Fendrix, injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fendrix injectable suspension

Hepatitis B vaccine (rDNA) (adjuvanted, adsorbed)

Read the entire leaflet carefully before receiving this vaccine, because it contains important information for you.

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

Contents of the leaflet

1. What Fendrix is and what it is used for
2. What you need to know before receiving Fendrix
3. How Fendrix is administered
4. Possible adverse effects
5. How to store Fendrix
6. Contents of the pack and other information

1. What Fendrix is and what it is used for

Fendrix is a vaccine that prevents hepatitis B.

It is used in patients with kidney problems:

• patients undergoing haemodialysis, in which a dialysis machine removes waste products from the blood
• patients who will undergo haemodialysis in the future.

Fendrix is for adults and adolescents from the age of 15 years.

What is hepatitis B

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

• Signs may not appear until 6 weeks to 6 months after infection.
• Main signs of the disease include mild flu-like symptoms such as headache or fever, extreme tiredness, dark-coloured urine, pale-coloured stools (faeces), yellow eyes or skin (jaundice). These or other signs may mean that the person needs treatment in hospital. Most people recover completely from the disease.
• Some people with hepatitis B do not look ill or feel ill (they have no signs of disease).
• The virus is found in body fluids such as vaginal fluid, blood, semen or saliva (spit).

Hepatitis B carriers

• The hepatitis B virus remains in the body of some people for life.
• This means they can infect others and are known as virus carriers.
• Carriers of the virus are likely to 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 purified non-toxic bacterial lipid derivative) and aluminium phosphate. Both help the vaccine to work faster, better and for a longer time.
• As with all vaccines, a course of vaccination with Fendrix may not fully protect all vaccinated individuals.
• Fendrix may not protect you from the disease if you have already been infected with the hepatitis B virus.
• Fendrix can only protect you against infection by the hepatitis B virus. It cannot protect you against other infections that may affect the liver, even if these infections cause signs similar to those caused by the hepatitis B virus.

2. What you need to know before receiving Fendrix

Fendrix must not be given

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include: itchy skin rash, 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 serious infection with fever. The vaccine can be given once you have recovered. A minor infection, such as a cold, should not be a problem for vaccination, but tell your doctor first.

Fendrix must not be administered if any of the above situations apply to you. If you are not sure, consult your doctor or pharmacist before receiving Fendrix.

Warnings and precautions

Talk to your doctor or pharmacist before receiving Fendrix:

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

Fainting may occur before or after any injection (especially in adolescents), so you should inform your doctor or nurse if you have previously fainted after an injection.

If any of the above situations apply to you (or if you are not sure), consult your doctor or pharmacist before receiving Fendrix.

Other medicines and Fendrix

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines, or if you have recently received any other vaccine.

• There should be an interval of at least 2 to 3 weeks between administration of Fendrix and any other vaccine.
• Fendrix may need to be given 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before receiving this vaccine.

Driving and using machines

You may feel tired or have a headache after receiving Fendrix. If this happens, take special care when driving or operating tools or machinery.

Fendrix contains sodium

This vaccine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How Fendrix is administered

How the vaccine is given

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

How much is given

• You will receive a series of four injections.

• The injections will be given 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 you should return for the following injections.

• After receiving the first dose of Fendrix, it is necessary that all subsequent doses also be Fendrix (not another type of hepatitis B vaccine).

Your doctor will inform you whether you will need any additional or booster doses in the future. Fendrix may also be used as a booster dose following a vaccination course 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 vaccination course of four injections. Otherwise, you may not be fully protected against the disease.

4. Possible adverse effects

Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur with this vaccine. Their frequency is defined as follows:

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

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

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

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

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

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

Allergic reactions, including anaphylactoid reactions, may also occur very rarely (in up to 1 in 10,000 doses of the vaccine). These may include localized or widespread skin rashes with itching or blisters, swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in blood pressure, and loss of consciousness. These reactions may occur before you leave the doctor's office. However, seek immediate medical attention in any case.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fendrix

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

• Do not use this vaccine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

• Store in a refrigerator (between 2 °C and 8 °C).

• Keep in the original packaging to protect from light.

• Do not freeze. Freezing destroys the vaccine.

• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fendrix

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

Hepatitis B virus surface antigen 1, 2, 3 20 micrograms

1adjuvanted with AS04C containing:

3-O-desacyl-4’-monophosphoryl lipid A (MPL) 2 50 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 injections.

Nature of the product and contents of the pack

Fendrix is a white, milky suspension.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

GlaxoSmithKline Biologicals s.a.

Rue de l’Institut 89

B-1330 Rixensart

Belgium

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 04/2023

Other sources of information

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

This information is intended for healthcare professionals only:

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

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

The vaccine should be inspected visually before and after resuspension for the presence of foreign particles and/or any change in physical appearance. The vaccine must not be used if any change in its appearance has occurred.

Disposal of unused medicine and of all materials that have been in contact with it should be carried out in accordance with local regulations.

Fendrix must not be administered to subjects with hypersensitivity to the active substance or to any of the excipients.

Fendrix must not be administered to subjects who have experienced hypersensitivity after a previous administration of other hepatitis B vaccines.

Fendrix must not be administered to subjects with serious 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 into the deltoid region.

Intramuscular administration into 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.

Since pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk of chronic infection, a preventive approach should be considered; that is, a booster dose should be administered to ensure a protective level of antibodies, according to local recommendations and guidelines.

Appropriate medical treatment should always be readily available in case a rare anaphylactic reaction occurs following vaccine administration.

Instructions for the pre-filled syringe

Waste disposal

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.