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 healthcare provider.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using EVUSHELD?
EVUSHELD contains the active ingredients tixagevimab and cilgavimab. EVUSHELD is used
to:
- help prevent adults and adolescents (aged 12 years and older weighing at least
40 kg), who have not been recently in contact with someone who has COVID-19, from
getting COVID-19 illness when they are unlikely to be protected by a COVID-19 vaccine
or when vaccination is not recommended.
- treat adults with COVID-19 who do not require supplemental oxygen to treat COVID-19
and who are at increased risk for the illness becoming severe based on the evaluation
of your doctor.
2. What should I know before I use EVUSHELD?
You must not be given EVUSHELD if you have ever had an allergic reaction to tixagevimab
and cilgavimab or any of the ingredients listed at the end of the CMI.
Check with your doctor if you have any low numbers of blood platelets (which help
blood clotting), have a bleeding disorder or are taking a blood thinning medicine
(to prevent blood clots).
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 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.
For more information, see Section
3. What if I am taking other medicines? in the full CMI.
4. How is EVUSHELD given?
EVUSHELD will be given to you by your healthcare provider as two intramuscular injections,
one into each of your buttocks.
5. What should I know while I am being given EVUSHELD?
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Things you should do
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Seek medical attention if you think you experience any problems with this medicine.
Remind any healthcare provider you visit that you are using EVUSHELD.
If you are taking EVUSHELD to help prevent you from getting COVID-19, and you get
symptoms of COVID-19 please contact your doctor right away.
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6. Are there any side effects?
Pain, bruising of the skin, soreness or swelling, at the injection site are common
side effects.
Serious allergic reactions. They may include the following symptoms: difficulty breathing
or swallowing, swelling of the face, lips, tongue or throat, severe itching of the
skin, with a red rash or raised bumps.
Serious cardiac and blood clot adverse events including the following symptoms: pain,
pressure, or discomfort in the chest, arms, neck, back, stomach, legs or jaw, abdominal
pain, shortness of breath, faster than normal heart beat, feeling tired or weak (fatigue),
feeling sick (nausea), swelling in your ankles or lower legs, coughing up blood, difficulties
speaking or confusion, loss of movement or weakness on one side of the body or face,
severe headache. It is not known if these events are related to EVUSHELD or underlying
medical conditions.
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 ingredients: tixagevimab and cilgavimab
EVUSHELD has provisional approval to:
- help prevent adults and adolescents (aged 12 years and older weighing at least
40 kg), who have not been recently in contact with someone who has COVID-19, from
getting COVID-19 illness when they:
- have an illness or take medicines making them unlikely to respond to or be protected
by vaccination against COVID- 9
- or are not recommended to have a vaccine due to a history of severe allergies to
a COVID-19 vaccine or its components.
Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination
is recommended.
- treat adults with COVID-19 who do not require supplemental oxygen to treat COVID-19
and who are at increased risk for the illness becoming severe based on the evaluation
of your doctor.
This approval has been granted on the basis of short term efficacy and safety data.
Evidence of longer term efficacy and safety from ongoing trial continues to be gathered
and assessed.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EVUSHELD. 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 EVUSHELD.
Where to find information in this leaflet:
1. Why am I using EVUSHELD?
EVUSHELD contains the active ingredients tixagevimab and cilgavimab.
Tixagevimab and cilgavimab are types of protein called ‘monoclonal antibodies’.
Tixagevimab and cilgavimab (EVUSHELD) work specifically against the SARS-CoV-2 virus
preventing it from entering your cells. This can help prevent you from getting COVID-19
illness or help your body to overcome the infection and reduce the risk of you developing
severe illness.
COVID-19 is an illness which can affect your lungs, airways and other organs. COVID-19
illnesses can be very mild (sometimes with no symptoms), however in some cases symptoms
can be severe and can result in hospitalisation or even death.
What EVUSHELD is used for
EVUSHELD is used to help prevent adults and adolescents (aged 12 years and older weighing
at least 40 kg), who have not been recently in contact with someone who has COVID-19,
from getting COVID-19 illness when they:
- have an illness or take medicines making them unlikely to respond to or be protected
by vaccination against COVID-19
- or are not recommended to have a vaccine due to a history of severe allergies to
a COVID-19 vaccine or its components.
Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination
is recommended.
EVUSHELD is also used to treat adults with COVID-19 who do not require supplemental
oxygen to treat COVID-19 and who are at increased risk for the illness becoming severe
based on the evaluation of your doctor.
2. What should I know before I use EVUSHELD?
Warnings
Do not use EVUSHELD if:
you are allergic to tixagevimab, cilgavimab 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 allergies
have any low numbers of blood platelets (which help blood clotting)
have had a heart attack or stroke, have other heart problems, or are at high-risk
of cardiac (heart) events
have a bleeding disorder or are taking a blood thinning medicine (to prevent blood
clots)
are taking, have recently taken or might take any medicines for any other condition.
If you have received a COVID-19 vaccine, tell your doctor or nurse, prior to using
EVUSHELD. It is possible that EVUSHELD may reduce your body’s immune response to a
COVID-19 vaccine.
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
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your healthcare provider for advice before receiving this medicine.
Tell your doctor if you are pregnant, or if you might be pregnant. There is not enough
information to be sure that this medicine is safe for use in pregnancy. EVUSHELD will
only be given if the potential benefits of treatment outweighs the potential risks
to the mother and the unborn child.
Talk to your doctor if you are breastfeeding. It is not yet known whether EVUSHELD
passes into human milk or what the effects might be on the baby or milk production.
Your doctor will help you decide whether to keep breastfeeding or to start treatment
with this medicine.
Children and adolescents
EVUSHELD should not be given to children below 12 years of age or weighing less than
40 kg.
3. What if I am taking other medicines?
If you are getting a COVID-19 vaccine, tell your doctor, nurse or pharmacist that
you have used or are using EVUSHELD.
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 EVUSHELD.
4. How is EVUSHELD given?
How much EVUSHELD is given
EVUSHELD consists of two medicines, tixagevimab and cilgavimab. You will receive 2
injections one after the other.
The recommended dose is 600 mg given as two 3 mL injections:
300 mg of tixagevimab
300 mg of cilgavimab.
You may also receive repeat doses of 600 mg EVUSHELD (300 mg of tixagevimab and 300
mg of cilgavimab) every 6 months for the continuous prevention of COVID-19, as advised
by your doctor.
How you will be given EVUSHELD
EVUSHELD will be given to you in a healthcare facility under the supervision of a
healthcare professional who is experienced in the use of this type of treatment. They
will watch you closely while you are being given this medicine. This is in case you
get any side effects.
EVUSHELD will be given to you by your healthcare provider as two intramuscular injections,
one into each of your buttocks.
Your doctor or nurse will decide how long you will be monitored after you are given
the medicine, in case you have any side effects.
If you use too much EVUSHELD
As EVUSHELD is given under the close supervision of a healthcare provider it is unlikely
that you will be given too much.
If you are concerned that you have been given too much EVUSHELD, tell your healthcare
provider immediately, phone the Poisons Information Centre (by calling 13 11 26) 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 I am being given EVUSHELD?
Things you should do
Tell any other doctors you see that you have had this medicine to prevent or treat
COVID-19.
If you are getting a COVID-19 vaccine, tell the doctor, nurse or pharmacist you have
had this medicine.
COVID-19 is caused by different strains (variants) of the SARS-CoV-2 virus that change
over time. EVUSHELD may be less effective at preventing COVID-19 caused by some strains
than others. If you are taking EVUSHELD to help prevent you from getting COVID-19,
and you get symptoms of COVID-19 please contact your doctor right away. COVID-19 affects
different people in different ways:
the most common symptoms include fever, cough, tiredness and loss of taste or smell;
the most serious symptoms include difficulty breathing or shortness of breath, loss
of speech or mobility, or confusion and chest pain.
Call your doctor straight away if you notice any signs of serious 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.
Driving or using machines
It is unlikely that EVUSHELD will affect your ability to drive or use machines.
Looking after your medicine
EVUSHELD will be given to you in a healthcare facility and the healthcare professionals
caring for you will be responsible for storing this medicine.
Unopened vials should be stored in a refrigerator (at 2°C to 8°C), in the original
carton to protect from light.
Do not freeze. Do not shake.
Do not use this medicine after the expiry date which is stated on the label and carton
after EXP. The expiry date refers to the last day of that month.
Prepared syringes should be used immediately. If necessary, store the prepared syringes
for no more than 4 hours either:
at 2°C to 8°C, or
at room temperature up to 25°C
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.
Cardiac (heart) and blood clot events: serious cardiac and blood clot adverse events
have happened, but were not common in clinical trials. In the clinical trial studying
preexposure prophylaxis for the prevention of COVID-19, in people with risk factors
for cardiac events (including a history of heart attack), more people who received
EVUSHELD experienced serious cardiac events than people who did not receive EVUSHELD.
More people who received EVUSHELD experienced blood clot events than people who did
not receive EVUSHELD. One event of blood clot in a major blood vessel was reported
6 days after EVUSHELD was given to an individual. The CT scan of the abdominal and
groin region at the time of the event showed pre-existing deposits in the blood vessels.
A possible relationship between this event and the treatment with EVUSHELD cannot
be ruled out. Overall, it is not known if these cardiac and blood clot events are
related to EVUSHELD or underlying medical conditions.
Contact your healthcare provider or get medical help right away if you get any symptoms
of cardiac events, including pain, pressure, or discomfort in the chest, arms, neck,
back, stomach or jaw, as well as shortness of breath, feeling tired or weak (fatigue),
feeling sick (nausea), or swelling in your ankles or lower legs.
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
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
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 EVUSHELD contains
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Active ingredient
(main ingredient)
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tixagevimab and cilgavimab
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Other ingredients
(inactive ingredients)
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histidine, histidine hydrochloride monohydrate, sucrose, polysorbate 80 and water
for injection
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You should not be given this medicine if you are allergic to any of these ingredients.
What EVUSHELD looks like
Each carton of EVUSHELD contains:
• one single use clear glass vial of tixagevimab solution for injection (dark grey
vial cap)
• one single use clear glass vial of cilgavimab solution for injection (white vial
cap).
Each of the single use vials contains a clear to opalescent, colourless to slightly
yellow solution.
Aust R 378245
Who distributes EVUSHELD
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342
This leaflet was prepared on 13 February 2023
© AstraZeneca 2023
Doc ID-004808156 v3