Biothrax
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
BioThrax® (Anthrax Vaccine Adsorbed) is a sterile, milky-white suspension for intramuscular or subcutaneous injections made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. The production cultures are grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins, inorganic salts, and sugars. The final product, prepared from the sterile filtrate culture fluid contains proteins, including the 83kDa protective antigen (PA) protein, released during the growth period and contains no dead or live bacteria. The final product is formulated to contain 1.2 mg/mL aluminum, added as aluminum hydroxide in 0.85% sodium chloride. The final product is formulated to contain 25 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde, added as preservatives.
Sources
Biothrax Manufacturers
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Emergent Biodefense Operations Lansing, Llc
![Biothrax (Bacillus Anthracis) Injection, Suspension [Emergent Biodefense Operations Lansing, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Biothrax | Emergent Biodefense Operations Lansing, Llc
For intramuscular or subcutaneous injection only.
2.1 Dose and ScheduleAdminister BioThrax as a three-dose primary series of intramuscular injections of 0.5 mL each at 0, 1, and 6 months. Administer booster injections of 0.5 mL 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.
BioThrax may be administered by the subcutaneous route (for example, in persons who are at risk for hematoma formation 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.
Select a different injection site (e.g. alternating arms) for each sequential injection of this vaccine. Do not mix with any other product in the syringe.
The optimal schedule for catch up of missed or delayed booster doses is unknown. [See Clinical Studies (14)]
2.2 Preparation for AdministrationShake the vial thoroughly to ensure that the suspension is homogeneous during withdrawal. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
For intramuscular administration, use a 1- or 1½ -inch 23- or 25-gauge sterile needle and syringe.
BioThrax may be administered by the subcutaneous route using a ⅝-inch, 25- to 27-gauge sterile needle and syringe.
Use a separate sterile needle and syringe to withdraw a single dose for each patient.
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