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BIOTHRAX
Vaccines
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Drug Name:

BIOTHRAX Rx

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

Company:
Emergent BioSolutions Inc.

Therapeutic Use:

Indications for BIOTHRAX:

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.

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.

Contraindications:

Severe allergic reaction after a previous BioThrax dose.

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.

Pharmacological Class:

Anthrax vaccine.

Interactions:

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

Adverse Reactions:

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

Note:

Register pregnant patients in the Vaccine pregnancy registry by calling (619) 553-9255.

Generic Availability:

NO

How Supplied:

Multi-dose vials (5mL)—1

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