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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).

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).

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 medicine 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 medicine 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 (urine, feces, vomit). 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. Caregivers should wear rubber gloves while cleaning up a patient's 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.

BCG side effects

Get emergency medical help if you have 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.

Side effects (in more detail)

BCG dosing information

Usual Adult Dose for Tuberculosis -- Prophylaxis:

Drop 0.2 to 0.3 mL of vaccine from syringe onto cleansed deltoid and spread over a 1 to 2 inch area using the edge of the multiple puncture device.

-Prepare vaccine, clean skin administration site on deltoid with alcohol or acetone sponge and allow to dry thoroughly.
-Position arm to maintain a horizontal surface where vaccine is to be placed.
-Drop vaccine on skin as described above.
-Grasp the arm firmly underneath, tensing the skin.
-Center the multiple puncture device over the vaccine area and apply firm downward pressure so that the device points are well buried in the skin; maintain pressure for 5 seconds - do no "rock" the device.
-Release pressure under arm and remove the device.
--If the points did not puncture the skin, repeat the above procedure.
-Spread the vaccine as evenly as possible over the puncture area with the edge of the device; an additional 1 to 2 drops of vaccine may be added to ensure a very wet vaccination site.
-Discard device in a biohazardous sharps container
-Loosely cover the site and keep dry for 24 hours.


Comments:
-Vaccination is reserved for patients with a less than 5 mm induration after testing with 5 tuberculin units (TU) of PPD tuberculin.
-The Mantoux skin test with 0.1 mL of 5 TU of PPD tuberculin is preferred, and is recommended to be performed prior to vaccination to demonstrate absence of tuberculosis infection.
-Fully explain the risks and benefits of this vaccine before administration.
-Tuberculin reactivity from vaccination should be documented.
-Perform a tuberculin skin test 2 to 3 months after vaccination; repeat vaccination for a negative response to a 5 TU tuberculin test.
-Immunization will not protect all susceptible individuals.

Use: Prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure

Usual Adult Dose for Urinary Tumor:

One vial of BCG suspended in 50 mL preservative free saline, intravesically into the bladder, and retained for 2 hours before voiding
-Standard treatment is one treatment per week for 6 weeks.
-May repeat standard treatment once for lack of tumor remission if clinical situation warrants.
-After standard treatment, administer about monthly for at least 6 to 12 months


Comments:
-Not recommended for stage TaG1 papillary tumors unless they are judged to be high risk of recurrence.
-Do not inject subcutaneously or intravenously.
-Patients should not drink fluids for 4 hours before treatment.
-Patients should empty their bladders before treatment.
-Patients unable to retain the solution for 2 hours should be allowed to void sooner.
-During retention, the patient should be repositioned every 15 minutes, from left side to right side and lying on their back and abdomen to maximize bladder surface exposure.

Uses:
-Treatment and prophylaxis of carcinoma in situ of the urinary bladder
-Prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection

Usual Pediatric Dose for Tuberculosis -- Prophylaxis:

Children 1 month and older:
Drop 0.2 to 0.3 mL of vaccine from syringe onto cleansed deltoid and spread over a 1 to 2 inch area using the edge of the multiple puncture device.

-Prepare vaccine, clean skin administration site on deltoid with alcohol or acetone sponge and allow to dry thoroughly.
-Position arm to maintain a horizontal surface where vaccine is to be placed.
-Drop vaccine on skin as described above.
-Grasp the arm firmly underneath, tensing the skin.
-Center the multiple puncture device over the vaccine area and apply firm downward pressure so that the device points are well buried in the skin; maintain pressure for 5 seconds - do no "rock" the device.
-Release pressure under arm and remove the device.
--If the points did not puncture the skin, repeat the above procedure.
-Spread the vaccine as evenly as possible over the puncture area with the edge of the device; an additional 1 to 2 drops of vaccine may be added to ensure a very wet vaccination site.
-Discard device in a biohazardous sharps container
-Loosely cover the site and keep dry for 24 hours.

Infants under 1 month:
-Reduce dose by one half by using 2 mL of sterile water for injection when reconstituting.
-If response to a 5 TU tuberculin test is negative, AND indications for vaccination persist, administer a full dose after 1 year of age.


Comments:
-Vaccination is reserved for patients with a less than 5 mm induration after testing with 5 tuberculin units (TU) of PPD tuberculin.
-The Mantoux skin test with 0.1 mL of 5 TU of PPD tuberculin is preferred, and is recommended to be performed prior to vaccination to demonstrate absence of tuberculosis infection.
-Fully explain the risks and benefits of this vaccine before administration.
-Tuberculin reactivity from vaccination should be documented.
-Perform a tuberculin skin test 2 to 3 months after vaccination; repeat vaccination for a negative response to a 5 TU tuberculin test.
-Immunization will not protect all susceptible individuals.

Use: Prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure

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; or

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

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: 3.04.

Date modified: November 15, 2017
Last reviewed: September 09, 2015

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