BioThrax

BioThrax is a vaccine used for prevention of anthrax disease.

BioThrax is given as a shot in the arm as a 3 dose series. 

Common side effects of BioThrax are pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot.

BioThrax is a vaccine used for the prevention of anthrax disease, whose occupation or other activities place them at high risk of exposure.

It is also used to prevent anthrax disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.

It is approved for use in persons 18 through 65 years of age.

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

Vaccination with BioThrax may not protect all individuals.

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

BioThrax is given as a three-dose primary series of intramuscular (into muscle) injections of 0.5 mL each at 0, 1, and 6 months. Booster injections of 0.5 mL are given intramuscularly at 12 and 18 months after initiation of the series. For those who remain at risk, administer booster injections at 1-year intervals thereafter.

Individuals are not considered protected until they have completed the three-dose primary immunization series.

In certain people, BioThrax may be given by the subcutaneous (just under the skin) route such as in persons who are at risk for hematoma formation (a solid swelling of clotted blood) following intramuscular injection. The schedule for BioThrax administered subcutaneously is 0, 2, 4 weeks, and 6 months with booster doses at 12 and 18 months, and at 1 year intervals thereafter.

The best schedule for catch up of missed or delayed booster doses is unknown.

• Hypersensitivity Reactions. Serious adverse reactions, including anaphylaxis, have occurred with BioThrax.
• Latex Sensitivity. The stopper of the vial contains dry natural rubber and may cause allergic reactions to patients with a possible history of latex sensitivity.
• Harm to an unborn baby. BioThrax can cause harm to an unborn baby when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to an unborn baby. Weigh the potential benefits of vaccination against the potential risk to the unborn baby.
• Severe injection site reactions. History of anthrax disease may increase the potential for severe injection site adverse reactions.
• If BioThrax is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
• Vaccination with BioThrax may not protect all individuals.

You should not get BioThrax if you:

• are allergic to BioThrax or any of its ingredients
• had a serious reaction after getting BioThrax before

Common side effects of BioThrax include:

• Pain, tenderness, redness, bruising, or problems moving the arm in which you got the shot
• Muscle aches
• Headaches
• Fatigue
• Fainting

This is not a complete list of BioThrax 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 FDA by calling 1-800-822-7967 or to the website www.vaers.hhs.gov. You may also report side effects directly to Emergent BioSolutions at 1-877-246-8472 or at productsafety@ebsi.com.

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 doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

BioThrax falls into category D. It has been shown that use of BioThrax is pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of the harm to the baby. 

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

It is not known if BioThrax crosses into human milk. Because some vaccines can cross into human milk and because 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 BioThrax.