Pediarix

Pediarix is a vaccine used for the prevention of diphtheria, tetanus (lockjaw), pertussis (whooping cough), infection caused by all known subtypes of hepatitis B virus, and polio (poliomyelitis). 

Pediarix is given as a shot into the thigh or upper arm.

Common side effects of Pediarix include pain, redness, and swelling at the injection site. 

Pediarix is a vaccine used for the prevention of diphtheria, tetanus (lockjaw), pertussis (whooping cough), infection caused by all known subtypes of hepatitis B virus, and polio (poliomyelitis).

Pediarix is approved for use as a three-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. Modified schedules are also available for children who have previously been vaccinated. 

Pediarix may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

• Glaxo SmithKline Pharmaceuticals

• GlaxoSmithKline Biologicals SA

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.

• Allergic reactions. Tell your healthcare provider about any signs or symptoms of  allergic reactions, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash
• Adverse reactions with prior pertussis (whooping cough) vaccination. If any of the following events occur within the specified period after receiving a pertussis vaccine, the decision to get Pediarix vaccine should be based on careful consideration of potential benefits and possible risks.
  • Temperature of ≥40.5°C (105°F) within 48 hours, not attributable to another identifiable cause.
  • Collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours.
  • Persistent, inconsolable crying lasting ≥3 hours within 48 hours.
  • Seizures with or without fever within 3 days.
• Guillain-Barré Syndrome. There is a causal relationship between tetanus toxoid and Guillain-Barré syndrome. Guillain-Barré Syndrome is a condition in which the immune system attacks the nerves.
• Previous history of seizures. For infants or children with a history of previous seizures, an appropriate fever reducer may be given at the time of vaccination and for the following 24 hours, to reduce the possibility of post-vaccination fever.
• Fainting. Fainting can occur in association with administration of Pediarix.
• Fever. In clinical trials, administration of Pediarix in infants was associated with higher rates of fever, relative to separately administered vaccines. 
• Latex. The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
• Premature infants may temporarily stop breathing. Breathing issues have been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Pediarix, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination.

Do not get Pediarix if your child:

• had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis B-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin B
• had encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause
• has a progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Pediarix, there are no specific foods that you must exclude from your diet when receiving this medication. 

Tell your healthcare provider your child:

• had a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis B-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin B
• had encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause
• have progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy
• is allergic to latex

Tell you doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pediarix falls into category C. No studies have been conducted in animals, and no well-controlled studies have been done in pregnant women. Pediarix should only be given to a pregnant woman if clearly needed. 

Tell your doctor is you are breastfeeding or plan to breastfeed. 

It is not known if Pediarix crosses into human milk. Because some vaccines can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this vaccine, a choice should be made whether to stop nursing or stop the use of this vaccine. Your doctor and you will decide if the benefits outweigh the risk of using Pediarix.

Pediarix is given by a healthcare provider as a shot into the thigh or upper arm.

• The preferred injection site is the thigh for children younger than 1 year. In older children, the upper arm is usually large enough for the injection. 

Pediarix is given by a healthcare provider as a single 0.5-mL dose injected into the thigh or upper arm. 

Immunization with Pediarix consists of 3 doses of 0.5 mL each, by intramuscular injection, at 2, 4, and 6 months of age (at intervals of 6 to 8 weeks, preferably 8 weeks). The first dose may be given as early as 6 weeks of age. Three doses of Pediarix constitute a primary immunization course for diphtheria, tetanus, pertussis, and poliomyelitis and the complete vaccination course for hepatitis B.

Modified schedules in previously vaccinated children:

• Children Previously Vaccinated With Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP): Pediarix may be used to complete the first 3 doses of the DTaP series in children who have received 1 or 2 doses of Infanrix
• Children Previously Vaccinated With Hepatitis B Vaccine: Pediarix may be used to complete the hepatitis B vaccination series following 1 or 2 doses of another hepatitis B vaccine (monovalent or as part of a combination vaccine),
• Children Previously Vaccinated With Inactivated Poliovirus Vaccine (IPV): Pediarix may be used to complete the first 3 doses of the IPV series in children who have received 1 or 2 doses of IPV

Pediarix is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention.