"European Union (EU) regulators have recommended market approval of a combination bacterial and viral vaccine (Vaxelis, Sanofi Pasteur) that immunizes children against six different disorders.
The new injectable vaccine is indic"...
BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age whose occupation or other activities place them at high risk of exposure.
Since the risk of anthrax infection in the general population is low, routine immunization is not recommended.
The safety and efficacy of BioThrax in a post-exposure setting have not been established.
DOSAGE AND ADMINISTRATION
For intramuscular or subcutaneous injection only.
Dose And Schedule
Administer BioThrax as a three-dose primary series of intramuscular injections of 0.5 mL each at 0, 1, and 6 months. Administer booster injections of 0.5 mL intramuscularly at 12 and 18 months after initiation of the series. For those who remain at risk, administer booster injections at 1-year intervals thereafter.
Individuals are not considered protected until they have completed the three-dose primary immunization series.
BioThrax may be administered by the subcutaneous route (for example, in persons who are at risk for hematoma formation following intramuscular injection). The schedule for BioThrax administered subcutaneously is 0, 2, 4 weeks, and 6 months with booster doses at 12 and 18 months, and at 1 year intervals thereafter.
Select a different injection site (e.g. alternating arms) for each sequential injection of this vaccine. Do not mix with any other product in the syringe.
The optimal schedule for catch up of missed or delayed booster doses is unknown. [See Clinical Studies]
Preparation For Administration
Shake the vial thoroughly to ensure that the suspension is homogeneous during withdrawal. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
For intramuscular administration, use a 1- or 1½ -inch 23- or 25-gauge sterile needle and syringe.
BioThrax may be administered by the subcutaneous route using a 5/8-inch, 25- to 27-gauge sterile needle and syringe.
Use a separate sterile needle and syringe to withdraw a single dose for each patient.
Dosage Forms And Strengths
BioThrax is a suspension for injection (0.5 mL dose) in 5 mL multidose vials. See DESCRIPTION for the complete listing of ingredients.
Storage And Handling
BioThrax is supplied in 5 mL multidose vials containing ten 0.5 mL doses.
NDC 64678-211-05 (vial), 64678-211-01 (carton)
Store at 2 °C to 8 °C (36 °F to 46 °F). Do not freeze. Do not use BioThrax after the expiration date printed on the label.
Manufactured by Emergent BioDefense Operations Lansing LLC, Lansing, MI 48906, US. Revised: May 2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/2/2015
Additional BioThrax Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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