BCG

Generic Name: BCG (bee cee jee)
Brand Name: TheraCys, Tice BCG Live (for intravesical use), Tice BCG Vaccine, Theracys 3, BCG Vaccine

What is BCG?

BCG (Bacillus Calmette and Guérin) is a freeze-dried product made from bacteria. BCG increases certain white blood cells that destroy invading 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 purposes not listed in this medication guide.

What is the most important information I should know about BCG?

You should not receive BCG if you have tuberculosis, a fever, a bladder infection, blood in your urine, or a weak immune system (caused by disease or by using certain medicines).

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You should also not receive BCG if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

Serious and sometimes fatal infections may occur during treatment with BCG. Stop using this medicine and call your doctor right away if you have signs of infection (fever, chills, body aches).

What should I discuss with my health care provider before I receive BCG?

You should not receive this medication if you are allergic to BCG, or if you have:

  • tuberculosis;

  • a weak immune system from diseases such as AIDS, leukemia, or lymphoma;

  • a 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.

To make sure BCG is safe for you, tell your doctor if you have:

  • any type of bacterial, fungal, or viral infection (including HIV);

  • myasthenia gravis;

  • 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).

FDA pregnancy category C. It is not known whether BCG will harm an unborn baby. Use effective birth control to prevent pregnancy while receiving BCG. 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. You should not breast-feed while using this medicine.

How is BCG given?

BCG 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.

BCG 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.

Call your doctor right away if you have a fever after receiving BCG, especially if the fever lasts for several hours or longer.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using BCG.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your BCG treatment.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving BCG?

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

BCG side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, chills, cough, body aches, joint pain, weakness, or other flu symptoms;

  • vomiting, stomach pain, jaundice (yellowing of your skin or eyes);

  • pain or burning when you urinate, more frequent or urgent urinating;

  • difficult urination, blood in your urine, lower back pain;

  • eye pain, redness, watering, severe burning or itching; or

  • vision changes, increased sensitivity to light.

Common side effects may include:

  • mild nausea, loss of appetite;

  • mild bladder or groin pain;

  • urine leakage or incontinence;

  • diarrhea, constipation; or

  • tissue particles in your urine (not blood).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

BCG dosing information

Usual Adult Dose for Tuberculosis -- Prophylaxis:

BCG vaccine for use in tuberculosis prophylaxis:

BCG vaccine is reserved for persons who have a reaction of <5 mm induration after skin testing with 5 TU of PPD tuberculin. It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculosis infection.

The immunizing dose of 0.2 to 0.3 mL of BCG vaccine is dropped from the syringe and needle onto the cleansed surface of the skin and spread over a 1" by 2" area using the edge of the multiple puncture device. The vaccine is administered percutaneously using a sterile multiple puncture device. The preferred site is the deltoid region. The multiple puncture device is centered over the vaccine and firm downward pressure is applied such that the device points are buried into the skin. Pressure should be maintained for five seconds. (The device should not be rocked.) Pressure underneath the arm is then released and the device is removed.

If the procedure is successful, the points will have punctured the skin. If the points only indent the skin, then the procedure must be repeated.

After a successful procedure, the vaccine should be spread as evenly as possible over the puncture area with the edge of the device. An additional 1 to 2 drops of BCG vaccine may be added to ensure a very wet vaccination site.

The patient should be tuberculin skin tested two to three months after BCG administration. BCG vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after two to three months.

Usual Adult Dose for Urinary Tumor:

Intravesical BCG for use in the treatment of urinary tumors:

Do not inject subcutaneously or intravenously.

The initial dosage of BCG for intravesical use recommended for this patient is one vial administered by intravesical installation into the urinary bladder.

TICE BCG (for intravesical use): The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of one vial of BCG suspended in 50 mL preservative-free saline.

A standard TICE BCG treatment schedule consists of one intravesical instillation per week for six weeks. This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Intravesical TICE BCG administration should then continue at approximately monthly intervals for at least six to twelve months.

TheraCys (for intravesical use): One dose of TheraCys BCG Live consists of the intravesical instillation of 81 mg (dry weight) BCG. This dose is prepared by reconstituting the vial containing freeze-dried BCG with the contents of the vial containing diluent. The vial of reconstituted BCG is further diluted in 50 mL of sterile, preservative-free saline, for a total of 53 mL instillation volume.

A standard TheraCys BCG treatment schedule also consists of one intravesical instillation per week for six weeks. However, the TheraCys therapy then continues on to one dose administered at 3, 6, 12, 18, and 24 months following the initial dose.

Usual Pediatric Dose for Tuberculosis -- Prophylaxis:

Safety and effectiveness of intravesical BCG for the treatment of superficial bladder cancer in pediatric patients have not been established.

BCG vaccine for use in tuberculosis prophylaxis:

BCG vaccine is reserved for persons who have a reaction of <5 mm induration after skin testing with 5 TU of PPD tuberculin. It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculosis infection.

The vaccine is administered percutaneously using a sterile multiple puncture device. The preferred site is the deltoid region.

Generally, 1 mL of sterile water for injection is added to one vial of vaccine. However, in infants less than one month old, the dosage of BCG vaccine should be reduced by one half by using 2 mL of sterile water for injection when reconstituting the vial.

The immunizing dose of 0.2 to 0.3 mL of BCG vaccine is dropped from the syringe and needle onto the cleansed surface of the skin and spread over a 1" by 2" area using the edge of the multiple puncture device. The multiple puncture device is centered over the vaccine and firm downward pressure is applied such that the device points are buried into the skin. Pressure should be maintained for five seconds. (The device should not be rocked.) Pressure underneath the arm is then released and the device is removed.

If the procedure is successful, the points will have punctured the skin. If the points only indent the skin, then the procedure must be repeated.

After a successful procedure, the vaccine should be spread as evenly as possible over the puncture area with the edge of the device. An additional 1 to 2 drops of BCG vaccine may be added to ensure a very wet vaccination site.

The patient should be tuberculin skin tested two to three months after BCG administration. BCG vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after two to three months. For infants vaccinated at less than one month of age, if the vaccinated infant remains tuberculin negative for 5 TU on skin testing, and if indications for vaccination persist, the infant should receive a full dose after one year of age..

What other drugs will affect BCG?

If you have an infection that must be treated with an antibiotic, you may need to stop receiving BCG for a short time. Antibiotics can make BCG less effective and should be avoided during your treatment with BCG. Follow your doctor's instructions and be sure to tell any other doctor who treats you that you are receiving BCG.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with BCG, especially an antibiotic, or any drugs that weaken your immune system, such as:

  • cancer medicine or radiation;

  • medicine to prevent organ transplant rejection;

  • medicines to treat multiple sclerosis, psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

  • tuberculosis medication--pyrazinamide, rifampin, rifabutin.

This list is not complete. Other drugs may interact with BCG, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about BCG.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2013-11-20, 9:40:38 AM.

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