Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed): patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

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

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

Suspension for Intramuscular

Injection Initial U.S. Approval: 2005

INGREDIENTS AND EXCIPIENTS

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).

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).

OOSTRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

BOOSTRIX is formulated without preservatives.

INDICATIONS AND USAGE

BOOSTRIX is a vaccine 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. (1)

DOSAGE AND ADMINISTRATION

A single intramuscular injection (0.5 mL). (2.2)

DOSAGE FORMS AND STRENGTHS

Single-dose vials and prefilled syringes containing a 0.5-mL suspension for injection. (3)

CONTRAINDICATIONS

– Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or to any component of BOOSTRIX. (4.1)

– Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)

WARNINGS AND PRECAUTIONS

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.1)

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoidcontaining vaccine, including BOOSTRIX. (5.2)

Syncope (fainting) can occur in association with administration of injectable vaccines, including BOOSTRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope. (5.3)

Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. (5.4)

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive BOOSTRIX unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)

ADVERSE REACTIONS

Common solicited adverse events (≥15%) in adolescents (10 to 18 years of age) were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, and gastrointestinal symptoms. (6.1)

Common solicited adverse events (≥15%) in adults (19 to 64 years of age) were pain, redness, and swelling at the injection site, headache, fatigue, and gastrointestinal symptoms. (6.1)

The most common solicited adverse event (≥15%) in the elderly (65 years of age and older) was pain at the injection site. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

DRUG INTERACTIONS

In subjects 11 to 18 years of age, lower levels for antibodies to pertactin were observed when BOOSTRIX was administered concomitantly with meningococcal conjugate vaccine (serogroups A, C, Y, and W-135) as compared with BOOSTRIX administered first. (7.1)

In subjects 19 to 64 years of age, lower levels for antibodies to FHA and pertactin were observed when BOOSTRIX was administered concomitantly with an inactivated influenza vaccine as compared with BOOSTRIX alone. (7.1)

Do not mix BOOSTRIX with any other vaccine in the same syringe or vial. (7.1)

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 pre-weaning 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 (14.4)]. Solicited adverse events following BOOSTRIX were similar in frequency to those reported with the comparator Td vaccine [see Adverse Reactions (6.1)].

Revised: xx/xxxx

https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM152842.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Boostrix.pdf