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 medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why is my child being given BEYFORTUS?
BEYFORTUS contains the active ingredient nirsevimab. BEYFORTUS is a medicine used
to protect your baby from getting respiratory syncytial virus (RSV) disease during
their first RSV season. It may also be given to children less than 2 years of age who are at risk of severe
RSV disease in their second RSV season.
2. What should I know before my child is given BEYFORTUS?
Do not use if you have ever had an allergic reaction to nirsevimab 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.
3. What if my child is taking other medicines?
Some medicines may interfere with BEYFORTUS and affect how it works.
4. How is BEYFORTUS given?
BEYFORTUS is given by a healthcare professional as an injection in the muscle, usually
in the outer part of the thigh.
BEYFORTUS should be given before the RSV season, or as soon as possible after birth
for children born during the RSV season.
The recommended dose is dependent on weight, if it’s for the first or second RSV season
and also if your child is having a heart operation.
5. What should I know after my child is given BEYFORTUS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that your child has recently received
BEYFORTUS.
Call your doctor straight away, or seek medical help immediately, if you notice any
signs of an allergic reaction, such as:
difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or raised bumps
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|
Looking after your medicine
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Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
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6. Are there any side effects?
The most common side effects include redness, swelling or pain at the injection site,
rash or fever.
This medicine 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:
nirsevimab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BEYFORTUS. 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 BEYFORTUS.
Where to find information in this leaflet:
1. Why is my child being given BEYFORTUS?
BEYFORTUS contains the active ingredient nirsevimab.
BEYFORTUS is a medicine used to protect your baby from getting respiratory syncytial
virus (RSV) disease during their first RSV season. It may also be given to children less than 2 years of age who are at risk of severe
RSV disease in their second RSV season.
Nirsevimab is an antibody that blocks the protein that RSV needs to infect the body
and helps stops the virus from entering and infecting human cells.
RSV is a common respiratory virus that usually causes mild symptoms (cold-like illness)
but can cause severe illness, including inflammation of the small airways in the lung
(bronchiolitis) and pneumonia (an infection of the lungs) that may lead to hospitalisation
or even death. The virus is usually more common during winter (known as the RSV season).
2. What should I know before my child is given BEYFORTUS?
Warnings
Do not use BEYFORTUS if:
Your child is allergic to nirsevimab, or any of the ingredients listed at the end
of this leaflet.
Check with your doctor or nurse if your child:
has a low number of blood platelets (which help blood clotting), a bleeding problem
or bruise easily or are taking a medicine to prevent blood clots (anticoagulant)
After treatment, your child 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?
3. What if my child is taking other medicines?
Tell your child’s doctor, nurse or pharmacist if your child is taking any other medicines,
including any medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
It is not expected that BEYFORTUS will be affected by other medicines or will affect
how other medicines work, but tell your doctor, nurse or pharmacist about all the
medicines your child is taking, regardless.
BEYFORTUS may be given at the same time as vaccines during the same visit.
4. How is BEYFORTUS given?
How and when BEYFORTUS is given
BEYFORTUS is given by a doctor, nurse or pharmacist as an injection in the muscle.
It is usually given in the outer part of the thigh.
BEYFORTUS should be given before the RSV season. If your child is born during the
RSV season, BEYFORTUS should be given as soon as possible after birth.
How much is given
The recommended dose is:
50 mg (given as a single injection) for babies weighing less than 5 Kg and 100 mg
for babies weighing 5 Kg or more in their first season.
200 mg (given as 2 x 100 mg injections) for children who are vulnerable to severe
RSV disease in their second RSV season
If your child is having a heart operation (cardiac surgery), he or she may be given
an extra dose of BEYFORTUS after the operation.
If too much BEYFORTUS is given
As BEYFORTUS is given by a doctor or other healthcare professional, it is not likely
that your child will receive too much. If necessary, your doctor can manage the situation
If you think your child has received too much BEYFORTUS 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 my child has been given BEYFORTUS?
Things you should do
Call your doctor straight away, or seek medical help immediately, if you:
notice any signs of an allergic reaction, such as:
difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or raised bumps
Remind any doctor, dentist or pharmacist you visit that your child has received BEYFORTUS
recently.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where young children cannot reach it.
6. Are there any side effects?
All medicines can have side effects. If your child does 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.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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Symptoms of a serious allergic reaction
difficulty breathing or swallowing
swelling of the face, lips, tongue or throat
severe itching of the skin, with a red rash or raised bumps
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Call your child’s doctor or nurse straight away, or go straight to the Emergency Department
at your nearest hospital if you notice your child has any of these serious side effects.
|
Tell your child’s doctor, nurse or pharmacist if you notice anything else that may
be making your child feel unwell.
Other side effects not listed here may occur in some children.
Reporting side effects
After you have received medical advice for any side effects your child experienced,
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 BEYFORTUS contains
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Active ingredient
(main ingredient)
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nirsevimab
|
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Other ingredients
(inactive ingredients)
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Histidine, histidine hydrochloride monohydrate, arginine hydrochloride, sucrose, polysorbate
80 and water for injections
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Your child should not receive this medicine if they are allergic to any of these ingredients.
What BEYFORTUS looks like
BEYFORTUS 50 mg in 0.5 mL (AUST R 397898) contains 0.5 mL of a colourless to yellow
solution in a needleless glass prefilled syringe with a purple plunger rod and a FluoroTec
(non-latex) coated stopper, plus a Luer Lock and syringe cap.
BEYFORTUS 100 mg in 1 mL (AUST R 397899) contains 1 mL of a colourless to yellow solution
in a needleless glass prefilled syringe with a light blue plunger rod and a FluoroTec
(non-latex) coated stopper, plus a Luer Lock and syringe cap.
Both strengths are registered in packs containing 1 or 5 single-dose prefilled syringes.
Who distributes BEYFORTUS
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
For all enquiries contact sanofi-aventis on 1800 818 806
This leaflet was prepared in November 2023.
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