Indication & Important Safety Info
Indication
Important Safety Information
Indication
BOOSTRIX is indicated for:
- active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older;
- immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
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 must be immediately available to manage potential anaphylactic reactions following administration of BOOSTRIX
- 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
- Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to BOOSTRIX
- 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.