Diphtheria, tetanus, acellular pertussis, polio, hib vaccine (Intramuscular)

Diphtheria, tetanus, and acellular pertussis vaccine (also called DTaP) combined with inactivated poliovirus and Haemophilus B conjugate vaccine (also known as IPV and Hib) is a combination vaccine that protects against infections from diphtheria, tetanus (lockjaw), pertussis (whooping cough), poliovirus, and Haemophilus influenzae type b. This vaccine helps the body create its own protection (antibodies) against these diseases. It is given only to babies and children aged 6 weeks to 4 years, before the child turns 5 years old.

Diphtheria is a serious illness that can lead to breathing problems, heart issues, nerve damage, pneumonia, and even death. The risk of severe complications is higher in very young children and older adults.

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

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

Polio is a very serious infection that causes paralysis of the muscles, including those needed for walking and breathing. A polio infection can leave someone unable to breathe without a breathing machine, or unable to walk without leg braces or a wheelchair. There is no cure for polio.

Infection from Haemophilus influenzae type b (Hib) bacteria can lead to life-threatening illnesses, such as meningitis (affecting the brain), epiglottitis (affecting the throat and potentially causing death by suffocation), pericarditis (affecting the heart), pneumonia (affecting the lungs), and septic arthritis (affecting the bones and joints).

Diphtheria, tetanus, and pertussis are serious diseases that can lead to life-threatening conditions. While some serious side effects can occur after a dose of DTaP (usually from the pertussis part), this is rare. The risk of your child getting one of these diseases and suffering permanent injury or death is much higher than the risk of a serious side effect from the DTaP vaccine.

This vaccine must be given only by or under the supervision of your child's doctor or another authorized health care professional.

It is very important to call the doctor right away if you or your child experience any unwanted effects after getting the vaccine. This may include fainting, seizures, a high fever, persistent crying, or severe redness or swelling at the injection site.

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

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

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

Fainting may happen after getting this vaccine. You may also notice changes in vision, 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 experience any of these symptoms.

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

In deciding to use a vaccine, you and your doctor should think about the risks of the vaccine compared to the benefits. Here are some important points to consider:

Allergies

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

Pediatric

Studies have not been done on how this vaccine affects babies younger than 6 weeks and children 5 years and older. Safety and effectiveness have not been proven.

Make sure your doctor knows if your child was born prematurely. This vaccine may cause breathing issues (like apnea) in infants born prematurely.

Geriatric

There is no information available on how this vaccine affects older patients.

Breast Feeding

Research in women suggests that this medication poses minimal risk to infants when used during breastfeeding.

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if interactions could happen. In those cases, your doctor might need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when you receive this vaccine. The following interactions are chosen for their potential significance and may not include all possible interactions.

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 modify the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods because interactions may occur. Using alcohol or tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Make sure to tell your doctor if you have any other medical issues, 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 get 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 be as effective in patients with this condition.

Along with its necessary effects, a medicine can also cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Contact your doctor right away if you notice any of the following side effects:

More common

• Chest pain or tightness
• Confusion
• Coughing
• Persistent and inconsolable crying that happens within 48 hours and lasts 3 or more hours
• Decreased urination
• Diarrhea
• Dizziness
• Dry mouth
• Fainting
• Fever
• Increased 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 happen that usually do not need medical attention. These side effects might go away as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or lessen some of these side effects. Talk to your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Irritability
• Tenderness at the injection site
• Unusual drowsiness, dullness, tiredness, weakness, or 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 happen in some patients. If you notice any other effects, talk to your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Pentacel

Available Dosage Forms:

• Suspension
• Powder for Suspension

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.