Dosing and uses of Biothrax (anthrax vaccine adsorbed)
Adult dosage forms and strengths
suspension for injection
- 5mL multidose vial containing ten 0.5mL doses
Anthrax Immunization
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
Preexposure prophylaxis
- 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
Postexposure prophylaxis
- 0.5 mL SC at 0, 2, and 4 weeks postexposure combined with antimicrobial therapy
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
>65 years: Safety and efficacy not established
Biothrax (anthrax vaccine adsorbed) adverse (side) effects
>10%
Headache
Fatigue
Tenderness
Erythema
Pain
Edema
Limitation of arm motion
Induration
Warmth
Myalgia
Nasopharyngitis
Pharyngolaryngeal pain
1-10%
Pruritus
Dysmenorrhea
Nausea
Itching
Bruising
Nodule
Back pain
Neck pain
Joint sprain
Rigors
Sinusitis
Upper respiratory tract infection
Sinus headache
Lymphadenopathy
Flu-like illness
Tender/painful axillary adenopathy
<1%
Safety and efficacy not established
Postmarketing Report
Allergic reactions
Alopecia
Anaphylactoid reaction
Arthralgia
Atrthropathy
Erythema multiforme
Injection site
Reactions
Paresthesia
Pyrexia
Rhabdomyolysis
Stevens-Johnson syndrome
Syncope
Tremor
Ulnar
Nerve neuropathy
Warnings
Contraindications
Documented hypersensitivity
History of anthrax infection
Cautions
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 and lactation
Pregnancy category: d
Lactation: Not known whether distributed in breast milk (use caution)
Pregnancy categories
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.
Pharmacology of Biothrax (anthrax vaccine adsorbed)
Mechanism of action
Active immunization against Bacillus anthracis prepared from a cell-free filtrate of B anthracis, but no dead or live bacteria
Administration
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
Storage
Refrigerate at 2-8°C (36-46°F)
Do not freeze
