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Pediarix

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Pediarix

Indications
Dosage
How Supplied

INDICATIONS

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older. 

Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin (Human) (HBIG) and monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]) (see DOSAGE AND ADMINISTRATION). 

Infants born of mothers of unknown HBsAg status should receive monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]) (see DOSAGE AND ADMINISTRATION). 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) will not prevent hepatitis caused by other agents, such as hepatitis A, C, and E viruses, or other pathogens known to infect the liver. As hepatitis D (caused by the delta virus) does not occur in the absence of hepatitis B infection, hepatitis D will also be prevented by vaccination with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . 

Hepatitis B has a long incubation period. Vaccination with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may not prevent hepatitis B infection in individuals who had an unrecognized hepatitis B infection at the time of vaccine administration. 

As with any vaccine, PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may not protect 100% of individuals receiving the vaccine. PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not recommended for treatment of actual infections.

DOSAGE AND ADMINISTRATION

Preparation for Administration

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) contains an adjuvant; therefore shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if a gel-like substance is present or if resuspension does not occur with vigorous shaking. Inspect PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) visually for particulate matter, discoloration, and cracks in the vial or syringe prior to administration. If any of these conditions exist, the vaccine should not be administered. After removal of the dose, any vaccine remaining in the vial should be discarded. 

Before injection, the skin at the injection site should be cleaned and prepared with a suitable germicide.

Recommended Schedule

The primary immunization series for PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is 3 doses of 0.5 mL, given intramuscularly, at 6- to 8-week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age. The preferred administration site is the anterolateral aspect of the thigh for children younger than 1 year. In older children, the deltoid muscle is usually large enough for an intramuscular injection. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk. Gluteal injections may result in suboptimal hepatitis B immune response. 

Do not administer this product subcutaneously or intravenously. 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should not be administered to any infant before the age of 6 weeks. Only monovalent hepatitis B vaccine can be used for the birth dose. 

Infants born of HBsAg-positive mothers should receive HBIG and Hepatitis B Vaccine (Recombinant) within 12 hours of birth at separate sites and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]).  Infants born of mothers of unknown HBsAg status should receive Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.18 (See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]). 

The administration of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) for completion of the hepatitis B vaccination series in infants who were born of HBsAg-positive mothers and who received monovalent Hepatitis B Vaccine (Recombinant) and HBIG has not been studied.

Modified Schedules

Children Previously Vaccinated With One or More Doses of Hepatitis B Vaccine

Infants born of HBsAg-negative mothers and who received a dose of hepatitis B vaccine at or shortly after birth may be administered 3 doses of PEDIARIX according to the recommended schedule. However, data are limited regarding the safety of PEDIARIX in such infants (see ADVERSE REACTIONS). There are no data to support the use of a 3-dose series of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in infants who have previously received more than one dose of hepatitis B vaccine. PEDIARIX may be used to complete a hepatitis B vaccination series in infants who have received 1 or more doses of Hepatitis B Vaccine (Recombinant) and who are also scheduled to receive the other vaccine components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . However, the safety and efficacy of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in such infants have not been studied.

Children Previously Vaccinated With One or More Doses of INFANRIX

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of INFANRIX and are also scheduled to receive the other vaccine components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . However, the safety and efficacy of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) in such infants have not been evaluated.

Children Previously Vaccinated With One or More Doses of IPV

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IPV and are also scheduled to receive the other vaccine components of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . However, the safety and efficacy of PEDIARIX in such infants have not been studied.

Interchangeability of PEDIARIX and Licensed DTaP, IPV, or Recombinant Hepatitis B Vaccines

It is recommended that PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) be given for all 3 doses because data are limited regarding the safety and efficacy of using DTaP vaccines from different manufacturers for successive doses of the pertussis vaccination series. PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not recommended for completion of the first 3 doses of the DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer because no data are available regarding the safety or efficacy of using such a regimen. 

PEDIARIX may be used to complete a hepatitis B vaccination series initiated with a licensed Hepatitis B Vaccine (Recombinant) vaccine from a different manufacturer. 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) may be used to complete the first 3 doses of the IPV vaccination series initiated with IPV from a different manufacturer.

Additional Dosing Information

If any recommended dose of pertussis vaccine cannot be given, DT (For Pediatric Use), Hepatitis B (Recombinant), and inactivated poliovirus vaccines should be given as needed to complete the series. 

Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . There is no need to start the series over again, regardless of the time elapsed between doses.

The use of reduced volume (fractional doses) is not recommended. The effect of such practices on the frequency of serious adverse events and on protection against disease has not been determined.5 

Preterm infants should be vaccinated according to their chronological age from birth.5 

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is not indicated for use as a booster dose following a 3-dose primary series of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) . Children who have received a 3-dose primary series of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) should receive a fourth dose of IPV at 4 to 6 years of age and a fourth dose of DTaP vaccine at 15 to 18 months of age. Because the pertussis antigen components of INFANRIX are the same as those components in PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) , these children should receive INFANRIX as their fourth and fifth dose of DTaP. However, data are insufficient to evaluate the safety of INFANRIX following 3 doses of PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) .

Concomitant Vaccine Administration

In clinical trials, PEDIARIX was routinely administered, at separate sites, concomitantly with Hib conjugate vaccine (see CLINICAL PHARMACOLOGY). Data are also available from 2 clinical studies in which PEDIARIX was administered concomitantly, at separate sites, with Hib and 7-valent pneumococcal conjugate vaccines (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS). 

When concomitant administration of other vaccines is required, they should be given with separate syringes and at different injection sites.

HOW SUPPLIED

PEDIARIX (diphtheria, tetanus toxoids and acellular pertussis adsorbed, hepatitis b and inactivated poliovirus vaccine) is supplied as a turbid white suspension in single-dose (0.5 mL) vials and disposable prefilled TIP-LOK® syringes. 

Single-Dose Vials and Prefilled Syringes (Preservative Free Formulation)

NDC 58160-811-11 Package of 10 Single-Dose Vials
NDC 58160-811-46 Package of 5 Single-Dose Prefilled Disposable TIP-LOK Syringes (packaged without needles)

Storage           

Store refrigerated between 2 and 8C (36 and 46F). Improper storage may result in the formation of a gel-like substance (see DOSAGE AND ADMINISTRATION). Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date shown on the label.

REFERENCES

5. Centers for Disease Control and Prevention. General recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

18. Centers for Disease Control and Prevention. Recommended childhood and adolescent immunization schedule — United States, 2006. MMWR 2005;54(51,52):Q1-Q4.

Manufactured by GlaxoSmithKline Biologicals Rixensart, Belgium. Distributed by GlaxoSmithKline Research Triangle Park, NC 27709. July 2009.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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