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);
- 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).
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.
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.
Seek emergency medical attention if you think you have received too much of this medicine.
Overdose symptoms may include signs of an infection, such as fever, chills, body aches, weakness, or other flu symptoms.
Call your doctor for instructions if you miss an appointment for your BCG treatment.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any side effects to your doctor. Some side effects may be serious, including:
- 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;
- difficult urination;
- 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;
- diarrhea, constipation;
- 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.
BCG, TheraCys, and Tice BCG Vaccine
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Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04