The updated Infanrix insert is available at www.fda.gov/cber/label/infanrixLB.pdf
More safety information has been added to the package insert for Infanrix, the Food and Drug Administration said.
The insert now includes the statement that Infanrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) “may be used to complete a DTaP vaccination series initiated” with Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B [Recombinant] and Inactivated Poliovirus Vaccine Combined), because both vaccines use the same pertussis antigen components, according to a statement issued by the FDA.
Infanrix is administered as a five-dose series at 2, 4, and 6 months, with booster doses at 15-20 months and at 4-6 years. Both vaccines are marketed by GlaxoSmithKline Biologicals. Pediarix is recommended as a three-dose primary series, starting as early as 6 weeks of age.
Also added were data on safety and immune responses on the concomitant administration of Infanrix with other vaccines.
The information was added when the insert was revised to conform with guidelines outlined in the FDA's Physician Labeling Rule, according to a GSK spokesperson. The rule requires that the package inserts of approved products be reordered and reorganized into a more user-friendly format.