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 using TEZSPIRE?
TEZSPIRE contains the active ingredient tezepelumab. It is used with other asthma
medicines to treat severe asthma in adults and adolescents (12 years of age and older).
2. What should I know before I use TEZSPIRE?
Do not use if you have ever had an allergic reaction to TEZSPIRE 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?
It is possible that some medicines and TEZSPIRE may interfere with each other.
Your doctor and pharmacist can advise you. TEZSPIRE has been used together with other
commonly used asthma medicines.
4. How do I use TEZSPIRE?
TEZSPIRE is given as an injection under the skin (subcutaneously). The recommended
dose is 210 mg every 4 weeks.
5. What should I know while using TEZSPIRE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TEZSPIRE.
Keep all of your doctor's and/or hospital's appointments so that your progress can
be checked.
Ask your doctor, nurse or pharmacist if you have any questions about your personal
Asthma Action Plan.
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Things you should not do
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Do not use in patients under 12 years old.
Do not stop using this medicine suddenly once you have started TEZSPIRE without checking
with your doctor.
Do not suddenly stop taking your asthma medicines (especially ones called corticosteroids)
once you have started TEZSPIRE, unless instructed by your doctor.
Do not use TEZSPIRE if you think it has been frozen, dropped or damaged.
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Looking after your medicine
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Store TEZSPIRE in the refrigerator at 2°C to 8°C. Do not freeze, shake or expose to
heat.
TEZSPIRE should be kept in the original package.
TEZSPIRE may be kept at room temperature up to 25˚C in the original carton for a maximum
of 30 days. Once TEZSPIRE has reached room temperature, do not put it back in the
refrigerator. Dispose of TEZSPIRE that has been stored at room temperature after 30
days.
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6. Are there any side effects?
Serious side effects may include an allergic reaction. Common side effects may include
sore throat (pharyngitis), injection site reaction (i.e. redness, swelling, and pain
at the injection site), joint pain (arthralgia), rash.
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):
tezepelumab
Consumer Medicine Information (CMI)
This leaflet provides important information about using TEZSPIRE. 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 TEZSPIRE.
Where to find information in this leaflet:
1. Why am I using TEZSPIRE?
TEZSPIRE contains the active ingredient tezepelumab. Tezepelumab is an antibody (a type of protein) that recognises and binds to a specific
target substance in the body. The target of tezepelumab is a protein called thymic
stromal lymphopoietin (TSLP).
TSLP plays a central role in causing the signs and symptoms of asthma. This medicine
works by blocking the action of TSLP.
TEZSPIRE is used with other asthma medicines to treat severe asthma in adults and
adolescents (12 years of age and older) when the disease is not controlled with the
current Asthma medicines. TEZSPIRE may reduce the number of asthma attacks you experience, improve your breathing
and reduce your asthma symptoms.
2. What should I know before I use TEZSPIRE?
Warnings
Do not use TEZSPIRE if:
you are allergic to tezepelumab or any of the other ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have a sudden asthma attack. TEZSPIRE is not a rescue medicine.
Check with your doctor if:
your asthma remains uncontrolled or worsens during treatment with TEZSPIRE.
you have ever had a severe allergic reaction (hypersensitivity) (symptoms may vary,
but can include swelling of your face, tongue or mouth, breathing problems, fainting,
dizziness, feeling lightheaded, hives, and rash). If you notice any of these signs,
speak to your healthcare provider immediately.
you have a parasitic infection or if you live in an area where parasitic infections
are common or if you are travelling to such a region. TEZSPIRE may weaken your ability
to fight certain types of parasitic infections.
you are taking or have recently taken any other medicines for any other condition,
even those not prescribed.
you have recently had or are due to have a vaccination.
If you already have a serious infection 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, think you may be pregnant or intend to
become pregnant. Do not use TEZSPIRE unless your doctor tells you to. It is not known
if TEZSPIRE can harm your unborn baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed. TEZSPIRE may
pass into breast milk. Your doctor will discuss with you whether you should stop treatment
with TEZSPIRE while you are breast-feeding, or if you should stop breast-feeding.
Children
Do not use TEZSPIRE in patients under 12 years old.
The safety and benefits of this medicine are not known in children below the age of
12.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking or have recently taken 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 TEZSPIRE.
Do not suddenly stop taking your other asthma medicines once you have started TEZSPIRE. These medicines (especially
ones called corticosteroids) must be stopped gradually, under the direct supervision
of your doctor and on your response to TEZSPIRE.
Tell your doctor if you have recently received a vaccine or are due to have a vaccination.
4. How do I use TEZSPIRE?
How much and when to use
The recommended dose is 210 mg every 4 weeks.
Follow the instructions provided and use TEZSPIRE exactly as your doctor has instructed
you.
How to use TEZSPIRE
TEZSPIRE is given as an injection under the skin (subcutaneously).
Always use TEZSPIRE exactly as your doctor has instructed you. If you or your caregiver
have any questions, talk to your doctor.
Your doctor should decide if you or your caregiver should inject TEZSPIRE. Before
using your TEZSPIRE prefilled syringe or prefilled pen, your doctor should show you
or your caregiver how to use it the right way. Read the 'Instructions for use for
TEZSPIRE prefilled syringe' or 'Instructions for use for TEZSPIRE prefilled pen' carefully
before using TEZSPIRE and each time you get a refill. There may be new information.
Do not share or use TEZSPIRE prefilled syringe or prefilled pen more than one time.
If you forget to use TEZSPIRE
TEZSPIRE should be used regularly at the same time on the day of administration.
If you missed a dose, inject a dose as soon as possible. Continue your next injection
on your usual injection day. If you did not notice that you have missed a dose until
it is time for your next scheduled dose, then inject the next scheduled dose as planned.
If you are not sure when to inject TEZSPIRE, call your doctor.
Do not take a double dose to make up for the dose you missed.
If you use too much TEZSPIRE
If you are concerned that you have used too much TEZSPIRE, you should contact your
doctor, nurse or pharmacist immediately.
Telephone the Poisons Information Centre
(by calling 13 11 26) for advice if you think that you have taken too much TEZSPIRE.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using TEZSPIRE?
Things you should do
Call your doctor straight away if:
your asthma remains uncontrolled or worsens during treatment with TEZSPIRE
you have had any symptoms of an allergic reaction (symptoms may vary, but can include
breathing problems, hives, and rash).
Remind any doctor, dentist or pharmacist you visit that you are using TEZSPIRE.
Look out for any signs of a possible serious infection while you are taking TEZSPIRE
such as fever, flu-like symptoms, night sweats; cough which will not go away; warm,
red and painful skin, or a painful skin rash with blisters. If you notice any of these
signs, speak to a doctor or nurse immediately.
Look out for any symptoms of a heart problem, such as chest pain; shortness of breath;
a general feeling of discomfort, illness, or lack of well-being; or feeling lightheaded
or faint. If you notice any of these symptoms, speak to a doctor or nurse immediately.
Things you should not do
Do not stop using TEZSPIRE without speaking to your doctor first. Interrupting or
stopping the treatment with TEZSPIRE may cause your asthma symptoms and attacks to
come back.
If you have any further questions on the use of TEZSPIRE, ask your doctor.
Driving or using machines
It is unlikely that TEZSPIRE will affect your ability to drive and use machines.
Looking after your medicine
Store TEZSPIRE in the refrigerator at 2°C to 8°C. Do not freeze, shake or expose to
heat.
TEZSPIRE should be kept in the original package to protect it from light.
TEZSPIRE may be kept at room temperature up to 25°C in the original carton for a maximum
of 30 days. This is important whether travelling by car, bus, train, plane or any
other form of transport. Once TEZSPIRE has reached room temperature, do not put it
back in the refrigerator. Follow the instructions in the carton on how to take care
of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
Dispose of TEZSPIRE that has been stored at room temperature after 30 days.
Do not use this medicine if it has been dropped or damaged, if the security seal on
the carton has been broken or after the expiry date which is stated on the label.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
6. Are there any side effects?
All medicines can have side effects, although not everybody gets them. 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
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Less serious side effects
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What to do
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Sore throat (pharyngitis)
Injection site reaction
(i.e. redness, swelling, and pain)
Joint pain (arthralgia)
Rash
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Allergic reaction - some of the symptoms of an allergic reaction may include:
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
shortness of breath, wheezing or difficulty breathing
fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
Allergic reactions may occur within minutes or hours after an injection or may even
occur several days after an injection.
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Call your doctor or nurse straight away, or go straight to the Emergency Department
at your nearest hospital. You may need urgent medical attention or hospitalisation.
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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 TEZSPIRE contains
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Active ingredient
(main ingredient)
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tezepelumab
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Other ingredients
(inactive ingredients)
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glacial acetic acid,
proline,
polysorbate 80,
sodium hydroxide,
water for injections.
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Do not take this medicine if you are allergic to any of these ingredients.
What TEZSPIRE looks like
TEZSPIRE is a clear to opalescent, colourless to light yellow solution.
TEZSPIRE 210 mg/1.91 mL (100 mg/mL) solution for injection prefilled syringe (Aust
R 427956).
TEZSPIRE 210 mg/1.91 mL (100 mg/mL) solution for injection prefilled pen (Aust R 432812).
TEZSPIRE is available in a pack containing 1 single-use prefilled syringe or 1 single-use
prefilled pen.
Who distributes TEZSPIRE
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342
This leaflet was prepared March 2025.
TEZSPIRE is a trademark of Amgen Inc. and AstraZeneca.
© AstraZeneca 2025
VV-RIM-08308313 v2.0