Data from FDA - Curated by Toby Galbraith - Last updated 17 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

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. (1)

Full Prescribing information

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Advisory information

contraindications

Severe allergic reaction (e.g. anaphylaxis) after a previous dose of BioThrax or a component of the vaccine. (4)

Special warnings and precautions

• The stopper of the vial contains natural rubber latex and may cause allergic reactions in latex sensitive individuals. (5.2)
• Pregnancy: Avoid use in pregnancy unless the potential benefit outweighs the potential risk to the fetus (5.3, 8.1)

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, fatigue, and headache. (6)

Usage information

Dosing and administration
For intramuscular or subcutaneous injection only.
Each dose is 0.5 mL.

Pre-Exposure Prophylaxis (2.1):
Schedule Route of Administration Dosing Schedule
Primary Series Intramuscular 0,1, and 6 months
Booster Series Intramuscular 6 and 12 months after
completion of the primary
series and at 12-month
intervals thereafter
In persons who are at risk for hematoma formation following intramuscular injection, BioThrax may be administered by the subcutaneous route. The pre-exposure prophylaxis schedule for BioThrax administered subcutaneously is 0, 2, 4 weeks, and 6 months with booster doses 6 and 12 months after completion of the primary series, and at 12-month intervals thereafter.

Post-Exposure Prophylaxis (2.1):
Schedule Route of Administration Dosing Schedule
Primary Series Subcutaneous 0, 2, and 4 weeks post-exposure
combined with antimicrobial
therapy
Use in special populations
• Pregnancy: Advise women of potential risk to the fetus. (5.3, 8.1) Pregnancy registry available, contact BioThrax (Anthrax) Vaccine in Pregnancy Registry (Phone: 1-619-553-9255). (8.1)
• Safety and effectiveness of BioThrax have not been established in pediatric or geriatric populations. (8.4, 8.5)

More information

Category Value
Authorisation number BLA103821
Orphan designation No
Product NDC 64678-211
Date First Approved 04-11-1970
Marketing authorisation holder Emergent BioDefense Operations Lansing LLC