Prospect: information for the user

Fendrix injectable suspension

Anti-hepatitis B vaccine (ADNr) (adjuvanted, adsorbed)

Read this prospect carefully before receiving this vaccine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This vaccine has been prescribed only for you, and you must not give it to other people.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Fendrix is a vaccine that prevents hepatitis B.

It is used in patients with kidney problems:

• patients undergoing hemodialysis, in which a dialysis machine removes waste products from the blood
• patients who are going to be undergoing hemodialysis in the future.

Fendrix is for adults and young people from 15 years old.

What is hepatitis B

hepatitis B is caused by a virus that makes the liver swell.

• It may not be noticeable until a period of 6 weeks to 6 months has passed after infection.
• The main signs of the disease include mild flu-like symptoms, such as headache or fever, extreme fatigue, dark urine, pale stools, or yellow eyes or skin (jaundice). These or other signs may mean that the person needs hospital treatment. Most people recover completely from the disease.
• Some people with hepatitis B do not appear to be ill or do not feel ill (do not have any symptoms of the disease).
• The virus is found in bodily fluids such as vaginal fluid, blood, semen, or saliva (sputum).

Carriers of hepatitis B

• The hepatitis B virus remains in the body of some people for their entire life.
• This means that they can infect others and are known as carriers of the virus.
• It is likely that carriers of the virus will develop serious liver problems, such as cirrhosis or liver cancer.

How Fendrix works

• Fendrix helps your body develop its own protection against the virus (antibodies). These antibodies are what will protect you from the disease.
• Fendrix contains two substances called MPL (a non-toxic, purified bacterial derivative) and aluminum phosphate. Both allow the vaccine to work faster, better, and for a longer time.
• Like all vaccines, a Fendrix vaccination cycle may not protect all vaccinated people completely.
• Fendrix may not protect you from the disease if you have already been infected with the hepatitis B virus.
• Fendrix can only protect you from infection with the hepatitis B virus. It cannot protect you from other infections that may affect the liver, even if these infections have similar symptoms to those caused by the hepatitis B virus.

Do not administer Fendrix

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6). Signs of an allergic reaction may include: skin rash with itching, difficulty breathing, and swelling of the face or tongue
• if you have ever had an allergic reaction to any hepatitis B vaccine
• if you have a severe infection with fever. The vaccine can be administered once you have recovered. A minor infection, such as a cold, should not be a problem for vaccination, but inform your doctor first.

Do not administer Fendrix if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before receiving Fendrix.

Warnings and precautions

Consult your doctor or pharmacist before Fendrix is administered:

• if you have known allergies
• if you have had any health problems after receiving a vaccine previously.

Before or after any injection, dizziness may occur (especially in adolescents), so inform your doctor or nurse if you have fainted on previous occasions after receiving an injection.

If any of the above situations apply to you (or you are unsure), consult your doctor or pharmacist before receiving Fendrix.

Other medications and Fendrix

Inform your doctor if you are using, have used recently, or may have to use any other medication or if you have received any other vaccine recently.

• You should have a gap of at least 2 to 3 weeks between the administration of Fendrix and any other vaccine.
• Fendrix may need to be administered at the same time as an injection of hepatitis B immunoglobulins. Your doctor will ensure that the vaccines are administered in different parts of the body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before this vaccine is administered.

Driving and operating machinery

You may feel tired or have a headache after receiving Fendrix. If this occurs, exercise special care while driving or operating tools or machinery.

Fendrix contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

How the vaccine is administered

Your doctor or nurse will inject Fendrix into a muscle, usually in the upper part of your arm.

How much is administered

• You will receive a series of four injections.
• You will be given the injections over a period of 6 months:

• First injection:on the date agreed with your doctor.
• Second injection:1 month after the first injection
• Third injection:2 months after the first injection.
• Fourth injection:6 months after the first injection.

• Your doctor or nurse will tell you when to return for the next injections.
• Once you have received the first injection of Fendrix, you must also receive the next injections of Fendrix (not another type of hepatitis B vaccine).

Your doctor will tell you if you need any additional or booster injections in the future. Fendrix can also be used as a booster dose after a vaccination cycle with a different type of hepatitis B vaccine.

If you miss a dose

• If you miss an injection, consult your doctor and schedule another appointment.
• Make sure you complete the full cycle of four injections. Otherwise, you may not be fully protected against the disease.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The following side effects may occur with this vaccine. Their frequency is determined using the following definition:

Very common(these may occur with more than 1 in 10 doses of the vaccine): headache, feeling of fatigue, pain or discomfort at the injection site.

Common(these may occur up to 1 in 10 doses of the vaccine): redness or swelling at the injection site, fever, digestive and stomach problems.

Uncommon(these may occur up to 1 in 100 doses of the vaccine): chills, skin rash with redness, other reactions at the injection site.

Rare(these may occur up to 1 in 1,000 doses of the vaccine): allergic reactions, hot flashes, feeling of dizziness, feeling of thirst, feeling of nervousness, viral infection, back pain, tendon inflammation.

In addition, the following side effects have been reported with other hepatitis B vaccines:

Very rare(these may occur up to 1 in 10,000 doses of the vaccine): seizures, fainting, eye nerve problems (optic neuritis), multiple sclerosis, loss of sensation or problems moving some parts of the body, severe headache with neck stiffness, numbness or weakness of arms and legs (neuropathy), nerve inflammation (neuritis), progressive weakness and paralysis of limbs often progressing to the chest and face (Guillain-Barré syndrome), brain swelling or infection (encephalitis, encephalopathy).

Allergic reactions, including anaphylactoid reactions, may also occur very rarely (up to 1 in 10,000 doses of the vaccine). They may be local or widespread skin rashes with itching or blisters, facial and eye swelling, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. Seek immediate medical attention in any case.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use,https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this vaccine out of sight and reach of children.

• Do not use this vaccine after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

• Store in a refrigerator (between 2 °C and 8 °C).
• Store in the original packaging to protect it from light.
• Do not freeze. Freezing destroys the vaccine.

• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Fendrix

• The active principle in 1 dose (0.5 ml) of Fendrix is:

Surface antigen of the Hepatitis B virus1, 2, 320 micrograms

1adjuvanted by AS04C containing:

3-O-desacyl-4’- monophosphoryl lipid A (MPL)250 micrograms

2adsorbed on aluminium phosphate (0.5 milligrams of Al3+in total)

3produced by recombinant DNA technology in yeast cells (Saccharomyces cerevisiae)

• The other components of Fendrix are: sodium chloride, water for injection.

Appearance of the product and contents of the pack

Fendrix is a white and milky suspension.

Fendrix is available in pre-filled syringe of 1 dose with or without separate needles, pack sizes of 1 and 10.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:04/2023

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

During the storage of the vaccine, a fine white deposit and a transparent supernatant may be observed.

Before administration, the vaccine must be shaken well to obtain a white slightly opaque suspension.

The vaccine must be visually examined before and after resuspension to observe any foreign particles and/or changes in physical appearance. The vaccine should not be used if any change in the appearance of the vaccine has occurred.

The disposal of unused medicinal product and of all materials that have been in contact with it will be carried out in accordance with local regulations.

Fendrix should not be administered to subjects with hypersensitivity to the active principle or to any of the excipients.

Fendrix should not be administered to subjects with hypersensitivity after previous administration of other hepatitis B vaccines.

Fendrix should not be administered to subjects with severe acute febrile illnesses. The presence of a minor infection, such as a cold, is not a contraindication to vaccination.

Fendrix should be administered by intramuscular injection in the deltoid region.

Administration by intramuscular injection in the gluteal muscle should be avoided as it may lead to a suboptimal immune response to the vaccine.

Under no circumstances should Fendrix be administered by intradermal or intravenous route.

Due to the fact that patients on haemodialysis and pre-haemodialysis are particularly exposed to HBV and have a higher risk of being chronically infected, a preventive attitude should be taken, i.e. a booster dose should be administered to ensure a protective level of antibodies according to local recommendations and guidelines.

At all times, appropriate medical treatment should be available in case of anaphylactic reaction following vaccination.

Instructions for the pre-filled syringe

Disposal of waste

The disposal of unused medicinal product and of all materials that have been in contact with it will be carried out in accordance with local regulations.