May 25, 2017
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How Supplied


BOOSTRIX® is 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.


Preparation For Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

Dose And Schedule

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

There are no data to support repeat administration of BOOSTRIX.

Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine and the administration of BOOSTRIX.

Additional Dosing Information

Primary Series

The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied.

Wound Management

If tetanus prophylaxis is needed for wound management, BOOSTRIX may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.


Dosage Forms And Strengths

BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.

Storage And Handling

BOOSTRIX is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes (packaged without needles):

NDC 58160-842-01 Vial in Package of 10: NDC 58160-842-11
NDC 58160-842-05 Syringe in Package of 1: NDC 58160-842-34
NDC 58160-842-43 Syringe in Package of 10: NDC 58160-842-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License 1617, and Novartis Vaccines and Diagnostics GmbH, Marburg, Germany, US License 1754. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/2/2017

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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