ENGERIX-B SUSPENSION FOR INJECTION IN PREFILLED SYRINGE 10MCG/0.5ML [SIN15807P]

Product Info

ENGERIX-B SUSPENSION FOR INJECTION IN PREFILLED SYRINGE 10MCG/0.5ML

[SIN15807P]

Indications
Engerix-B is indicated for active immunisation against hepatitis B virus (HBV) infection caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV. It can be expected that hepatitis D will also be prevented by immunisation with Engerix-B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Immunisation against hepatitis B is expected in the long-term to reduce not only the incidence of this disease, but also its chronic complications such as chronic active hepatitis B and hepatitis B associated cirrhosis.
In areas of low prevalence of hepatitis B, immunisation is particularly recommended for those belonging to groups identified at increased risk of infection (see below), however, universal immunisation of all infants and adolescents will contribute to the control of hepatitis B on a population basis.
In areas of intermediate and high prevalence of hepatitis B, with most of the population at risk of acquiring the HBV, the best strategy is to provide universal immunisation of neonates, infants, children and adolescents, as well as adults belonging to groups at increased risk of infection.
The WHO, the US Immunisation Practices Advisory Committee (ACIP) and the American Academy of Paediatrics advocate that the vaccination of new-borns and/or the vaccination of adolescents is the optimal strategy for the control of hepatitis B in all countries.
Groups identified at increased risk of infection: health care personnel, patients frequently receiving blood products, personnel and residents of institutions, persons at increased risk due to their sexual behaviour, illicit users of addictive injectable drugs, travellers to areas with a high endemicity of HBV, infants born of mothers who are HBV carriers, persons originating from areas with a high endemicity of HBV, patients with sickle-cell anaemia, patients who are candidates for organ transplantation, household contacts of any of the above groups and of patients with acute or chronic HBV infection, subjects with chronic liver disease (CLD) or at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol), others: police personnel, fire brigade personnel, armed forces personnel and anybody who through their work or personal lifestyle may be exposed to HBV.

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.

Contraindications
Engerix-B should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous Engerix-B administration.
HIV infection is not considered as a contraindication for hepatitis B vaccination.