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 or pharmacist.
This vaccine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I being given ABRYSVO?
ABRYSVO is a vaccine given to prevent disease of the respiratory tract (airways and
lungs) caused by a virus called respiratory syncytial virus (RSV). ABRYSVO is given
to pregnant individuals to protect their infants from birth through 6 months of age,
or individuals 60 years of age or older.
ABRYSVO contains the active ingredient recombinant respiratory syncytial virus pre-fusion
F protein.
2. What should I know before I am given ABRYSVO?
You should not be given ABRYSVO if you have ever had an allergic reaction to ABRYSVO
or any of the ingredients listed at the end of the CMI. Tell your healthcare professional
if you have or have had an allergic reaction after being given any other vaccine in
the past, bleeding problems, have an infection with a high fever, anxiety or fainting
following any needle injections or a weakened immune system.
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.
3. What if I am taking other medicines?
Tell your healthcare professional 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.
Tell your healthcare professional if you have recently been given or plan to be given
any other vaccine.
4. How is ABRYSVO given?
ABRYSVO will be given as a single dose injection into the muscle of your upper arm
by a doctor, nurse or other trained healthcare professional.
5. What should I know after being given ABRYSVO?
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Things you should do
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Check with your healthcare professional before you receive any other vaccines or take
other medicines.
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Driving or using machines
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ABRYSVO is unlikely to affect your ability to drive or use machines.
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Looking after your medicine
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ABRYSVO will normally be stored at the doctor's surgery or in the pharmacy.
If you need to store ABRYSVO, store the carton in a refrigerator (2°C to 8°C) in the
original package.
Do not freeze. Discard if the carton has been frozen.
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6. Are there any side effects?
Side effects of ABRYSVO include: pain, swelling or redness in the area where the vaccine
was given, muscle pain and headaches. Serious side effects include allergic reactions.
This vaccine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
recombinant respiratory syncytial virus pre-fusion F protein
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ABRYSVO. You should also speak to your healthcare professional if you would like further information
or if you have any concerns or questions about using ABRYSVO.
Where to find information in this leaflet:
1. Why am I being given ABRYSVO?
ABRYSVO is a vaccine, which is a type of medicine that helps to protect (immunise)
people from certain infectious diseases. It does this by preparing the body's defences
to fight the infection before you catch the bacteria or virus.
ABRYSVO is used to prevent disease of the respiratory tract (lungs) caused by a virus
called respiratory syncytial virus (RSV).
ABRYSVO contains a protein (antigen) from each of the two subgroups (A and B) of RSV.
RSV is a common virus which, in most cases, causes mild, cold-like symptoms such as
a sore throat, cough or a blocked nose. However, some individuals are at higher risk
of respiratory disease caused by RSV. This includes young infants, older adults and
those with chronic medical conditions such as heart or lung disease. In infants RSV
can cause serious lung problems such as bronchiolitis and pneumonia. In older adults
it can make existing conditions such as chronic obstructive pulmonary disease (COPD)
and congestive heart failure (CHF) worse. It can lead to hospitalisation in severe
cases, and in some cases it can be fatal.
ABRYSVO is given to:
pregnant individuals to protect their infants from birth through 6 months of age,
or
individuals 60 years of age or older.
As with any vaccine, ABRYSVO may not fully protect all those who receive it.
2. What should I know before I am given ABRYSVO?
Warnings
Do not use ABRYSVO if:
you are allergic to ABRYSVO or any of the ingredients listed at the end of this leaflet
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have an infection with a high fever
If this is the case, then vaccination will be postponed. There is no need to delay
vaccination for a minor infection, such as a cold, but talk to your doctor first.
have any bleeding problems or disorders, or bruise easily
are feeling nervous about the vaccination process or have ever fainted following any
needle injection
have a weakened immune system which may prevent you from getting the full benefit
from ABRYSVO
are less than 24 weeks pregnant
are less than 18 years of age
During vaccination, 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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.
Pregnant individuals can be given this vaccine in the late second or third trimester
(weeks 24 to 36).
It is unknown whether ABRYSVO is excreted into breast milk.
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.
Tell your healthcare professional if you have recently been given or plan to be given
any other vaccine.
4. How is ABRYSVO given?
How many injections will be given
For the vaccination of pregnant individuals to protect their infants
One single dose is given in the late second or third trimester of pregnancy (24 -
36 weeks).
For the vaccination of adults aged 60 years or over
One single dose is given.
Multiple vaccinations
If ABRYSVO is given at the same time as another vaccine, a different injection site
will be used for each injection.
If you are given too much ABRYSVO
Overdose is unlikely as ABRYSVO is available in a single dose presentation and will
be given by a trained healthcare professional.
5. What should I know after being given ABRYSVO?
Things you should do
Check with your healthcare professional before you receive any other vaccines or take
other medicines.
Driving or using machines
ABRYSVO is unlikely to affect your ability to drive or use machines.
Looking after your medicine
ABRYSVO will normally be stored at the doctor's surgery or in the pharmacy.
If you need to store ABRYSVO, store the carton in a refrigerator (2°C to 8°C) in the
original package.
Do not freeze. Discard if the carton has been frozen.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Your healthcare professional will dispose of any unused vaccine.
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. However, some side effects may need medical attention.
See the information below and, if you need to, ask your healthcare professional if
you have any further questions about side effects.
Side effects
Tell your healthcare professional
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.
7. Product details
This medicine is only available with a doctor's prescription.
What ABRYSVO contains
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Active ingredients
(main ingredients)
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Powder:
RSV subgroup A stabilised pre-fusion F protein
RSV subgroup B stabilised pre-fusion F protein
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Other ingredients
(inactive ingredients)
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Powder:
trometamol
trometamol hydrochloride
sucrose
mannitol
polysorbate 80
sodium chloride
Diluent:
water for injections
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Potential allergens
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n/a
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Do not use this medicine if you are allergic to any of these ingredients.
ABRYSVO does not contain lactose, gluten, tartrazine or any other azo dyes.
What ABRYSVO looks like
ABRYSVO is supplied as:
a white powder in a glass vial, plus
a diluent in a pre-filled syringe to dissolve the powder
After dissolving the powder in the diluent, the solution is clear and colourless.
ABRYSVO is supplied in cartons containing:
1 vial of powder for injection, 1 pre-filled syringe of diluent and 1 vial adapter
10 vials of powder for injection, 10 pre-filled syringes of diluent and 10 vial adapters
(AUST R 406624)
Who distributes ABRYSVO
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in March 2024.