Pediarix (data from Glaxo-Smithkline official website)

• DTaP, HepB, IPV
• @ 2,4,6 mos of age, if mom is HBsAg-negative
• contraindicated in infants with known hypersensitivity to any component of the vaccine including yeast, neomycin, and polymyxin B.
• In clinical studies, adverse events in infants receiving PEDIARIX included injection-site reactions (pain, redness, or swelling), fever and fussiness. Administration of PEDIARIX was associated with higher rates of fever relative to separately administered vaccines (see Adverse Reactions section of the package insert). PEDIARIX
• Infants born of HBsAg-negative mothers and who have 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 and immunogenicity of PEDIARIX in such infants.The ACIP, AAP, and AAFP recommendations state that four doses of hepatitis B vaccine, including the birth dose, may be administered if a combination vaccine is used to complete the series.

How do I complete the primary series with PEDIARIX following DTaP from another manufacturer?

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 3-dose infant DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer because no data are available regarding the efficacy of using such a regimen.  The ACIP/AAP/AAFP recommend that immunization providers who cannot determine which DTaP vaccine was previously administered, or who do not have the same vaccine, should use any of the licensed acellular pertussis products to continue the immunization series.

Can I use PEDIARIX for a child who is partially immunized with another IPV vaccine? If I start the polio series with PEDIARIX, can I use a different IPV brand for the 4th dose?

Yes, in both instances. PEDIARIX may be used to complete a 3-dose IPV vaccination series initiated with IPV from a different manufacturer. PEDIARIX is not indicated for use as a booster dose; therefore, IPOL^® (Poliovirus Vaccine Inactivated) should be used for the fourth IPV dose. PEDIARIX contains the same viral types, strains, and antigen contents as IPOL

Can I use PEDIARIX in a child partially immunized with another hepatitis B vaccine?

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

Can PEDIARIX be given concomitantly with Hib vaccine?

When concomitant administration of Hib vaccine is required, it should be given with a separate syringe and at a different injection site

Can PEDIARIX be given concomitantly with pneumococcal conjugate vaccine?

Yes. Safety data are available following the first dose of PEDIARIX administered concomitantly, at separate sites, with Hib and pneumococcal conjugate vaccines (see safety profile).

How can I integrate PEDIARIX into the immunization schedule of patients who have been partially immunized with other vaccines?

At any point in time infants will be at various stages of immunization depending on their age and immunization history. When deciding to complete a vaccination series with PEDIARIX the ACIP states that "vaccines from different manufacturers that protect against the same disease may be administered interchangeably in sequential doses in the immunization series for an individual patient (e.g., hepatitis A [HepA], HepB, and Hib). " PEDIARIX may be used to complete the primary series in infants who have received one or two doses of Infanrix^® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). PEDIARIX is not indicated for completion of the primary series in infants who have received doses of DTaP from other manufacturers because no data are available. In addition, PEDIARIX may be used to complete a vaccination series initiated with IPV and/or a hepatitis B-containing vaccine from a different manufacturer. (note: per dr eyal ben-isaac, pediarix may be used interchangeably with dtap from other manufacturers).

Will PEDIARIX be reimbursed by third-party payors?

Yes, it is expected that PEDIARIX will be reimbursed in the same manner as other routine childhood vaccines.

The ACIP, AAP, and AAFP suggest that administering extra antigens contained in a combination vaccine is accepted practice and should be reimbursed on the patient’s behalf by indemnity health insurance and managed care systems. Consult with individual payors for confirmation of reimbursement