Pharmaceutical Name

Trade (marketing or proprietary) name: Biothrax®

Generic (nonproprietary or active ingredient) name: Anthrax Vaccine Adsorbed

Indication and Usage

Reason the product has been approved for sale on the market.

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. The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax. BioThrax is approved for:

• Pre-exposure prophylaxis of disease in persons at high risk of exposure.
• Post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. The final product is formulated to contain 1.2 mg/mL aluminum, added as aluminum hydroxide in 0.85% sodium chloride. The final product is formulated to contain 25 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde, added as preservatives.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Do not administer BioThrax to individuals 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.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Hypersensitivity Reactions: 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.

Latex: The stopper of the vial contains natural rubber latex and may cause allergic reactions to patients with a possible history of latex sensitivity.

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.

History of Anthrax Disease: History of anthrax disease may increase the potential for severe local adverse reactions.

Altered Immunocompetence: If BioThrax is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Limitations of Vaccine Effectiveness: Vaccination with BioThrax may not protect all individuals.

Immunosuppressive Therapies: Immunosuppressive therapies, including chemotherapy, corticosteroids (used in high-doses longer than 2 weeks), and radiation therapy may reduce the response of BioThrax.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Lymphadenopathy, Nausea, Flu-like symptoms, Angioedema, Rash, Urticaria (hives), Pruritus (itchy Skin), Erythema multiforme, Anaphylactoid reaction, Stevens Johnson syndrome, Paresthesia syncope, Dizziness, Tremor, Ulnar nerve neuropathy, Arthralgia (joint stiffness), Anaphylaxis, Arthropathy (joint disease), Myalgia (muscle pain), Rhabdomyolysis (damaged skeletal muscle), Alopecia (male/female patterned baldness), Malaise (weakness), Pain, Cellulitis, Insomnia, Flushing

Limitations of Vaccine Effectiveness

Vaccination with BioThrax may not protect all individuals.

Specific Populations

Pregnancy

Pregnancy Category D. 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.

Breastfeeding

It is not known whether BioThrax is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BioThrax is administered to a nursing woman.

Pediatric

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

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

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.

Analytical Deep Dive

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