Pronunciation:

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-a-nus TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar, POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated

Brand Names:

• Kinrix
• Quadracel

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) combined with inactivated poliovirus vaccine (also known as IPV) is a combination vaccine that is given to protect against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), and poliovirus. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is given only to children 4 to 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 is greater in very young children and the elderly.

Tetanus (also known as lockjaw) is a very serious illness that causes seizures and severe muscle spasms that can be strong enough to cause bone fractures of the spine. The disease continues to occur almost exclusively among people who do not get vaccinated or do not have enough protection from previous vaccines.

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

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you to walk and breathe. A polio infection may leave a person unable to breathe without the help of a breathing machine. It may also leave a person unable to walk without leg braces or being confined to a wheelchair. There is no cure for polio.

This vaccine is to be given only by or under the supervision of your child’s 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 this vaccine in children younger than 4 years of age and children 7 years of age and older. Safety and efficacy have not been established.

Older adults—

This vaccine is not recommended for use in adult patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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:

• 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.

• Fever, high or
• Moderate or severe illness, with or without fever—This vaccine may make these conditions worse or may increase the chance of side effects.

• Guillain-Barré syndrome (nerve disease that causes 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 these conditions.

• 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 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. This vaccine is given as a shot into one of your child’s muscles, usually in the shoulder muscle.

Kinrix® may be given as the fifth dose in the DTaP vaccine and as the fourth dose in IPV vaccine in children who have received previous DTaP vaccine (eg, Infanrix®, Pediarix®) for the first 3 doses and Infanrix® for the fourth dose.

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, such as 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.

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines.

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 latex rubber. The tip caps of the prefilled 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, pertussis, or polio, 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 have any of these symptoms.

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

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:

Rare

Blurred vision

confusion

decreased urination

diarrhea

difficulty having a bowel movement (stool)

dizziness

dry mouth

fainting

fast heartbeat

fever

inability to speak

irritability

itching, pain, redness, swelling, tenderness, or warmth on the skin

lightheadedness

loss of appetite

muscle twitching

nausea

rapid breathing

restlessness

seizures

severe or sudden headache

slurred speech

stomach pain

sunken eyes

swelling of the feet or lower legs

temporary blindness

thirst

unusual tiredness or weakness

weakness

weakness in the arm and/or leg on one side of the body, sudden and severe

wrinkled skin

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

bluish lips or skin

chest tightness

collapse or shock-like state

cough

difficulty swallowing

hives

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

pinpoint red spots on the skin

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

skin rash

slow breathing

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

unusual bleeding or bruising

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

Loss of appetite

pain, redness, or swelling at the injection site

sleepiness

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.