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, hee-MOF-i-lus B KON-joo-gate VAX-een

Brand Names:

• Pentacel

Dosage Forms:

• Suspension
• Powder for Suspension

Uses of This Medicine:

Diphtheria, tetanus, and acellular pertussis vaccine (also known as DTaP) combined with inactivated poliovirus and Haemophilus B conjugate vaccine (also known as IPV and Hib) is a combination vaccine that is given to protect against infections caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliovirus, and Haemophilus influenzae type b. This vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is only given to babies and children who are 6 weeks to 4 years of age, and is given before the child's 5th 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.

Infection by Haemophilus influenzae type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis, which affects the brain; epiglottitis, which affects the throat and can cause death by suffocation; pericarditis, which affects the heart; pneumonia, which affects the lungs; and septic arthritis, which affects the bones and joints.

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 administered only by or under the supervision of your child's doctor or other authorized health care professional.

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 babies younger than 6 weeks of age and in children 5 years of age and older. Safety and efficacy have not been established.

Make sure your doctor knows if your child was born prematurely. This vaccine may cause breathing problems (eg, apnea) to infants born prematurely.

Older adults—

No information is available on the relationship of age to the effects of this vaccine in geriatric 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:

• Brachial neuritis (nerve problem) or
• Guillain-Barré syndrome (nerve disorder with paralysis), history of after a vaccine with tetanus—Your doctor will decide if you or your child should receive this vaccine.

• Brain or nerve disorder, unstable or progressive or
• Encephalopathy (brain disease), history of within 7 days after a pertussis vaccine or
• Epilepsy (seizures or convulsions), uncontrolled—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 your child this vaccine. It is given as a shot into one of your muscles.

This vaccine is given as a 4-dose series at 2, 4, 6, and 15 to 18 months of age. Your child may receive a 5th dose of DTaP vaccine (eg, Daptacel® or Quadracel®) at 4 to 6 years of age.

This vaccine may also be used to complete the first 4 doses in a 5-dose DTaP series in children who have received 1 or more doses of Daptacel® or 3-dose series of Vaxelis®.

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.

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.

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.

This vaccine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

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.

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, polio, or Haemophilus influenzae type b, 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.

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 immediately if any of the following side effects occur:

More common

Chest pain or tightness

confusion

coughing

crying, persistent and inconsolable, occurring within 48 hours and lasting 3 or more hours

decreased urination

diarrhea

dizziness

dry mouth

fainting

fever

increase in heart rate

lightheadedness

loss of appetite

nausea

noisy, rapid, or trouble breathing

sneezing

sore throat

stomach pain

sunken eyes

thirst

unusual tiredness or weakness

wrinkled skin

Incidence not known

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

chills

cold or flu-like symptoms

drowsiness

fainting

fast heartbeat

general feeling of illness

hives

hoarseness

irritation

itching

joint pain, stiffness, or swelling

rash

redness of the skin

runny nose

severe headache

slow breathing

sneezing

stiff neck or back

stuffy nose

swelling of the eyelids, face, lips, hands, or feet

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

Irritability

tenderness at the injection site

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Incidence not known

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

change in skin color at the injection site

paleness of the skin

sleepiness or unusual drowsiness

vomiting

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.