Important Safety Information

• Contraindications for BOOSTRIX are: a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine; and encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine
• Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute allergic reaction occurs following administration of BOOSTRIX
• 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-Barré syndrome occurred within 6 weeks of receipt of a prior tetanus toxoid-containing vaccine
• 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
• If BOOSTRIX is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained
• Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting
• Common solicited adverse reactions (≥15%) in adolescents (aged 10 to 18 years) were pain, redness, and swelling at the injection site; increase in arm circumference of the injected arm; headache; fatigue; and gastrointestinal symptoms
• Common solicited adverse reactions (≥15%) in adults (aged 19 to 64 years) were pain, redness, and swelling at the injection site; headache; fatigue; and gastrointestinal symptoms
• The most common solicited adverse reaction (≥15%) in the elderly (aged 65 years and older) was pain at the injection site
• Pregnancy: Available data from a controlled clinical study showed that the use of the non-U.S. formulation of BOOSTRIX* during the third trimester of pregnancy did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child
• Pregnancy Registry: HCPs are encouraged to register pregnant individuals by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html
• Vaccination with BOOSTRIX may not result in protection in all vaccine recipients

* The non-U.S. formulation of BOOSTRIX is manufactured to contain 0.5 mg aluminum per dose. The U.S. formulation is manufactured to contain 0.3 mg aluminum per dose.

Please see full Prescribing Information for BOOSTRIX.