCG passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
BCG is a freeze-dried product that is mixed with saline and other diluents (liquids) in an amount equal to approximately 8 ounces. This liquid mixture is injected directly into the bladder using a catheter inserted into the urethra (the tube for passing urine out of your bladder). You will receive this medication in a clinic or hospital setting.
This medication is usually given once every week for 6 weeks, and then given every 3 to 6 months for up to 2 years. Follow your doctor's instructions about your specific dosing schedule.
After BCG is placed into the bladder, you will need hold the medication in your bladder as long as possible up to 2 hours. During that time you may be encouraged to lie down or stay relaxed.For at least 6 hours after you are treated with BCG, your urine will still contain some of the medication and the bacteria it is made from. To prevent the spread of this bacteria, use a toilet rather than a urinal, and sit on the toilet while urinating.
Before you flush the toilet, disinfect the urine with household bleach in an amount that is approximately equal to how much you have urinated. Pour the bleach into the toilet in which you urinated, let it stand for 15 minutes and then flush.
Your doctor may ask you to drink extra fluids for several hours after your BCG treatment to help flush out your bladder. Follow your doctor's instructions about the type and amount of liquids you should drink.Call your doctor right away if you have a fever after receiving BCG, especially if the fever lasts for several hours or longer.
Being treated with BCG can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using BCG.
Call your doctor for instructions if you miss an appointment for your BCG treatment.
Overdose symptoms may include signs of an infection, such as fever, chills, body aches, weakness, or other flu symptoms.
fever, chills, cough, body aches, joint pain, weakness, vomiting, or other flu symptoms;
nausea, vomiting, stomach pain, jaundice (yellowing of your skin or eyes);
pain or burning when you urinate;
more frequent or urgent urinating;
blood in your urine, lower back pain;
pain or swelling in your testicles;
easy bruising or bleeding;
eye pain, redness, watering, severe burning or itching; or
vision changes, increased sensitivity to light.
Less serious side effects may include:
mild nausea, stomach pain, or loss of appetite;
mild bladder or groin pain;
urine leakage or incontinence;
mild skin rash;
dizziness, tired feeling; or
tissue particles in your urine (not blood).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Before you receive BCG, tell your doctor if you are taking an antibiotic, or if you are using any drugs that weaken your immune system, such as:
cancer medicine or radiation;
cyclosporine (Neoral, Sandimmune, Gengraf);
sirolimus (Rapamune), tacrolimus (Prograf);
basiliximab (Simulect), efalizumab (Raptiva), muromonab-CD3 (Orthoclone);
mycophenolate mofetil (CellCept);
azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel); or
steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.
This list is not complete and there may be other drugs that can interact with BCG. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.