BIOTHRAX

Biothrax Generic Name & Formulations

Legal Class

General Description

Anthrax vaccine adsorbed; per 0.5mL dose; susp for IM or SC inj; contains aluminum hydroxide, benzethonium chloride, formaldehyde.

Pharmacological Class

Anthrax vaccine.

How Supplied

Multi-dose vials (5mL)—1

Manufacturer

Emergent BioSolutions Inc.

Generic Availability

Biothrax Indications

Indications

Pre-exposure prophylaxis of disease caused by Bacillus anthracis in high risk persons due to occupation or other activities for anthrax disease. Post-exposure prophylaxis after suspected or confirmed Bacillus anthracis exposure, when given with recommended antibacterial drugs.

Biothrax Dosage and Administration

Adult

For IM inj (into the deltoid) or SC inj (over the deltoid) only. Each dose is 0.5mL. 18–65yrs (Pre-exposure): give as IM inj at 0, 1, and 6 months with booster doses at 6 and 12 months after completion of primary series, then at 12-month intervals thereafter; if at risk of hematoma: may give as SC inj at 0, 2, 4 weeks, and 6 months with booster doses at 6 and 12 months after completion of primary series, then at 12-month intervals thereafter; (Post-exposure): give as SC inj at 0, 2, and 4 weeks post-exposure in combination with antimicrobial therapy.

Children

Not established.

Biothrax Contraindications

Contraindications

Severe allergic reaction after a previous BioThrax dose.

Biothrax Boxed Warnings

Not Applicable

Biothrax Warnings/Precautions

Warnings/Precautions

Vaccination may not protect all individuals. Have medical treatment and supervision available to manage anaphylactic reactions. History of anthrax disease. Latex allergy. Immunocompromised. Elderly (>65yrs): not indicated. Pregnancy (Cat.D): not recommended. Nursing mothers.

Biothrax Pharmacokinetics

See Literature

Biothrax Interactions

Interactions

Concomitant other vaccines: inject at different sites. Concomitant immunosuppressants, chemotherapy, high-dose corticosteroids (>2 weeks), radiation therapy: may get sub-optimal response.

Biothrax Adverse Reactions

Adverse Reactions

Tenderness, pain, erythema, edema, limited arm motion, muscle aches, fatigue, headache; allergic reactions.

Biothrax

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