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, nurse or pharmacist.
1. Why am I receiving BEXSERO?
BEXSERO is a vaccine used for the immunisation of children from the age of 2 months
and older, adolescents and adults to prevent disease caused by Neisseria meningitidis
Group B. Neisseria meningitidis can cause meningitis, a very serious infection.
2. What should I know before I receive BEXSERO?
Do not receive if you have ever had an allergic reaction to BEXSERO or any of the
ingredients listed at the end of the CMI.
Tell your doctor or nurse if you or your child have an allergy to kanamycin (an antibiotic),
or allergy to any other vaccine or you have a very high fever or any other infection.
Talk to your doctor or nurse if you have any other medical conditions, take any other
medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with BEXSERO and affect how it works.
4. How do I receive BEXSERO?
Your doctor or nurse will give you BEXSERO as an injection into your upper arm or
for children into the upper thigh muscle.
5. What should I know after receiving BEXSERO?
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Things you should do
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Keep a record of your immunisation history
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how BEXSERO
affects you
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Looking after your medicine
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BEXSERO will normally be stored at the doctor’s surgery or in the pharmacy
If you need to store BEXSERO, keep it in the refrigerator between 2oC and 8oC. Do not freeze. Protect from light.
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6. Are there any side effects?
Side effects which have been reported following administration of BEXSERO include
pain at the injection site, redness at the injection site, swelling of the skin at
the injection site, hardness of skin at the injection site, fever, a general feeling
of being unwell, feeling irritable, unusual crying, loss of appetite, painful muscles
and joints, headache, nausea, vomiting, diarrhoea, skin rashes and sleepiness.
Allergic reactions have also occurred following administration of BEXSERO. Allergy
is rare and severe reactions will usually occur within the first few hours of vaccination.
If this occurs go to the Emergency Department of the nearest hospital immediately.
Active ingredient(s):
multicomponent meningococcal group B vaccine (recombinant, adsorbed)
Consumer Medicine Information (CMI)
This leaflet provides important information about using BEXSERO. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using BEXSERO.
Where to find information in this leaflet:
1. Why am I receiving BEXSERO?
BEXSERO is a vaccine used for the active immunisation of individuals from 2 months
of age and older to help prevent disease caused by Neisseria meningitidis serogroup
B.
Neisseria meningitidis (meningococcal disease) can cause meningitis (inflammation
of the spinal fluid and the tissues that surround the brain) or sepsis (blood poisoning).
Meningococcal disease is an infectious disease that is spread from person to person
through regular close contact through respiratory droplets. It is a very serious disease
and is sometimes fatal. It may cause permanent physical and neurological damage.
BEXSERO can help to protect you or your child from meningococcal disease caused by
Neisseria meningitidis group B. It is not expected to provide protection against all
circulating meningococcal group B types or from meningococcal disease caused by different
kinds of microbes.
BEXSERO works by causing your body to produce its own protection (antibodies) against
meningococcal bacteria. Your body usually takes a few weeks after receiving the vaccination
to develop protection against Neisseria meningitidis group B.
If a vaccinated person comes into contact with Neisseria meningitidis group B, the
body is usually able to destroy it. However, as with all vaccines, 100% protection
cannot be guaranteed.
Sometimes individuals may react unfavourably to the vaccine. The chance of a severe
reaction from BEXSERO is very small but the risks from not being vaccinated against
meningococcal disease may be very serious.
2. What should I know before I receive BEXSERO?
Warnings
Do not receive BEXSERO if you or your child:
are allergic to BEXSERO, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor or nurse if you or your child:
are allergic to kanamycin, an antibiotic. If present, the level of kanamycin in the
vaccine is low.
have had an allergic reaction or become unwell after receiving any other vaccine.
have a severe infection with a high temperature.
In this case vaccination with BEXSERO may have to be delayed. A minor infection such
as a cold should not be problem however talk to your doctor or nurse about this before
being vaccinated.
have any other medical conditions including any that involve your immune system
Little is known about the effectiveness of BEXSERO when administered to individuals
with weakened immunity due to the use of immunosuppressive medications or genetic
disorders of the body's natural defence system. It is possible the effectiveness of
BEXSERO could be reduced in such individuals.
take any medicines for any other condition
are receiving treatment that blocks part of the immune system known as complement
activation such as eculizumab. Individuals could remain at risk of Neisseria meningitidis
group B infection even after vaccination with BEXSERO.
If your child was born prematurely (before or at 28 weeks gestation), particularly
if they had breathing difficulties, please tell your doctor. Stopping breathing or
irregular breathing for a short time may be more common in the first 3 days following
vaccination in these babies and they may need special monitoring.
The safety and efficacy of BEXSERO in adults over the age of 50 has not been established.
There are limited data on the use in patients with chronic medical conditions.
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.
They will discuss with you the benefits and risks of receiving BEXSERO during pregnancy
or whilst breastfeeding.
Fainting
Fainting can occur following, or even before, any needle injection. Tell the person
giving you your injection if you or your child have ever fainted with a previous injection.
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 BEXSERO and affect how it works.
Tell your doctor or nurse if you or your child have had any vaccines recently.
BEXSERO may be given at the same time as other vaccinations.
Other vaccines must be injected into a different arm or leg from the site of the BEXSERO
injection. These include any of the following vaccine components:
diphtheria, tetanus, whooping cough (pertussis), Haemophilius influenzae type B, polio,
hepatitis B, pneumococcal, measles, mumps, rubella, chickenpox and meningococcus A,
C, W and Y.
Your doctor or nurse may ask you to give your child medicines that helps to lower
fever (a common side effect). This will help to reduce some of the side effects of
BEXSERO.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BEXSERO.
4. How do I receive BEXSERO?
How much is given
Your doctor or nurse will give you BEXSERO as an injection
The dose is 0.5 mL
You or your child may be given more than one single dose of BEXSERO. Talk to your
doctor or nurse for more information.
How it is given
BEXSERO is injected into your upper arm or in children it can be given into the thigh
muscle
It should not be injected directly into a blood vessel or into or under the skin
If you are given too much BEXSERO
If you think that you have been given too much BEXSERO, 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 after receiving BEXSERO?
Things you should do
keep a record of your/your child’s vaccination history
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BEXSERO
affects you.
No studies on the effects on the ability to drive and use machines have been performed.
Looking after your medicine
BEXSERO will usually be stored at the doctor’s clinic or at the pharmacy.
If you need to store BEXSERO it is important to keep it in the refrigerator between
2oC and 8oC.
Keep BEXSERO in the carton to protect it from light.
DO NOT FREEZE BEXSERO. FREEZING THIS MEDICINE WILL DESTROY THE VACCINE.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
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 or your child do experience any side effects,
most of them are minor and temporary. However, some side effects may need medical
attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Your doctor or nurse might ask you to remain for observation following your vaccination.
Less serious side effects
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Less serious side effects
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What to do
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All age groups:
Common:
pain at the injection site, redness at the injection site, swelling of the skin at
the injection site, hardness of skin at the injection site
headache
painful joints
Infants, toddlers and children up to 10 years of age:
Very common:
fever (38oC or higher)
loss of appetite
tenderness at the injection site (including severe tenderness at the injection site
resulting in crying when injected limb was moved), redness of skin at the injection
site, hardness of skin at the injection site, swelling of skin at the injection site
sleepiness
feeling irritable, unusual crying
vomiting (uncommon after booster)
diarrhoea
headache
painful joints
Common:
skin rash in infants and children aged 2 to 10 years
fever (39.5oC or higher)
The incidence of fever may be decreased by the use of paracetamol. Before you or your
child receives the vaccination, ask your doctor about the risks of fever and how to
treat it, including what to do if fever does not respond to initial treatment.
Adolescents from 11 years of age and adults:
Very common:
pain at the injection site (potentially severe which may lead to an inability to perform
normal daily activity
redness of the skin at the injection site, swelling of the skin at the injection site,
hardness of skin at the injection site
painful muscles and joints
nausea
a general feeling of being unwell
headache
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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allergic reaction
Signs of an allergic reaction include:
swelling of the limbs, face, eyes, inside of the nose, mouth or throat
shortness of breath, breathing or swallowing difficulties
hives, itching (especially of the hands or feet), reddening of the skin (especially
around the ears) or severe skin reactions
unusual tiredness or weakness that is sudden and severe
Allergy to BEXSERO is rare. Severe reactions will usually occur within the first few
hours of vaccination. If this occurs go to the Emergency Department of the nearest
hospital immediately.
Infants, toddlers and children up to 10 years of age:
Uncommon:
high fever (40oC or higher)
seizures (including febrile seizures due to fever)
dry skin
paleness (rare after booster)
Rare:
itchy skin, skin rash
Kawasaki disease – symptoms may include fever that lasts more than 5 days associated
with a rash on the trunk of the body and sometimes followed by a peeling of the skin
on the hands and fingers, swollen glands in the neck, red eyes, lips, throat, tongue
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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.
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Side effects reported during marketed use include:
enlarged lymph nodes
allergic reactions
collapse, sudden onset of muscle floppiness
less responsive than usual or a lack of awareness
paleness or bluish skin discolouration in young children
skin rash, fever (adolescents from 11 years of age and adults)
feeling faint or fainting
injection site reactions like extensive swelling of the vaccinated limb, blisters
at or around the injection site and hard lump at the injection site (which may persist
for more than one month)
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 prescription.
What BEXSERO contains
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Active ingredient
(main ingredient)
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Neisseria meningitidis Group B factor H binding protein fusion protein
Neisseria meningitidis Group B Neisseria adhesin A protein
Neisseria meningitidis Group B Neisseria heparin binding antigen fusion protein
Neisseria meningitidis serogroup B outer membrane vesicles
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Other ingredients
(inactive ingredients)
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aluminium hydroxide hydrate
histidine
sodium chloride
sucrose
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What BEXSERO looks like
BEXSERO is a white, opalescent liquid suspension for injection, supplied in a pre-filled
syringe providing 1 dose of 0.5 ml.
BEXSERO pre-filled syringes without needle (AUST R 190718). Available in packs of
1 or 10.
BEXSERO pre-filled syringes with needle (AUST R 190719). Available in a pack of 1
pre-filled syringe plus 2 needles.
Not all presentations and pack sizes may be marketed.
Who distributes BEXSERO
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067
Trade marks are owned by or licensed to the GSK group of companies.
© 2023 GSK group of companies or its licensor.
This leaflet was prepared 9 November 2023.
Version 11.0.