BCG Vaccine

Serious side effects have been reported with the BCG vaccine. See the "BCG Vaccine Precautions" section.

Common side effects of the BCG vaccine include the following:

• skin reactions. Following vaccination with BCG, initial skin lesions usually appear within 10–14 days and consist of small red papules (a small, raised, solid pimple or swelling) at the vaccination site. The papules reach a maximum diameter (about 3 mm) after 4 to 6 weeks, after which they may scale and slowly subside. Six months afterwards there is usually no visible sign of the vaccination, though on occasion, a faintly discernable pattern of the points from the multiple puncture device may be visible
• Patients may experience "flu-like" symptoms for 24–48 hours following BCG vaccination. However, the patient should consult with their physician immediately if they experience fever of 103°F or greater, or acute local reactions persisting longer than 2–3 days.
• swollen lymph nodes (lymphadenopathy)

This is not a complete list of BCG vaccine side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you are taking:

• antibiotics
• cancer chemotherapy agents
• steroids
• tuberculosis medications
• vitamins

This is not a complete list of BCG vaccine drug interactions. Ask your doctor or pharmacist for more information. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of BCG vaccine, there are no specific foods that you must exclude from your diet when receiving this medication. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if BCG vaccine crosses into human milk. Because some vaccines can cross into human milk and becuase of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using BCG vaccine.

Bacillus Calmette-Guérin (BCG) vaccine is given by injection to help prevent tuberculosis (TB). TB is a serious disease that can cause severe illness. It is spread by close contact with people who already have TB, such as people living in the same house. Some infected people do not appear to be sick, but they can still spread TB to others. BCG vaccine does not provide 100% protection. Therefore it is important to avoid people with TB, even if you have received the vaccine.

BCG vaccine is to be administered only by or under the direct supervision of a doctor.

This section provides information on the proper use of a number of products that contain bacillus of calmette and guerin vaccine, live. It may not be specific to BCG Vaccine. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

• Accumulation of pus
• peeling or scaling of the skin
• sores at place of injection
• sores at different sites of the skin
• swollen lymph glands

• Cough
• fever
• increase in bone pain
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Administration should be by the percutaneous route with the multiple puncture device as described below. DO NOT INJECT INTRAVENOUSLY, SUBCUTANEOUSLY, OR INTRADERMALLY.

Although BCG vaccination often results in local adverse effects, serious or long-term complications are rare. Reactions that can be expected after vaccination include moderate axillary or cervical lymphadenopathy and induration and subsequent pustule formation at the injection site; these reactions can persist for as long as 3 months after vaccination. More severe local reactions include ulceration at the vaccination site, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent drainage at the puncture site; these manifestations might occur within the 5 months after vaccination and could persist for several weeks.

Acute, localized irritative toxicities of BCG may be accompanied by systemic manifestations, consistent with a "flu-like" syndrome. Systemic adverse effects of 1–2 days' duration such as fever, anorexia, myalgia, and neuralgia, often reflect hypersensitivity reactions. However, symptoms such as fever of 103°F or greater, or acute localized inflammation persisting longer than 2–3 days suggest active infections, and evaluation for serious infectious complication should be considered. If a BCG infection is suspected, the physician should consult with an infectious disease expert before therapy is initiated. Treatment should be started without delay. In patients who develop persistent fever or experience an acute febrile illness consistent with BCG infection, two or more antimycobacterial agents should be administered while diagnostic evaluation, including cultures, is conducted. Negative cultures do not necessarily rule out infection. Physicians or persons caring for patients that use this product should be familiar with the literature on prevention, diagnosis, and treatment of BCG-related complications and, when appropriate, should consult an infectious disease specialist or other physician with experience in the diagnosis and treatment of mycobacterial infections.

The most serious complication of BCG vaccination is disseminated BCG infection. BCG osteitis affecting the epiphyses of the long bones, particularly the epiphyses of the leg, can occur from 4 months to 2 years after vaccination. Fatal disseminated BCG disease has occurred at a rate of 0.06–1.56 cases per million doses of vaccine administered; these deaths occurred primarily among immunocompromised persons.3 The appropriate therapy for systemic BCG infections is discussed in the ADVERSE REACTIONS section.

Although BCG vaccination often causes local reactions, serious or long-term complications are rare.3 Reactions that can be expected after vaccination include moderate axillary or cervical lymphadenopathy and induration and subsequent pustule formation at the injection site; these reactions can persist for as long as 3 months after vaccination. More serious local reactions include ulceration at the vaccination site, regional suppurative lymphadenitis with draining sinuses, and caseous lesions or purulent draining at the puncture site. These manifestations might occur up to 5 months after vaccination and could persist for several weeks. The intensity and duration of the local reaction depends on the depth of penetration of the multiple puncture device and individual variations in patients' tissue reactions. Slight tenderness at the puncture site may be encountered as well as some itching. The initial skin lesions usually appear within 10–14 days and consist of small red papules at the site. The papules reach maximum diameter (about 3 mm) after 4 to 6 weeks, after which they may scale and then slowly subside.

The most serious complication of BCG vaccination is disseminated BCG infection.24,25 The most frequent disseminated infection is BCG osteomyelitis (0.01 to 43 cases per million doses of vaccine administered) which usually occurs 4 months to 2 years after vaccination. Fatal disseminated BCG infection has occurred at a rate of 0.06–1.56 cases per million doses; these deaths occurred primarily among immunocompromised persons.

BCG Vaccination of Individuals Infected with HIV

The safety of BCG vaccination in HIV-infected adults and children, including infants, has not been determined by controlled or large studies. This is a concern because of the association between disseminated BCG infection and underlying immunosuppression. Individuals with HIV infection should not receive the BCG Vaccine.3

Treatment of Adverse Reactions

If a systemic BCG infection occurs, an infectious disease expert should be consulted and anti-tuberculosis therapy should be initiated. Since BCG strains are resistant to pyrazinamide, this antibiotic should not be used.

Reporting of Adverse Reactions

All suspected adverse reactions to BCG vaccination should be reported to Organon USA Inc. at (800) 842-3220 and to the Vaccine Adverse Effect Reporting System (VAERS); telephone (800) 822-7967. These reactions occasionally could occur more than 1 year after vaccination.

BCG Vaccine is supplied in a box of one vial of BCG. Each vial contains 1 to 8 × 108 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0603-02.

Multiple puncture devices may be obtained separately from Organon Teknika Corporation LLC, 100 Rodolphe Street, Building 1300, Durham, NC 27712; telephone number (800) 662-6842.

Storage

The intact vials of BCG Vaccine should be stored refrigerated at 2–8°C (36–46°F).

This agent contains live bacteria and should be protected from direct sunlight. The product should not be used after the expiration date printed on the label.

Rx Only