Description
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.
This product is available in the following dosage forms:
- Suspension
Before Using
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.
Pediatric
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.
Geriatric
This vaccine is not recommended for use in adult patients.
Breastfeeding
Substance Name
Substance Name
Substance Name
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Substance Name
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.
Drug Interactions
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.
- Atidarsagene Autotemcel
- 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
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
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.
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
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.
CON-XXXXXXXX
