BioThrax vaccine is used to help prevent anthrax in adults with a high risk of exposure to the anthrax bacteria in certain work settings, while traveling, or during military service. This vaccine works by exposing you to an antigen protein that causes your body to develop immunity to the disease. BioThrax vaccine does not contain live or killed forms of the bacteria that causes anthrax.

BioThrax will not treat an active infection that has already developed in the body.

Like any vaccine, BioThrax may not provide protection from disease in every person.

What is anthrax?

Anthrax is a disease caused by infection with spore-forming bacteria called Bacillus anthracis, which occur naturally in soil. These bacteria most often infect animals such as sheep, goats, cattle, deer, antelope, and other herbivores. Anthrax disease can occur in people who are exposed to an infected animal or other source of anthrax bacteria.

Anthrax is most common in agricultural regions lacking in good veterinary prevention programs, especially in Africa, Asia, Central and South America, the Caribbean, the Middle East and Southeastern Europe. Although less common, anthrax does occur in the United States among both wild game animals and domestic livestock.

Anthrax is spread to a human through the skin, the stomach, or the lungs. The bacteria can enter the skin through a cut or wound that comes into contact with products from an infected animal (such as meat, wool, hide, or hair). Infection can also occur through the lungs when a person inhales the bacterial spore, or through the stomach when a person eats undercooked meat from an infected animal. Anthrax is a serious disease that can spread quickly throughout the body and it is fatal in a high number of cases, especially when acquired through the lungs.

BioThrax is used to help prevent anthrax disease in adults. Anthrax vaccine will not treat an active infection that has already developed in the body.

BioThrax is used before exposure in people who may come into contact with anthrax bacteria in certain work settings, while traveling, or during military service. BioThrax is used together with antibiotics after exposure in people who have already come into contact with anthrax bacteria.

BioThrax works by exposing you to an antigen protein that causes your body to develop immunity to the disease. Anthrax vaccine does not contain live or killed forms of the bacteria that causes anthrax.

Like any vaccine, the anthrax vaccine may not provide protection from disease in every person.

You should not receive BioThrax if you have ever had a life-threatening allergic reaction to an anthrax vaccine, or if you have ever had anthrax disease acquired through the skin.

Before receiving BioThrax, tell the doctor if you have ever had an allergic reaction to a vaccine, or if you have a weak immune system, if you are pregnant or breast-feeding, if you are allergic to latex rubber, if you are receiving chemotherapy or radiation, or if you have a history of Guillain-Barré syndrome.

You can still receive a vaccine if you have a cold or mild fever. In the case of a more severe illness with a high fever or any type of infection, wait until you get better before receiving BioThrax.

Before receiving BioThrax, tell the doctor about all other vaccines you have recently received. Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, such as steroids, psoriasis or arthritis medications, medicines to treat or prevent organ transplant rejection, or chemotherapy or radiation treatments. You may not be able to receive the BioThrax, or may need to wait until the other treatments are finished.

Becoming infected with anthrax is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, BioThrax can cause side effects, but the risk of serious side effects is extremely low.

BioThrax will not treat an active infection that has already developed in the body.

BioThrax vaccine is given as an injection (shot) into a muscle or under the skin.

BioThrax is recommended before exposure for adults age 18 through 65 in the following situations:

• people who handle anthrax bacteria in a laboratory or other work setting;

• people who handle animal hides or furs imported from areas where anthrax is common;

• people who handle meat or other animal products in areas where anthrax is common;

• veterinarians who travel to countries where anthrax is common; and

• military personnel at risk of exposure through potential biological warfare when anthrax may be used as a weapon.

When used after exposure, BioThrax vaccine is given in combination with antibiotic medicine. Be sure to use the antibiotic for the full prescribed length of time, even if you feel fine.

BioThrax vaccine is given in a series of shots. An annual booster shot is also recommended every year during possible exposure to anthrax. Follow your doctor's instructions or the booster schedule recommended by the health department of the state where you live.

Usual Adult Dose of BioThrax for Anthrax Prophylaxis:

Less than 65 years: 0.5 mL subcutaneously every 2 weeks for 3 doses, followed by 0.5 mL at 6, 12, and 18 months. Annual booster injections are recommended thereafter.

You should not receive BioThrax vaccine if you have ever had a life-threatening allergic reaction to an anthrax vaccine.

To make sure BioThrax is safe for you, tell your doctor if you have:

• an allergy to latex, aluminum hydroxide, benzothonium chloride, or formaldehyde;

• a weak immune system caused by receiving certain medicines such as steroids, chemotherapy or radiation; or

• if you take a blood thinner (warfarin, Coumadin, Jantoven).

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that BioThrax could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with anthrax.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of anthrax vaccine on the baby.

It is not known whether anthrax vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of BioThrax vaccine. You may not be fully protected against disease if you do not receive the full series.

An overdose of this vaccine is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving BioThrax vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with anthrax is much more dangerous to your health than receiving this vaccine. However, like any medicine, BioThrax vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any signs of an allergic reaction to BioThrax: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• fever, chills, body aches, nausea, flu symptoms; or

• severe swelling or a hard lump where the shot was given.

Common BioThrax side effects include:

• mild redness, swelling, or tenderness where the shot was given;

• trouble moving the injected arm;

• muscle pain;

• tired feeling; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Other drugs may interact with BioThrax, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.