Biothrax: Anthrax Vaccine Adsorbed: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BIOTHRAX safely and effectively. See full prescribing information for BIOTHRAX.

See full insert sheet at this link at the Natural News Reference website.

BIOTHRAX® (Anthrax Vaccine Adsorbed)

Suspension for Intramuscular or Subcutaneous Injection

Initial U.S. Approval: 1970

INGREDIENTS AND EXCIPIENTS

BioThrax® (Anthrax Vaccine Adsorbed) is a sterile, milky-white suspension for intramuscular or subcutaneous 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 (PA) 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 mcg/mL benzethonium chloride and 100 mcg/mL formaldehyde, added as preservatives.

INDICATIONS AND USAGE

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. BioThrax is approved for:

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

The efficacy of BioThrax for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax. (1)

DOSAGE AND ADMINISTRATION

For intramuscular or subcutaneous injection only. Each dose is 0.5 mL.

Pre-Exposure Prophylaxis (2.1):

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

In persons who are at risk for hematoma formation following intramuscular injection, BioThrax may be administered by the subcutaneous route. The preexposure prophylaxis schedule for BioThrax administered subcutaneously is 0, 2, 4 weeks, and 6 months with booster doses 6 and 12 months after completion of the primary series, and at 12-month intervals thereafter.

Post-Exposure Prophylaxis (2.1):

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

DOSAGE FORMS AND STRENGTHS

Suspension for injection (0.5 mL dose) in 5 mL multidose vials. (3, 11)

CONTRAINDICATIONS

Severe allergic reaction (e.g. anaphylaxis) after a previous dose of BioThrax or a component of the vaccine. (4)

WARNINGS AND PRECAUTIONS

The stopper of the vial contains natural rubber latex and may cause allergic reactions in latex sensitive individuals. (5.2)

Pregnancy: Avoid use in pregnancy unless the potential benefit outweighs the potential risk to the fetus (5.3, 8.1)

ADVERSE REACTIONS

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema, edema, and arm motion limitation. The most common (≥5%) systemic adverse reactions were muscle aches, fatigue, and headache. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions at 1-877-246-8472 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

USE IN SPECIFIC POPULATIONS

Pregnancy Category D. [See Warnings and Precautions (5.3)]

Healthcare practitioners are encouraged to register women who receive BioThrax during pregnancy in Emergent’s vaccination pregnancy registry by calling 1-619-553-9255.

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

BioThrax has not been approved for use in patients greater than 65 years of age.

Pregnancy: Advise women of potential risk to the fetus. (5.3, 8.1) Pregnancy registry available, contact BioThrax (Anthrax) Vaccine in Pregnancy Registry (Phone: 1-619-553-9255). (8.1)

Safety and effectiveness of BioThrax have not been established in pediatric or geriatric populations. (8.4, 8.5)

Revised: November 2015

http://vaccines.procon.org/sourcefiles/Biothrax-Package-Insert-2015.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Biothrax-Anthrax-Vaccine-Adsorbed.pdf