DOSAGE AND ADMINISTRATION
Preparation for Administration: PEDIARIX contains an adjuvant; therefore shake vigorously to obtain a homogeneous, turbid, white suspension. DO NOT USE IF RESUSPENSION DOES NOT OCCUR WITH VIGOROUS SHAKING. Inspect visually for particulate matter or discoloration prior to administration. After removal of the dose, any vaccine remaining in the vial should be discarded.
PEDIARIX should be administered by intramuscular injection. The preferred sites are the anterolateral aspects of the thigh or the deltoid muscle of the upper arm. 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. Before injection, the skin at the injection site should be cleaned and prepared with a suitable germicide. After insertion of the needle, aspirate to ensure that the needle has not entered a blood vessel.
Do not administer this product subcutaneously or intravenously. Recommended Schedule: The primary immunization series for PEDIARIX 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.
PEDIARIX 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.36(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.36(See manufacturer's prescribing information for Hepatitis B Vaccine [Recombinant]).
The administration of PEDIARIX 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 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. However, the safety and efficacy of PEDIARIX in such infants have not been studied. Children Previously Vaccinated With One or More Doses of INFANRIX: PEDIARIX 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. However, the safety and efficacy of PEDIARIX in such infants have not been evaluated. Children Previously Vaccinated With One or More Doses of IPV: PEDIARIX 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. 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 be given for all 3 doses because data are limited regarding the safety and efficacy of using acellular pertussis vaccines from different manufacturers for successive doses of the pertussis vaccination series. PEDIARIX 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 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. 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. 10
Preterm infants should be vaccinated according to their chronological age from birth.10
PEDIARIX is not indicated for use as a booster dose following a 3-dose primary series of PEDIARIX. Children who have received a 3-dose primary series of PEDIARIX 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, these children should receive INFANRIX as their fourth dose of DTaP. However, data are insufficient to evaluate the safety of INFANRIX following 3 doses of PEDIARIX. Concomitant Vaccine Administration: In clinical trials, PEDIARIX was routinely administered, at separate sites, concomitantly with Hib vaccine (see CLINICAL PHARMACOLOGY). Safety data are available following the first dose of PEDIARIX administered concomitantly, at separate sites, with Hib and pneumococcal conjugate vaccines (see ADVERSE REACTIONS).
When concomitant administration of other vaccines is required, they should be given with separate syringes and at different injection sites.
STORAGE
Store PEDIARIX refrigerated between 2° and 8° C (36° and 46° F). Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date shown on the label.
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