Bacillus Calmette-Guerin Vaccine, BCG injection

What is BCG Vaccine, USP?

BCG VACCINE, USP (TICE® BCG) is a vaccine that helps prevent tuberculosis infection. Generic BCG vaccines are not available.

What should my health care professional know before I receive BCG vaccine?

They need to know if you have any of these conditions:

• active tuberculosis or a positive skin test for tuberculosis

• an immune deficiency (natural or due to cancer chemotherapy, radiation, or steroid therapy)

• diabetes mellitus

• fever or infection

• infection with the human immunodeficiency virus (HIV) or AIDS

• leukemia or lymphoma

• renal failure

• an unusual or allergic reaction to vaccines, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

BCG vaccine is injected into the skin of the arm using a small, pointed disk. It is usually given by a health care professional in a hospital, clinic, or prescriber's office.

The use of this vaccine must be officially recorded. Federal law requires that the manufacturer's name and lot number; the name, address, and phone number of the person giving the vaccine; and the date of administration be recorded in the patient's permanent medical record. Your health care professional will give you some written information about the vaccine, you should read this information.

What if I miss a dose?

This does not apply.

What drug(s) may interact with BCG vaccine?

• chemotherapy (drugs to treat cancer) or radiation therapy

• medicines that suppress your immune function (e.g., corticosteroids, etanercept, anakinra, infliximab, adalimumab)

• medicine to treat tuberculosis

BCG vaccine may or may not be administered at the same time as other common vaccines. In some cases more than one type of vaccine may be given to you at the same time but at different sites on the body. Ask your health care provider if you have questions regarding your vaccination schedules.

Tell your prescriber or health care professional about all other medicines you are taking including non-prescription medicines. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking BCG vaccine?

Report any side effects to your prescriber or health care professional that do not go away. Ask your health care professional about immunization for other family members.

Keep the vaccination site clean until any local reaction is gone. The vaccine contains live bacteria. Do not touch the site, as you could infect others. If you accidentally touch the site, wash your hands well.

What side effects may I notice from receiving BCG vaccine?

Serious side effects to the BCG vaccine are rare but could occur.

Side effects that you should report to your prescriber or health care professional as soon as possible:

• signs of an allergic reaction including difficulty breathing, wheezing, chest tightness, severe rash, or hives

• fever of 103 degrees F or higher

• skin ulcer at the injection site

Side effects that usually do not require immediate medical attention (report these side effects to your prescriber or health care professional if they continue or are bothersome):

• red bumps at the injection site

• loss of appetite, muscle or joint pain, or low grade fever for 1—2 days after vaccination

• enlarged lymph node

Where can I keep my medicine?

This vaccine will be administered in the clinic or office of a health care professional. You will not be given vaccine doses to store at home.

Bacillus Calmette-Guerin Vaccine, BCG intravesical solution

What is BCG Live intravesical solution?

BCG Live Intravesical solution (PACIS®, TICE® BCG, TheraCys®) is a bacteria that is used to stimulate your body's immune system against certain types of superficial cancers, especially bladder cancer. Generic BCG Live intravesical solutions are not available.

What should my health care professional know before I receive BCG Live intravesical solution?

They need to know if you have any of these conditions:

• fever or infection

• active tuberculosis or a positive skin test for tuberculosis

• blood in the urine

• bladder biopsy within 2 weeks

• an immune deficiency (natural or due to cancer chemotherapy, radiation, or steroid therapy)

• an unusual or allergic reaction to vaccines, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

BCG intravesical solution is placed within the bladder through a catheter. It is usually given by a trained health care professional in a hospital, clinic or prescriber's office. Do not drink any liquids 4 hours before you receive BCG intravesical solution. Empty your bladder just before the treatment is given. You will need to hold this solution in your bladder for at least 2 hours. Treatments are usually given weekly for 6 weeks.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss a dose. Let your prescriber or health care professional know if you are unable to keep an appointment.

What drug(s) may interact with BCG Live intravesical solution?

• medicines that suppress your immune system such as chemotherapy agents or corticosteroids

• medicine to treat tuberculosis

Because BCG intravesical solution is given into your bladder, there is very little absorption into the rest of your body.

Tell your prescriber or health care professional about all other medicines that you are taking, including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking BCG Live intravesical solution?

Visit your prescriber or health care professional for regular checks on your progress.

BCG Live intravesical solution contains live bacteria. If you have an immune deficiency or have lesions in your bladder that have not healed, you may be at increased risk to get an infection due to this bacteria. If you develop a cough, have a fever more than 103 degrees F or a fever that lasts longer than 3 days, or bladder symptoms that do not go away, call your presciber or health care professional. You may have developed an infection that needs treatment with certain antibiotics.

For 24 hours after receiving BCG Live intravesical solution, urinate by sitting down on the toilet. After you urinate, add 2 cups of chlorine bleach to the toilet bowl. Let stand for at least 15 minutes before flushing. Repeat this process each time you urinate for 6 hours after each treatment. Make sure to wash your hands and genital area thoroughly after you urinate.

Drink several glasses of water a day after taking BCG intravesical solution to wash out your bladder.

Side effects after BCG intravesical may not be bothersome until after the third treatment. Side effects may gradually get worse after each administration.

Men and women of childbearing age should use effective birth control methods during BCG intravesical treatment. Women should not become pregnant while being treated with BCG intravesical solution.

What side effects may I notice from receiving BCG Live intravesical solution?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• blood in urine

• fever, chills, or other signs of infection

• increased or new cough

• nausea or vomiting

• skin rash

Side effects that usually do not require immediate medical attention (report these side effects to your prescriber or health care professional if they continue or are bothersome):

• bladder spasm

• bladder pain

• burning when urinating

• difficulty urinating

• flu-like symptoms

• having to urinate often

• unable to control urination

• waking up at night to urinate

Most side effects occur after placing BCG intravesical solution in your bladder and may last up to 7 days.

Where can I keep my medicine?

This medicine is given into your bladder at a clinic or hospital. You will not be given doses to store at home.