Fendrix

How does it work?

Fendrix is a hepatitis B vaccine that contains an inactivated extract of the hepatitis B virus. The vaccine works by provoking the body's immune response, without causing the disease.

When the body is exposed to foreign organisms, such as bacteria and viruses, the immune system produces antibodies against them. Antibodies help the body recognise and kill the foreign organisms. They then remain in the body to help protect the body against future infections with the same organism. This is known as active immunity.

The immune system produces different antibodies for each foreign organism it encounters. This establishes a pool of antibodies that helps protect the body from various different diseases.

Vaccines contain extracts or inactivated forms of bacteria or viruses that cause disease. These altered forms of the organisms stimulate the immune system to produce antibodies against them, but don't actually cause disease themselves. The antibodies produced remain in the body so that if the organism is encountered naturally, the immune system can recognise it and attack it, thus preventing it from causing disease.

Each bacteria or virus stimulates the immune system to produce a specific type of antibody. This means that different vaccines are needed to prevent different diseases.

Fendrix contains an inactivated extract of the virus that causes hepatitis B. It stimulates the immune system to produce antibodies against the hepatitis B virus and thus is given to prevent hepatitis B.

Fendrix is not given as a routine vaccine. It is only given to adults with chronic kidney failure, who are at high risk of contracting hepatitis B.

The vaccine is usually given by injection into the muscle of the upper arm. People who are at risk of bleeding following an intramuscular injection, for example people with haemophilia or low numbers of platelets in their blood (thrombocytopenia), may be adminstered the vaccine under the skin. At least four doses are needed and it can take up to six months for the body to form adequate numbers of antibodies to provide immunity against the disease.

The first three doses are given a month apart, followed by a fourth dose six months after the first dose. Further booster doses may then be recommended in some vaccination schedules.

What is it used for?

Prevention of hepatitis B in people from the age of 15 years onwards with kidney failure, who are having haemodialysis, or who will need haemodialysis in the future.

Warning!

People who have an underactive immune system, for example due to disease such as HIV infection, or treatment with immunosuppressant medicines such as chemotherapy, high-dose corticosteroids, or immunosuppressants used following an organ transplant, may not produce an adequate numbers of antibodies in response to this vaccine. These people may need additional doses of the vaccine if blood tests show their antibody levels are too low.

This vaccine will not prevent infection by other hepatitis viruses, eg hepatitis A or C.

Not to be used in

Sudden feverish illness

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

The safety of this vaccine when given during pregnancy has not been studied. However, as it contains inactivated virus it is not expected to cause any harm to the developing baby. The vaccine should be given with caution during pregnancy, and only if the potential benefits outweigh any risks to the foetus. Seek medical advice from your doctor.

The effect of this vaccine on a breastfeeding child after the mother is given the vaccine have not been studied. It should be given with caution to breastfeeding mothers, and only if the potential benefits outweigh any risks to the nursing infant. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Headache

Fatigue

Temporary soreness, redness or hardening of the skin around the injection site

Disturbances of the gut such as diarrhoea, nausea, vomiting or abdominal pain

Fever

Rash or itching

Pins and needles sensations (paraesthesia)

Pain in the muscles or joints

Allergic reactions such as skin rash, swelling of the lips, tongue and throat (angioedema) or narrowing of the airways (bronchospasm)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

This vaccine is not known to affect other medicines.

This effect of giving this particular hepatitis B vaccine at the same time as other vaccines has not been studied. The manufacturer recommends that if other vaccines are needed, they should be given at an interval of two to three weeks from Fendrix.

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