BioThrax (Anthrax Vaccine Adsorbed Emergent BioSolutions)
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BioThrax (Anthrax Vaccine Adsorbed Emergent BioSolutions)

BioThrax®
(anthrax) Vaccine Adsorbed Emergent BioSolutions

DRUG DESCRIPTION

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.

What are the possible side effects of anthrax vaccine (Biothrax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with anthrax is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any...

Read All Potential Side Effects and See Pictures of BioThrax »

What are the precautions when taking anthrax vaccine adsorbed emergent biosolutions (BioThrax)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, immune system problems (such as HIV infection), bleeding disorders (such as hemophilia, thrombocytopenia).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

It is unknown if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of BioThrax »

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

BioThrax (anthrax vaccine adsorbed emergent biosolutions) is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 65 years of age whose occupation or other activities place them at high risk of exposure.

Since the risk of anthrax infection in the general population is low, routine immunization is not recommended.

The safety and efficacy of BioThrax (anthrax vaccine adsorbed emergent biosolutions) in a post-exposure setting have not been established.

DOSAGE AND ADMINISTRATION

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 (anthrax vaccine adsorbed emergent biosolutions) 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 (anthrax vaccine adsorbed emergent biosolutions) may be administered by the subcutaneous route.

HOW SUPPLIED

Dosage Forms And Strengths

BioThrax (anthrax vaccine adsorbed emergent biosolutions) is available as a sterile suspension in 5 mL multidose vials containing 10 doses each. See DESCRIPTION section for the complete listing of ingredients.

BioThrax (anthrax vaccine adsorbed emergent biosolutions) 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 (anthrax vaccine adsorbed emergent biosolutions) after the expiration date printed on the label.

Manufactured by: Emergent BioDefense Operations Lansing Inc. Lansing, MI 48906.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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

Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to rates in the clinical trials of another product and may not reflect the rates observed in clinical practice.

Local and systemic reactions were monitored in an open-label safety study of 15,907 doses of BioThrax (anthrax vaccine adsorbed emergent biosolutions) administered by the subcutaneous route to approximately 7,000 textile employees, laboratory workers and other at risk individuals. Over the course of the 5-year study the following local reactions were reported: 24 (0.15% of doses administered) severe local reactions (defined as edema or induration measuring greater than 120 mm in diameter or accompanied by marked limitation of arm motion or marked axillary node tenderness), 150 (0.94% of doses administered) moderate local reactions (edema or induration greater than 30 mm but less than 120 mm in diameter), and 1,373 (8.63% of doses administered) mild local reactions (erythema only or induration measuring less than 30 mm in diameter). Four cases of systemic reactions were reported during the 5-year reporting period ( < 0.06% of doses administered). These reactions, which were reported to have been transient, included fever, chills, nausea and general body aches.

The CDC sponsored a randomized, double-blind, placebo-controlled, multi-center clinical study [NCT00119067] in which 1,564 healthy volunteers were enrolled [See Clinical Studies section]. The objective of this study was to evaluate the effect of (1) changing the route of vaccine administration from subcutaneous (SQ) to intramuscular (IM), and (2) of reducing the number of doses on the safety and immunogenicity of BioThrax (anthrax vaccine adsorbed emergent biosolutions) . A planned analysis of the first 1,005 subjects compared four treatment groups over a period of seven months in which subjects received a total of either three (3) or four (4) doses of BioThrax (anthrax vaccine adsorbed emergent biosolutions) . Subjects were instructed to complete a 14-day post-vaccination diary card after the first 2 doses and a 28-day diary card after the subsequent doses to capture solicited and unsolicited adverse events. Adverse reaction data were also collected from in-clinic exams, which were performed prior to, and 15 to 60 minutes post each injection, at 1 to 3 days after each injection, and at 28 days after injections 3 and 4. Demographic characteristics for each respective treatment group in the analysis are provided in Table 1.

Table 1: Demographic characteristics: CDC Study

Study Group
(Total vaccinated cohortn= 1,005)
Group A BioThrax SQ Weeks-0-2-4-26
n=165
Group B BioThrax IM Weeks-0-2-4-26
n=170
Group C BioThrax IM Weeks-0-4-26
n=501
Placebo Control
n=169
Characteristic Parameters or categories Value or n (%) Value or n (%) Value or n (%) Value or n (%)
Age < 30 yrs 58
(35.15%)
42
(24.71%)
149
(29.74%)
52
(30.77%)
30 to < 40 yrs 30
(18.18%)
44
(25.88%)
132
(26.35%)
35
(20.71%)
40 to < 50 yrs 50
(30.30%)
52
(30.59%)
128
(25.55%)
51
(30.18%)
≥ 50 yrs 27
(16.36%)
32
(18.82%)
92
(18.36%)
31
(18.34%)
Gender Female 81
(49%)
87
(51 %)
249
(50 %)
83
(49%)
Male 84
(51%)
83
(49 %)
252
(50%)
86
(51%)
Race Caucasian 129
(78%)
126
(74%)
383
(76%)
130
(79%)
African-American 28
(17%)
32
(19%)
96
(19%)
31
(18%)
Other 8
(5%)
12
(7%)
22
(4%)
8
(5%)

Shown in Table 2 and Table 3, respectively, are the rates (percentage) of prospectively defined local and systemic solicited adverse reactions observed in the in-clinic exams.

The analysis of injection site (local) reactions demonstrated that administration of the vaccine by the IM route, as compared to the SQ route, resulted in a statistically significant reduction in reactogenicity (i.e. cutaneous adverse reactions). Injection site adverse reactions, including warmth, tenderness, itching, erythema, induration, edema, and nodule, consistently occurred at lower frequencies and for shorter duration in participants given BioThrax (anthrax vaccine adsorbed emergent biosolutions) by the IM route. Route of administration did not statistically significantly influence the occurrence or duration of systemic adverse reactions, with the exception of muscle ache (increased occurrence only). Most local and systemic adverse reactions were mild or moderate in severity; the proportion of participants with severe adverse reactions reported was very low ( < 1%). It was observed in this study that women receiving BioThrax (anthrax vaccine adsorbed emergent biosolutions) reported significantly more injection-site adverse reactions than did men. This gender-related difference was seen regardless of the route of administration, but was more pronounced in those receiving the vaccine by the SQ route. Women also reported more systemic adverse reactions than men (in particular fatigue, muscle ache and headache), but these gender differences were not influenced by route of administration. A brief pain or burning sensation, felt immediately after vaccine injection, was reported by most study participants. The pain was rated on a visual analog scale as 0-10. It was described as significant ( > 3) more often following SQ administration (41%) than IM administration (26%). Female participants generally experienced a higher pain scale rating than male participants.

Serious adverse reactions were infrequently reported during this study but two (2) important serious adverse reactions that were noted to be possibly related to BioThrax (anthrax vaccine adsorbed emergent biosolutions) administration include: a case of anaphylaxis and a case of an ANA positive autoimmune disorder manifesting as a moderate bilateral arthralgia of the metacarpophalangeal (MCP) joints. The majority of serious adverse reactions reported were unrelated to vaccination. Out of a total of 44 pregnancies reported in this study, no distinct patterns of infant outcome were seen, with the majority of pregnancies uncomplicated and healthy term infants delivered. Of women who received vaccine approximately within the first trimester (n = 15), 2 reports of spontaneous abortion were reported, along with one report of a healthy term infant with mild right clubbed foot abnormality.

Table 2: Local Adverse Reactions: In-Clinic Solicited by Dose Number*

  TREATMENT ARM
Group B BioThrax IM Weeks-0-2-4-26 Group C BioThrax IM Weeks-0-4-26 Placebo SQ/IM Weeks-0-2-4-26 Group A BioThrax SQWeeks-0-2-4-26
Number of Subjects (N)** 170 501 169 165
Dose Dose Dose Dose
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
% % % % % % % % % % % % % % % %
Adverse Reactions
Warmth 4 8 6 11 3 1 10 9 2 0 0 0 28 37 29 36
Tenderness 51 61 37 42 47 10 52 51 5 6 6 9 67 72 45 60
Itching 1 3 4 9 0 1 3 6 0 0 0 0 4 15 21 19
Pain 23 23 11 17 18 4 23 15 2 2 3 3 18 24 8 16
Arm motion limitation 11 14 5 10 16 1 16 13 1 0 2 0 9 14 6 12
Erythema 13 22 21 31 10 8 20 25 12 10 8 13 52 60 57 63
Induration 5 9 8 11 4 3 9 14 1 2 4 3 26 32 30 43
Edema 4 12 13 16 3 1 13 11 1 4 3 2 14 28 27 29
Nodule 4 2 5 6 2 1 3 6 0 1 0 1 38 45 36 27
Bruise 6 4 3 3 4 3 5 4 4 6 2 4 5 5 5 3
Presence of any local adverse reaction 62 69 52 62 58 25 67 68 20 19 17 23 81 86 79 81
Presence of any moderate/severe localadverse reactions§ 6 9 5 8 5 1 9 5 1 0 0 0 6 16 8 10
Presence of any large local adverse reaction¦ 0 1 3 1 0 0 1 2 0 0 0 0 1 1 5 3
*Per-dose, statistical assessment performed on Intent-to-Treat population data. Evaluations performed at 15-60 minutes and 1-3 days following each injection and prior to the next scheduled injection.
** N is the highest number per treatment arm; denominator (N) varied with dose number due to attrition over time.
Subjects received saline (instead of BioThrax (anthrax vaccine adsorbed emergent biosolutions) ) for the Week 2 dose.
The two saline groups (SQ and IM) were combined.
§Moderate = causes discomfort and interferes with normal daily activities; Severe = incapacitating and completely prevents performing normal daily activities.
¦Large = an occurrence of induration, erythema, edema, nodule and bruise with a largest diameter greater than 120 mm.

Table 3: Systemic Adverse Reactions: In-Clinic Solicited by Dose Number*

  TREATMENT ARM
Group B BioThrax IM Weeks-0-2-4-26 Group C BioThrax IM Weeks-0-4-26 Placebo SQ/IM Weeks-0-2-4-26 Group A BioThrax SQ Weeks-0-2-4-26
Number of Subjects (N)** 170 501 169 165
Dose Dose Dose Dose
1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4
% % % % % % % % % % % % % % % %
Systemic Adverse Reactions
Fatigue 7 10 12 8 8 5 12 8 5 5 6 5 8 9 7 8
Muscle ache 11 10 6 6 9 2 14 7 1 2 3 3 6 8 3 5
Headache 4 7 9 5 5 5 7 4 2 6 3 1 7 6 8 9
Fever > 100.4 oF 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Tender/painful axillary adenopathy 0 1 0 1 0 0 1 0 0 0 0 0 1 1 4 1
Presence of any systemic adverse reaction 20 22 21 15 18 10 26 15 8 10 12 8 17 17 17 17
Presence of any moderate/severe systemic adversereactions§ 1 3 3 4 2 1 6 4 1 1 3 2 1 4 3 3
*Per-dose, statistical assessment performed on Intent-to-Treat population data. Evaluations performed at 15-60 minutes and 1-3 days following each injection and prior to the next scheduled injection.
** N is the highest number per treatment arm; denominator (N) varied with dose number due to attrition over time.
Subjects received saline (instead of BioThrax (anthrax vaccine adsorbed emergent biosolutions) ) for the Week 2 dose.
The two saline groups (SQ and IM) were combined.
§Moderate = causes discomfort and interferes with normal daily activities; Severe = incapacitating and completely prevents performing normal daily activities.

Table 4 shows adverse events (excluding injection site reactions) that occurred in ≥ 2% of participants through Study Month 7, and excluding those that occurred at a lower rate than those observed in the placebo group.

Table 4: Solicited and Unsolicited Adverse Events Occurring in > 2% of Subjects*

MedDRA Preferred Term Group B BioThrax IM Weeks 0-2-4-26 Group C BioThrax IM Weeks 0-4-26 Placebo SQ/IM Weeks 0-2-4-26 Group A BioThrax SQWeeks 0-2-4-26
Number of Subjects 170 501 169 165
N (%) N (%) N (%) N (%)
Headache 108 (63.5) 312 (62.3) 82 (48.5) 111 (67.3)
Myalgia 105 (61.8) 360 (71.9) 63 (37.3) 101 (61.2)
Fatigue 104 (61.2) 311 (62.1) 82 (48.5) 101 (61.2)
Nasopharyngitis 26 (15.3) 61 (12.2) 13 (7.7) 18 (10.9)
Pharyngolaryngeal Pain 21 (12.4) 58 (11.6) 18 (10.7) 20 (12.1)
Back Pain 15 (8.8) 36 (7.2) 6 (3.6) 11 (6.7)
Diarrhea NOS 13 (7.7) 31 (6.2) 6 (3.6) 7 (4.2)
Dysmenorrhoea 12 (7.1) 36 (7.2) 11 (6.5) 7 (4.2)
Sinusitis NOS 12 (7.1) 24 (4.8) 8 (4.7) 7 (4.2)
Nausea 10 (5.9) 29 (5.8) 8 (4.7) 15 (9.1)
Hypersensitivity NOS 6 (3.5) 12 (2.4) 0 (0.0) 6 (3.6)
Neck Pain 5 (2.9) 16 (3.2) 3 (1.8) 1 (0.6)
Sinus Headache 5 (2.9) 7 (1.4) 0 (0.0) 3 (1.8)
Rigors 4 (2.3) 7 (1.4) 2 (1.2) 0 (0.0)
Upper Respiratory Tract Infection NOS 3 (1.8) 16 (3.2) 2 (1.2) 7 (4.2)
Influenza Like Illness 3 (1.8) 12 (2.4) 2 (1.2) 1 (0.6)
Lymphadenopathy 5 (2.9) 9 (1.8) 2 (1.2) 5 (3.0)
Rash NOS 0 (0.0) 12 (2.4) 1(0.6) 3 (1.8)
Joint Sprain 0 (0.0) 10 (2.0) 3 (1.8) 1 (0.6)
Pruritus 0 (0.0) 10 (2.0) 1 (0.6) 3 (1.8)
* Listed MedDRA terms (N) are limited to those for which the adverse reaction rate for BioThrax (anthrax vaccine adsorbed emergent biosolutions) (Weeks 0-2-4-26 or Weeks 0-4-26) exceeds the adverse reactions rate for placebo (Weeks 0-2-4-26) through month 7 irrespective of causality and severity; for each MedDRA Preferred Term in this table, an adverse event is only listed once per subject, even if the adverse event occurs more than once during the 7-month observation period; events already listed in Table 2 are not listed here. The denominator includes any subject who was randomized and received at least one dose of vaccine.
The two saline groups (SQ and IM) were combined

Postmarketing Experience

The following adverse events have been identified during postapproval use of BioThrax (anthrax vaccine adsorbed emergent biosolutions) . Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The reports included below are listed due to one or more of the following factors: (1) seriousness of the event, (2) number of reports, or (3) strength of causal relationship to the drug.

  • Blood and lymphatic system disorders

Lymphadenopathy

  • Immune system disorders

Allergic reactions (including anaphylaxis, angioedema, rash, urticaria, pruritus, erythema multiforme, anaphylactoid reaction and Stevens Johnson syndrome)

  • Nervous system disorders

Headache, paresthesia syncope, tremor, ulnar nerve neuropathy

  • Musculoskeletal, connective tissue and bone disorders

Arthralgia, arthropathy, myalgia, rhabdomyolysis, alopecia

  • General disorders and administration site conditions

Injection site reactions (including pain, nodule, edema, induration, erythema, warmth, pruritus, cellulitis), fatigue, pyrexia, flu-like symptoms

Infrequent reports were also received of multisystem disorders defined as chronic symptoms involving at least two of the following three categories: fatigue, mood-cognition and musculoskeletal system.

No fatalities have been determined to have been causally related to the administration of BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Read the BioThrax (anthrax vaccine adsorbed emergent biosolutions) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Concomitant Administration with Other Vaccines

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

BioThrax (anthrax vaccine adsorbed emergent biosolutions) 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 (anthrax vaccine adsorbed emergent biosolutions) .

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Latex

Administer with caution to patients with a possible history of latex sensitivity because the vial stopper contains dry natural rubber and may cause allergic reactions.

Hypersensitivity Reactions

Before administration, the patient's medical immunization history should be reviewed for possible vaccine sensitivities and/or previous vaccination-related adverse reactions, to determine the existence of any contraindications to immunization. [See CONTRAINDICATIONS section] Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. [See CONTRAINDICATIONS section]

Pregnancy

Pregnancy Category D

Pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. Results of a large observational study that examined the rate of birth defects among 37,140 infants born to U.S. military service women who received anthrax vaccine in pregnancy between 1998 and 2004 showed that birth defects were slightly more common in first trimester-exposed infants (odds ratio = 1.18, 95% confidence interval: 0.997, 1.41) when compared with infants of women vaccinated outside of the first trimester and compared to unvaccinated women.1 While the increased birth defect rates were not statistically significant when compared with infants born to women vaccinated outside of pregnancy, pregnant women should not be vaccinated against anthrax unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus.

The effect of BioThrax (anthrax vaccine adsorbed emergent biosolutions) on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rabbits. One group of rabbits was administered BioThrax (anthrax vaccine adsorbed emergent biosolutions) twice prior to gestation and during the period of organogenesis (gestation day 7). A second group of rabbits was administered BioThrax (anthrax vaccine adsorbed emergent biosolutions) twice prior to gestation and on gestation day 17. BioThrax (anthrax vaccine adsorbed emergent biosolutions) was administered at 0.5 ml/rabbit/occasion, by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study.

BioThrax (anthrax vaccine adsorbed emergent biosolutions) can cause fetal harm when administered to a pregnant woman. If this vaccine is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to a fetus.

History of Anthrax Disease

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

Altered Immunocompetence

If BioThrax (anthrax vaccine adsorbed emergent biosolutions) is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished.

Limitations of Vaccine Effectiveness

Vaccination with BioThrax (anthrax vaccine adsorbed emergent biosolutions) may not protect all individuals. The extent to which one is protected prior to completion of the full immunization schedule is unknown.

Nonclinical Toxicology

BioThrax (anthrax vaccine adsorbed emergent biosolutions) has not been evaluated in non-clinical toxicology studies.

Use In Specific Populations

Pregnancy and Fertility

Pregnancy: Category D. See WARNINGS AND PRECAUTIONS section

Male Fertility: A retrospective study was performed at an in-vitro fertilization clinic to evaluate whether BioThrax (anthrax vaccine adsorbed emergent biosolutions) 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 (anthrax vaccine adsorbed emergent biosolutions) , with those of 791 male clients who did not.2 Prior receipt of BioThrax (anthrax vaccine adsorbed emergent biosolutions) 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 (anthrax vaccine adsorbed emergent biosolutions) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BioThrax (anthrax vaccine adsorbed emergent biosolutions) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established for BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Geriatric Use

Clinical studies of BioThrax (anthrax vaccine adsorbed emergent biosolutions) 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. Subgroup 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.

REFERENCES

2. Catherino, W., et al., 2005. The anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member. Fertility and Sterility, 83:480-483

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

The use of BioThrax (anthrax vaccine adsorbed emergent biosolutions) is contraindicated in persons with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax (anthrax vaccine adsorbed emergent biosolutions) .

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Anthrax is a zoonotic disease caused by the gram-positive, spore-forming bacterium Bacillus anthracis. The spore form of Bacillus anthracis is the predominant phase of the bacterium in the environment and anthrax disease is contracted largely through the uptake of spores. Spores are markedly resistant to heat, cold, drought, UV light, and gamma radiation. Following germination at the site of infection, the bacilli can also enter the blood and lead to septicemia.

Virulence components of Bacillus anthracis include an antiphagocytic polypeptide capsule and three proteins known as protective antigen (PA), lethal factor (LF) and edema factor (EF). Individually these proteins are not cytotoxic but the combination of PA with LF or EF results in the formation of the cytotoxic lethal toxin and edema toxin, respectively. Although an immune correlate of protection is unknown, antibodies raised against PA may contribute to protection by neutralizing the activities of these toxins.3 Bacillus anthracis proteins other than PA may be present in BioThrax (anthrax vaccine adsorbed emergent biosolutions) , but their contribution to protection has not been determined.

Clinical Studies

A controlled field study using an earlier version of a protective antigen-based anthrax vaccine, developed in the 1950's, that consisted of an aluminum potassium sulfate-precipitated cell-free filtrate from an aerobic culture, was conducted from 1955-1959.4 This study included 1,249 workers [379 received anthrax vaccine, 414 received placebo, 116 received incomplete inoculations (with either vaccine or placebo) and 340 were in the observational group (no treatment)] in four mills in the northeastern United States that processed imported animal hides. Prior to vaccination, the yearly average number of human anthrax cases (both cutaneous and inhalational) was 1.2 cases per 100 employees in these mills. During the trial, 26 cases of anthrax were reported across the four mills – 5 inhalation and 21 cutaneous. Of the five inhalation cases (four of which were fatal), two received placebo and three were in the observational group. Of the 21 cutaneous cases, 15 received placebo, three were in the observational group, and three received anthrax vaccine. Of those three cases in the vaccine group, one case occurred just prior to administration of the scheduled third dose, one case occurred 13 months after an individual received the third of the scheduled 6 doses (but no subsequent doses), and one case occurred prior to receiving the scheduled fourth dose of vaccine. Because the comparison of anthrax cases between the placebo and vaccine groups included both inhalation and cutaneous cases, the calculated efficacy of the vaccine to prevent all types of anthrax disease combined was 92.5% (lower 95% CI = 65%). The efficacy analysis in this study included all cases of anthrax disease, regardless of the route of exposure or manifestation of the disease.

Between 1962 and 1974, the Centers for Disease Control and Prevention (CDC) collected surveillance data on the occurrence of anthrax disease in mill workers or those living near mills in the United States.5, 6 In that time period, individuals received either BioThrax or the earlier protective antigen-based anthrax vaccine used in the field trial described above. Of the 27 cases of anthrax identified by CDC, 24 cases occurred in unvaccinated individuals. In vaccinated individuals one case occurred after the person had been given one dose of anthrax vaccine and two cases occurred after individuals had been given two doses of anthrax vaccine. No documented cases of anthrax were reported for individuals who had received at least three doses of the recommended six doses of anthrax vaccine.

Between 2002 and 2008, the CDC sponsored a prospective double-blinded, randomized, placebo-controlled study to evaluate the impact on safety and immunogenicity of changing the administration route from SQ to IM, and reducing the number of doses (i.e. omitting the week 2 dose) [NCT00119067]. This study enrolled a total of 1,564 healthy civilian men and women between the ages of 18 and 61. Subjects were randomized to one of six groups. A planned analysis of the first 1005 subjects enrolled with 7 month follow-up was conducted to compare safety and immunogenicity of study groups at Week 8 (four weeks after the Week-4 dose) and Month 7 (one month after the Month-6 dose). These designations are used when referring to the data analyses of study groups:

Group A (N=165) received BioThrax (anthrax vaccine adsorbed emergent biosolutions) via the SQ route of administration at Weeks 0, 2, 4 and Months 6, 12, 18 followed by 2 annual boosters (initial U.S. licensed route/schedule). Group A served as the active control in this study.

Group B (N=170) received BioThrax (anthrax vaccine adsorbed emergent biosolutions) via the IM route of administration at Weeks 0, 2, 4 and Months 6, 12, 18 followed by 2 annual boosters.

Group C (N=501) received BioThrax (anthrax vaccine adsorbed emergent biosolutions) via the IM route of administration at Weeks 0, 4 (no Week 2 dose) and Month 6 with various schedules thereafter. (Group C represents data from 3 randomized groups combined for the analysis because the schedules are identical through the Month 6 dose.)

The placebo group (N=169) received saline administered by the IM or SQ route, respectively, using the Weeks 0, 2, 4 and Months 6, 12, 18 schedule, followed by 2 annual boosters.

Immune responses were assessed using an ELISA and were reported as the serum geometric mean concentration (GMC) and geometric mean titers (GMT) of IgG antibodies directed against anthrax protective antigen (PA). Non-inferiority analyses of Group B vs. Group A and Group C vs. Group A were performed. The three immunogenicity endpoints were: (1) Geometric Mean Concentration (GMC) (µg/mL), (2) Geometric Mean Titer (GMT), and (3) percentage with 4-fold rise in anti-PA titer from baseline. These immunogenicity endpoints were assessed at the Week 8 and Month 7 time points. Group B (IM route) was shown to be non-inferior to Group A (SQ route) for all 3 primary endpoints at the Week 8 and Month 7 time points (Tables 5 and 6). Group C (abbreviated IM route) at the Week 8 time point (Table 7) was shown to be non-inferior to Group A for the percentage with 4-fold rise in titer but not non-inferior to Group A for GMCs and GMTs. However, by the Month 7 time point (Table 8). Group C was non-inferior to Group A for all 3 primary endpoints. The elimination of the Week 2 dose did not impact the immune response following the Month 6 vaccination.

The level of protection against Bacillus anthracis prior to completion of the full vaccination series is unknown.

In an exploratory subgroup analysis, a diminished immune response was noted in male subjects in Group B (IM route) at the 8 week time point compared to male subjects vaccinated via the SQ route (Group A). The diminished immune response in males was not, however, seen by 7 months (i.e. after the fourth dose of vaccine). At the 7 month time point, non-inferiority was observed between the IM and SQ routes in male subjects. A summary of the gender-by-treatment interaction findings for the three immunogenicity endpoints at the week 8 and month 7 time point is provided in Table 9.

Table 5: Immune Responses at Week 8 - Group A vs. Group B

Endpoint Group A BioThrax (anthrax vaccine adsorbed emergent biosolutions) SQ Weeks-0-2-4-26
N=153 point estimate
(2-sided 95% CI)
Group B BioThrax (anthrax vaccine adsorbed emergent biosolutions) IM Weeks 0-2-4-26
N=154 point estimate
(2-sided 95% CI)
Comparisons Non-Inferiority Criteria Passed?
      Ratios
(2-sided 97.5% CI)
1
Antibody Concentration GMC (µg/mL) 101.92
(88.34, 117.58)
87.78
(74.99, 102.76 )
1.161
(0.911, 1.480)
Yes*
Antibody Titer GMT 1250.12
(1079.55, 1447.63)
1080.96
(926.08, 1261.74)
1.156
(0.907, 1.475)
Yes**
      Difference of rates
(2-sided 97.5% CI)
 
Titer 4-fold increase frombaseline+ (Proportion of Responders) 98.69%
(95.36, 99.85 )
97.40%
(93.49, 99.30 )
0.013
(-0.031, 0.062)
Yes***
*Criteria for non-inferiority of comparisons based on ratios of GMCs: Mean antibody concentration ratio (GMCGroup A/GMCGroup B). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
**Criteria for non-inferiority of comparisons based on ratios of GMTs: Mean antibody titer ratio (GMTGroup A/GMTGroup B). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
***Criteria for non-inferiority of comparisons based on differences in rates of 4-fold rise in antibody titer: 4-fold rise in antibody titer (Group A – Group B). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 0.10.
+Baseline values below LLOQ set to ½-empirical LLOQ to calculate post-vaccination 4-fold rise in titer.

Table 6: Immune Responses at Month 7 - Group A vs. Group B

Endpoint Group A BioThrax (anthrax vaccine adsorbed emergent biosolutions) SQ Weeks-0-2-4-26
N=139 point estimate
(2-sided 95% CI)
Group B BioThrax (anthrax vaccine adsorbed emergent biosolutions) IM Weeks 0-2-4-26
N=145 point estimate
(2-sided 95% CI)
Comparisons Non- Inferiority Criteria Passed?
      Ratios
(2-sided 97.5% CI)
 
Antibody Concentration GMC (µg/mL) 218.32
(187.52, 254.17 )
262.61
(228.81, 301.41)
0.831
(0.658, 1.050)
Yes*
Antibody Titer GMT 2614.95
(2251.57, 3036.98)
3065.95
(2678.19, 3509.86)
0.853
(0.678, 1.073)
Yes**
      Difference of rates
(2-sided 97.5% CI)
 
Titer 4-fold increase from baseline+ (Proportion of Responders) 99.28%
(96.06, 99.98)
100%
(97.49, 100.0 )
-0.007
(-0.048, 0.027)
Yes***
*Criteria for non-inferiority of comparisons based on ratios of GMCs: Mean antibody concentration ratio (GMCGroup A/GMCGroup B). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
**Criteria for non-inferiority of comparisons based on ratios of GMTs: Mean antibody titer ratio (GMTGroup A/GMTGroup B). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5. ***Criteria for non-inferiority of comparisons based on differences in rates of 4-fold rise in antibody titer: 4-fold rise in antibody titer (Group A – Group B). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 0.10.
+Baseline values below LLOQ set to ½-empirical LLOQ to calculate post-vaccination 4-fold rise in titer.

Table 7: Immune Responses at Week 8 – Group A vs. Group C

Endpoint Group A BioThrax (anthrax vaccine adsorbed emergent biosolutions) SQ Weeks-0-2-4-26
N=153 point estimate
(2-sided 95% CI)
Group C BioThrax (anthrax vaccine adsorbed emergent biosolutions) IM Weeks 0-4-26
N=446 point estimate
(2-sided 95% CI)
Comparisons Non- Inferiority Criteria Passed?
      Ratios
(2-sided 97.5% CI)
 
Antibody Concentration GMC (µg/mL) 101.92
(88.34, 117.58 )
54.21
(49.40, 59.50 )
1.880
(1.531, 2.308)
No*
Antibody Titer GMT 1250.12
(1079.55,1447.63)
662.09
(601.13, 729.23)
1.888
(1.527, 2.335)
No**
      Difference of rates
(2-sided 97.5% CI)
 
Titer 4-fold increase from baseline+ (Proportion of Responders) 98.69 %
(95.36, 99.85)
92.83%
(90.02, 95.04)
0.059
(0.014, 0.094)
Yes***
*Criteria for non-inferiority of comparisons based on ratios of GMCs: Mean antibody concentration ratio (GMCGroup A/GMCGroup C). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
**Criteria for non-inferiority of comparisons based on ratios of GMTs: Mean antibody titer ratio (GMTGroup A/GMTGroup C). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
***Criteria for non-inferiority of comparisons based on differences in rates of 4-fold rise in antibody titer: 4-fold rise in antibody titer (Group A – Group C). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 0.10.
+ Baseline values below LLOQ set to ½-empirical LLOQ to calculate post-vaccination 4-fold rise in titer.

Table 8: Immune Responses at Month 7 - Group A vs. Group C

Endpoint Group A BioThrax (anthrax vaccine adsorbed emergent biosolutions) SQ Weeks-0-2-4-26
N=139 point estimate
(2-sided 95% CI)
Group C BioThrax (anthrax vaccine adsorbed emergent biosolutions) IM Weeks 0-4-26
N=410 point estimate
(2-sided 95% CI)
Comparisons Non-Inferiority Criteria Passed?
      Ratios
(2-sided 97.5% CI)
 
Antibody Concentration GMC (µg/mL) 218.32
(187.52, 254.17 )
258.13
(232.96, 286.02 )
0.846
(0.675, 1.059)
Yes*
Antibody Titer GMT 2614.95
(2251.57, 3036.98)
3087.00
(2785.20, 3421.51)
0.847
(0.676, 1.061)
Yes**
      Difference of rates
(2-sided 97.5% CI)
 
Titer 4-fold increase frombaseline+ (Proportion of Responders) 99.28%
(96.06,99.98)
99.27%
(97.88, 99.85)
0.000
(-0.041, 0.019)
Yes***
*Criteria for non-inferiority of comparisons based on ratios of GMCs: Mean antibody concentration ratio (GMCGroup A/GMCGroup C). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
**Criteria for non-inferiority of comparisons based on ratios of GMTs: Mean antibody titer ratio (GMTGroup A/GMTGroup C). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 1.5.
***Criteria for non-inferiority of comparisons based on differences in rates of 4-fold rise in antibody titer: 4-fold rise in antibody titer (Group A – Group C). Non-inferiority is achieved (passed) when the upper 97.5% confidence limit is ≤ 0.10.
+ Baseline values below LLOQ set to ½-empirical LLOQ to calculate post-vaccination 4-fold rise in titer.

Table 9: Immune Response by Gender: Group A (SQ) vs. Group B (IM)

Immunogenicity Endpoints Group A BioThrax SQ Weeks-0-2-4-26 Group B BioThrax IM Weeks 0-2-4-26 Ratio (of GMCs, GMTs) or Difference (of rates of 4-fold rise) 2-sided 97.5% CIs of ratios of GMCs, GMTs, or 2-sided 97.5% CI of Difference of rates of 4-fold rise
  N
(Point Estimate) (95% Cl)
N
(Point Estimate) (95% Cl)
  Lower Limit Upper Limit
Antibody Concentration GMC (µg/ml): Males: week 8 7994.41
(79.43, 112.21)
7369.54
(52.92, 91.37)
Ratio of GMCs 1.358 0.946 1.949
Log Antibody Concentration GMC (µg/ml): Males: month 7 70216.66
(177.89, 263.87)
68263.11
(210.39, 329.05)
Ratio of GMCs 0.823 0.587 1.155
Antibody Concentration GMC (µg/ml): Females: week 8 74110.59
(87.52, 139.74)
81108.29
(91.96, 127.51)
Ratio of GMCs 1.021 0.742 1.406
Antibody Concentration GMC (µg/ml): Females: month 7 69220.01
(173.56, 278.90)
77262.17
(220.47, 311.76)
Ratio of GMCs 0.839 0.604 1.166
Antibody Titer GMT: Males: week 8 791159.35
(974.45, 1379.34)
73873.23
(670.54, 1137.19)
Ratio of GMTs 1.328 0.932 1.892
Antibody Titer GMT: Males: month 7 702586.05
(2128.41, 3142.09)
683093.38
(2484.02, 3852.21)
Ratio of GMTs 0.836 0.599 1.166
Antibody Titer GMT: Females: week 8 741354.88
(1062.53, 1727.66)
811310.19
(1108.37, 1548.76)
Ratio of GMTs 1.034 0.743 1.439
Antibody Titer GMT: Females: month 7 692644.60
(2095.66, 3337.32)
773041.94
(2566.20, 3605.87)
Ratio of GMTs 0.869 0.630 1.201
4-fold rise in Titer (Proportion of responders): Males: week 8 79100%
(95.44, 100.00)
7394.52%
(86.56, 98.51)
0.055 -0.007 0.148
4-fold rise in Titer (Proportion of responders): Males: month 7 70100%
(94.87, 100.00)
68100%
(94.72, 100.00)
0.000 -0.067 0.069
4-fold rise in Titer (Proportion of responders): Females: week 8 7497.30%
(90.58, 99.69)
81100%
(95.55, 100.0)
-0.027 -0.108 0.033
4-fold rise in Titer (Proportion of responders): Females: Month 7 6998.55%
(92.20, 99.96)
77100%
(95.32, 100.00)
-0.014 -0.093 0.048
Criteria for non-inferiority based on the ratio of GMCs and GMTs and differences in the rate of 4-fold rise in antibody titer. Mean antibody concentration ratio (GMCGroup A/GMCGroup B): Non-inferiority criteria met when the upper 97.5% confidence limit is ≤ 1.5
Mean antibody titer ratio (GMTGroup A/GMTGroup B): Non-inferiority criteria met when the upper 97.5% confidence limit is ≤ 1.5 4-fold rise in antibody titer (Group A)-(Group B): Non-inferiority criteria met when the upper 97.5% confidence limit is ≤ 0.10.

REFERENCES

1. Ryan, M.A.D., et al. 2008. Birth defects among infants born to women who received anthrax vaccine in pregnancy. Am J Epidimiol, 168:434-442.

2. Catherino, W., et al., 2005. The anthrax vaccine does not affect semen parameters, embryo quality, or pregnancy outcome in couples with a vaccinated male military service member. Fertility and Sterility, 83:480-483

3. Brachman, P.; Friedlander, A.; Grabenstein, J., 2008. Anthrax Vaccine. In: Vaccines, Fifth Edition, Plotkin, S.A.: Orenstein W.A. and Offit P.A. (eds.), 111-126

4. Brachman, P., et al., 1962. Field evaluation of a human anthrax vaccine. Amer. J. Public Health, 52:632-645.

5. Food and Drug Administration, 2005, Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order. FDA Federal Register 2005; 70(242): 75180-75198.

6. Food and Drug Administration. Biological Products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register (December 13, 1985), 50(240):51002-51117.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Inform patients of the benefits and risks of immunization with BioThrax (anthrax vaccine adsorbed emergent biosolutions) . Instruct patients to report any serious adverse reaction to their health care provider.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Inform patients of the benefits and risks of immunization with BioThrax (anthrax vaccine adsorbed emergent biosolutions) . Instruct patients to report any serious adverse reaction to their health care provider.

Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

BioThrax Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ANTHRAX VACCINE - INJECTION

(AN-thrax vak-SEEN)

COMMON BRAND NAME(S): Biothrax

USES: This medication is used to help prevent serious, sometimes fatal, infections caused by a certain bacteria (Bacillus anthracis) in high-risk people (such as military personnel, laboratory workers who handle the bacteria Bacillus anthracis).

This vaccine contains parts from Bacillus anthracis. It works by causing the body to produce its own protection (antibodies) against the bacteria.

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This vaccine is given by injection into a muscle by a health care professional. It is usually given as a series of 5 doses (1, 6, 12, and 18 months after the first dose). This vaccine may also be given under the skin for certain people (such as people with clotting disorders, people taking "blood thinners") although this may increase the risk of side effects.

Follow the dosing schedule closely for the vaccine to be most effective. To help you remember, mark your calendar to keep track of when to receive your next dose.

You will need a yearly booster vaccine if you still remain at risk for anthrax. Ask your doctor or pharmacist for more details.

Disclaimer

BioThrax Consumer (continued)

SIDE EFFECTS: Pain/redness/swelling at the injection site, limited arm movement, muscle ache, headache, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the BioThrax (anthrax vaccine adsorbed emergent biosolutions) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to latex; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, immune system problems (such as HIV infection), bleeding disorders (such as hemophilia, thrombocytopenia).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

BioThrax Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: "blood thinners" (such as warfarin), chemotherapy, corticosteroids (such as prednisone, dexamethasone), drugs that weaken the immune system (such as cyclosporine, efalizumab, tacrolimus).

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.

MISSED DOSE: It is important that you receive each vaccination as scheduled. Be sure to ask when each dose should be received, and make a note on a calendar to help you remember.

STORAGE: Not applicable. This vaccine is given in a clinic and will not be stored at home.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

BioThrax Patient Information Including Side Effects

Brand Names: Biothrax

Generic Name: anthrax vaccine (Pronunciation: ANTH rax vax EEN)

What is anthrax vaccine (BioThrax)?

Anthrax is a disease caused by infection with a spore-forming bacteria. It usually occurs in animals such as sheep, goats, cattle, deer, antelope, and other herbivores. Anthrax can also occur in people who are exposed to an infected animal or other source of the anthrax bacteria.

Anthrax is spread to a human through the skin, the stomach, or the lungs. The bacteria can enter the skin through a cut or wound that comes into contact with products from an infected animal (such as meat, wool, hide, or hair). Infection can also occur through the lungs when a person inhales the bacterial spore, or through the stomach when a person eats undercooked meat from an infected animal.

Anthrax is most common in agricultural regions lacking in good veterinary prevention programs, especially in Africa, Asia, Central and South America, the Carribean, the Middle East and Southeastern Europe. Although less common, anthrax does occur in the United States each year among both wild game animals and domestic livestock.

Anthrax is a serious disease that can spread quickly throughout the body and it is fatal in a high number of cases, especially when acquired through the lungs.

The anthrax vaccine is used to help prevent this disease in people exposed to the bacteria through the skin or lungs. This vaccine works by exposing you to an antigen protein that causes your body to develop immunity to the disease. Anthrax vaccine does not contain live or killed forms of the bacteria that causes anthrax.

Anthrax vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the anthrax vaccine may not provide protection from disease in every person.

What are the possible side effects of anthrax vaccine (BioThrax)?

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with anthrax is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect (some are rare but serious) such as:

  • severe swelling or a hard lump where the shot was given;
  • severe swelling spreading to other parts of your arm;
  • fever, chills, body aches, nausea, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • confusion, changes in mood or behavior;
  • seizure (convulsions);
  • blistering, redness, and swelling or warmth of the skin;
  • weakness, numbness or tingly feeling in your feet spreading upward;
  • problems with vision, hearing, speech, swallowing, or bladder and bowel functions;
  • severe lower back pain; or
  • slow heart rate, trouble breathing, weak pulse, or feeling like you might pass out.

Less serious side effects include:

  • mild redness, warmth, itching, or tenderness where the shot was given;
  • low fever;
  • feeling tired or weak;
  • headache, dizziness;
  • mild pain or stiffness in the injected arm;
  • joint or muscle pain;
  • swelling in your hands or feet; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the BioThrax (anthrax vaccine adsorbed emergent biosolutions) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about anthrax vaccine (BioThrax)?

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to an anthrax vaccine, or if you have ever had anthrax disease acquired through the skin.

Before receiving this vaccine, tell the doctor if you have ever had an allergic reaction to a vaccine, or if you have a weak immune system, if you are pregnant or breast-feeding, if you are allergic to latex rubber, if you are receiving chemotherapy or radiation, or if you have a history of Guillain-Barré syndrome.

You can still receive a vaccine if you have a cold or mild fever. In the case of a more severe illness with a high fever or any type of infection, wait until you get better before receiving this vaccine.

Before receiving anthrax vaccine, tell the doctor about all other vaccines you have recently received. Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, such as steroids, psoriasis or arthritis medications, medicines to treat or prevent organ transplant rejection, or chemotherapy or radiation treatments. You may not be able to receive the anthrax vaccine, or may need to wait until the other treatments are finished.

Becoming infected with anthrax is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Anthrax vaccine will not treat an active infection that has already developed in the body.

Side Effects Centers

BioThrax Patient Information including How Should I Take

What should I discuss with my health care provider before receiving anthrax vaccine (BioThrax)?

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to an anthrax vaccine, or if you have ever had anthrax disease acquired through the skin.

Before receiving this vaccine, tell the doctor if you have ever had an allergic reaction to any type of vaccine, or if you have:

  • an allergy to latex rubber;
  • a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by taking certain medicines;
  • a history of infection with anthrax;
  • a history of Guillain-Barré syndrome;
  • if you are pregnant or breast-feeding; or
  • if you have received cancer chemotherapy, radiation treatment, or steroid medications in the past 3 months.

You can still receive a vaccine if you have a cold or mild fever. In the case of a more severe illness with a high fever or any type of infection, wait until you get better before receiving this vaccine.

Vaccines generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with anthrax.

How is anthrax vaccine given (BioThrax)?

This vaccine is given as an injection (shot) under the skin. You will receive this injection in a doctor's office or other clinic setting.

Anthrax vaccine is recommended for adults in the following situations:

  • people who handle anthrax bacteria in a laboratory or other work setting;
  • people who handle animal hides or furs imported from areas where anthrax is common;
  • people who handle meat or other animal products in areas where anthrax is common;
  • veterinarians who travel to countries where anthrax is common; and
  • military personnel at risk of exposure through potential biological warfare when anthrax may be used as a weapon.

The anthrax vaccine is given in a series of 6 shots. The first 3 shots are given 2 weeks apart. The following three 3 shots are given 6, 12, and 18 months after the first shot. An annual booster shot is then recommended every year during possible exposure to anthrax. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state where you live.

You may receive anthrax vaccine at the same time as other vaccines.

Side Effects Centers

BioThrax Patient Information including If I Miss a Dose

What happens if I miss a dose (BioThrax)?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (BioThrax)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving anthrax vaccine (BioThrax)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity after you receive this vaccine.

What other drugs will affect anthrax vaccine (BioThrax)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect the anthrax vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. While you are receiving the anthrax vaccine series, do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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