Vaccination Schedule
VAXELIS is to be administered as a 3-dose series at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Three doses of VAXELIS constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis.
VAXELIS may be used to complete the hepatitis B immunization series.
A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series. [See Pertussis Vaccination Following VAXELIS.]
Pertussis Vaccination following VAXELIS
VAXELIS, Pentacel® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine): DTaP-IPV/Hib], Quadracel® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine): DTaP-IPV] and DAPTACEL® [(Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed): DTaP] contain the same pertussis antigens manufactured by the same process. Children who have received a 3-dose series of VAXELIS should complete the primary and pertussis vaccination series with Pentacel, Quadracel or DAPTACEL according to the respective prescribing information in the approved package inserts. [See ADVERSE REACTIONS (6.1) AND CLINICAL STUDIES (14).]
Administration of VAXELIS following previous doses of other DTaP-containing Vaccines
VAXELIS may be used to complete the first 3 doses of the 5-dose DTaP series in infants and children who have received 1 or 2 doses of Pentacel or DAPTACEL and are also scheduled to receive the other antigens in VAXELIS. Data are not available on the safety and immunogenicity of such mixed sequences.
Data are not available on the safety and effectiveness of using VAXELIS following 1 or 2 doses of a DTaP vaccine from a different manufacturer.
Administration of VAXELIS following previous doses of any Hepatitis B Vaccine
A 3-dose series of VAXELIS may be administered to infants born to HBsAg-negative mothers, and who have received a dose of any hepatitis B vaccine, prior to or at 1 month of age. [See ADVERSE REACTIONS (6.1) AND CLINICAL STUDIES (14).]
VAXELIS may be used to complete the hepatitis B vaccination series following 1 or 2 doses of other hepatitis B vaccines, in infants and children born of HBsAg-negative mothers and who are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
Administration of VAXELIS following previous doses of Inactivated Polio Vaccine (IPV)
VAXELIS may be administered to infants and children who have received 1 or 2 doses of IPV and are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
Administration of VAXELIS following previous doses of Haemophilus b Conjugate Vaccines
VAXELIS may be administered to infants and children who have received 1 or 2 doses of H. influenzae type b Conjugate Vaccine and are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
Administration
Just before use, shake the vial until a uniform, white, cloudy suspension results.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exist, the product should not be administered.
Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of VAXELIS intramuscularly.
In infants younger than 1 year, the anterolateral aspect of the thigh is the preferred site of injection. The vaccine should not be injected into the gluteal area.
VAXELIS should not be combined through reconstitution or mixed with any other vaccine. Discard unused portion.
