PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]
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Physician Resources
Indications & Usage

INDICATIONS AND USAGE

PEDIARIX is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

 

 

These highlights do not include all the information needed to use PEDIARIX safely and effectively. Consult the Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Dosage & Administration

DOSAGE AND ADMINISTRATION

Three doses (0.5-mL each) by intramuscular injection at 2, 4, and 6 months of age.

 

DOSAGE FORMS AND STRENGTHS

Single-dose, prefilled syringes containing a 0.5-mL suspension for injection.

 

 

These highlights do not include all the information needed to use PEDIARIX safely and effectively. Consult the Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Contraindications

CONTRAINDICATIONS

  • Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX.

  • Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine.

  • Progressive neurologic disorders.

 

 

These highlights do not include all the information needed to use PEDIARIX safely and effectively. Consult the Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Warnings & Precautions

WARNINGS AND PRECAUTIONS

  • In clinical trials, PEDIARIX was associated with higher rates of fever, relative to separately administered vaccines.

  • If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give PEDIARIX should be based on potential benefits and risks.

  • Syncope (fainting) can occur in association with administration of injectable vaccines, including PEDIARIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

  • If temperature ≥105°F, collapse or shock-like state, or persistent, inconsolable crying lasting ≥3 hours have occurred within 48 hours after receipt of a pertussis-containing vaccine, or if seizures have occurred within 3 days after receipt of a pertussis-containing vaccine, the decision to give PEDIARIX should be based on potential benefits and risks.

  • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX.

  • Apnea following intramuscular vaccination has 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.

 

 

These highlights do not include all the information needed to use PEDIARIX safely and effectively. Consult the Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Adverse Reactions

ADVERSE REACTIONS

Common solicited adverse reactions following any dose (≥25%) included local injection site reactions (pain, redness, and swelling), fever (≥100.4°F), drowsiness, irritability/fussiness, and loss of appetite.

 

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

 

These highlights do not include all the information needed to use PEDIARIX safely and effectively. Consult the Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Drug Interactions

DRUG INTERACTIONS

Do not mix PEDIARIX with any other vaccine in the same syringe.

 

 

These highlights do not include all the information needed to use PEDIARIX safely and effectively. Consult the Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

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Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday).

IMPORTANT SAFETY INFORMATION

  • Contraindications for PEDIARIX are: severe allergic reaction (eg, anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine, or to any component of PEDIARIX; encephalopathy within 7 days of administration of a previous pertussis-containing vaccine; progressive neurologic disorders

  • In clinical trials, PEDIARIX was associated with higher rates of fever relative to separately administered vaccines

  • The decision to give PEDIARIX should be based on potential benefits and risks if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events (ie, temperature ≥105°F, collapse or shock-like state, persistent, inconsolable crying lasting ≥3 hours, occurring within 48 hours after vaccination; seizures within 3 days after vaccination) have occurred after receipt of a pertussis-containing vaccine

  • The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton

  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope

  • For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with PEDIARIX

  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination with PEDIARIX should be based on consideration of the individual infant's medical status and the potential benefits and possible risks of vaccination

  • In clinical trials, common adverse reactions in infants receiving PEDIARIX included injection-site reactions (pain, redness, and swelling), fever, drowsiness, irritability/fussiness, and loss of appetite

  • Vaccination with PEDIARIX may not result in protection in all vaccine recipients

 

Prescribing Information for PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]