What is Fendrix?
Fendrix is a vaccine in the form of a suspension for injection. Contains parts of the hepatitis B virus as the active ingredient.
What is Fendrix used for?
Fendrix is used to protect patients with kidney problems against hepatitis B. It can be used in patients aged 15 and up including those requiring hemodialysis (a blood clearance technique).
The medicine can only be obtained with a prescription.
How is Fendrix used?
The recommended vaccination schedule for Fendrix is four doses. An interval of one month must be observed between the first and second injection and between the second and third injection. The fourth injection is given four months after the third. It is recommended that people who receive the first dose should complete the cycle with Fendrix. The vaccine is injected into the upper arm muscle.
A booster dose of Fendrix can be given according to official recommendations.
How does Fendrix work?
Fendrix is a vaccine. Vaccines act by 'teaching' the immune system (the body's natural defenses) to defend itself against a disease. Fendrix contains small amounts of the surface antigen (surface proteins) of the hepatitis B virus. When a patient receives the vaccine, the immune system recognizes the surface antigens as 'foreign' and produces antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to the hepatitis B virus. Antibodies help protect the patient from the disease caused by the virus.
Surface antigens are produced by a method called "recombinant DNA technology": they are produced by a yeast that has received a gene (DNA) that makes it capable of producing proteins.
The active substance in Fendrix has been available in other vaccines authorized in the European Union (EU) for several years, including Engerix-B, Ambirix, Twinrix, Tritanrix-HepB and Infanrix-HepB. In Fendrix, it is used with an "adjuvant system" that contains 'MPL', a purified fat from bacteria and an aluminum compound. This system enhances the response of the immune system which can be useful when vaccines are used in patients who may have a reduced response, such as those with kidney problems.
What studies have been carried out on Fendrix?
Since the active substance in Fendrix was already present in the EU in other vaccines, some of the data used in favor of the use of other vaccines were used to justify the use of Fendrix.
Fendrix has been studied in only one main study involving 165 patients aged 15 and over with kidney disease and the need for hemodialysis. Fendrix was compared with Engerix-B (another hepatitis B vaccine) used in a double dose. The main measure of effectiveness was the percentage of patients who developed protective levels of antibodies against the hepatitis B virus.
The company also presented data on the use of Fendrix in liver transplant patients but withdrew the application for Fendrix use in these patients during the evaluation.
What benefit has Fendrix shown during the studies?
Fendrix has shown the same efficacy as a double dose of the comparator vaccine. One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against hepatitis B, compared to 84% of those receiving the comparator vaccine.
The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of patients receiving Fendrix maintained protective levels of antibodies for up to three years, compared to 51% of those receiving the drug of comparison.
What is the risk associated with Fendrix?
The most common side effects of Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling of the injection site and fatigue (tiredness). For the full list of all side effects reported with Fendrix, see the Package Leaflet.
Fendrix should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other components. It must also not be used in people who have had an allergic reaction after receiving a hepatitis B vaccine. Fendrix should not be given to patients with a sudden high fever.
Why has Fendrix been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Fendrix outweigh its risks for active immunization against hepatitis B virus infection caused by all known subtypes in patients, from age 15 up, suffering from renal failure (including patients on pre-hemodialysis and hemodialysis). The committee recommended the granting of the marketing authorization for Fendrix.
More information on Fendrix:
On 2 February 2005, the European Commission issued a marketing authorization for Fendrix, valid throughout the European Union, to GlaxoSmithKline Biologicals sa.
The full EPAR for Fendrix can be found here.
Last update of this summary: 02-2008.
