Pediarix

Diphtheria, pertussis, and tetanus are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Hepatitis B and polio are serious diseases caused by virus.

Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when the mother is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

Diphtheria, hepatitis B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine is used to help prevent these diseases in children who are ages 6 weeks to 6 years old, before the child has reached his or her 7th birthday.

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the diphtheria, hepatitis B, pertussis acellular, polio, and tetanus vaccine may not provide protection from disease in every person.

The diphtheria, hepatitis B, pertussis, polio, and tetanus vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months and 6 months of age. Your child's individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side effects reported with Pediarix include:

• pain, redness, and swelling at the injection site
• fever
• drowsiness
• irritability/fussiness
• loss of appetite

Tell your healthcare provider if you have any new or unusual symptoms after you receive Pediarix. For a complete list of side effects, ask your health care provider.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use:

• immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids

This is not a complete list of Pediarix drug interactions. Ask your doctor or pharmacist for more information.

Your child should not receive this vaccine if he or she has a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine).

Keep track of any and all side effects your child has after receiving this vaccine. Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Before your child receives this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has received drugs or treatments in the past 2 weeks that can weaken the immune system. If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

This list is not complete. Other drugs may interact with this vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Give Pediarix as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• Your child's doctor will give this medicine.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Mechanism of Action

Diphtheria: Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C. diphtheriae. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection; a level of 0.1 IU/mL is regarded as protective.2

Tetanus: Tetanus is an acute toxin-mediated disease caused by a potent exotoxin released by C. tetani. Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level.3,4 A level ≥0.1 IU/mL is considered protective.5

Pertussis: Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no established serological correlate of protection for pertussis.

Hepatitis B: Infection with hepatitis B virus can have serious consequences including acute massive hepatic necrosis and chronic active hepatitis. Chronically infected persons are at increased risk for cirrhosis and hepatocellular carcinoma.

Antibody concentrations ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.6

Poliomyelitis: Poliovirus is an enterovirus that belongs to the picornavirus family. Three serotypes of poliovirus have been identified (Types 1, 2, and 3). Poliovirus neutralizing antibodies confer protection against poliomyelitis disease.7

Pediarix vaccine is used to help prevent diphtheria, hepatitis B, pertussis, polio and tetanus in children who are ages 6 weeks to 6 years old, before the child has reached his or her 7th birthday.

Diphtheria, pertussis, and tetanus are serious diseases caused by bacteria. Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death. Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death. Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Hepatitis B and polio are serious diseases caused by viruses. Hepatitis B is a disease of the liver that is spread through blood or bodily fluids, sexual contact or sharing IV drug needles with an infected person, or during childbirth when the mother is infected. Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death. Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

Diphtheria, hepatitis B, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

Pediarix works by exposing your child to a small dose of the bacteria or virus, which causes the body to develop immunity to the disease. Pediarix will not treat an active infection that has already developed in the body.

Like any vaccine, Pediarix vaccine may not provide protection from disease in every person.

An overdose of Pediarix is unlikely to occur.

Get emergency medical help if your child has any of these signs of an allergic reaction to Pediarix: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot. Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with diphtheria, hepatitis B, pertussis, polio, or tetanus is much more dangerous to your child's health than receiving Pediarix vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if the child has:

• extreme drowsiness, fainting;

• slow breathing with long pauses between breaths;

• fussiness, irritability, crying for an hour or longer;

• seizure (black-out or convulsions); or

• high fever (can occur for up to 4 days after the vaccine).

Common Pediarix side effects include:

• redness, pain, or swelling where the shot was given;

• mild fever;

• mild fussiness or crying;

• drowsiness; or

• loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Applies to diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid: intramuscular suspension

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 while taking diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid:

• 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 of diphtheria toxoid / hepatitis b pediatric vaccine / pertussis, acellular / poliovirus vaccine, inactivated / tetanus toxoid 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:

• 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

• 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