BIOTHRAX- bacillus anthracis injection, suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS (UNII: 873OI62848) (BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS - UNII:873OI62848)

Available from:

Emergent BioDefense Operations Lansing, LLC

INN (International Name):

BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS

Composition:

BACILLUS ANTHRACIS STRAIN V770-NP1-R ANTIGENS 100 ug in 1 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

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. 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. [See Description (11).] 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 cli

Product summary:

BioThrax is supplied in 5 mL multidose vials containing ten 0.5 mL doses. NDC 64678-211-05 (vial), 64678-211-01 (carton) 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

BIOTHRAX- BACILLUS ANTHRACIS INJECTION, SUSPENSION
EMERGENT BIODEFENSE OPERATIONS LANSING, LLC
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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.
BIOTHRAX (ANTHRAX VACCINE ADSORBED)
SUSPENSION FOR INTRAMUSCULAR OR SUBCUTANEOUS INJECTION
INITIAL U.S. APPROVAL: 1970
RECENT MAJOR CHANGES
INDICATIONS AND USAGE (1.1, 1.2) November/2015
DOSAGE AND ADMINISTRATION, (2.1, 2.2) November/2015
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.
2.
The efficacy of BioThrax for post-exposure prophylaxis is based solely
on studies in animal models of inhalational anthrax.
(1)
DOSAGE AND ADMINISTRATION 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 pre-exposure 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
the re afte r.
_ 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
•
®
Pre-exposure prophylaxis of disease in persons at high risk of
exposure.
Post-exposure prophylaxis of disease following sus