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Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

Product Overview

What is Fendrix:

  • Fendrix is an adjuvanted, adsorbed Hepatitis B recombinant DNA vaccine.
  • One dose (0.5 ml) of Fendrix contains 20 μg of Hepatitis B surface antigen (HBsAg), adsorbed on aluminium phosphate (0.5 mg of Al3+in total) and adjuvanted by AS04C containing: -3-0-desacyl-4'-monophosphoryl lipid A (MPL).
  • Fendrix is produced in Saccharomyces cerevisiae yeast cells by recombinant DNA technology.

Who should be given Fendrix?:

  • Fendrix is indicated in adults and adolescents with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from age 15 onwards, for active immunisation against Hepatitis B virus (HBV) infection.
  • How effective is Fendrix?:

    Fendrix confers immunity against HBV infection by inducing specific anti-HBs antibodies.

    An anti-HBs antibody titre ≥10 mIU/ml correlates with protection to HBV infection.

    It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

    In clinical studies evaluating Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed) in pre-haemodialysis and haemodialysis patients aged ≥15 years:

    • Following immunisation at 0, 1, 2 and 6 months in a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and above), a protective efficacy (anti-HBs ≥ a prote)was observed in 74% of Fendrix recipients (n=82) at three months compared to 52% of patients in a controlled group (n=83) receiving a double dose of a commercially available hepatitis B vaccine.
    • Protective efficacy increased to 91% of Fendrix recipients at 7 months versus 84% for the comparator hepatitis B vaccine.
    • After 36 months, 80% of Fendrix recipients retained protective anti-HBs antibody levels, compared with 51% of patients receiving the comparator hepatitis B vaccine.

    Presentation of Fendrix:

    • Fendrix is available as a suspension for intramuscular injection, supplied in a pre-filled syringe

    Contraindication of Fendrix:

    • Fendrix is contraindicated in individuals with documented hypersensitivity to the vaccine or any of its components, or to any other Hepatitis B vaccines.
    • Fendrix administration should not be performed in individuals with acute severe febrile illness.

    For further information on Fendrix for immunisation against HBV infection please see the Fendrix  Summary of Product Characteristics (SPC ). [1 ]

    Fendrix is a trade mark of the GlaxoSmithKline group of companies

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    P.W-S: Last updated 09 May 2012: UK/FEN/0002/12

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    Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)

    *Important Notice: This site is intended for UK Healthcare Professionals. By entering this site you are confirming that you are a Healthcare Professional. M.C: Last updated xx July 2013 : UK/COM/0131/12)3

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