Drug: BioThrax

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.

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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 effectsLearn More »

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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.

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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) . Read the BioThrax Drug Interactions Center for a complete guide to possible interactions Learn More »

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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.

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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
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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
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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, 83:480-483Last reviewed on RxList: 10/28/2009
This monograph has been modified to include the generic and brand name in many instances.

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