Heplisav B - patient leaflet, side effects, dosage

1. What HEPLISAV B is and what it is used for

HEPLISAV B is a vaccine for use in adults 18 years of age and older to protect against infection with the hepatitis B virus.

HEPLISAV B may also protect against hepatitis D which can only occur in people who have hepatitis B infection.

What is hepatitis B?

• Hepatitis B is an infectious illness of the liver, caused by a virus. Hepatitis B virus infection can cause serious liver problems such as “cirrhosis” (scarring in the liver) or liver cancer.
• Some people infected with the hepatitis B virus become carriers, which means that they may not feel ill but continue to have the virus in their body and they can still infect other people.
• The disease spreads by the hepatitis B virus entering the body through contact with an infected person’s body fluids, such as in the vagina, blood, semen, or spit (saliva). A mother who is a carrier of the virus can also pass the virus to her baby at birth.
• The main signs of the illness include mild signs of flu (such as headache and fever, feeling very tired, dark urine, pale stools (faeces), yellowing of the skin and eyes (jaundice)). However, some people with hepatitis B do not look or feel ill.

How HEPLISAV B works

When a person is given the HEPLISAV B vaccine, it helps the body’s natural defence system (immune system) produce specific protection (antibodies) against the hepatitis B virus.

• HEPLISAV B contains an adjuvant, a substance which improves the body’s production of antibodies and makes the protection last for longer.
• A course of two injections of HEPLISAV B is required to provide full protection against hepatitis B.
• HEPLISAV B is not used to treat a person who is already infected with the hepatitis B virus, including people infected with the hepatitis B virus and have become carriers for infection.

2. What you need to know before you receive HEPLISAV B

Do not receive HEPLISAV B:

• – If you are allergic to any of the components of this vaccine, including yeast (listed in Section 6). Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

• – If you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past.

HEPLISAV B should not be given if any of the above apply to you. If you are not sure, talk to your doctor, <pharmacist> or nurse before vaccination with HEPLISAV B.

Warnings and precautions

Talk to your doctor, <pharmacist> or nurse before receiving HEPLISAV B:

• – If you have any allergies to any of the components of HEPLISAV B (see Section 6).

• – If you have had any health problems after having a vaccine in the past.

• – Fainting can occur after, or even before, any injection. Therefore tell the doctor, <pharmacist> or nurse if you fainted with a previous injection.

• – If you are ill with a high fever, your doctor, <pharmacist> or nurse will delay the vaccination until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor, <pharmacist> or nurse will decide if you could still be vaccinated.

If you are on dialysis for a kidney problem or if you have a weakened immune system your doctor may need to do a blood test to check if the vaccination has worked well enough to protect you against hepatitis B.

HEPLISAV B does not protect you against other liver infections such as hepatitis A, C, and E.

As with any vaccine, HEPLISAV B may not protect all people who are vaccinated.

If you are not sure if any of the above apply to you, talk to your doctor, <pharmacist> or nurse before receiving HEPLISAV B.

Children and adolescents

Since HEPLISAV B has not been tested fully in young people under 18 years of age, it should not be used in this age group.

Other medicines and HEPLISAV B

Tell your doctor, <pharmacist> or nurse if you are taking, have recently taken or might take any other medicines or vaccines.

If HEPLISAV B is given at the same time as an injection of hepatitis B “immuno-globulins”, which would be given to provide immediate, short-term protection against hepatitis B infection, your doctor, <pharmacist> or nurse will make sure that the two are injected into 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 have a baby, ask your doctor for advice before receiving this vaccine.

As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy.

It is unknown whether HEPLISAV B is excreted in human milk. A risk to the suckling child cannot be excluded. Discuss with your doctor or nurse if you should discontinue breast-feeding or abstain from HEPLISAV B vaccination taking into account the benefit of breast-feeding for the child and the benefit of vaccination for the woman.

Driving and using machines

You may feel tired or get a headache after receiving HEPLISAV B. If this happens, do not drive or use any tools or machines.

• 3. How HEPLISAV B is given

The doctor, <pharmacist> or nurse will give HEPLISAV B as an injection into your muscle, usually in your upper arm.

For adults, the course of vaccination is 2 injections:

• – The first injection on a date agreed upon with your doctor or nurse.

• – The second injection 1 month after the first injection.

If you forget a return visit to receive HEPLISAV B

Talk to your doctor and arrange another visit.

Make sure you complete the injections or you may not be fully protected. Once you have had the first injection of HEPLISAV B, the second injection must also be HEPLISAV B (not another type of hepatitis B vaccine).

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.

Side effects that occurred during clinical trials with HEPLISAV B were as follows:

Serious side effects

Very rare (may affect up to 1 in 10,000 people)

You should seek immediate treatment if you get any signs of a serious allergic reaction.

The signs may include: face swelling, low blood pressure, difficulty breathing, loss of consciousness, fever, joint stiffness and a skin rash. Such reactions usually start very soon after injection.

Other side effects

Very Common (may affect more than 1 in 10 people)

• Headache
• Muscle aches
• Feeling tired
• Pain at the spot where the injection was given
• Feeling unwell (malaise)

Common (may affect up to 1 in 10 people)

• Swelling or redness at the spot where the injection was given
• Fever

Uncommon (may affect up to 1 in 100 people)

• Feeling sick (nausea)
• Being sick (vomiting)
• Diarrhoea
• Abdominal (belly) pain
• Allergic reactions (hives, rash and itchiness)

Rare (may affect up to 1 in 1,000 people)

• Dizziness
• Pins and needles

Reporting of side effects

If you get any side effects, talk to your doctor, <pharmacist> or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store HEPLISAV B

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

Do not use this vaccine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What HEPLISAV B contains

One dose (0.5 ml) contains:

Active substances:

Hepatitis B surface antigen (HBsAg)1,2 20 micrograms

• 1Adjuvanted with 3000 micrograms CpG 1018 adjuvant, a 22-mer immunostimulatory sequence oligonucleotide

• 2Produced in yeast cells (Hansenula polymorpha ) by recombinant DNA technology

Substance CpG 1018 is included in this vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccine.

The other ingredients are:

• sodium chloride
• disodium phosphate dodecahydrate
• sodium dihydrogen phosphate dihydrate
• polysorbate 80
• water for injections

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

What HEPLISAV B looks like and contents of the pack

HEPLISAV B is a clear to slightly milky, colourless to slightly yellow liquid for injection in pre-filled syringe.

HEPLISAV B is available in pre-filled syringes of 1 dose (0.5 ml) in a package of 5 syringes.

Marketing Authorisation Holder and Manufacturer

Dynavax GmbH

Eichsfelder Strasse 11

D-40595 Düsseldorf

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien, Et.nrapun, Česká republika, Danmark, Eesti, EXXáSa, España, France, Hrvatska, Ireland, Ísland, Italia, Kúnpog, Latvija, Lietuva, Luxembourg/Lu­xemburg, Magyarország, Malta, Nederland, Norge, Österreich, Polska, Portugal, Romania, Slovenija, Slovenská republika, Suomi/Finland, Sverige, United Kingdom (Northern Ireland)

Dynavax GmbH

Tél/Tel/Ten./Tlf/TnVSí­mi/Puh:

+49 211 758450

This leaflet was last revised in {MM/YYYY }.

Detailed information on this medicine is available on the European Medicines Agency web site:.

The following information is intended for healthcare professionals only:

HEPLISAV B:

• is a clear to slightly opalescent, colourless to slightly yellow solution and should essentially be free of visible particles. Discard if the content appears otherwise.
• should be injected intramuscularly (IM) in the deltoid region of the upper arm.
• should not be administered in the gluteal region (buttocks).
• should not be administered intravenously, subcutaneously, or intradermally.
• should not be given to subjects with hypersensitivity to the active substance or to any of the

excipients.

• should not be given to subjects suffering from acute severe febrile illness. The presence of a minor infection such as a cold, is not a contraindication for immunisation.
• must not be mixed with any other vaccines in the same syringe.