Pronunciation:

ree-DOOST dif-THEER-ee-a TOX-oyd, TET-a-nus TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar

Brand Names:

• Adacel
• Boostrix

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Diphtheria, tetanus, and acellular pertussis booster vaccine (also known as Tdap) is a combination immunizing agent given by injection to protect against infections caused by diphtheria, tetanus (lockjaw), and pertussis (whooping cough). This vaccine is given to children 10 years of age and older, and to adults who have already been given this vaccine in the past. The vaccine will "boost" or increase the protection that the child or adult had from an earlier dose.

Diphtheria is a serious illness that can cause breathing difficulties, heart problems, nerve damage, pneumonia, and possibly death. The risk of serious complications and death is greater in very young children and in the elderly.

Tetanus (also known as lockjaw) is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

Pertussis (also known as whooping cough) is a serious disease that causes severe spells of coughing that can interfere with breathing. Pertussis also can cause pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Children 10 years of age and older, and adults, may need an additional immunization called a booster against diphtheria, tetanus, and pertussis. Adults and teenagers should receive Tdap instead of the tetanus-diphtheria (Td) injection if it has been 10 years or more since their last tetanus-diphtheria vaccine. Tdap vaccine is recommended for adults who are in close contact with a baby who is less than a year old and for adults who work in the healthcare field.

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of Tdap (usually from the pertussis vaccine part), this rarely happens. The chance of your child catching one of these diseases, and being permanently injured or dying as a result, is much greater than the chance of your child getting a serious side effect from the Tdap vaccine.

This vaccine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Boostrix® and Adacel® are not used in children younger than 10 years of age.

The Advisory Committee on Immunization Practices (ACIP) has recommended that teenagers be given a Tdap vaccine instead of the tetanus-diphtheria (Td) vaccine. The committee is also encouraging all teenagers, even those who have already received Td, to get a Tdap booster to help protect against pertussis (eg, whooping cough). If you have questions about whether your teenager should receive Tdap, contact your doctor.

Older adults—

Adacel® is not used in adults 65 years of age and older.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Boostrix® in the elderly.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Meningococcal Vaccine, Tetanus Toxoid Conjugate Quadrivalent

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brachial neuritis (nerve problem) or
• Epilepsy (seizures or convulsions), uncontrolled or
• Guillain-Barré syndrome (nerve disorder with paralysis), history of after a vaccine with tetanus or
• Infection, severe or
• Progressive encephalopathy (a brain disease) or
• Stroke, active—Your doctor will decide if you or your child should receive this vaccine.

• Encephalopathy (a brain disease), history of after a vaccine with pertussis—Should not be used in patients with this condition.

• Immunodeficiency disorder (weak immune system)—May not work as well in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles.

This vaccine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or nurse if you have any questions.

You or your child may receive other vaccines at the same time as this one, but in a different body area. You should receive patient instructions for all of the vaccines. Make sure you understand all of the information and talk to your doctor or nurse if you have questions.

Precautions While Using This Medicine:

It is very important that you call the doctor right away if you or your child have any unwanted effects after receiving the vaccine. This may include fainting, seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

Fainting may occur after you receive this vaccine. You may also have vision changes, numbness or tingling in your arms, hands, or feet, or jerky movements of the arms and legs. Call the doctor right away if you or your child have any of these symptoms.

It is very important to tell the doctor if you or your child are allergic to rubber. The syringes may contain dry natural latex rubber. This may cause an allergic reaction if you have a latex allergy.

This vaccine will not treat an active infection. If you or your child have a diphtheria, tetanus, or pertussis infection, you will need medicine to treat the infection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Crying for 3 or more hours

fainting

Rare

Confusion

convulsions (seizures)

difficulty with breathing or swallowing

fever of 102.2 degrees F or more

headache (severe or continuing)

hives

itching, especially of the feet or hands

low blood pressure

reddening of the skin, especially around the ears

sleepiness (unusual and continuing)

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

vomiting (severe or continuing)

Incidence not known

Blood in the urine

bloody or black, tarry stools

blurred vision

chest pain or discomfort

chills

cough

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast heartbeat

flushed, dry skin

fruit-like breath odor

inability to move the arms and legs

increased hunger

increased thirst

increased urination

large, flat, blue or purplish patches on the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of consciousness

muscle pain or spasm

nausea

painful knees and ankles

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness and swelling on the skin, buttocks, legs, or ankles

skin rash

stiff neck

stomach pain

sudden numbness and weakness in the arms and legs

sweating

tightness in the chest

trouble breathing

unexplained weight loss

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches

diarrhea

fever of 99.5 degrees F or more

headache

redness, swelling, tenderness, pain, or a lump at the place of injection

tiredness

Incidence not known

Back pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

injection site bruising

muscle or joint pain

swollen, painful, or tender lymph glands in the neck, armpit, or groin

weakness of the muscles in the face

welts on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.