Anthrax Vaccine Adsorbed

How is Anthrax Vaccine Adsorbed?

• Anthrax Vaccine Adsorbed (Biothrax) is a vaccine used for the prevention of disease caused by Bacillus anthracis.

Bacillus anthracis

Bacillus anthracis CDC 17097

What are the uses of this medicine?

Anthrax Vaccine Adsorbed (Biothrax) is a vaccine licensed by the FDA to protect against anthrax disease in persons 18 through 65 years of age:

• It can be used before exposure to anthrax to protect people at high risk of getting the disease.
• It can be used after exposure to anthrax, along with antibiotics, to protect people from getting the disease.

• BioThrax may not protect all people who get the vaccine.
• How well BioThrax works when given after exposure to anthrax has been studied only in animals. It has not been studied in humans because there are not enough people who get the disease naturally, and it is not ethical to expose people to anthrax on purpose to find out how well BioThrax works.

How does this medicine work?

• Anthrax is a zoonotic disease caused by the Gram-positive, spore-forming bacterium Bacillus anthracis.
• BioThrax induces antibodies raised against PA that may contribute to protection by neutralizing the activities of the cytotoxic lethal toxin and edema toxin of Bacillus anthracis.
• Bacillus anthracis proteins other than PA may be present in BioThrax, but their contribution to protection has not been determined.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax or any component of the vaccine, including aluminum, benzethonium chloride, and formaldehyde.

What drug interactions can this medicine cause?

• The safety and efficacy of concomitant administration of BioThrax with other licensed vaccines has not been evaluated. BioThrax should not be mixed with any other vaccine in the same syringe or vial.
• Immunosuppressive therapies, including chemotherapy, corticosteroids (used in high-doses longer than 2 weeks), and radiation therapy may reduce the response of BioThrax.

Is this medicine FDA approved?

• AVA originated in studies done in the 1950s and was first licensed for use in humans in 1970.

How should this medicine be used?

Recommended dosage:

Pre-Exposure Prophylaxis:

Schedule	Route of Administration	Dosing Schedule
Primary Series	Intramuscular	0,1, and 6 months
Booster Series	Intramuscular	6 and 12 months after completion of the primary series and at 12-month intervals thereafter

Post-Exposure Prophylaxis:

Schedule	Route of Administration	Dosing Schedule
Primary Series	Intramuscular	0, 2, and 4 weeks post-exposure combined with antimicrobial therapy

Administration:

• BioThrax is given as a shot in your arm.
• After getting the first shot, you should come back for the next shots on the schedule given to you by your health care provider. It is important that you get all your shots to get the best protection.
• If you get BioThrax because you may have been exposed to anthrax, it is important that you also take antibiotics for 60 days.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Suspension for injection (0.5 mL dose) in 5 mL multidose vials

This medicine is available in fallowing brand namesː

• BioThrax

What side effects can this medication cause?

The most common side effects of this medicine include:

• Muscle aches
• Headaches
• Fatigue
• Fainting

What special precautions should I follow?

• Acute allergic reactions, including anaphylaxis, have occurred with BioThrax. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
• The stopper of the vial contains natural rubber latex and may cause allergic reactions to patients with a possible history of latex sensitivity.
• BioThrax can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
• History of anthrax disease may increase the potential for severe local adverse reactions.
• If BioThrax is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.
• Vaccination with BioThrax may not protect all individuals.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• BioThrax can cause fetal harm when administered to a pregnant woman.
• If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
• Weigh the potential benefits of vaccination against the potential risk to the fetus.
• Healthcare practitioners are encouraged to register women who receive BioThrax during pregnancy in Emergent’s vaccination pregnancy registry by calling 1-619-553-9255.
• Pregnancy Category D.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established for BioThrax.

What are the active and inactive ingredients in this medicine?

• BioThrax does not contain live bacteria. BioThrax contains non-infectious proteins, aluminum hydroxide, benzothonium chloride and formaldehyde (as preservatives).
• The vial stopper contains natural rubber latex.

Who manufactures and distributes this medicine?

• Manufactured by Emergent BioDefense Operations Lansing LLC
• Lansing, MI , US

What should I know about storage and disposal of this medication?

• 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.
• The stopper of the vial contains natural rubber latex and may cause allergic reactions in latex sensitive individuals.

• Dailymed label info on Anthrax Vaccine Adsorbed
• FDA Anthrax Vaccine Adsorbed

Anthrax Vaccine Adsorbed Resources
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