Indication for BOOSTRIX

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.

Important Safety Information for BOOSTRIX

  • Severe allergic reaction after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine, or to any component of BOOSTRIX, or encephalopathy within 7 days of a previous pertussis antigen-containing vaccine is a contraindication
  • The tip caps of the prefilled syringes for BOOSTRIX contain natural rubber latex, which may cause allergic reactions
  • The decision to give BOOSTRIX should be based on benefits and risks if Guillain-Barr√© syndrome occurred within 6 weeks of receipt of a prior tetanus toxoid-containing vaccine
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX
  • Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus toxoid-containing vaccine should not receive BOOSTRIX unless 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine
  • In clinical studies, common adverse reactions were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, gastrointestinal symptoms, and fever
  • Vaccination with BOOSTRIX may not result in protection in all vaccine recipients

References

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825072R0 October 2017