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 tetanus, diphtheria, acellular pertussis vaccine (Adacel (Tdap), Boostrix (Tdap))?

You should not receive this vaccine a second time 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 have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

Becoming infected with diphtheria, pertussis, or tetanus is much more dangerous to your health than receiving the vaccine to protect against these...

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness or infection with high fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune...

Read All Potential Precautions of Boostrix


Boostrix Consumer (continued)

SIDE EFFECTS: Pain, swelling, or redness at the injection site may occur. Headache, fatigue, body aches, nausea, diarrhea, fever, chills, vomiting, or sore/swollen joints may also occur. Acetaminophen or ibuprofen (non-aspirin) may be used to reduce soreness. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: illness or infection with high fever, uncontrolled seizures or other nervous system disorder (e.g., encephalopathy).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, history of Guillain-Barre syndrome, immune system disorders (e.g., autoimmune disorders, radiation treatment), other illnesses or infections including pertussis, seizures (e.g., epilepsy controlled by medication, febrile seizures) or other nervous system disorders, vaccination history including previous reactions to any vaccines.

This vaccine should not be used in children less than 10 years of age because the lower strength may not provide enough protection. Consult your healthcare professional for vaccines for this age group.

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

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Boostrix Patient Information Including Side Effects

Brand Names: Adacel (Tdap), Boostrix (Tdap)

Generic Name: tetanus, diphtheria, acellular pertussis vaccine (Tdap) (Pronunciation: TET a nus, dif THEER ee a, and ay SEL yoo ler per TUS iss)

  • What is tetanus, diphtheria, acellular pertussis vaccine (Tdap) (Boostrix)?
  • What are the possible side effects of tetanus, diphtheria, acellular pertussis vaccine (Boostrix)?
  • What is the most important information I should know about this vaccine (Boostrix)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Boostrix)?
  • How is this vaccine given (Boostrix)?
  • What happens if I miss a dose (Boostrix)?
  • What happens if I overdose (Boostrix)?
  • What should I avoid before or after receiving this vaccine (Boostrix)?
  • What other drugs will affect tetanus, diphtheria, acellular pertussis vaccine (Boostrix)?
  • Where can I get more information?

What is tetanus, diphtheria, acellular pertussis vaccine (Tdap) (Boostrix)?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, tetanus acellular, and pertussis adult vaccine (also called Tdap) is used to help prevent these diseases in people who are ages 10 to 64 years old. Most people in this age group require only one Tdap shot for protection against these diseases.

This vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the Tdap vaccine may not provide protection from disease in every person.

What are the possible side effects of tetanus, diphtheria, acellular pertussis vaccine (Boostrix)?

You should not receive this vaccine a second time 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 have to receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects within 7 days after receiving this vaccine:

  • extreme drowsiness, fainting;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • mild fever or chills;
  • redness, pain, tenderness, or swelling where the shot was given;
  • headache or tiredness;
  • joint pain, body aches; or
  • mild nausea, diarrhea, or vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What is the most important information I should know about this vaccine (Boostrix)?

In most cases, tetanus, diphtheria, acellular pertussis vaccine is given in only one dose. Follow your doctor's instructions about receiving a booster dose if needed.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive this vaccine a second time 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 the vaccine again, you will need to tell your doctor if the first shot caused any side effects.

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

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  • Adacel
  • Boostrix


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