Privacy Policy

Thank you for visiting BioThrax.com. Emergent is committed to respecting the privacy of visitors to our web site. This policy describes how and when we gather information from our site's visitors.

You may access the Emergent web site without registering or providing any information that identifies you personally. Our servers and other equipment do, however, automatically gather and log certain technical information such as (for example) your IP address, the name of the web site from which you accessed the Emergent web site and the date and time of your visit for the purposes of system administration and tracking. Emergent may use this information on an anonymous or aggregate basis to learn more about how our visitors interact with the web site.

We do not collect information that identifies you as an individual (such as name, address, email address, telephone number and any other information that might reasonably be used to identify you personally) unless you provide this information to us voluntarily, such as during a registration process, via e-mail to Emergent, or any posting to the web site. By providing such information, you consent to our use of it for reasonable business purposes including, but not limited to, contacting you by e-mail, regular mail or phone, to provide you with information about our products and to compile statistics about our customers. We do not sell, share or otherwise distribute your personal data to third parties without your consent.

 

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.