Source: FDA, National Drug Code (US) Revision Year: 2015
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 pre-exposure prophylaxis of disease in persons whose occupation or other activities place them at high risk of exposure.
BioThrax is approved for 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.
For intramuscular or subcutaneous injection only.
Each dose is 0.5 mL.
Pre-Exposure Prophylaxis:
| 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 at 6 and 12 months after completion of the primary series and at 12-month intervals thereafter.
The optimal schedule for catch up of missed or delayed booster doses is unknown. [See Clinical Studies (14)].
Post-Exposure Prophylaxis:
| Schedule | Route of Administration | Dosing Schedule |
|---|---|---|
| Primary Series | Subcutaneous | 0, 2, and 4 weeks post-exposure combined with antimicrobial therapy |
Shake 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, do not administer the vaccine.
Administer pre-exposure prophylaxis vaccinations intramuscularly into the deltoid muscle. If pre-exposure prophylaxis requires subcutaneous administration, administer over the deltoid muscle. Administer post-exposure prophylaxis vaccinations subcutaneously over the deltoid muscle.
Do not mix with any other product in the syringe.
Store at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use BioThrax after the expiration date printed on the label.
The stopper of the vial contains natural rubber latex and may cause allergic reactions in latex sensitive individuals.
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