October 3, 2015
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How Supplied


BioThrax (anthrax vaccine adsorbed emergent biosolutions) is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 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 (anthrax vaccine adsorbed emergent biosolutions) in a post-exposure setting have not been established.


Preparation for Administration

Use a separate 1- or 1½ -inch 23- or 25-gauge sterile needle and syringe for each patient to avoid transmission of viral hepatitis and other infectious agents.

Shake the bottle thoroughly to ensure that the suspension is homogeneous during withdrawal. Inspect visually for particulate matter and discoloration prior to administration. If the product appears discolored or has visible particulate matter, DISCARD THE VIAL.

Dose and Schedule

Immunization consists of a series of 5 intramuscular doses administered at 0 and 4 weeks and 6, 12 and 18 months. Select a different injection site for each sequential injection of this vaccine. Do not mix with any other product in the syringe. Individuals should not be considered protected until they have received the full series of vaccinations. Do not inject BioThrax (anthrax vaccine adsorbed emergent biosolutions) intravenously or intradermally.

Yearly booster injections of 0.5 mL intramuscularly are recommended for those who remain at risk.

When medically indicated, such as in persons with coagulation disorders or receiving medications that affect coagulation (e.g. warfarin), BioThrax (anthrax vaccine adsorbed emergent biosolutions) may be administered by the subcutaneous route.


Dosage Forms And Strengths

BioThrax (anthrax vaccine adsorbed emergent biosolutions) is available as a sterile suspension in 5 mL multidose vials containing 10 doses each. See DESCRIPTION section for the complete listing of ingredients.

BioThrax (anthrax vaccine adsorbed emergent biosolutions) is supplied in 5.0 mL multidose vials containing ten 0.5 mL doses. (NDC 64678-211-05).

Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use BioThrax (anthrax vaccine adsorbed emergent biosolutions) after the expiration date printed on the label.

Manufactured by: Emergent BioDefense Operations Lansing Inc. Lansing, MI 48906.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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