BCG Vaccine, Percutaneous

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KEY POINTS

• This medicine is given by injection (shots) to protect against tuberculosis (TB) infection.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: vaccine

Generic and brand names: BCG vaccine, percutaneous; Bacillus of Calmette and Guérin

What is this medicine used for?

This medicine is given by injection (shots) to protect against tuberculosis (TB) infection. It is only given to people at high risk for TB, such as:

• Children who live with an adult infected with TB
• Certain healthcare workers

What should my healthcare provider know before I take this medicine?

Before receiving this vaccine, tell your healthcare provider if you:

• Are allergic to any medicine or vaccine
• Have a weakened immune system from diseases such as HIV/AIDS, leukemia, lymphoma, or tuberculosis, or from cancer treatment, organ transplant medicine, or steroid medicine
• Have a fever or infection

Also, tell your healthcare provider if you have ever had a positive TB skin test.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine must be given by your healthcare provider.

What should I watch out for?

It is normal for your skin to form small red bumps or scabs 10 to 14 days after you get the injection. Keep this area clean. The scab will heal in 4 to 6 weeks.

This vaccine contains live bacteria. You can spread the bacteria if you touch the vaccination site and then touch other parts of your body or other people. Loosely cover the vaccination site and keep it dry for 24 hours after the injection as instructed by your healthcare provider. Do not touch the site, to keep from spreading the infection. If you do touch the site, wash your hands well.

Do not have any other vaccines or TB skin tests without getting your healthcare provider's approval first. After you receive this vaccine, you may test positive to TB skin tests in the future. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, rash, itching, tightness in your chest, trouble breathing).

Serious (Report these to your healthcare provider right away.): High fever (over 103°F, or 39.5°C) or continued fever; chills; headache; new cough; swollen lymph nodes; peeling or scaly skin; bone or joint pain; pus coming from the injection site; severe or continued pain or swelling at the injection site.

Other: Mild skin irritation, swelling, or itching where the shot was given; mild muscle aches or mild fever for 24 to 48 hours after the injection; loss of appetite.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Cancer medicines such as cisplatin, doxorubicin (Doxil), hydroxyurea (Droxia, Hydrea), vinblastine, and vincristine (Marqibo)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Immune globulin
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Isoniazid
• Live vaccines
• Medicines to treat psoriasis, rheumatoid arthritis, and other immune disorders such as adalimumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), leflunomide (Arava), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Multiple sclerosis medicines such as fingolimod (Gilenya), glatiramer (Copaxone), natalizumab (Tysabri), and teriflunomide (Aubagio)
• Radiation therapy
• Rifampin (Rifadin)

Also, chemotherapy or radiation treatments may interfere with your response to this vaccine. Be sure your healthcare provider knows about all medicines you are taking and all treatments you are receiving. Keep a record of all vaccines you receive.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.