Engerix-B 20 Adult Dose Suspension for Injection

Manufacturer
GLAXOSMITHKLINE BIOLOGICALS S.A
 
Contents
HBsAg, recombinant DNA produced in yeast cells
 
Indication
Active immunisation against HBV infection caused by all known subtypes in subjects considered at risk of exposure to HBV.
 
Instruction
IM Adult ≥20 yr 20 mcg dose. Childn 11-15 yr 20 mcg at 0, 6 mth or 3-dose accelerated schedule of 10 mcg. Renal insufficiency/undergoing hemodialysis ≥16 yr 4 double dose at elected date 1, 2 & 6 mth from date of 1st dose, ≤15 yr, including neonate 10 mcg at 0, 1, 2 & 12 mth or 0, 1, 6 mth. Known or presumed HBV exposure 1st dose at 0, 1, 2-12 mth.
 
Drug interaction
The simultaneous administration of Engerix-B and a standard dose of HBIg does not result in lower anti-HBs antibody titres provided that they are administered at separate injection sites.
Engerix-B can be given concomitantly with DTP, DT and/or polio vaccines, if this fits conveniently in an immunisation scheme recommended by the country Health Authority.
Engerix-B can also be administered together with measles-mumps-rubella vaccines, Haemophilus influenzae b vaccine, hepatitis A vaccine and BCG.
Engerix-B can be given concomitantly with Human Papillomavirus (HPV) vaccine (Cervarix).
Administration of Engerix-B at the same time as Cervarix has shown no clinically relevant interference in the antibody response to the HPV antigens. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 97.9% for concomitant vaccination and 100% for Engerix-B alone.
Different injectable vaccines should always be administered at different injection sites.
Interchangeability of hepatitis B vaccines: Engerix-B may be used to complete a primary immunisation course started either with plasma-derived or with other genetically-engineered hepatitis B vaccines, or as a booster dose in subjects who have previously received a primary immunisation course with plasma-derived or with other genetically-engineered hepatitis B vaccines.