What Is Boostrix Vaccine Used For

First Off What Are These Diseases

• Tetanus, also known as lockjaw, is a rare infection caused by bacteria. Tetanus can cause painful muscle tightening all over the body, including the head and neck. This tightening can make it difficult to swallow or breathe. People can get tetanus from getting pricked by a rusty nail or needle.

• Diphtheria is a rare infection spread from person-to-person through bacteria in respiratory secretions like coughing or sneezing. A diphtheria infection can cause a thick, gray coating to build up in the throat or nose, making it difficult to swallow or breathe.

• Pertussis, also known as whooping cough, is an infection spread from person-to-person through respiratory secretions such as coughing or sneezing. A pertussis infection can cause severe coughing spells which may make it difficult to breathe and can lead vomiting and disturbed sleep.

What Are The Side Effects Of The Whooping Cough Vaccine

You may have some mild side effects such as swelling, redness or tenderness where the vaccine is injected in your upper arm, just as you would with any vaccine. These only last a few days. Other side effects can include fever, irritation at the injection site, swelling of the vaccinated arm, loss of appetite, irritability and headache. Serious side effects are extremely rare.

What Does Boostrix Do

Boostrix works by stimulating your immune system to make antibodies against these bacteria.

Boostrix contains extracts from diphtheria, tetanus, and pertussis bacteria. The extracts have been inactivated so they cant cause illness. Boostrix also contains fragments of Bordetella pertussis bacteria, which are also inactivated. All these bacterial extracts and fragments are called antigens.

When you receive the Boostrix vaccine, your immune system recognizes that there are foreign antigens in your body. As a result, your immune system starts making antibodies against these antigens. Your immune system produces a different type of antibody for each different antigen. The antibodies attach themselves to the antigens, and this flags them for destruction by your immune system.

The antibodies stay in your body. So if the actual bacteria that cause diphtheria, tetanus, and pertussis ever enter your system, the antibodies will attach to the bacteria or the substances the bacteria produce. This allows your immune system to quickly destroy the bacteria or the substances before they cause a serious infection.

The protection that antibodies provide is called immunity.

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Can I Take Boostrix If Im Pregnant Or Breastfeeding

It is not known whether Tdap vaccine will harm an unborn baby. However, you may need a Tdap vaccine during pregnancy to protect your newborn baby from pertussis. Young babies are most at risk for severe, life-threatening complications from pertussis. Your doctor should determine whether you need this vaccine during pregnancy.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of the Tdap vaccine on the baby.

It is not known whether Tdap vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How Does This Medication Work What Will It Do For Me

This medication belongs to a group of medications known as vaccines. It is used to prevent tetanus, diphtheria, and pertussis for people 4 years of age and older. This medication may also be given to pregnant women to help protect developing babies against whooping cough. This vaccine increases a person’s defences against pertussis infection and against the toxins produced by tetanus and diphtheria bacteria. It works by introducing very small amounts of bacterial and toxin components into the bloodstream. Only certain parts of the bacteria are used , and the toxins have been detoxified. Still, these components are enough to stimulate the production of a person’s own antibodies , which will remain in the body ready to attack any future bacteria that may cause infection and deal with the toxins produced during tetanus or diphtheria infection.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

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How To Take Boostrix

Use Boostrix ) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

This vaccine is given as an injection into a muscle. You will receive this injection in a doctor’s office or clinic setting.

Tdap vaccine is usually given as a one-time injection. Unless your doctor’s tells you otherwise, you will not need a booster vaccine.

Tdap vaccine is usually given once every 10 years.

Since the Tdap vaccine is usually given only once, you are not likely to miss a dose.

Drug Forms And Administration

Boostrix and Adacel both come as a suspension in a single-dose vial and a single-dose prefilled syringe. These vaccines are given by a healthcare provider as intramuscular injections in your upper arm.

Your doctor will advise you on how often you should receive Boostrix or Adacel. But theyll likely follow the recommendations from the Centers for Disease Control and Prevention for

• diarrhea

* These lists contain side effects that were seen in clinical trials for Boostrix and Adacel. Only some side effects occurred for each drug. However, according to postmarketing reports, all of these side effects have been caused by both drugs.

Serious side effects

An example of a serious side effect that can occur with both Boostrix and Adacel is:

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Side Effects And Risks

Boostrix and Tenivac both contain tetanus and diphtheria toxoids, while Boostrix also contains fragments of pertussis bacteria. Therefore, these vaccines can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each vaccine, or with both Boostrix and Tenivac .

• Can occur with Boostrix:

• fever

Serious side effects

An example of a serious side effect that can occur with both Boostrix and Tenivac is:

• severe allergic reaction

When It Is Given

BOOSTRIX is generally given whenever a booster dose of diphtheria and tetanus vaccine is required and where a booster for pertussis is desired.

BOOSTRIX may also be given in the case of a tetanus-prone injury where a booster for diphtheria and pertussis is also required, provided no previous dose of tetanus vaccine was given within five years previously.

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Concomitant Administration With Meningococcal Conjugate Vaccine

The concomitant use of Boostrix and a tetravalent meningococcal conjugate vaccine was evaluated in a randomized study in healthy adolescents aged 11 to 18 years. A total of 1,341 adolescents were vaccinated with Boostrix. Of these, 446 subjects received Boostrix administered concomitantly with meningococcal conjugate vaccine at different injection sites, 446 subjects received Boostrix followed by meningococcal conjugate vaccine 1 month later, and 449 subjects received meningococcal conjugate vaccine followed by Boostrix 1 month later.

Immune responses to diphtheria and tetanus toxoids , pertussis antigens , and meningococcal antigens were measured 1 month after concomitant or separate administration of Boostrix and meningococcal conjugate vaccine. For Boostrix given concomitantly with meningococcal conjugate vaccine compared with Boostrix administered first, non-inferiority was demonstrated for all antigens, with the exception of the anti-PRN GMC. The lower limit of the 95% CI for the GMC ratio was 0.54 for anti-PRN . For the anti-PRN booster response, non-inferiority was demonstrated. It is not known if the efficacy of Boostrix is affected by the reduced response to PRN.

There was no evidence that Boostrix interfered with the antibody responses to the meningococcal antigens when measured by rabbit serum bactericidal assays when given concomitantly or sequentially .

When Should Someone Get A Tdap Vaccination

A person should typically receive their one-dose Tdap vaccination around the age of 11 or 12. Pregnant mothers should also receive a dose of Tdap to protect their newborn babies from pertussis. Additionally, some people may be given a dose of Tdap after a severe cut or burn to prevent a tetanus infection.

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Safety And Adverse Events

Refer to Adverse events following immunization in Part 2 for additional general information. Refer to Diphtheria Toxoid, Tetanus Toxoid, Poliomyelitis Vaccine, Haemophilus influenzae type b Vaccine and Hepatitis B Vaccine in Part 4 for additional information regarding other components in pertussis-containing combination vaccines.

Common adverse events

• Local reactions at and near the site of injection: 10-40%
• Extensive limb swelling: 2-6% of children more commonly associated with the 4th or 5th dose but resolve spontaneously
• Fever, irritability and/or fussiness: 8 29%
• Drowsiness: 40-52%

Uncommon and rare adverse events

• Anaphylaxis following vaccination with pertussis-containing vaccine may occur, but is very rare
• Severe arthus-type injection site reactions
• Hypotonic hyporesponsive episodes : The case definition of HHE includes sudden onset of hypotonia , hyporesponsiveness , and pallor or cyanosis. However, there is evidence that there are no adverse consequences to these events and the adverse consequences of being incompletely immunized have been well documented.
• High fever with or without seizure: High fever and convulsions, both febrile and afebrile, are rarely reported and are not contraindications to further immunization with acellular pertussis-containing vaccine.

Other safety issues

Epidemiological studies do not support allegations of a causal relationship between pertussis-containing vaccines and either permanent neurological injury or Type 1 diabetes.

Boostrix Ingredients And Form

Boostrix contains tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine.

Boostrix comes as a suspension . The vaccine comes in a 0.5-milliliter single-dose vial and a 0.5-mL single-dose prefilled syringe. A healthcare provider will give you Boostrix as an intramuscular injection in your upper arm.

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Progressive Or Unstable Neurologic Disorders

Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including Boostrix. It is not known whether administration of Boostrix to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of Boostrix to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

Is Boostrix A Live Vaccine

No, Boostrix is a non-live vaccine. It contains inactive substances produced by the bacteria that cause tetanus and diphtheria. Boostrix also contains fragments of the bacteria that cause pertussis . None of these substances or bacterial fragments can cause disease.

Live vaccines contain live, but weakened forms of bacteria or viruses. Examples include the yellow fever vaccine and the shingles vaccine. Live vaccines shouldnt cause infections in people whose immune systems work well. But theres a risk that live vaccines could cause infections in people with weakened immune systems. These people shouldnt have live vaccines, but they may be able to have non-live vaccines.

If you have questions about whether you can receive Boostrix, talk with your doctor.

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The Manufacturer’s Leaflet Says There’s No Information On The Use Of Boostrix Ipv In Pregnancy Should It Be Used In Pregnancy

The licence for Boostrix IPV allows for its use in pregnancy when clearly needed, and when the possible benefits outweigh the possible risks.

It is standard practice with most medicines not to test them on pregnant women. This is why the manufacturer’s information leaflet includes this statement, and not because of any specific safety concerns or evidence of harm in pregnancy.

Whooping cough-containing vaccine has been used routinely in pregnant women in the UK since October 2012, and the Medicines and Healthcare products Regulatory Agency is carefully monitoring its safety. The MHRA’s study of around 20,000 women vaccinated with Repevax, the whooping cough vaccine previously offered to pregnant women, found no evidence of risks to pregnancy or pregnancy outcome.

Boostrix is one of the vaccines routinely recommended in the US for immunisation of pregnant women. There have been no reported safety concerns in the US with the use of the vaccine in pregnancy.

There is no evidence of risk to the pregnant woman or unborn child with inactivated vaccines like Boostrix IPV. An inactivated vaccine is one that does not contain “live” vaccine.

Read more about why vaccines are safe and important.

Whooping Cough Vaccination In Pregnancy

Whooping cough rates have risen sharply in recent years and babies who are too young to start their vaccinations are at greatest risk.

Young babies with whooping cough are often very unwell and most will be admitted to hospital because of their illness. When whooping cough is particularly severe, they can die.

Pregnant women can help protect their babies by getting vaccinated ideally from 16 weeks up to 32 weeks pregnant. If for any reason you miss having the vaccine, you can still have it up until you go into labour.

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Side Effects In Children

Boostrix is approved for use in children ages 10 years and older. In clinical studies, side effects in this age group were similar to side effects in adults, as described above and below. However, mild side effects were more common in children ages 10 to 18 years than in adults. Side effects that were more common in this age group included:

• headache
• diarrhea
• abdominal pain

In addition, injection site reactions such as pain, redness, and swelling were more common in children ages 10 to 12 years than in older age groups. See the section below called Injection site reactions for more information about this.

And to learn more about the frequency of side effects in children, see Side effect details right below.

Is Whooping Cough Vaccination In Pregnancy Working

Yes, it is. Published research from the UK vaccination programme shows that vaccinating pregnant women against whooping cough has been highly effective in protecting young babies until they can have their first vaccination when they are 8 weeks old.

Babies born to women vaccinated at least a week before birth had a 91% reduced risk of becoming ill with whooping cough in their first weeks of life, compared to babies whose mothers had not been vaccinated.

An additional benefit is that the protection the mother receives from the vaccination will lower her own risk of infection and of passing whooping cough on to her baby.

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Adult Household Contacts And Carers Of Infants

Adult household contacts and carers of infants < 6 months of age are recommended to receive dTpa vaccine at least 2 weeks before they have close contact with the infant if their last dose was more than 10 years ago.27,28 Pertussis infection in infants < 6 months of age is associated with significant morbidity. The infection source in infants is often a household contact.29 See Epidemiology.

It is safe to give pertussis-containing vaccine to children, adolescents or adults who have had laboratory-confirmed pertussis infection. These people should receive all routinely scheduled pertussis-containing vaccines because natural immunity does not provide lifelong protection.

This is particularly important for infants < 6 months of age who develop pertussis because they may not mount an adequate immune response after infection.

See also Vaccine information and Variations from product information for more details.

What Other Drugs Will Affect Boostrix

Before receiving Boostrix, tell your doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders or

• medicines to treat or prevent organ transplant rejection.

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete. Other drugs may interact with tetanus, diphtheria, and pertussis vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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Can I Get Boostrix If I Have A Latex Or Egg Allergy

Yes, you can likely get Boostrix with either of these allergies.

If you have a latex allergy, you can use one of the two forms available of Boostrix.

Boostrix comes in a single-dose vial or a single-dose prefilled syringe. The tip cap of the prefilled syringe contains latex. So this form of Boostrix isnt suitable for you if you have a severe latex allergy. But the vial stopper doesnt contain latex, so if you have a latex allergy, you can have this form of the vaccine.

Before getting Boostrix, be sure to tell your healthcare provider if youve ever had an allergic reaction to latex. They can make sure they give you the vial form of the vaccine, and not to use latex gloves.

If you have an egg allergy, you should have no problem getting either form of the Boostrix vaccine. Boostrix isnt produced using eggs and doesnt contain any form of egg protein. So its safe to get the Boostrix vaccine if you have an egg allergy.

If you have any questions about Boostrix and any allergies, talk with your doctor.