Biothrax

Anthrax vaccine is used to prevent infection caused by anthrax bacteria. It is used before exposure to anthrax to protect people at high risk of getting the disease. It is also used after exposure to anthrax, together with antibiotics, to protect people from getting the disease. The vaccine works by causing the body to produce its own protection (antibodies) against anthrax.

Anthrax is a serious disease that may cause death. It is spread by touching or eating something that is infected with the anthrax germ, such as animals, or by breathing in the anthrax germ.

This vaccine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

• Suspension

BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age whose occupation or other activities place them at high risk of exposure.

Since the risk of anthrax infection in the general population is low, routine immunization is not recommended.

The safety and efficacy of BioThrax in a post-exposure setting have not been established.

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

• Immunosuppressive therapies, including chemotherapy, corticosteroids (used in high-doses longer than 2 weeks), and radiation therapy may reduce the response of BioThrax.

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

Tell your health care provider:

• If you may be pregnant, plan to get pregnant soon, or are nursing a baby
• About medicines that you take, including over-the-counter medicines and supplements.
• About immune problems you have, including steroid treatments and cancer treatments.
• About blood clotting problems or if you take “blood thinners.”
• If you are allergic to latex

BioThrax is given as a shot in your arm by your healthcare provider. 

After getting the first shot, you should come back for the next shots on the schedule given to you by your health care provider. It is important that you get all your shots to get the best protection.

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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.

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

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

This vaccine 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.

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

Anthrax vaccine 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, anthrax 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.

The anthrax 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.

An overdose of this vaccine is unlikely to occur.

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 this 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, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have signs of an allergic reaction: 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 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.

In the U.S.

• Biothrax

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

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.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Pain, redness, tenderness, or limited movement of the arm where the injection is given

• Swollen, painful, or tender lymph glands in the neck, armpit, or groin

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fainting
• fast heartbeat
• hives or welts, skin rash
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sores, ulcers, or white spots in the mouth or on the lips
• trembling or shaking of the hands or feet
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• muscle aches and pains

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dark-colored urine
• difficulty with moving
• feeling of warmth
• hair loss or thinning of the hair
• muscle cramps or spasms
• muscle pain or stiffness
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• swollen joints
• trouble sleeping

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.