Drugs & Vitamins

BCG Live Active Ingredients: Bacillus Calmette-Guerin (BCG) Vaccine Representative Names: BCG Live, BCG Vaccine, TICE BCG What is BCG Vaccine, USP? What should I tell my health care provider before I take this medicine? How should I use this medicine? What if I miss a dose? What drug(s) may interact with BCG vaccine? What side effects may I notice from receiving BCG vaccine? What should I watch for while taking BCG vaccine? Where can I keep my medicine? What is BCG Vaccine, USP? (Back to top) BCG VACCINE, USP (TICE® BCG) is a vaccine that helps prevent tuberculosis infection. Generic BCG vaccines are not available. What should I tell my health care provider before I take this medicine? (Back to top) 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? (Back to top) 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? (Back to top) This does not apply. What drug(s) may interact with BCG vaccine? (Back to top) •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 side effects may I notice from receiving BCG vaccine? (Back to top) 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 What should I watch for while taking BCG vaccine? (Back to top) 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. Where can I keep my medicine? (Back to top) 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. Last Updated:09/07/2005 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.