Drug: Boostrix

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of pertactin (69 kiloDalton outer membrane protein). Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, < 100 mcg of residual formaldehyde, and ≤ 100 mcg of polysorbate 80 (Tween 80). BOOSTRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

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Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of BOOSTRIX could reveal adverse reactions not observed in clinical trials. In clinical studies, 4,949 adolescents (10 to 18 years of age) and 4,076 adults (19 years of age and older) were vaccinated with a single dose of BOOSTRIX. Of these adolescents, 1,341 were vaccinated with BOOSTRIX in a coadministration study with meningococcal conjugate vaccine [see DRUG INTERACTIONS and Clinical Studies]. Of these adults, 1,104 were 65 years of age and older [see Clinical Studies]. A total of 860 adults19 years of age and older received concomitant vaccination with BOOSTRIX and influenza vaccines in a coadministration study [see DRUG INTERACTIONS and Clinical Studies]. An additional 1,092 adolescents 10 to 18 years of age received a non-US formulation of BOOSTRIX (formulated to contain 0.5 mg aluminum per dose) in non-US clinical studies. In a randomized, observer-blinded, controlled study in the US, 3,080 adolescents 10 to 18 years of age received a single dose of BOOSTRIX and 1,034 received the comparator Td vaccine, manufactured by MassBioLogics. There were no substantive differences in demographic characteristics between the vaccine groups. Among BOOSTRIX and comparator vaccine recipients, approximately 75% were 10 to 14 years of age and approximately 25% were 15 to 18 years of age. Approximately 98% of participants in this study had received the recommended series of 4 or 5 doses of either Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTwP) or a combination of DTwP and DTaP in childhood. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for non-routine medical visits, visits to an emergency room, onset of new chronic illness, and serious adverse events. Information regarding late onset adverse events was obtained via a telephone call 6 months following vaccination. At least 97% of subjects completed the 6-month follow-up evaluation. In a study conducted in Germany, BOOSTRIX was administered to 319 children 10 to 12 years of age previously vaccinated with 5 doses of acellular pertussis antigen-containing vaccines; 193 of these subjects had previously received 5 doses of INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). Adverse events were recorded on diary cards during the 15 days following vaccination. Unsolicited adverse events that occurred within 31 days of vaccination (day 0-30) were recorded on the diary card or verbally reported to the investigator. Subjects were monitored for 6 months post-vaccination for physician office visits, emergency room visits, onset of new chronic illness, and serious adverse events. The 6- month follow-up evaluation, conducted via telephone interview, was completed by 90% of subjects. The US adult (19 to 64 years of age) study, a randomized, observer-blinded study, evaluated the safety of BOOSTRIX (N = 1,522) compared with ADACEL® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) (N = 762), a Tdap vaccine manufactured by Sanofi Pasteur SA. Vaccines were administered as a single dose. There were no substantive differences in demographic characteristics between the vaccine groups. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 030). Subjects were also monitored for 6 months post-vaccination for serious adverse events, visits to an emergency room, hospitalizations, and onset of new chronic illness. Approximately 95% of subjects completed the 6-month follow-up evaluation. The US elderly (65 years of age and older) study, a randomized, observer-blinded study, evaluated the safety of BOOSTRIX (N = 887) compared with DECAVAC® (Tetanus and Diphtheria Toxoids Adsorbed) (N = 445), a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA. Vaccines were administered as a single dose. Among all vaccine recipients, the mean age was approximately 72 years; 54% were female and 95% were white. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-3). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for serious adverse events. Approximately 99% of subjects completed the 6-month follow-up evaluation. Solicited Adverse Events in the US Adolescent Study Table 1 presents the solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or Td vaccine for the total vaccinated cohort. The primary safety endpoint was the incidence of grade 3 pain (spontaneously painful and/or prevented normal activity) at the injection site within 15 days of vaccination. Grade 3 pain was reported in 4.6% of those who received BOOSTRIX compared with 4.0% of those who received the Td vaccine. The difference in rate of grade 3 pain was within the pre-defined clinical limit for non-inferiority (upper limit of the 95% CI for the difference [BOOSTRIX minus Td] ≤ 4%). Table 1: Rates of Solicited Local Adverse Reactions or General Adverse Events Within the 15- daya Post-Vaccination Period in Adolescents 10 to 18 Years of Age (Total Vaccinated Cohort)
  BOOSTRIX
(N = 3,032) % Td
(N = 1,013) % Local Pain, anyb 75.3 71.7 Pain, grade 2 or 3b 51.2 42.5 Pain, grade 3c 4.6 4.0 Redness, any 22.5 19.8 Redness, > 20 mm 4.1 3.9 Redness, ≥ 50 mm 1.7 1.6 Swelling, any 21.1 20.1 Swelling, > 20 mm 5.3 4.9 Swelling, ≥ 50 mm 2.5 3.2 Arm circumference increase, > 5 mmd 28.3 29.5 Arm circumference increase, > 20 mmd 2.0 2.2 Arm circumference increase, > 40 mmd 0.5 0.3 General Headache, any 43.1 41.5 Headache, grade 2 or 3b 15.7 12.7 Headache, grade 3 3.7 2.7 Fatigue, any 37.0 36.7 Fatigue, grade 2 or 3 14.4 12.9 Fatigue, grade 3 3.7 3.2 Gastrointestinal symptoms, anye 26.0 25.8 Gastrointestinal symptoms, grade 2 or 3e 9.8 9.7 Gastrointestinal symptoms, grade 3e 3.0 3.2 Fever, ≥ 99.5°F (37.5°C)f 13.5 13.1 Fever, > 100.4°F (38.0°C)f 5.0 4.7 Fever, > 102.2°F (39.0°C)f 1.4 1.0 Td = Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by MassBioLogics.
N = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local: spontaneously painful and/or prevented normal activity; General: prevented normal activity.
a Day of vaccination and the next 14 days.
b Statistically significantly higher (P < 0.05) following BOOSTRIX as compared to Td vaccine.
c Grade 3 injection site pain following BOOSTRIX was not inferior to Td vaccine (upper limit of two-sided 95% CI for the difference [BOOSTRIX minus Td] in the percentage of subjects ≤ 4%).
d Mid-upper region of the vaccinated arm.
e Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
fOral temperatures or axillary temperatures. Unsolicited Adverse Events in the US Adolescent Study The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (25.4% and 24.5% for BOOSTRIX and Td vaccine, respectively). Solicited Adverse Events in the German Adolescent Study Table 2 presents the rates of solicited local adverse reactions and fever within 15 days of vaccination for those subjects who had previously been vaccinated with 5 doses of INFANRIX. No cases of whole arm swelling were reported. Two individuals (2/193) reported large injection site swelling (range 110 to 200 mm diameter), in one case associated with grade 3 pain. Neither individual sought medical attention. These episodes were reported to resolve without sequelae within 5 days. Table 2: Rates of Solicited Adverse Events Reported Within the 15-daya Post-Vaccination Period Following Administration of BOOSTRIX in Adolescents 10 to 12 Years of Age Who Had Previously Received 5 Doses of INFANRIX
  BOOSTRIX
(N = 193) % Pain, any 62.2 Pain, grade 2 or 3 33.2 Pain, grade 3 5.7 Redness, any 47.7 Redness, > 20 mm 15.0 Redness, ≥ 50 mm 10.9 Swelling, any 38.9 Swelling, > 20 mm 17.6 Swelling, ≥ 50 mm 14.0 Fever, ≥ 99.5°F (37.5°C)b 8.8 Fever, > 100.4°F (38.0°C)b 4.1 Fever, > 102.2°F (39.0°C)b 1.0 N = Number of subjects with local/general symptoms sheets completed.
Grade 2 = Painful when limb moved.
Grade 3 = Spontaneously painful and/or prevented normal activity.
a Day of vaccination and the next 14 days.
b Oral temperatures or axillary temperatures. Solicited Adverse Events in the US Adult (19 to 64 Years of Age) Study Table 3 presents solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or the comparator Tdap vaccine for the total vaccinated cohort. Table 3: Rates of Solicited Local Adverse Reactions or General Adverse Events Within the 15-daya Post-Vaccination Period in Adults 19 to 64 Years of Age (Total Vaccinated Cohort)
  BOOSTRIX
(N = 1,480) % Tdap
(N = 741) % Local Pain, any 61.0 69.2 Pain, grade 2 or 3 35.1 44.4 Pain, grade 3 1.6 2.3 Redness, any 21.1 27.1 Redness, > 20 mm 4.0 6.2 Redness, ≥ 50 mm 1.6 2.3 Swelling, any 17.6 25.6 Swelling, > 20 mm 3.9 6.3 Swelling, ≥ 50 mm 1.4 2.8 General Headache, any 30.1 31.0 Headache, grade 2 or 3 11.1 10.5 Headache, grade 3 2.2 1.5 Fatigue, any 28.1 28.9 Fatigue, grade 2 or 3 9.1 9.4 Fatigue, grade 3 2.5 1.2 Gastrointestinal symptoms, anyb 15.9 17.5 Gastrointestinal symptoms, grade 2 or 3b 4.3 5.7 Gastrointestinal symptoms, grade 3b 1.2 1.3 Fever, ≥ 99.5°F (37.5°C)c 5.5 8.0 Fever, > 100.4°F (38.0°C)c 1.0 1.5 Fever, > 102.2°F (39.0°C)c 0.1 0.4 Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur SA. N = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local/General: prevented normal activity.
a Day of vaccination and the next 14 days.
b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
c Oral temperatures. Unsolicited Adverse Events in the US Adult (19 to 64 Years of Age) Study The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.8% and 22.2% for BOOSTRIX and Tdap vaccine, respectively). Solicited Adverse Events in the US Elderly (65 Years of Age and Older) Study Table 4 presents solicited local adverse reactions and general adverse events within 4 days of vaccination with BOOSTRIX or the comparator Td vaccine for the total vaccinated cohort. Table 4: Rates of Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of Vaccination in the Elderly 65 Years of Age and Older (Total Vaccinated Cohort)
Local BOOSTRIX %
(N = 882) Td %
(N = 444) Pain, any 21.5 27.7 Pain, grade 2 or 3 7.5 10.1 Pain, grade 3 0.2 0.7 Redness, any 10.8 12.6 Redness, > 20 mm 1.4 2.5 Redness, ≥ 50 mm 0.6 0.9 Swelling, any 7.5 11.7 Swelling, > 20 mm 2.2 3.4 Swelling, ≥ 50 mm 0.7 0.7 General (N = 882) (N = 445) Fatigue, any 12.5 14.8 Fatigue, grade 2 or 3 2.5 2.9 Fatigue, grade 3 0.7 0.7 Headache, any 11.5 11.7 Headache, grade 2 or 3 1.9 2.2 Headache, grade 3 0.6 0.0 Gastrointestinal symptoms, anyb 7.6 9.2 Gastrointestinal symptoms, grade 2 or 3b 1.7 1.8 Gastrointestinal symptoms, grade 3b 0.3 0.4 Fever, ≥ 99.5°F (37.5°C)c 2.0 2.5 Fever, > 100.4°F (38.0°C)c 0.2 0.2 Fever, > 102.2°F (39.0°C)c 0.0 0.0 Td = Tetanus and Diphtheria Toxoids Adsorbed, a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA. N = Number of subjects with a documented dose.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local/General: prevented normal activity.
a Day of vaccination and the next 3 days.
b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
c Oral temperatures. Unsolicited Adverse Events in the US Elderly (65 Years of Age and Older) Study The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.1% and 14.4% for BOOSTRIX and Td vaccine, respectively). Serious Adverse Events (SAEs) In the US and German adolescent safety studies, no serious adverse events were reported to occur within 31 days of vaccination. During the 6-month extended safety evaluation period, no serious adverse events that were of potential autoimmune origin or new onset and chronic in nature were reported to occur. In non-US adolescent studies in which serious adverse events were monitored for up to 37 days, one subject was diagnosed with insulin-dependent diabetes 20 days following administration of BOOSTRIX. No other serious adverse events of potential autoimmune origin or that were new onset and chronic in nature were reported to occur in these studies. In the US adult (19 to 64 years of age) study, serious adverse events were reported to occur during the entire study period (0-6 months) by 1.4% and 1.7% of subjects who received BOOSTRIX and the comparator Tdap vaccine, respectively. During the 6- month extended safety evaluation period, no serious adverse events of a neuroinflammatory nature or with information suggesting an autoimmune etiology were reported in subjects who received BOOSTRIX. In the US elderly (65 years of age and older) study, serious adverse events were reported to occur by 0.7% and 0.9% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 31-day period after vaccination. Serious adverse events were reported to occur by 4.2% and 2.2% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 6-month period after vaccination. Concomitant Vaccination With Meningococcal Conjugate Vaccine in Adolescents In a randomized study in the US, 1,341 adolescents (11 to 18 years of age) received either BOOSTRIX administered concomitantly with MENACTRA® (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine), (Sanofi Pasteur SA), or each vaccine administered separately 1 month apart [see DRUG INTERACTIONS and Clinical Studies]. Safety was evaluated in 446 subjects who received BOOSTRIX administered concomitantly with meningococcal conjugate vaccine at different injection sites, 446 subjects who received BOOSTRIX followed by meningococcal conjugate vaccine 1 month later, and 449 subjects who received meningococcal conjugate vaccine followed by BOOSTRIX 1 month later. Solicited local adverse reactions and general adverse events were recorded on diary cards for 4 days (day 0-3) following each vaccination. Unsolicited adverse events were monitored for the 31-day period following each vaccination (day 0-30). Table 5 presents the percentages of subjects experiencing local reactions at the injection site for BOOSTRIX and solicited general events following BOOSTRIX. The incidence of unsolicited adverse events reported in the 31 days after any vaccination was similar following each dose of BOOSTRIX in all cohorts. Table 5: Rates of Solicited Local Adverse Reactions or General Adverse Events Reported Within the 4-day Post-Vaccination Period following Administration of BOOSTRIX in Individuals 11 to 18 Years of Age (Total Vaccinated Cohort)
  BOOSTRIX + MCV4a
(N = 441) % BOOSTRIX → MCV4b
(N = 432-433) % MCV4 → BOOSTRIXc
(N = 441) % Local (at injection site for BOOSTRIX) Pain, any 70.1 70.4 47.8 Redness, any 22.7 25.7 17.9 Swelling, any 17.7 18.1 12.0 General (following administration of BOOSTRIX) Fatigue 34.0 32.1 20.4 Headache 34.0 30.7 17.0 Gastrointestinal symptomsd 15.2 14.5 7.7 Fever, ≥ 99.5 °F (37.5°C)e 5.2 3.5 2.3 MCV4 = MENACTRA (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine), Sanofi Pasteur SA. N = number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
a BOOSTRIX+MCV4 = concomitant vaccination with BOOSTRIX and MENACTRA.
b BOOSTRIX→MCV4 = BOOSTRIX followed by MCV4 1 month later.
c MCV4→BOOSTRIX = MCV4 followed by BOOSTRIX 1 month later.
d Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
e Oral temperatures. Postmarketing Experience In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for BOOSTRIX in persons 10 years of age and older since market introduction of this vaccine are listed below. This list includes serious events or events which have causal connection to components of this or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to the vaccine. Blood and Lymphatic System Disorders: Lymphadenitis, lymphadenopathy. Immune System Disorders: Allergic reactions, including anaphylactic and anaphylactoid reactions. Cardiac Disorders: Myocarditis. General Disorders and Administration Site Conditions: Extensive swelling of the injected limb, injection site induration, injection site inflammation, injection site mass, injection site pruritus, injection site nodule, injection site warmth, injection site reaction. Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia. Nervous System Disorders: Convulsions (with and without fever), encephalitis, facial palsy, loss of consciousness, paraesthesia, syncope. Skin and Subcutaneous Tissue Disorders: Angioedema, exanthem, Henoch- Schonlein purpura, rash, urticaria. Read the Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) Side Effects Center for a complete guide to possible side effectsLearn More »

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Preparation For Administration Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered. For the prefilled syringes, attach a sterile needle and administer intramuscularly. For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual. Do not administer this product intravenously, intradermally, or subcutaneously. Dose And Schedule BOOSTRIX is administered as a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm. There are no data to support repeat administration of BOOSTRIX. Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine and the administration of BOOSTRIX. Additional Dosing Information Primary Series The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied. Wound Management If tetanus prophylaxis is needed for wound management, BOOSTRIX may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.

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Concomitant Vaccine Administration BOOSTRIX was administered concomitantly with MENACTRA in a clinical study of subjects 11 to 18 years of age [see Clinical Studies]. Post-vaccination geometric mean antibody concentrations (GMCs) to pertactin were lower following BOOSTRIX administered concomitantly with meningococcal conjugate vaccine compared to BOOSTRIX administered first. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to pertactin. BOOSTRIX was administered concomitantly with FLUARIX® (Influenza Virus Vaccine) in a clinical study of subjects 19 to 64 years of age [see Clinical Studies]. Lower GMCs for antibodies to the pertussis antigens filamentous hemagglutinin (FHA) and pertactin were observed when BOOSTRIX was administered concomitantly with FLUARIX as compared with BOOSTRIX alone. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to FHA and pertactin. When BOOSTRIX is administered concomitantly with other injectable vaccines or Tetanus Immune Globulin, they should be given with separate syringes and at different injection sites. BOOSTRIX should not be mixed with any other vaccine in the same syringe or vial. Immunosuppressive Therapies Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to BOOSTRIX. Read the Boostrix Drug Interactions Center for a complete guide to possible interactions Learn More »

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BOOSTRIX® is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.

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Hypersensitivity A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX [see DESCRIPTION]. Because of the uncertainty as to which component of the vaccine might be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered. Encephalopathy Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX. Last reviewed on RxList: 10/6/2014
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No information provided.

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Dosage Forms And Strengths BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes. Storage And Handling BOOSTRIX is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes (packaged without needles): NDC 58160-842-01 Vial in Package of 10: NDC 58160-842-11
NDC 58160-842-05 Syringe in Package of 1: NDC 58160-842-34
NDC 58160-842-43 Syringe in Package of 10: NDC 58160-842-52 Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617, and Novartis Vaccines and Diagnostics GmbH, Marburg, Germany, US License 1754. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709 Last reviewed on RxList: 10/6/2014
This monograph has been modified to include the generic and brand name in many instances.

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Latex The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals. Guillain-Barre Syndrome And Brachial Neuritis If Guillain-Barre syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barre syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.1 Syncope Syncope (fainting) can occur in association with administration of injectable vaccines, including BOOSTRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. Progressive Or Unstable Neurologic Disorders Progressive or unstable neurologic conditions (e.g., cerebrovascular events and acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. It is not known whether administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination. Arthus-Type Hypersensitivity Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have a high serum tetanus antitoxin level and should not receive BOOSTRIX or other tetanus toxoid-containing vaccines unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine. Altered Immunocompetence As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained. Prevention And Management Of Acute Allergic Reactions Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur. REFERENCES 1. Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB, eds. Adverse events associated with childhood vaccines. Evidence bearing on causality. Washington, DC: National Academy Press; 1994. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility. Use In Specific Populations Pregnancy Pregnancy Category B A developmental toxicity study has been performed in female rats at a dose approximately 40 times the human dose (on a mL/kg basis) and revealed no evidence of harm to the fetus due to BOOSTRIX. Animal fertility studies have not been conducted with BOOSTRIX. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, BOOSTRIX should be given to a pregnant woman only if clearly needed. In a developmental toxicity study, the effect of BOOSTRIX on embryo-fetal and preweaning development was evaluated in pregnant rats. Animals were administered INFANRIX by intramuscular injection once prior to gestation and BOOSTRIX by intramuscular injection during the period of organogenesis (gestation days 6, 8, 11, and 15), 0.1 mL/rat/occasion (approximately 40-fold excess relative to the projected human dose of BOOSTRIX on a body weight basis). The antigens in INFANRIX are the same as those in BOOSTRIX, but INFANRIX is formulated with higher quantities of these antigens. No adverse effects on pregnancy, parturition, lactation parameters, and embryo-fetal or pre-weaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis. Pregnancy Registry GlaxoSmithKline maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with BOOSTRIX during pregnancy. Women who receive BOOSTRIX during pregnancy should be encouraged to contact GlaxoSmithKline directly or their healthcare provider should contact GlaxoSmithKline by calling 1-888-452-9622. Nursing Mothers It is not known whether BOOSTRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOOSTRIX is administered to a nursing woman. Pediatric Use BOOSTRIX is not indicated for use in children younger than 10 years of age. Safety and effectiveness of BOOSTRIX in this age group have not been established. Geriatric Use In clinical trials, 1,104 subjects 65 years of age and older received BOOSTRIX; of these subjects, 299 were 75 years of age and older. In the US elderly (65 years and older) study, immune responses to tetanus and diphtheria toxoids following BOOSTRIX were non-inferior to the comparator Td vaccine. Antibody responses to pertussis antigens following a single dose of BOOSTRIX in the elderly were non-inferior to those observed with INFANRIX administered as a 3-dose series in infants [see Clinical Studies]. Solicited adverse events following BOOSTRIX were similar in frequency to those reported with the comparator Td vaccine [see ADVERSE REACTIONS]. Last reviewed on RxList: 10/6/2014
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