Pronunciation:

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

Brand Names:

• Daptacel
• Infanrix
• Tripedia

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) 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 only to children 6 weeks through 6 years of age (before the child's 7th birthday).

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.

Diphtheria, tetanus, and pertussis are serious diseases that can cause life-threatening illnesses. Although some serious side effects can occur after a dose of DTaP (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 DTaP 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—

Appropriate studies have not been performed on the relationship of age to the effects of diphtheria, tetanus, and acellular pertussis vaccine in children younger than 6 weeks of age and in children 7 years of age and older. Safety and efficacy have not been established.

Older adults—

Diphtheria, tetanus, and acellular pertussis vaccine is not recommended for use in adult populations.

No information is available on the relationship of age to the effects of Daptacel® in geriatric patients.

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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

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:

• Bleeding disorders (eg, hemophilia, thrombocytopenia)—Should not use in patients with this condition.

• Brain disease (eg, encephalopathy)—This includes a coma, a decreased level of consciousness, or seizures lasting a long time. Children who have these symptoms within 7 days of receiving a vaccine with pertussis should not get this vaccine.

• Guillain-Barré syndrome (nerve disorder with paralysis), history of—If your child had this condition after getting a vaccine with tetanus toxoid in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine.

• Immunodeficiency disorder or
• Weakened immune system—This vaccine may not work as well in children with this condition.

• Previous serious reaction to a vaccine—If your child had a serious reaction to this vaccine or another vaccine with pertussis in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine. Some serious reactions include being less responsive than normal, crying continuously without stopping for 3 hours or more, having a seizure with or without a fever, or having a fever that was 105 degrees F or higher.

• Progressive neurologic disorder—This includes infantile spasms, progressive brain disease, or uncontrolled seizures. This vaccine should not be given until these conditions are treated and under control.

Proper Use of This Medicine:

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

This vaccine is usually given as a series of 4 or 5 shots. Your child may receive the first 3 doses of Infanrix® at 2, 4, and 6 months of age. 2 booster doses will be given at 15 to 20 months of age and 4 to 6 years of age.

It is important that you or your child receive all of the shots. Try to keep all scheduled appointments. Make another appointment as soon as possible if you or your child misses a dose of this vaccine.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Your child may also receive a medicine to help prevent or treat some of the minor side effects of the vaccine, like fever and soreness.

Precautions While Using This Medicine:

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects. It is very important that you return to your child's doctor for the next dose in the series.

Contact your doctor immediately if your child has sudden weakness in the arms and legs. This could be a sign of a serious condition called Guillain-Barré syndrome.

It is very important to tell the doctor if your child is allergic to rubber. The vial and syringes may contain dry natural latex rubber, which may cause an allergic reaction if your child has a latex allergy.

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, or pertussis, your child will need medicines to treat these infections.

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 has any of these symptoms.

Be sure to tell your child's doctor about any side effects that occur after your child receives the vaccine. This may include seizures, fever, crying that will not stop, or severe redness or swelling where the shot was given.

This vaccine may cause apnea (breathing stops for short periods) in some premature infants. Discuss this with your child's doctor if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Collapse or shock-like state

crying for 3 hours or more

fever over 102.2 °F

redness or swelling of 4 inches or more at the injection site

seizures

severe pain at the injection site

Incidence not known

Agitation

back pain

black, tarry stools

bleeding gums

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blood in the urine or stools

bloody nose

bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

chest tightness

confusion

cough

diarrhea

difficulty with swallowing

dizziness

drowsiness

fast heartbeat

hallucinations

headache

hoarseness

irritability

irritation

joint pain, stiffness, or swelling

loss of bladder control

loss of consciousness

loss of strength or energy

muscle pain or weakness

nausea and vomiting

pain or cramping in the abdomen or stomach

pinpoint red spots on the skin

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

rash with flat lesions or small raised lesions on the skin

screaming

sleepiness or unusual drowsiness

sneezing

sore throat

stiff neck

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

total body jerking

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness (sudden and severe)

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

Fever of 99.5 °F or more

fussiness

loss of appetite

mild pain, redness, swelling, or tenderness at the injection site

restlessness

weight loss

Incidence not known

Crying

ear pain

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.