What Is BioThrax®
(Anthrax Vaccine Adsorbed)

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease

BioThrax, when administered pre-exposure, has been assessed in more than 500,000 people and in more than 25 scientific studies

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. BioThrax is approved for:

  1. Pre-exposure prophylaxis of disease in persons at high risk of exposure.
  2. Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

For more information on BioThrax, please refer to the prescribing information.

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IMPORTANT SAFETY INFORMATION

Indication

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. BioThrax is approved for:

  1. Pre-exposure prophylaxis of disease in persons at high risk of exposure.
  2. Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

Contraindication

Severe allergic reaction (e.g. anaphylaxis) after a previous dose of BioThrax or a component of the vaccine.

Adverse Reactions

The most common (≥10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema, edema, and arm motion limitation. The most common (≥5%) systemic adverse reactions were muscle aches, headache, and fatigue. Acute allergic reactions, including anaphylaxis, have occurred with BioThrax.

Warnings and Precautions

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax or any component of the vaccine. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. It is not known whether BioThrax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BioThrax is administered to a nursing woman.

BioThrax should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.