ENGERIX-B SUSPENSION FOR INJECTION IN PREFILLED SYRINGE 10mcg/0.5ml

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

INJECTION, SUSPENSION

**Dosage and Administration** - **Dosage** **20 mcg dose vaccine.** The 20 mcg dose (in 1 ml suspension) is intended for use in subjects 20 years of age and older. **10 mcg dose vaccine.** The 10 mcg dose (in 0.5 ml suspension) is intended for use in neonates, infants and children up to and including the age of 19 years. However, the 20 mcg vaccine can also be used in subjects from 11 years up to and including 15 years of age as a 2-dose schedule in situations when there is a low risk of hepatitis B infection during the vaccination course and when compliance with the complete vaccination course can be assured (see “Pharmacodynamics” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Primary immunisation schedules** - All subjects: A 0, 1 and 6 months schedule gives optimal protection at month 7 and produces high antibody titres. An accelerated schedule, with immunisation at 0, 1 and 2 months, will confer protection more quickly and is expected to provide better patient compliance. With this schedule, a fourth dose should be administered at 12 months to assure long-term protection as titres after the third dose are lower than those obtained after the 0, 1, 6 months schedule. In infants, this schedule will allow for simultaneous administration of hepatitis B with other childhood vaccines. - Subjects 20 years of age and above: In exceptional circumstances in adults, where an even more rapid induction of protection is required, e.g. persons travelling to areas of high endemicity and who commence a course of vaccination against hepatitis B within one month prior to departure, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose (see section “Pharmacodynamics” for seroconversion rates – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Subjects from 11 years up to and including 15 years of age: The 20 mcg vaccine may be administered in subjects from 11 years up to and including 15 years of age according to a 0, 6 months schedule. However, in this case, protection against hepatitis B infections may not be obtained until after the second dose (see section “Pharmacodynamics” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Therefore, this schedule should be used only when there is a low risk of hepatitis B infection during the vaccination course and when completion of the two-dose vaccination course can be assured. If both conditions cannot be assured (for instance patients undergoing haemodialysis, travellers to endemic regions and close contacts of infected subjects), the three-dose or the accelerated schedule of the 10 mcg vaccine should be used. - Patients with renal insufficiency including patients undergoing haemodialysis 16 years of age and above: The primary immunisation schedule for patients with renal insufficiency including patients undergoing haemodialysis is four double doses (2 x 20 mcg) at elected date, 1 month, 2 months and 6 months from the date of the first dose. The immunisation schedule should be adapted in order to ensure that the anti-HBs antibody titre remains equal to or higher than the accepted protective level of 10 milli-international units/ml. - Patients with renal insufficiency including patients undergoing haemodialysis up to and including 15 years of age, including neonates: Patients with renal insufficiency, including patients undergoing haemodialysis, have a reduced immune response to hepatitis B vaccines. Either the 0, 1, 2 and 12 months or the 0, 1, 6 months schedule of Engerix-B 10 mcg can be used. Based on adult experience, vaccination with a higher dosage of antigen may improve the immune response. Consideration should be given to serological testing following vaccination. Additional doses of vaccine may be needed to ensure a protective anti-HBs level ≥ 10 milli-international units/ml. - Known or presumed exposure to HBV: In circumstances where exposure to HBV has recently occurred (e.g. needlestick with contaminated needle) the first dose of Engerix-B can be administered simultaneously with hepatitis B immune globulins (HBIg) which however must be given at a separate injection site (see section “Interactions” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The 0, 1, 2–12 months immunisation schedule should be advised. - Neonates born of mothers who are HBV carriers: The immunisation with Engerix-B (10 mcg) of these neonates should start at birth, and one of the two immunisation schedules have to be followed. Either the 0, 1, 2 and 12 months or the 0, 1 and 6 months schedule can be used; however, the former schedule provides a more rapid immune response. When available, HBIg should be given simultaneously with Engerix-B at a separate injection site as this may increase the protective efficacy. These immunisation schedules may be adjusted to accommodate local immunisation practices with regard to the recommended age of administration of other childhood vaccines. **Booster dose** The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established; however, some official vaccination programmes currently include a recommendation for a booster and these should be respected. For haemodialysis and other immunocompromised patients, booster doses are recommended in order to ensure an antibody level of ≥ 10 milli-international units/ml. Booster data are available. The booster dose is as well tolerated as the primary vaccination course. **Method of Administration** Engerix-B should be injected intramuscularly in the deltoid region in adults and children or in the anterolateral thigh in neonates, infants and young children. Exceptionally the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. Engerix-B should not be administered in the buttock or intradermally since this may result in a lower immune response.