XEVUDY has provisional approval for treatment of COVID-19 in adults and adolescents (aged 12 years and over and weighing
at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation
of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation
or death. This approval has been granted on the basis of short term efficacy and safety
data. Evidence of longer term efficacy and safety from ongoing trials continues to
be gathered and assessed.
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 am I being given XEVUDY?
XEVUDY contains the active ingredient sotrovimab. XEVUDY is used to treat COVID-19.
For more information, see Section
1. Why am I being given XEVUDY? in the full CMI.
2. What should I know before I am given XEVUDY?
Do not use if you have ever had an allergic reaction to sotrovimab 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 XEVUDY? in the full CMI.
3. What if I am taking other medicines?
4. How XEVUDY is given?
XEVUDY should not be given to you if you have been hospitalised due to COVID-19.
The recommended dose for adults and adolescents aged 12 years and older and weighing
at least 40 kg is one 500 mg dose of XEVUDY.
XEVUDY is recommended to be given to you within 5 days of showing symptoms of COVID-19.
It is given as a drip into a vein (intravenous infusion) by a doctor or nurse. It
takes 30 minutes to give you the full dose of medicine.
5. What should I know when being given XEVUDY?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you have taken XEVUDY.
Seek medical attention if you think you may be having an allergic reaction.
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Things you should not do
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Do not stop before the full dose of medicine is taken.
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Driving or using machines
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XEVUDY is not expected to have any effect on your ability to drive or use machines.
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Looking after your medicine
|
XEVUDY will be given to you in a healthcare facility and the healthcare professionals
will be responsible for its storage.
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6. Are there any side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets
them. Some of the side effects can be serious, and you need to know what symptoms
to look out for. XEVUDY can cause allergic reactions which may be severe. If you develop
symptoms of an allergic reaction, you must tell your doctor or nurse as soon as possible.
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.
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:
sotrovimab
XEVUDY has provisional approval for treatment of COVID-19 in adults and adolescents (aged 12 years and over and weighing
at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require initiation
of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation
or death.
This approval has been granted on the basis of short term efficacy and safety data.
Evidence of longer term efficacy and safety from ongoing trials continues to be gathered
and assessed.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using XEVUDY. 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 XEVUDY.
Where to find information in this leaflet:
1. Why am I being given XEVUDY?
XEVUDY contains the active ingredient sotrovimab, a monoclonal antibody which is a type of protein designed to recognise a specific
target on the SARS-CoV-2 virus, the virus that causes COVID-19 .
XEVUDY is used to treat COVID-19.
XEVUDY stops the virus from attaching to cells and this blocks the virus from multiplying
in the body. This can help your body to overcome the infection and prevent you from
getting seriously ill.
2. What should I know before I am given XEVUDY?
Warnings
Do not take XEVUDY if:
you are allergic to sotrovimab, 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 if you:
have any other medical conditions
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives or dyes. XEVUDY can cause
allergic reactions.
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 think you could be pregnant or intend
to become pregnant and discuss if you should receive XEVUDY. Your doctor will consider
the benefit to you and the risk to your baby of receiving XEVUDY while you're pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. There is insufficient
data on whether the ingredients of XEVUDY can pass into breast milk. If you are breast-feeding,
you must check with your doctor before you receive XEVUDY.
Children
XEVUDY is not intended to be given to children younger than 12 years old or weighing
less than 40 kg.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect XEVUDY.
4. How XEVUDY is given?
XEVUDY should not be given to you if you have been hospitalised due to COVID-19.
How much is given
The recommended dose for adults and adolescents aged 12 years and older and weighing at least 40 kg is
one 500 mg dose of XEVUDY.
When XEVUDY is given
XEVUDY is recommended to be given to you within 5 days of showing symptoms of COVID-19.
XEVUDY will be given to you in a healthcare facility under the supervision of a healthcare
professional.
It will be given to you as a drip into a vein (intravenous infusion).
It takes 30 minutes to give you the full dose of medicine.
After the infusion, your doctor or nurse will observe you for 1 hour to monitor for
signs of an allergic reaction.
5. What should I know when being given XEVUDY?
Things you should do
Remind any doctor, dentist or pharmacist you visit that have taken XEVUDY.
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines before you receive XEVUDY.
Tell your doctor if you are pregnant, think you may be pregnant or are planning to
have a baby.
Call your doctor straight away if you:
Think you may be having an allergic reaction
Things you should not do
Do not stop your medicine before the full dose has been taken.
Driving or using machines
XEVUDY is not expected to have any effect on your ability to drive or use machines.
Looking after your medicine
XEVUDY will be given to you in a healthcare facility and the healthcare professionals
caring for you will be responsible for storing this medicine.
XEVUDY should be stored in a refrigerator between 2°C to 8°C, in the original carton
to protect from light.
Do not freeze
Do not use after the expiry date
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
Unused medicine or waste material will be discarded by your healthcare professional.
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 doctor or pharmacist if you
have any further questions about side effects.
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 XEVUDY contains
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Active ingredient
(main ingredient)
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Sotrovimab
|
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Other ingredients
(inactive ingredients)
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Histidine
Histidine hydrochloride monohydrate
Sucrose
Methionine
Polysorbate 80
Water for injections
|
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Potential allergens
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None
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Do not be given this medicine if you are allergic to any of these ingredients.
What XEVUDY looks like
XEVUDY is supplied as a clear, colourless or yellow to brown concentrated injection
solution, in a 10 mL clear glass vial, with a rubber stopper and flip-off aluminium
over-seal.
(Aust R 364110).
Who distributes XEVUDY
XEVUDY is supplied in Australia by:
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067
Australia
Trademarks are owned by or licensed to the GSK group of companies.
© 2021 GSK group of companies or its licensor.
This leaflet was prepared in August 2021.
Version 1.0