Brand and Other Names:BioThrax
- Classes: Vaccines, Inactivated, Bacterial
Dosing & Uses
Dosage Forms & Strengths
suspension for injection
- 5mL multidose vial containing ten 0.5mL doses
Indicated for active immunization for prevention of disease caused by Bacillus anthracis in individuals aged 18 through 65 yr
Approved in the United States for preexposure prophylaxis in persons at high risk of exposure and for postexposure prophylaxis following suspected or confirmed Bacillus anthracis exposure
- 3-dose primary series: 0.5 mL IM at 0, 1, and 6 months
- Booster series: 0.5 mL IM at 6 and 12 months after primary series initiation and then at 1-year intervals thereafter for persons who remain at risk
- Note: Individuals are not considered protected until completion of 3-dose primary series
- SC administration for preexposure prophylaxis
- In persons who are at risk for hematoma formation following IM injection, may administer SC
- 4-dose primary series: 0.5 mL SC at 0, 2, 4 weeks, and 6 months
- Booster series: 0.5 mL SC at 6 and 12 months after completion of the primary series, and at 1-year intervals thereafter
- 0.5 mL SC at 0, 2, and 4 weeks postexposure combined with antimicrobial therapy
Safety and efficacy not established
>65 years: Safety and efficacy not established
Limitation of arm motion
Upper respiratory tract infection
Tender/painful axillary adenopathy
Safety and efficacy not established
History of anthrax infection
Immediate treatment for anaphylactoid reaction should be available during vaccine use
May consider deferring administration in patients with moderate or severe acute illness (with or without fever)
Use with caution in patients with history of bleeding disorders and or anticoagulant therapy
Use caution in patients severely immunocompromised
Pregnancy & Lactation
Pregnancy Category: D
Lactation: Not known whether distributed in breast milk (use caution)
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Active immunization against Bacillus anthracis prepared from a cell-free filtrate of B anthracis, but no dead or live bacteria
IM or SC Administration
Shake well before use to ensure that the suspension is homogeneous during withdrawal from the vial
May use acetaminophen to provide comfort; routine prophylactic administration of acetaminophen to prevent fever due to vaccine may decrease immune response (significance not established)
Preexposure prophylaxis: Administer IM into the deltoid muscle; if preexposure prophylaxis requires SC administration, administer over the deltoid muscle
Postexposure prophylaxis: Administer SC over the deltoid muscle
Do not mix with any other product in the syringe
Refrigerate at 2-8°C (36-46°F)
Do not freeze
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