® BioThrax This document is based on the U.S. Prescribing Information. Adsorbed

BIOTHRAX® () Suspension for Intramuscular or Subcutaneous Injection1

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 B. anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

About BioThrax Efficacy & Safety • Delivers pre- and post-exposure protection against • The efficacy of BioThrax for post-exposure prophylaxis is anthrax disease.1 based solely on studies in animal models of inhalational anthrax.1 • BioThrax stimulates the immune system to produce against protective antigen (PA), • The most common (≥10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, therebyneutralizing the toxins produced by anthrax 1 bacteria.1 pain, erythema, edema, and arm motion limitation. • The most common (≥5%) systemic adverse reactions • To date, more than 15 million BioThrax doses have 2 were muscle aches, headache, and fatigue. Acute allergic been administered to over 3 million individuals. reactions, including anaphylaxis, have occurred with BioThrax.1 See reverse for full Important Safety Information.

Mechanism of Action

FURIN- MEDIATED Anthrax bacteria produce three protein CLEAVAGE toxins known as protective antigen (PA), lethal factor (LF), and edema factor (EF). The PA toxin binds to cell surface receptors and is cleaved. The cleaved fragments combine to form a cluster. LF or EF binds to this cluster, which enters the cell. The LF and EF toxins are released and cause cell death via their cytotoxic effects. (Figure 1).3

BioThrax stimulates the immune system to produce antibodies against PA, which block it from binding to the cell receptor. When PA is blocked, LF and EF are not able to interact with PA and the toxins Figure 1. Pathogenesis of Anthrax Figure 2. Mechanism of Action of BioThrax are thereby neutralized (Figure 2).1

For more information about BioThrax or to report an adverse event, call Emergent BioSolutions at +1-877-246-8472 or email [email protected]. 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 confirmedBacillus 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.

Please see accompanying full U.S. Prescribing Information.

REFERENCES 1. BioThrax (Anthrax Vaccine Adsorbed) US Prescribing Information. Emergent BioSolutions. Revised November 2015. 2. Data on file. Emergent BioSolutions. 3. Ascenzi, P. et al. Anthrax Toxin: a Tripartite Lethal Combination. FEBS Letters. 531;2002:384-388.

© 2019 Emergent BioSolutions Inc. NP-BioT-00001 June 2019. BioThrax® and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries.