Boostrix

What is Boostrix?

• Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older.

Boostrix

What are the uses of this medicine?

• Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine) is used for active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older.

How does this medicine work?

• Tetanus is a condition manifested primarily by neuromuscular dysfunction caused by a potent exotoxin released by C.tetani. Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin.
• Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C.diphtheriae. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin.
• Pertussis (whooping cough) is a disease of the respiratory tract caused by B.pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

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

What drug interactions can this medicine cause?

• Lower levels for antibodies to pertactin (PRN) were observed when BOOSTRIX was administered concomitantly with meningococcal conjugate vaccine (serogroups A, C, Y, and W-135) as compared with BOOSTRIX administered first.
• Lower levels for antibodies to filamentous hemagglutinin (FHA) and PRN were observed when BOOSTRIX was administered concomitantly with an inactivated influenza vaccine as compared with BOOSTRIX alone.
• Do not mix BOOSTRIX with any other vaccine in the same syringe or vial.
• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to BOOSTRIX.

Is this medicine FDA approved?

• Initial U.S. Approval: 2005

How should this medicine be used?

Recommended dosage:

• Each dose of BOOSTRIX is administered as a 0.5-mL injection.
• An initial dose of BOOSTRIX is administered 5 years or more after the last dose of the Diphtheria and Tetanus toxoid and Acellular Pertussis (DTaP) series or 5 years or more after a dose of Tetanus and Diphtheria Toxoids Adsorbed (Td).
• BOOSTRIX may be administered as an additional dose 9 years or more after the initial dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).
• BOOSTRIX may be administered for tetanus prophylaxis for wound management. For management of a tetanus-prone wound, a dose of BOOSTRIX may be administered if at least 5 years have elapsed since previous receipt of a tetanus toxoid-containing vaccine.

Administration:

• BOOSTRIX is administered as a 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose vials and single-dose prefilled syringes containing a 0.5-mL suspension for injection.

This medicine is available in fallowing brand namesː

• BOOSTRIX

What side effects can this medication cause?

The most common side effects of this medicine include: In adolescents (aged 10 to 18 years):

• pain
• redness
• swelling at the injection site
• increase in arm circumference of the injected arm
• headache
• fatigue
• gastrointestinal symptoms

In adults (aged 19 to 64 years):

• pain
• redness
• swelling at the injection site
• headache
• fatigue
• gastrointestinal symptoms

In the elderly (aged 65 years and older):

• pain at the injection site

Following revaccination with BOOSTRIX:

• pain
• redness
• swelling at the injection site
• headache
• fatigue

What special precautions should I follow?

• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.
• Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute hypersensitivity or anaphylactic reaction occur following the administration of BOOSTRIX.
• 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 toxoid-containing vaccine, including BOOSTRIX.
• Progressive or unstable neurologic conditions (e.g., cerebrovascular events, acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. 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.
• 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.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Available data suggest that the rates of major birth defects and miscarriage in women who received BOOSTRIX within 28 days prior to conception or during pregnancy are consistent.

Can this medicine be used in children?

• BOOSTRIX is not indicated for use in children aged younger than 10 years.
• Safety and effectiveness of BOOSTRIX in this age group have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CLOSTRIDIUM TETANI TOXOID ANTIGEN
• CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
• BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)
• BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
• BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)

Inactive ingredients:

• ALUMINUM HYDROXIDE
• FORMALDEHYDE
• SODIUM CHLORIDE
• POLYSORBATE 80

Who manufactures and distributes this medicine?

• Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, and GSK Vaccines GmbH Marburg, Germany

• Distributed by GlaxoSmithKline

Research Triangle Park

What should I know about storage and disposal of this medication?

• Store refrigerated between 2º and 8ºC (36º and 46ºF).
• Do not freeze.
• Discard if the vaccine has been frozen.

• Dailymed label info on Boostrix
• FDA Boostrix

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