What is Fendrix?
Fendrix is a vaccine that comes as 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 over including those who need 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 should 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 receiving the first dose should complete their course with Fendrix. The vaccine is injected into the muscle of the upper arm.
A booster dose of Fendrix may be given according to official recommendations.
How does Fendrix work?
Fendrix is a vaccine. Vaccines work 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. vaccine, the immune system recognizes surface antigens as 'foreign' and makes antibodies against them. In the future, the immune system will be able to produce antibodies faster when exposed to the hepatitis B virus. The antibodies help protect the patient from disease caused by the virus.
Surface antigens are produced by a method called 'recombinant DNA technology': they are made by a yeast that has received a gene (DNA) which 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. "which contains" MPL, "a purified fat from bacteria and an aluminum compound. This system enhances the immune system response which can be useful when vaccines are used in patients who may have a reduced response, such as those with kidney problems.
How has Fendrix been studied?
As the active substance of Fendrix was already found 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 one main study involving 165 patients aged 15 years and over with kidney disease and a need for hemodialysis. Fendrix was compared with Engerix-B (another hepatitis B vaccine) used in double doses. The main measure of effectiveness was the proportion 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 the use of Fendrix in these patients during the evaluation.
What benefit has Fendrix shown during the studies?
Fendrix demonstrated the same efficacy as a double dose of the comparator vaccine. One month after the last dose, 91% of patients receiving Fendrix had protective levels of antibodies against hepatitis B, compared with 84% of those receiving the comparator vaccine.
The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective antibody levels for up to three years, compared with 51% of those receiving the Fendrix drug. comparison.
What is the risk associated with Fendrix?
The most common side effects with Fendrix (seen in more than 1 in 10 patients) are headache, pain, redness, injection site swelling and fatigue (tiredness). For the complete list of side effects reported with Fendrix, see the package leaflet.
Fendrix must not be used in people who may be hypersensitive (allergic) to the active substance or to any of the other ingredients. It should 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 Fendrix's benefits are greater than its risks for active immunization against hepatitis B virus infection caused by all known subtypes in patients from 15 years of age. and above, with renal insufficiency (including patients on pre-hemodialysis and hemodialysis). The Committee recommended the granting of a marketing authorization for Fendrix.
Other information about Fendrix:
On February 2, 2005, the European Commission released GlaxoSmithKline Biologicals s.a. a "Marketing Authorization" for Fendrix, valid throughout the European Union.
For the full version of the Fendrix EPAR click here.
Last update of this summary: 02-2008.
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