anthrax vaccine adsorbed (Rx)Brand and Other Names:BioThrax

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & 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

Safety and efficacy not established

>65 years: Safety and efficacy not established

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Adverse 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

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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

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Pregnancy & 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.

more...
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Pharmacology

Mechanism of Action

Active immunization against Bacillus anthracis prepared from a cell-free filtrate of B anthracis, but no dead or live bacteria

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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

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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Code Definition
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