Biothrax: Uses, Side Effects and Dosage

What is BioThrax used for?

BioThrax (Anthrax Vaccine Adsorbed) is a vaccine used to prevent infection due to Bacillus anthracis.

Vaccination with BioThrax is indicated for use by individuals between 18 and 65 years of age who are at risk for exposure to anthrax through contact with animal products such as hides, hair, or bones that come from anthrax endemic areas, or that may be contaminated with Bacillus anthracis spores. BioThrax is also indicated for individuals who are at risk of exposure to Bacillus anthracis spores, such as exposure resulting from acts of bio-warfare or bioterrorism, regardless of route of exposure. BioThrax is also indicated for individuals following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

How does BioThrax work?

Anthrax disease is a bacterial infection caused by exposure to Bacillus anthracis and your body’s response to this infection. Vaccination with BioThrax prepares your body to fight off the infection by blocking the toxin that is produced by the bacteria.

Anthrax infection can occur in the following ways:

I) Cutaneous (skin): The first sign of a skin infection with anthrax can be a small red mark similar to an insect bite appearing on the skin. Then, after a short period of time, a small pus-filled blister is formed. The skin around the blister will start to turn red, then a black, hard ulcer will form with swelling around the area. Occasionally, the lymph nodes will be painfully swollen. Without antibiotics, approximately 20% of cutaneous anthrax can be fatal due to the spread of the organism throughout the blood system (sepsis).

II) Inhalational anthrax is caused by breathing in airborne spores of anthrax. The first symptoms are non-specific and similar to cold or flu symptoms. Later, a severe disease will develop with high fever, chills, shortness of breath, and shock. Even after treatment with antibiotics, a large number of patients die within 3 to 5 days.

III) Gastrointestinal (gut): In rare instances, anthrax may be ingested with contaminated foods and is known as gastrointestinal anthrax. Infected patients experience abdominal pain and flatulence. Within a short period of time, bloody diarrhoea and peritonitis will develop. High mortality is associated with the disease from this route of exposure.

IV) Injectional: In 2000, a novel form of cutaneous anthrax, termed injectional anthrax, was proposed after anthrax was diagnosed in individuals following injection of illicit drugs. Injectional anthrax symptoms are more severe than those of cutaneous anthrax and are typified by severe soft tissue infection at the injection site, which can progress to septic shock, meningitis, and death.

What are the ingredients in BioThrax?

One dose (0.5 mL) contains:

• Anthrax antigen filtrate: 50 micrograms
• Adsorbed on aluminum hydroxide (0.6 mg aluminum per dose)
• Benzethonium chloride, as a preservative
• Formaldehyde, as a preservative
• Sodium chloride, as part of a saline solution
• Water for injection

The product is sterile and does not contain any living or dead bacteria.

BioThrax comes in the following dosage forms:

BioThrax is a milky-white suspension (when mixed) contained in a clear glass vial. The vial is closed with a chlorobutyl dry natural rubber blend stopper and sealed with an aluminum cap. The product is supplied sterile and one vial contains enough vaccine for 10 injections of 0.5 mL each.

Do not use BioThrax if:

• If you have a history of severe allergic reactions (anaphylactic or anaphylactic-like) following a previous dose of BioThrax or any of the vaccine components.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you are administered BioThrax. Talk about any health conditions or problems you may have, including if you:

• are pregnant, think you may be pregnant, or are trying to get pregnant. Ask your doctor or healthcare provider to advise before receiving any vaccination or medication. As a precaution, pregnant women should not be routinely vaccinated with anthrax vaccine.

• have had anthrax disease in the past;
• have impaired immune responsiveness due to congenital or acquired immunodeficiency or are receiving immunosuppressive therapy;
• have a moderate or severe illness. Vaccination is allowed in people with mild illnesses with or without low-grade fever;
• have had an allergic reaction following a previous dose of BioThrax or any of the vaccine components;
• have a latex allergy or hypersensitivity, because the vial stopper contains dry natural rubber blend which may contain trace amounts of latex proteins.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with BioThrax:

• Please tell your doctor or healthcare provider if you are being treated with immunosuppresive therapy, high-dose corticosteroid therapy, or cytotoxic medicine (e.g., chemotherapy).

How to take BioThrax:

This vaccine has been prescribed for you and will be administered by your doctor or healthcare provider. To administer, a small sterile needle and syringe will be used to withdraw a 0.5 mL dose of BioThrax from the multidose vial. The dose will be administered either through an intramuscular or subcutaneous injection in your upper arm.

What are possible side effects from using BioThrax?

The most common side effects of BioThrax are:

• Soreness, pain, redness, bruising, itching, swelling, or warmth at the injection site
• Motion limitation of the injected arm
• A lump where the shot was given
• A burning sensation may occur immediately after the shot is given and can last about a minute
• Muscle aches, fatigue, or headaches

If you experience any unusual condition, such as difficulty breathing, weakness, hoarseness or wheezing, a fast heartbeat, hives, dizziness, paleness or swelling of the throat, lips, or face within a few minutes after the shot or within a few minutes to an hour after the injection, notify your doctor or healthcare provider immediately as this could be a sign of a severe reaction.

These are not all the side effects you may feel when taking BioThrax. Please also see WARNINGS AND PRECAUTIONS. If you experience any side effects, contact your doctor or healthcare provider. If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Reporting Suspected Side Effects:

For Healthcare professionals: If a patient experiences a side effect following the immunization, please complete the Adverse Events Following Immunization (AEFI) Form appropriate for your province/territory (http://www.phac-aspc.gc.ca/im/aefi-essi-form-eng.php) and send it to your local Health Unit.

Storage:

Store in a refrigerator (2 ºC to 8 ºC). Do not freeze.

Store in the original package in order to protect from light.

After first opening, the vial is to be used within 28 days.

Shelf life: Four (4) years (unopened vial). Do not use more than 28 days after first opening.

Keep out of the reach and sight of children.

If you want more information about BioThrax:

• Talk to your healthcare professional
• Obtain the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website or the manufacturer’s website http://www.emergentbiosolutions.com, calling 1-877-246-8472, or sending an email to medicalinformation@ebsi.com.

Last Revised 23 December 2020

BioThrax^® is a registered trademark of Emergent BioSolutions Inc.