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 receiving ANDEXXA?
ANDEXXA contains the active ingredient andexanet alfa. ANDEXXA is used to reverse
the effects of certain blood thinning medications called factor Xa inhibitors (apixaban
or rivaroxaban) in case of a life-threatening or uncontrolled bleeding situation.
2. What should I know before I am given ANDEXXA?
Do not use if you have ever had an allergic reaction to ANDEXXA 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 I am taking other medicines?
Tell your doctor or nurse if you are taking, have recently taken, or might take any
other medicines.
4. How will I be given ANDEXXA?
ANDEXXA will be given to you in a hospital or clinic by a doctor or nurse.
5. What should I know while receiving ANDEXXA?
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Things you should do
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Tell your doctor if surgery is planned for you which requires treatment with heparin.
Tell your doctor if any urgent surgery is planned for you.
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Looking after your medicine
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ANDEXXA will be stored by your healthcare providers at the hospital or clinic where
you receive treatment.
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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. The most common side effects are sweating or chills
(fever) and feeling hot (flushing). The more serious side effects are sudden numbness
or weakness in the face, arm, or leg, especially on one side of the body (stroke),
pressure, tightness, pain, or a squeezing or aching sensation in your chest or arms
that may spread to your neck, jaw or back (heart-attack), rapid or irregular heartbeat,
loss of consciousness or unresponsiveness (cardiac arrest), swelling, change in skin
colour, trouble breathing (blood clot in the leg, arm, or lung)
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(s): andexanet alfa
This medicine has provisional approval in Australia for adult patients treated with a direct factor Xa (FXa) inhibitors
apixaban or rivaroxaban when reversal of anticoagulation is needed due to life-threatening
or uncontrolled bleeding. The decision to approve this medicine has been made on the
basis of promising results from preliminary studies. More evidence is required to
be submitted when available to fully confirm the benefit and safety of the medicine
for this use.
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ANDEXXA. 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 ANDEXXA.
Where to find information in this leaflet:
1. Why am I receiving ANDEXXA?
ANDEXXA contains the active ingredient andexanet alfa. ANDEXXA is factor Xa (FXa) decoy molecule that binds to certain blood thinning medications
called FXa inhibitors (apixaban or rivaroxaban).
ANDEXXA is used to reverse the effects of certain FXa inhibitors (apixaban or rivaroxaban).
FXa inhibitors are given to prevent clots in your blood vessels. Your doctor may decide
to give you ANDEXXA to rapidly reverse the effects of these blood thinning medications
in case of a life-threatening or uncontrolled bleeding situation.
2. What should I know before I am given ANDEXXA?
Warnings
Do not use ANDEXXA if:
you are allergic to andexanet alfa 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 surgery planned for you which requires treatment with heparin
have any urgent surgery planned for you
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
ANDEXXA is not recommended during pregnancy or if you have the potential to become
pregnant and are not using contraception. It is not known if ANDEXXA can harm your unborn baby.
Do not breast-feed your child while you are taking ANDEXXA. It is not known whether ANDEXXA is passed into breast milk.
Children and adolescents
There is no information on the use of ANDEXXA in children and adolescents under 18
years of age.
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 ANDEXXA.
4. How will I be given ANDEXXA?
ANDEXXA will be given to you in a hospital or clinic
Your doctor or nurse will give you ANDEXXA by injection or infusion into a vein
Your doctor will decide how much ANDEXXA you need to take. This is based on the type
and dose of blood thinning medication you take, as well as the time since your last
dose of blood thinning medication
After you have received ANDEXXA, your doctor will decide when to restart your blood
thinning medication
If you stop taking ANDEXXA
Do not stop treatment with ANDEXXA unless you have discussed this with your doctor
If you have any further questions about your treatment, ask your doctor
5. What should I know while receiving ANDEXXA?
Things you should do
Tell your doctor if surgery is planned for you which requires treatment with heparin
Tell your doctor if any urgent surgery is planned for you
Tell your doctor if any urgent surgery is planned for you Call your doctor straight
away if you:
have a serious allergic reaction to ANDEXXA. Symptoms may include swelling of your
face, tongue or mouth, breathing difficulties, feeling faint, dizzy or lightheaded
Things you should not do
Do not stop taking this medicine suddenly, unless you have discussed this with your
doctor
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ANDEXXA
affects you.
ANDEXXA is not expected to affect your ability to drive or use any machines or tools.
Be careful if you feel tired, dizzy, or have a headache.
Looking after your medicine
ANDEXXA will be stored by your healthcare providers at the hospital or clinic where
you receive treatment.
Unopened vials should be stored refrigerated at 2°C to 8°C. Do not freeze. Protect
from light.
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.
Less serious side effects
The above list includes the more common side effects of your medicine. They are usually
mild and short-lived.
Serious side effects
The above list includes serious side effects that require medical attention or hospitalisation.
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 ANDEXXA contains
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Active ingredient
(main ingredient)
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andexanet alfa
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Other ingredients
(inactive ingredients)
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Trometamol, trometamol hydrochloride, arginine hydrochloride, sucrose, mannitol, and
polysorbate 80
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You should not receive this medicine if you are allergic to any of these ingredients.
What ANDEXXA looks like
ANDEXXA (AUST R 388713) is a white to off-white powder supplied in a clear glass vial
closed by a rubber stopper. There are 4 or 5 vials in each pack.
Who distributes ANDEXXA
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
Macquarie Park NSW 2113
Telephone: 1800 805 342
This leaflet was prepared in January 2024.
ANDEXXA is a registered trade mark of the AstraZeneca group of companies.
© AstraZeneca 2024
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