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Boostrix

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Boostrix

BOOSTRIX
(tetanus toxoid, reduced diphtheria toxoid and accllular pertussis vaccine, adsorbed) Suspension for Intramuscular Injection

Boostrix

DRUG DESCRIPTION

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens.

Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.

Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of pertactin (69 kiloDalton outer membrane protein).

Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.

Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.5 mg of sodium chloride, ≤ 100 mcg of residual formaldehyde, and ≤ 100 mcg of polysorbate 80 (Tween 80).

BOOSTRIX is available in vials and 2 types of prefilled syringes. One type of prefilled syringe has a tip cap which may contain natural rubber latex and a plunger which does not contain latex. The other type has a tip cap and a rubber plunger which contain dry natural latex rubber. The vial stopper does not contain latex. [See HOW SUPPLIED, Storage and Handling.]

What are the possible side effects of this vaccine (Adacel (Tdap), Boostrix (Tdap))?

You should not receive a booster vaccine if you had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive a booster dose, you will need to tell your doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely...

Read All Potential Side Effects and See Pictures of Boostrix »

What are the precautions when taking tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix)?

Before receiving this vaccination, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this medication, tell your doctor or pharmacist your medical history, especially of: nervous system disorders (e.g., seizures, encephalopathy, Guillain-Barre syndrome), current illness/infection, bleeding disorders, immune system disorders (e.g., autoimmune disorders, radiation treatment), vaccination history including previous reactions to any vaccines.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and...

Read All Potential Precautions of Boostrix »

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

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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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