Consumer medicine information

Engerix-B

Hepatitis B child vaccine

BRAND INFORMATION

Brand name

Engerix-B Vaccine

Active ingredient

Hepatitis B child vaccine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Engerix-B.

SUMMARY CMI

ENGERIX-B

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor/pharmacist.

1. Why am I being given ENGERIX-B?

ENGERIX-B is a vaccine used to protect you or your child against hepatitis B infection. The vaccine works by causing the body to produce its own protection (antibodies) against this disease.

For more information, see Section 1. Why am I being given ENGERIX-B? in the full CMI.

2. What should I know before I am given ENGERIX-B?

Do not use if you have ever had an allergic reaction to ENGERIX-B or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given ENGERIX-B? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ENGERIX-B and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is ENGERIX-B given?

  • ENGERIX-B will be injected into your upper arm muscle. For babies, the vaccine may be given in the upper thigh muscle. For some people with bleeding problems, the dose may need to be given under the skin (subcutaneously).
  • ENGERIX-B is generally given as a total of three doses over 6 months.

More instructions can be found in Section 4. How is ENGERIX-B given? in the full CMI.

5. What should I know while being given ENGERIX-B?

Things you should do
  • Check with your doctor if you have an allergy to yeast, you are or think you may be pregnant, or if you intend to become pregnant, you are breastfeeding, you have any medical conditions, such as a severe heart or lung disease, a bleeding disorder, a liver or kidney problem, an immune deficiency condition (e.g. are HIV positive), or a nervous system illness.
Things you should not do
  • Do not have ENGERIX-B if you have an allergic reaction to ENGERIX-B, any ingredients in the vaccine, to H-B-Vax II, or another hepatitis B vaccine, or have a severe infection with a high temperature.
Driving or using machines
  • Be careful driving or operating machinery until you know how ENGERIX-B affects you. ENGERIX-B should not normally interfere with your ability to drive a car or operate machinery. In some people vaccination can cause dizziness or light-headedness.
Looking after your medicine
  • ENGERIX-B is usually stored at the doctor's clinic or surgery, or at the pharmacy. If you need to store ENGERIX-B always store in the refrigerator between +2°C and +8°C in the original pack until it is time for it to be given. The pack should never be frozen. Freezing destroys the vaccine.

For more information, see Section 5. What should I know while being given ENGERIX-B? in the full CMI.

6. Are there any side effects?

Side effects that have been most commonly reported include irritability, headache, pain and redness at injection site, and fatigue. There is a rare risk of serious allergic reactions. Contact your doctor immediately if or go to the casualty department of your nearest hospital if you notice any of the following, swelling of limbs, face, eyes, inside of nose, mouth or throat. Shortness of breath, breathing or swallowing difficulties, hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions, unusual tiredness or weakness that is sudden and severe. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

ENGERIX-B

Active ingredient: Hepatitis B surface protein (yeast)

Consumer Medicine Information (CMI)

This leaflet provides important information about using ENGERIX-B. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ENGERIX-B.

Where to find information in this leaflet:

1. Why am I being given ENGERIX-B?
2. What should I know before I am given ENGERIX-B?
3. What if I am taking other medicines?
4. How is ENGERIX-B given?
5. What should I know while being given ENGERIX-B?
6. Are there any side effects?
7. Product details

1. Why am I being given ENGERIX-B?

ENGERIX-B is a vaccine used to protect you or your child against hepatitis B infection. The vaccine works by causing your body to produce its own protection (antibodies) against this disease. ENGERIX-B can be given to adults, adolescents, children and infants.

Hepatitis B is an infectious disease, which causes the liver to become swollen (inflamed). It is caused by a virus (hepatitis B virus).

The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva of infected people. You can catch the virus if it can enter your bloodstream. Ways this can happen are through:

  • injection (e.g. needlestick injury, or sharing needles for IV drug use)
  • sexual intercourse
  • sores, cuts or tiny wounds coming into contact with infected fluids (e.g. from a human bite, sharing razors or toothbrushes, or working with human blood or body fluids)
  • an infected mother passing the virus onto her baby during or shortly after birth.

Some people infected with hepatitis B may not look or feel sick. But others will get symptoms, which may not be seen for 6 weeks to 6 months after infection. Sometimes people will only have mild flu-like symptoms, but other people can become very ill. They may be extremely tired, and have dark urine, pale faeces, yellowish skin and/or eyes (jaundice), and other symptoms possibly requiring hospitalisation.

Most adults fully recover from the disease. But some people, particularly children, who may not have had symptoms can remain infected. They are called hepatitis B virus carriers. Hepatitis B carriers can infect others throughout their lives.

Babies infected with hepatitis B at birth almost always become carriers. Often they do not show symptoms, and seem healthy for many years. However, after 30, 40 or 50 years they can become sick and develop symptoms.

For all chronic hepatitis B carriers there is a risk of serious liver disease, such as cirrhosis (liver scarring) and liver cancer.

There is no specific treatment for hepatitis B. Therefore vaccination is the best way to help protect against infection and possible serious long-term disease.

ENGERIX-B will not protect against hepatitis caused by other agents or viruses (such as hepatitis A, hepatitis C, hepatitis E). If a person is already infected with the hepatitis B virus at the time of vaccination, ENGERIX-B may not prevent the disease in these people.

2. What should I know before I am given ENGERIX-B?

Warnings

Do not use ENGERIX-B if:

  • you are allergic to ENGERIX-B, or any of the ingredients listed at the end of this leaflet.
    Signs of an allergic reaction may include skin rash, itchiness, shortness of breath, or swelling of the face, neck or tongue.
  • If you had ENGERIX-B before and became unwell, tell your doctor, nurse or pharmacist before receiving the next dose.
  • you have had an allergic reaction to H-B-Vax II, or another hepatitis B vaccine.
  • you have a severe infection with a high temperature. A minor infection such as a cold should not be a problem, but talk to your doctor about this before being vaccinated.
  • the expiry date printed on the pack has passed
  • the packaging is torn or shows signs of tampering

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

  • have an allergy to yeast
  • you have any medical conditions, such as:
    - severe heart or lung disease
    - a bleeding disorder
    - a liver or kidney problem
    - an immune deficiency condition (e.g. are HIV positive)
    - or a nervous system illness.

Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you/your child fainted with a previous injection.

If your child has breathing difficulties, please contact your doctor. This may be more common in the first three days following vaccination if your child is born prematurely (before or at 28 weeks of pregnancy).

Sometimes ENGERIX-B may need to be given differently (e.g. people with bleeding problems) or a higher dose used (e.g. dialysis patients, or HIV positive people) if

  • you have allergies to any other medicines or substances, such as dyes, foods or preservatives.
  • you have received another vaccine, or are taking any prescription or OTC (over-the-counter) medicines. In particular mention if you are taking medicines which suppress the immune system, such as steroids or cyclosporin.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known if ENGERIX-B passes into breast milk, but as it can safely be given to infants, it is not expected to cause problems in nursing babies. However, the infant should be checked for any reactions.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with ENGERIX-B and affect how it works, in particular medicines which suppress the immune system, such as steroids or cyclosporin.

Your doctor, nurse or pharmacist will be able to tell you what to do if ENGERIX-B is to be given with another vaccine or medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ENGERIX-B.

4. How is ENGERIX-B given?

The doctor or nurse will give ENGERIX-B as an injection.

If you have any concerns about this, talk to your doctor, nurse or pharmacist.

How much is given

Usually, for adults and adolescents over 19 years of age:

1mL (20 microgram) is given.

For adolescents aged 10 up to and including 19 years of age:

0.5 mL (10 microgram) is given.

Where compliance cannot be assured a 1mL dose (20 microgram) should be given. For babies and children under 10 years of age: 0.5mL (10 microgram) is given.

People with some conditions may need to have higher dosages.

How it is given

ENGERIX-B will be injected into your upper arm muscle. For babies, the vaccine may be given in the upper thigh muscle. For some people with bleeding problems, the dose may need to be given under the skin (subcutaneously).

The vaccine should not be given directly into the veins (intravenously).

When is it given

ENGERIX-B is generally given as a total of three doses over 6 months. Each dose is given at a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month, and six months after the first dose.

It is important to return at the recommended times for follow up doses.

  • First dose: at an elected date
  • Second dose: 1 month later
  • Third dose: 6 months after the first dose

For babies born to mothers infected with hepatitis B, the first dose of ENGERIX-B should be given at birth or shortly afterwards. Hepatitis B immunoglobulin can also be given at this time.

ENGERIX-B can also be given as a total of three doses over 3 months. This schedule may be given to people needing rapid protection (e.g. overseas travellers). The first dose will be given on an elected date. The remaining two doses will be given one month and two months after the first dose. A booster dose is recommended at 12 months.

For adults, ENGERIX-B can also be given as a total of three doses over 3 weeks (a 0, 7, 21 day schedule). However, the body's immune response to this rapid schedule may be reduced compared to the above two schedules. Therefore, this rapid schedule should only be used under special circumstances (e.g. travellers wanting to be vaccinated within one month of departure). A booster dose is recommended at 12 months.

For adolescents aged from 11 to 15 years, ENGERIX-B can also be given as a total of two adult (1 mL) doses 6 months apart. However, as protection against hepatitis B is only achieved after the second dose is given, this schedule should only be used when there is a relatively low risk of hepatitis B infection during the vaccination course and when it can be anticipated that the complete course is given.

Your doctor will advise on the possible need for extra doses, and future booster dosing.

If a dose is missed

If you miss a scheduled dose, talk to your doctor and arrange another visit as soon as possible.

If you are given too much ENGERIX-B

If you think that you have been given too much ENGERIX-B, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while being given ENGERIX-B?

Things you should do

Keep your follow up visits with the doctor or clinic. It is important the two follow-up doses of ENGERIX-B are given at the correct times. This will ensure the best effect of the vaccine in protecting you or your child against hepatitis B

Call your doctor straight away if you:

  • You do not feel well during or after having had a dose of ENGERIX-B.
  • ENGERIX-B helps protect most people from hepatitis B, but it may have unwanted side effects in a few people. All medicines and vaccines can have side effects. Sometimes they are serious; most of the time they are not. Some side effects may need medical treatment.

Remind any doctor, dentist or pharmacist you visit that you have been given ENGERIX-B.

Things you should not do

  • Do not miss follow up doses.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ENGERIX-B affects you.

ENGERIX-B should not normally interfere with your ability to drive a car or operate machinery. But in some people vaccination can cause dizziness or light-headedness. Make sure you know how you react to ENGERIX-B before you drive a car or operate machinery, or do anything that could be dangerous if you are dizzy or lightheaded.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

ENGERIX-B is usually stored at the doctor's clinic or surgery, or at the pharmacy. But if you need to store ENGERIX-B always:

  • Keep ENGERIX-B in the refrigerator stored between +2°C and +8°C. THE PACK SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
  • Keep the vaccine out of the reach of children.
  • Keep ENGERIX-B in the original pack until it is time to be given.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

When to discard your medicine

Ask your pharmacist what to do with any leftover ENGERIX-B that has expired or has not been used.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary and generally occur around the injection site.

However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
General disorders and administration site conditions:
  • Pain, redness, swelling, a hard lump, bruising or itching around the injection site
  • Headache, unusual tiredness, drowsiness, dizziness or feeling generally unwell
  • Fever
  • Fainting, or chills
Gastrointestinal disorders:
  • Vomiting or feeling sick, stomach pains or diarrhoea
Metabolic disorders:
  • Loss of appetite
Musculoskeletal disorders:
  • Muscle aches and pains, back pain or neck stiffness
  • Aches or pains in joints
Lymphatic disorders:
  • Swollen glands in armpit or neck
Psychiatric disorders:
  • Disturbed sleep, irritability
Respiratory and mouth disorders:
  • Coughing, sore throat, runny nose
Skin disorders:
  • Mild skin rash
  • Sweating, flushing
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Respiratory and mouth disorders:
  • Breathing difficulties in your child
Nervous system disorders:
  • Difficulty in walking, numbness, weakness and/or fatigue in limbs, tingling in fingers, toes, or other body parts, pain
  • Bowel or bladder problems
  • Guillain-Barre Syndrome (an inflammatory illness affecting nerves, resulting in weakness of muscles)
  • Disease of the brain including infection and swelling
  • Convulsions
Eye disorders:
  • Blurred vision or other visual changes
  • Drooping eyelid or sagging muscles on one side of the face, also called Bell's palsy
Lymphatic disorders:
  • Swelling with fluid in tissues
  • Swollen glands in neck, armpit or groin
Skin disorders:
  • Reddening of the skin, red swellings over the skin or in the mouth and on the lips, or other skin problems
  • Bleeding or bruising more easily than normal
Infections and immune system disorders:Allergic reactions
  • Swelling of limbs, face, eyes, inside of nose, mouth or throat
  • Shortness of breath, breathing or swallowing difficulties
  • Hives, itching (especially of the hands or feet), reddening of skin (especially around the ears), or severe skin reactions
  • Unusual tiredness or weakness that is sudden and severe

Allergy to ENGERIX-B is rare. Any such severe reactions will usually occur within the first few hours of vaccination

Blood disorders:
  • Blood disorders or low blood pressure
  • * narrowing or blockage of blood vessels
  • changes in liver function tests
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What ENGERIX-B contains

Active ingredientSurface protein of the hepatitis B virus, derived from genetically engineered yeast cells. The vaccine is not infectious, and will not give you the hepatitis B virus.
Other ingredientsAluminium hydroxide hydrate, dibasic sodium phosphate dihydrate, monobasic sodium phosphate, sodium chloride (salt), and water. ENGERIX-B contains no thiomersal.
Potential allergens

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.

ENGERIX-B is made without any human blood or blood products, or any other substances of human origin.

Do not take this medicine if you are allergic to any of these ingredients.

What ENGERIX-B looks like

ENGERIX-B comes in glass prefilled syringes, as a white, slightly milky liquid. Two different vaccine dosages are available:

  • 10 microgram in 0.5mL of liquid - Monodose pre-filled syringes in packs of 1 and 10
  • 20 microgram in 1mL of liquid - Monodose pre-filled syringe in packs of 1 and 10

Not all presentations and packs may be available.

ENGERIX-B is Aust R 123712 and Aust R 123713.

Who distributes ENGERIX-B

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street,
Abbotsford, Victoria, 3067
Phone: 1800 033 109
www.gsk.com.au

Trademarks are owned by or licensed to the GSK group of companies.

©2024 GSK group of companies or its licensor

This leaflet was prepared in February 2024.

Version 6.0

Published by MIMS April 2024

BRAND INFORMATION

Brand name

Engerix-B Vaccine

Active ingredient

Hepatitis B child vaccine

Schedule

S4

 

1 Name of Medicine

Hepatitis B surface antigen recombinant (yeast).

2 Qualitative and Quantitative Composition

Engerix-B paediatric dose: 10 microgram dose vaccine.

1 dose (0.5 mL) contains: hepatitis B surface antigen1,2 10 microgram.
1 Adsorbed on aluminium hydroxide hydrate, total: 0.25 milligram Al3+.
2 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.

Engerix-B: 20 microgram dose vaccine.

1 dose (1 mL) contains: hepatitis B surface antigen1,2 20 microgram.
1 Adsorbed on aluminium hydroxide hydrate, total: 0.50 milligram Al3+.
2 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
For the full list of excipients, see Section 6.1 List of Excipients.
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
Engerix-B is highly purified, and meets the WHO requirements for recombinant hepatitis B vaccines. No substances of human origin are used in its manufacture.

3 Pharmaceutical Form

Suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Engerix-B is indicated for active immunisation against hepatitis B virus infection. The use of the vaccine should be in accordance with official recommendations.
As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection, it can be expected that hepatitis D will also be prevented by vaccination with Engerix-B. The vaccine will not protect against infection caused by hepatitis A, hepatitis C and hepatitis E viruses, and other pathogens known to infect the liver.

4.2 Dose and Method of Administration

Dosage.

The vaccine can be administered at any age from birth onwards. Vaccination of individuals who have antibodies against hepatitis B virus from a previous infection is not necessary.

Adults and adolescents older than 19 years.

A dose of 20 microgram of antigen protein in 1 mL is recommended in a 0, 1, 6 month schedule.

Adolescents.

In adolescents from the age of 10 years, up to and including 19 years, a 10 microgram dose is recommended provided the immunisation is carried out in the 0, 1, 6 month schedule in circumstances which will ensure compliance to the full vaccination course. If compliance cannot be assured, then a 20 microgram dose should be used to increase the proportion of participants protected after the first and second doses.
The 20 microgram vaccine can also be used in participants from 11 years up to and including 15 years of age in a 0 and 6 month schedule in situations when there is a relatively low risk of hepatitis B infection during the vaccination course and when compliance with the complete vaccination course can be anticipated.
Adolescent vaccination is not necessary for children who have received a primary course of hepatitis B vaccine.

Neonates, infants and children below 10 years of age.

A dose of 10 microgram of antigen protein in 0.5 mL suspension is recommended in a 0, 1, 6 month schedule. For details on the recommended vaccination schedule, including use in preterm babies, refer to the Australian Immunisation Handbook.
In neonates and infants, maternally transferred antibodies do not interfere with the active immune response to the vaccine.

Vaccination schedules.

For primary vaccination of adults, adolescents and children not previously exposed to the hepatitis B virus the schedules are shown in Table 1.
The recommended treatment regimen for infants born to HBsAg positive mothers (irrespective of the mother's HBeAg status) is shown in Table 2.
The first dose of vaccine and immunoglobulin should preferably be given within 12 hours of birth at separate sites. The efficacy of HBIG decreases markedly if treatment is delayed beyond 48 hours. If this is not possible, vaccination should not be delayed beyond 7 days after birth.
Testing for HBsAg and anti-HBs is suggested at 12-15 months of age. If HBsAg is not detectable and anti-HBs is present, the child has been protected.

Accelerated schedules.

In circumstances where more rapid protection is required (e.g. contacts of carriers, immunisation of travellers and newborns to carrier women) two accelerated vaccination schedules of 0, 1 and 2 months or 0, 7 and 21 days may be used. However, as higher seroprotective rates are observed following the 0, 1, 2 month schedule, it is recommended the 0, 7, 21 day schedule be administered only to adults, and only in exceptional circumstances (e.g. travellers commencing hepatitis B primary vaccination within one month of departure) (see Section 5.1 Pharmacodynamic Properties). Since the peak antibody levels reached after these shorter schedules of primary vaccination are lower compared to the 0, 1 and 6 month schedule, it is recommended that a fourth dose (booster) be given at 12 months after the first dose of vaccine, in order to ensure adequate seroprotection rates.

Dosage adjustment.

Renal impairment/dialysis.

Chronic adult haemodialysis patients/ patients with impaired renal function (creatinine clearance < 30 mL/min) 16 years of age and above.

The primary vaccination schedule for chronic adult haemodialysis patients or patients with impaired renal function 16 years of age and above consists of four doses of 40 microgram. The 40 microgram (2 mL) dose may be administered as 2 x 20 microgram in one injection site or in each arm. (See Table 3.)
As vaccine induced protection in haemodialysis patients is less complete, boosting should be adapted in order to ensure the anti-HBs antibody titre remains above 10 IU/L (see Section 4.4 Special Warnings and Precautions for Use). The need for booster dosing should be assessed by antibody testing at six to twelve monthly intervals. Engerix-B booster doses of 40 microgram (2 x 20 microgram) are recommended for these patients.

Postexposure prophylaxis.

There are no adequately controlled studies on the effectiveness of hepatitis B immunoglobulin administration along with the vaccine in adults and older children exposed to hepatitis B virus through: 1) needlestick, ocular or mucous membrane exposure to blood known or presumed to contain HBsAg; 2) human bites by known or presumed HBsAg carriers that penetrate the skin; 3) following intimate sexual contact with known or presumed HBsAg carriers.
Hepatitis B immunoglobulin (human) (400 IU) should be given intramuscularly as soon as possible (must be within 72 hours of exposure). Engerix-B should be given at a separate site within 7 days, and then at 1 month and 6 months. Passive immunisation will not interfere with active response to Engerix-B.

Booster dose.

The Australian Immunisation Handbook recommends that booster doses against hepatitis B are not required in immunocompetent individuals, since there is good evidence that a completed primary course of hepatitis B vaccination provides long lasting protection in these individuals. This applies to adults, children and all subgroups (such as healthcare workers). Booster doses are recommended for immunosuppressed individuals, for people living with HIV infection or with renal failure. The timing for boosting in these individuals should be decided by regular monitoring of hepatitis B antibody levels at six to twelve monthly intervals.

Method of administration.

The vaccine is a ready to use suspension. It must be shaken well before use since upon storage the vaccine settles down as a fine white deposit with a clear colourless supernatant. After shaking, the vaccine is a slightly opaque, white suspension.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, do not administer the vaccine. The vaccine should be discarded.
The prefilled syringe presentations are for use in a single patient only and any residue must be discarded.

Instructions for the pre-filled syringe.

Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by twisting it anticlockwise.
To attach the needle, connect the hub to the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.
Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
Engerix-B should be injected intramuscularly. In adults, the injection should be given in the deltoid region but it may be preferable to inject Engerix-B in the anterolateral thigh in neonates and infants because of the small size of their deltoid muscle. Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or severe bleeding tendencies (e.g. haemophiliacs).
Engerix-B must not be given intravenously.
NB: Each vaccination should be carried out with a separate syringe.

4.3 Contraindications

Engerix-B should not be administered to participants with known hypersensitivity to any component of the vaccine, or to participants having shown signs of hypersensitivity after previous Engerix-B administration.
As for any vaccine, Engerix-B should not be administered to participants with severe febrile infections. However, the presence of minor infection without fever does not contraindicate vaccination.
HIV infection is not considered a contraindication to hepatitis B vaccination.

4.4 Special Warnings and Precautions for Use

The vaccine should never be administered intravenously.
As with all injectable vaccines, appropriate medical treatment (i.e. adrenaline) and supervision should always be readily available in case of anaphylactic reactions following the administration of the vaccine.
It is good clinical practice that any vaccination be preceded by a review of medical history (especially with regard to previous vaccinations and possible adverse events) and a clinical examination.
Engerix-B should not be administered in the gluteal region or intradermally/ subcutaneously since these routes of administration may not result in an optimum immune response. Exceptionally, in patients with thrombocytopenia or severe bleeding disorders (e.g. haemophiliacs), the vaccine may be administered subcutaneously, since bleeding after intramuscular injection may occur in these patients (see Section 4.2 Dose and Method of Administration).
The immune response to hepatitis B vaccines is related to a number of factors including route of administration, age (more than 40 years of age), male gender, obesity and smoking habits. As individuals in these groups may respond less optimally to hepatitis B vaccines, the administration of additional vaccine doses may be considered.
In dialysis patients, HIV infected patients and participants who have impairment of the immune system, adequate antibody concentrations may not be obtained after the recommended primary vaccination course. The need for monitoring antibody levels in such patients should be considered (see Section 4.2 Dose and Method of Administration, Chronic adult haemodialysis patients/ patients with impaired renal function (creatinine clearance < 30 mL/min) 16 years of age and above).
Caution should be exercised in administering the vaccine to patients in whom a systemic reaction due to the vaccine may pose a significant risk, e.g. in patients with severely compromised cardiopulmonary function.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
Because of the long incubation period of hepatitis B, it is possible for unrecognised infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B in such cases.
The vaccine may not prevent infection in individuals who do not achieve protective antibody titres.
The vaccine will not protect against infection caused by hepatitis A, hepatitis C and hepatitis E viruses and other pathogens known to infect the liver.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.

Use in hepatic impairment.

No data available.

Use in renal impairment.

See Section 4.4 Special Warnings and Precautions for Use, for use in haemodialysis patients.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Engerix-B should not be mixed in the same syringe with other vaccines.
Engerix-B may be administered concomitantly with the following vaccines: diphtheria-tetanus-pertussis (DTP), diphtheria-tetanus (DT), poliomyelitis (oral or injectable), measles-mumps-rubella, Haemophilus influenzae type b (Hib) and hepatitis A, providing separate syringes and separate injection sites are used.
Engerix-B can be given concomitantly with human papillomavirus (HPV) vaccine (Cervarix).
Administration of Engerix-B at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV antigens. Anti-HBs geometric mean antibody concentrations were lower on coadministration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of participants reaching anti-HBs ≥ 10 mIU/mL was 97.9% for concomitant vaccination and 100% for Engerix-B alone.
The simultaneous administration of Engerix-B and hepatitis B immunoglobulin (HBIG) does not result in reduced anti-HBs antibody titres provided separate injection sites are used.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)
Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. Therefore, vaccination of pregnant women cannot be recommended, unless expected benefits outweigh potential risks, as might occur in high risk situations.
 Adequate human data on use during lactation and adequate animal reproduction studies are not available.

4.7 Effects on Ability to Drive and Use Machines

The vaccine is considered unlikely to affect the ability to drive and operate machinery.

4.8 Adverse Effects (Undesirable Effects)

Engerix-B is generally well tolerated.

Clinical trials experience.

Based on clinical trial symptom sheet data, the incidence of local side effects is 24% and of systemic side effects 8%. Both local and systemic side effects occurred in approximately 13% of participants. The incidence of local and systemic reactions was comparable to those of plasma derived hepatitis B vaccines.
In a comparative trial in participants from 11 years up to and including 15 years of age, the incidence of local and general solicited symptoms reported after a two dose regimen of Engerix-B 20 microgram was overall similar to that reported after the standard three dose regimen of Engerix-B 10 microgram.
Adverse effects data from patients who received a challenge dose of Engerix-B 10 microgram (preservative free) at 72 to 78 months after primary vaccination is shown in Table 4. The group 1 participants had received 2 doses of thiomersal free Engerix-B (20 microgram) at 0 and 6 months, with placebo at month 1. The group 2 participants had received 3 doses of preservative free Engerix-B (10 microgram) at 0, 1 and 6 months.
The safety profile presented below is based on data from more than 5,300 participants. Events are listed within body systems and categorised by frequency according to the following definitions.
Frequencies are reported as very common: ≥ 1/10; common: ≥ 1/100, < 1/10; uncommon: ≥ 1/1,000, < 1/100; rare: ≥ 1/10,000, < 1/1,000; very rare: < 1/10,000 including isolated reports.

Blood and lymphatic system disorders.

Rare: lymphadenopathy.

Metabolism and nutrition disorders.

Common: appetite lost.

Psychiatric disorders.

Very common: irritability.

Nervous system disorders.

Common: headache (very common with 10 microgram formulation), drowsiness. Uncommon: dizziness. Rare: paresthesia.

Gastrointestinal disorders.

Common: gastrointestinal symptoms (such as nausea, vomiting, diarrhea, abdominal pain).

Skin and subcutaneous tissue disorders.

Rare: rash, pruritus, urticaria.

Musculoskeletal and connective tissue disorders.

Uncommon: myalgia. Rare: arthralgia.

General disorders and administration site conditions.

Very common: pain and redness at injection site, fatigue.
Common: swelling at injection site, malaise, injection site reaction (such as induration), fever (≥ 37.5°C). Uncommon: influenza-like illness.

Postmarketing data.

The following adverse events have been reported following widespread use of the vaccine. As with other hepatitis B vaccines, in many instances the causal relationship to the vaccine has not been established.

Infections and infestations.

Herpes zoster.

Autonomic nervous system.

Rare: flushing, sweating.

Body as a whole.

Rare: fever, fatigue, malaise, chills.
Very rare: anaphylaxis, delayed hypersensitivity reactions, mimicking serum sickness.
Unknown frequency: allergic reactions including anaphylactoid reactions.

Cardiovascular.

Very rare: syncope, hypotension.

Central and peripheral nervous system.

Rare: paraesthesia, dizziness, headache.
Very rare: paralysis, neuropathy (including Guillain-Barre syndrome, facial paralysis, optic neuritis (visual disturbance) and multiple sclerosis), encephalitis, encephalopathy, meningitis, neck stiffness, neuritis, vertigo and convulsions. Unknown frequency: hypoaesthesia, myelitis including transverse myelitis.

Gastrointestinal system.

Rare: nausea, vomiting, diarrhoea, abdominal pain. Very rare: anorexia.

Hearing and vestibular.

Very rare: tinnitus.

Liver and biliary system.

Rare: abnormal liver function tests.

Local reactions.

Common: transient soreness, pain, induration, erythema and swelling at the injection site have been reported. These reactions are usually mild and subside within two days. Very rare: ecchymosis at the injection site.

Musculoskeletal system.

Rare: arthralgia, myalgia. Very rare: arthritis. Unknown frequency: muscular weakness.

Platelet bleeding and clotting.

Very rare: thrombocytopenia.

Psychiatric.

Very rare: disturbed sleep.

Respiratory system.

Very rare: bronchospasm-like symptoms, pharyngitis or other upper respiratory infection, cough.

Skin and appendages.

Rare: urticaria, rash, pruritus. Very rare: severe skin disorders such as erythema multiforme, angioedema. Unknown frequency: lichen planus.

Urinary system.

Very rare: dysuria.

Vascular extracardiac.

Very rare: vasculitis.

White cell and reticuloendothelial system.

Very rare: lymphadenopathy.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Cases of overdose have been reported during postmarketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Engerix-B induces the production of specific humoral antibodies (anti-HBs), which confer immunity against hepatitis B. A peak anti-HBs antibody concentration of ≥ 10 IU/L correlates with long-term protection against hepatitis B virus (HBV) infection (seroprotection).
Seroconversion (SC) is defined as the appearance of antibodies ≥ 1 IU/L in a previously seronegative participant.

Clinical trials.

Protective efficacy. Clinical trials demonstrated SC rates of ≥ 97% (seroprotection (SP) rates of ≥ 96%) in normal immunocompetent adults and children following a 0, 1, 6 months schedule, and SC rates of > 90% in neonates following injections at 0, 1, 2 months.
In healthy adults administered vaccine doses according to a 0, 1, 2 month primary schedule with a 12 month booster, seroprotective rates of 15% and 89% were achieved one month after the first and third doses, respectively. One month after the 12 month booster dose, 95.8% of vaccinees achieved seroprotective antibody levels. In healthy adults administered a 0, 7, 21 day primary schedule with a 12 month booster, seroprotective rates of 65.2% and 76.4% were achieved one week and one month, respectively following the third vaccine dose. One month after the 12 month booster dose, 98.6% of vaccinees achieved seroprotective antibody levels.
In healthy adolescents (from 11 years up to and including 15 years of age) administered doses of 20 microgram at 0 and 6 months, SP rates were 11.3% at month 2, 26.4% at month 6 and 96.7% at month 7. Immunogenicity in this study was measured by the development of antibody to HBsAg as detected by enzyme immunoassay (seropositivity cutoff: 3.3 mIU/mL), using a titre of ≥ 10 IU/L as indicative of seroprotection.
The seroprotection rates (SP) obtained with the two different dosages and schedules recommended in participants from 11 years up to and including 15 years of age were evaluated up to 66 months after the first dose of the primary vaccination and are presented in Table 5.
These data show that a primary vaccination with Engerix-B vaccine induces circulating anti-HBs antibodies that persist for at least 66 months. From one month after completion of the primary course through to 66 months, i.e. month 7 to month 66, the seroprotection rates were comparable between the 2 groups but tended to be lower in the 20 microgram group (0, 6 months schedule) compared to the 10 microgram group (0, 1, 6 month schedule) at all timepoints. The seroprotection rates at month 66 were 79.5% (95% CI 71.7%, 86.1%) and 91.4% (95% CI 82.3%, 96.8%) in the 20 microgram group and 10 microgram group respectively. All participants in both vaccine groups (including participants with anti-HBs antibody concentrations < 10 IU/L) received a challenge dose 72 to 78 months after primary vaccination. One month after the challenge dose, all participants mounted an anamnestic response to the challenge dose and were shown to be seroprotected (i.e. anti-HBs antibody concentrations ≥ 10 IU/L). These data suggest that protection against hepatitis B may still be conferred through immune memory in all participants who responded to primary vaccination but lost seroprotection level of anti-HBs antibodies.

Rechallenge in healthy participants.

In a clinical study conducted in Germany, healthy participants (N=284) aged 12 to 13 years vaccinated during infancy with 3 doses of Engerix-B received a challenge dose of Engerix-B. One month later, 98.9% of participants were shown to be seroprotected.

At risk groups.

In clinical studies performed in Thailand twenty years after primary vaccination during infancy, participants born to mothers who were HBV carriers, received a challenge dose of Engerix-B. One month later, at least 93% of participants (N=75) mounted an anamnestic response i.e. at least (greater than or equal to) a 4-fold rise in post-challenge dose anti-HB's antibody concentrations in subjects seropositive at the previous available long-term time-point, demonstrating immune memory.
Following a 0, 1, 6 month schedule, SC rates of 96.6% and 99% (corresponding to SP rates of 92.3% and 93%) were obtained in intellectually impaired individuals and male homosexuals respectively. In a clinical trial where thalassaemic patients received three doses of 20 microgram at 0, 1, 6 months, SC rates as well as SP rates were 100% (17 participants tested).

Patients with renal insufficiency.

In patients 16 years of age and above with impaired renal function, including patients undergoing haemodialysis administered 40 microgram (2 x 20 microgram) doses at 0, 1, 2 and 6 months, SP rates were 55.4% at month 3 and 87.1% at month 7. See Table 6.
Immunogenicity was measured by the development of antibody to HBsAg as detected by enzyme immunoassay (seropositivity cutoff: 3.3 mIU/mL), using a titre of ≥ 10 IU/L as indicative of seroprotection.

Patients with type II diabetes.

The seroprotection rates in subjects 20 years of age and above with type II diabetes were evaluated one month after the last dose of the primary vaccination and are presented in Table 7.

Reduction in the incidence of hepatocellular carcinoma in children.

A significant reduction in the incidence of hepatocellular carcinoma was observed in Taiwanese children aged 6-14 years, following a nationwide hepatitis B vaccination program.

Interchangeability of hepatitis B vaccines.

Although no clinical data has been submitted, there is no reason to believe that the use of a different formulation of hepatitis B vaccine used either during a primary vaccination course or during booster dosing will not be satisfactory.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

The final vaccines also contain dibasic sodium phosphate dihydrate, monobasic sodium phosphate, sodium chloride, aluminium hydroxide hydrate and water for injections and traces of polysorbate 20. Engerix-B contains no thiomersal.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The shelf-life of Engerix-B is three years from the date of manufacture. When stored between +2°C to +8°C. Do not freeze, discard if the vaccine has been frozen.

6.4 Special Precautions for Storage

Engerix-B must be stored between +2°C to +8°C. Do not freeze, discard if the vaccine has been frozen.
The expiry date of the vaccine is indicated on the label and packaging.

6.5 Nature and Contents of Container

Engerix-B 20 microgram (adult dose).

1 mL of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.
Pre-filled syringes in packs of 1, 10 and 25.

Engerix-B paediatric dose 10 microgram.

0.5 mL of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.
Pre-filled syringe in packs of 1, 10 and 25.
The tip cap and rubber plunger stopper of the pre-filled syringe are not made with natural rubber latex.
Not all pack sizes and container types may be distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes