Pronunciation:

dif-THEER-ee-a TOX-oyd, ad-SORBD, TET-a-nus TOX-oyd, per-TUS-iss VAX-een, a-SELL-yoo-lar, hep-a-TYE-tis B VAX-een re-KOM-bin-ant, POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated

Brand Names:

• Pediarix

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Diphtheria and tetanus toxoids and pertussis vaccine (also known as DTP vaccine) combined with hepatitis B and poliovirus vaccine (also known as HepB and IPV) is a combination immunizing agent used to prevent illness caused by diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and poliovirus. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. This vaccine is given only to infants and children who are 6 weeks to 6 years of age, and is given before the child’s 7th birthday.

This vaccine combines five agents into one vaccine. In order to complete the series, you must get three injections of this vaccine at separate intervals. Because there are many different diseases you will need to be vaccinated against, make sure to follow your doctor's directions about your vaccination schedule.

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 convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30% to 40% of cases. 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.

Hepatitis B infection is a major cause of serious liver diseases, including liver cancer. You get hepatitis B by being exposed to someone else's body fluids. Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease. People who have the virus can give it to others without them knowing it.

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 administered only by or under the direct supervision of your 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 infants younger than 6 weeks 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.

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:

• Encephalopathy (a brain disease), history of after a vaccine with pertussis—Should not be used in patients with this condition.

• 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-Barre syndrome (nerve disease that causes paralysis), history of—If your child had this condition after getting a vaccine with tetanus in it, you should talk to your doctor about the potential benefits and possible risks of getting this vaccine.

• Immunodeficiency disorder—If you have an immune system disorder, this vaccine may not work well for you.

• Previous side effects, history of after a vaccine with pertussis—If your child has had certain side effects 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 a fever, or having a fever that is 105 degrees F or higher.

• Progressive neurologic disorders—This includes infantile spasms, progressive brain disease, or uncontrolled epilepsy (seizures). This vaccine should not be given until these conditions are 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 or thighs.

This vaccine is usually given as three shots. The first dose may be given as early as 6 weeks of age. You will need another dose at 4 and 6 months after the first dose, unless your doctor tells you otherwise.

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 your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.

Precautions While Using This Medicine:

It is very important that your child return to your doctor's office for the second and third dose of this vaccine. Be sure to notify your doctor or clinic of any side effects that may occur after your child has received the vaccine.

If your child develops a skin rash, hives, or any allergic reaction after receiving this vaccine, tell your child's doctor right away.

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.

Make sure your doctor knows if your child is allergic to latex rubber. One of the prefilled syringes for this vaccine contains dry natural latex rubber. This may cause an allergic reaction in children who are sensitive to latex.

This vaccine may cause apnea (breathing problem) in some premature infants. The doctor will decide if your child should receive this vaccine.

This vaccine will not treat an active infection. If your child have a diphtheria, tetanus, pertussis, hepatitis B, or polio infection, you will need medicine to treat the infection.

Be sure to tell your child’s doctor about any serious side effects that occur after your child receives 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.

Side Effects of This Medicine:

Along with its needed effects, a vaccine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. It is very important that you tell your doctor about any side effect that occurs after a dose of DTaP-HepB-IPV vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that your child should not receive any more doses of DTaP-HepB-IPV vaccine.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Abdominal or stomach pain

agitation

back pain

black, tarry stools

bleeding gums

blood in the urine or stools

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

blurred vision

chills

clay colored stools

collapse or shock-like state

coma

confusion

cough

dark urine

diarrhea

difficulty with swallowing

dizziness

drowsiness

fast heartbeat

fever

hallucinations

headache

heavier menstrual periods

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

hoarseness

irritability

irritation

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

itching

joint pain

loosening of the skin

mood or mental changes

nausea

pain or cramping in the abdomen or stomach

pinpoint red spots on the skin

redness of the skin

red, irritated eyes

seizures

shortness of breath

skin rash

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stiff neck

stiffness or swelling

Sudden Infant Death Syndrome (SIDS)

swelling

tightness in the chest

troubled breathing

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting or vomiting of blood

weight loss

wheezing

yellow eyes or skin

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

Bleeding

blistering

burning

coldness

discoloration of the skin

fussiness

feeling of pressure

infection

inflammation

lumps

numbness

pain

restlessness

scarring

sleeping more than usual

soreness

stinging

tenderness

tingling

ulceration

unusual cry

warmth on the skin

Incidence not known

Arm or leg swelling

difficulty with moving

dullness, tiredness, weakness, or feeling of sluggishness

feeling of warmth

general feeling of discomfort or illness

hair loss

itching skin

lack or loss of strength

loss of appetite

loss of strength or energy

muscle pain, weakness, or stiffness

pain in the joints

paleness of the skin

redness of the face, neck, arms, and occasionally, upper chest

sneezing

sores, ulcers, or white spots in the mouth or on the lips

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

thinning of the hair

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.