Biothrax Vaccine

Preparation for Administration

Use a separate 1- or 1½ -inch 23- or 25-gauge sterile needle and syringe for each patient to avoid transmission of viral hepatitis and other infectious agents.

Shake the bottle thoroughly to ensure that the suspension is homogeneous during withdrawal. Inspect visually for particulate matter and discoloration prior to administration. If the product appears discolored or has visible particulate matter, DISCARD THE VIAL.

Dose and Schedule

Immunization consists of a series of 5 intramuscular doses administered at 0 and 4 weeks and 6, 12 and 18 months. Select a different injection site for each sequential injection of this vaccine. Do not mix with any other product in the syringe. Individuals should not be considered protected until they have received the full series of vaccinations. Do not inject BioThrax intravenously or intradermally.

Yearly booster injections of 0.5 mL intramuscularly are recommended for those who remain at risk.

When medically indicated, such as in persons with coagulation disorders or receiving medications that affect coagulation (e.g. warfarin), BioThrax may be administered by the subcutaneous route.

The use of BioThrax is contraindicated in persons with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

Concomitant Administration with Other Vaccines

No prospective, controlled clinical studies to assess the concomitant administration of BioThrax with other vaccines have been performed. If BioThrax is to be given at the same time as another injectable vaccine(s), the vaccine(s) should be administered at different injection sites.

BioThrax should not be mixed with any other vaccine in the same syringe or vial.

Immunosuppressive Therapies

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

Pregnancy and Fertility

Pregnancy: Category D. See Warnings and Precautions section (5)

Male Fertility: A retrospective study was performed at an in-vitro fertilization clinic to evaluate whether BioThrax may impact reproductive function in men. This study compared semen parameters, embryo quality, and pregnancy outcomes in 254 male clients who stated that they had received BioThrax, with those of 791 male clients who did not.² Prior receipt of BioThrax did not influence semen parameters (including concentration, motility and morphology), fertilization rate, embryo quality or clinical pregnancy rates.

Nursing Mothers

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 Use

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

Geriatric Use

Clinical studies of BioThrax did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from subjects in the adult population under age 65. Sub-group analysis of study subjects < 30 years, 30 to < 40 years, 40 to < 50 years and > 50 years indicated that subjects in the > 50 years category had statistically insignificant but numerically lower immune responses than younger subjects.

BioThrax, Anthrax Vaccine Adsorbed, is a sterile, milky-white suspension for intramuscular injections made from cell-free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis. The production cultures are grown in a chemically defined protein-free medium consisting of a mixture of amino acids, vitamins, inorganic salts and sugars. The final product, prepared from the sterile filtrate culture fluid contains proteins, including the 83kDa protective antigen protein, released during the growth period and contains no dead or live bacteria. 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 µg/mL benzethonium chloride and 100 µg/mL formaldehyde, added as preservatives.

BioThrax is supplied in 5.0 mL multidose vials containing ten 0.5 mL doses. (NDC 64678-211-05).

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.