Quadracel (Intramuscular)

Diphtheria, tetanus, and acellular pertussis vaccine (also called DTaP) combined with inactivated poliovirus vaccine (also known as IPV) is a combination vaccine that protects against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), and poliovirus. The vaccine helps the body create 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 lead to breathing problems, heart issues, nerve damage, pneumonia, and possibly death. The risk of serious complications is higher in very young children and older adults.

Tetanus (also known as lockjaw) is a very serious illness that causes seizures and severe muscle spasms, which can be strong enough to break bones in the spine. The disease mainly affects people who are not vaccinated or do not have enough protection from previous vaccines.

Pertussis (also known as whooping cough) is a serious disease that causes intense coughing spells that can make it hard to breathe. Pertussis can also lead to pneumonia, long-lasting bronchitis, seizures, brain damage, and death.

Polio is a very serious infection that can cause paralysis of the muscles, including those needed to walk and breathe. A polio infection may leave a person unable to breathe without a breathing machine. It may also leave a person unable to walk without leg braces or confine them 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.

It is very important for the doctor to check your child at regular visits to ensure this vaccine is working properly and to look for any unwanted effects.

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

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

This vaccine will not treat an active infection. If your child has an infection caused by diphtheria, tetanus, pertussis, or polio, your child will need medications to treat these infections.

Fainting may occur after receiving this vaccine. You may also experience 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 inform your child’s doctor about any serious side effects that happen after your child receives the vaccine. This may include seizures, a high fever, persistent crying, or severe redness or swelling at the injection site.

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

In deciding to use a vaccine, you and your doctor will weigh the risks of the vaccine against its benefits. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on how this vaccine affects children younger than 4 years old and children 7 years old and older. Safety and effectiveness have not been established.

Geriatric

This vaccine is not recommended for adult patients.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. However, there are no adequate studies in women to determine the infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. When receiving this vaccine, it is especially important for your healthcare professional to know if you are taking any of the following medicines. The following interactions are important and may not be all-inclusive.

Using this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this vaccine. Make sure to inform your doctor if you have any other medical problems, especially:

• Brain disease (e.g., encephalopathy)—This includes a coma, decreased consciousness, or prolonged seizures. Children who show these symptoms within 7 days of receiving a vaccine with pertussis should not receive this vaccine.

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

• Guillain-Barré syndrome (nerve disease causing paralysis), history of—If your child had this condition after receiving a vaccine with tetanus toxoid, discuss the potential benefits and risks of this vaccine with your doctor.

• Immunodeficiency disorder or
• Weakened immune system—This vaccine may not be as effective in children with these conditions.

• Previous serious reaction to a vaccine—If your child experienced a serious reaction to this vaccine or another vaccine with pertussis, discuss the potential benefits and risks of this vaccine with your doctor. Serious reactions include being less responsive than normal, continuous crying for 3 hours or more, having a seizure with or without fever, or a fever of 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.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your health care professional may be able to provide ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Kinrix
• Quadracel

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

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.