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.
1. Why am I using FASENRA?
FASENRA PEN contains the active ingredient benralizumab. FASENRA PEN is used to treat
a type of asthma - eosinophilic asthma – in adults and children aged 12 years and
over, or eosinophilic granulomatosis with polyangiitis (EGPA) in adults aged 18 years
and over.
For more information, see Section
1. Why am I using FASENRA PEN? in the full CMI.
2. What should I know before I use FASENRA PEN?
Do not use if you have ever had an allergic reaction to FASENRA PEN or any of the
ingredients listed at the end of the CMI.
Do not use to treat acute asthma symptoms such as a sudden asthma attack. You will
still need your reliever puffer/inhaler.
Tell your doctor if you have, or have had, an infection caused by parasites (eg parasitic
worms) or if you live in/are travelling to an area where parasitic infections are
common.
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 use FASENRA PEN? in the full CMI.
3. What if I am taking other medicines?
4. How FASENRA PEN is given?
Your doctor or nurse may have recommended that you/your caregiver can give your subcutaneous
(under the skin) injection, or it may be given to you by a healthcare professional.
The recommended dose for asthma is 30 mg (one injection of FASENRA PEN) every 4 weeks
for the first 3 doses, then one injection every 8 weeks after that.
The recommended dose for EGPA is 30 mg (one injection of FASENRA PEN) every 4 weeks.
Continue FASENRA PEN for as long as your doctor tells you.
More instructions can be found in Section
4. How FASENRA PEN is given? in the full CMI.
5. What should I know while using FASENRA PEN?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using FASENRA PEN.
If you have an Asthma Action Plan follow it closely at all times. If your asthma is
uncontrolled or worsening tell your doctor.
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Things you should not do
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Do not stop using FASENRA PEN unless your doctor advises you to. It is important to
keep using FASENRA PEN even if you feel well.
Do not stop using/reduce the dose of your other medicines unless your doctor advises
you to
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Looking after your medicine
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Keep FASENRA PEN in the refrigerator (2°C to 8°C). Do not freeze, shake or expose
to heat. Protect from light.
FASENRA PEN may be kept at room temperature up to 25°C for no more than 14 days.
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6. Are there any side effects?
Call your doctor or nurse straight away, or go straight to the Emergency Department
at your nearest hospital if you have symptoms of an allergic reaction. Allergic reactions
may occur within minutes or hours after an injection or may even occur several days
after an injection.
Less serious side effects include headache, sore throat, fever/high temperature and
injection site reactions.
Active ingredient:
benralizumab
Consumer Medicine Information (CMI)
This leaflet provides important information about using FASENRA PEN prefilled pen.
You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using FASENRA PEN.
Where to find information in this leaflet:
1. Why am I using FASENRA PEN?
FASENRA PEN contains the active ingredient benralizumab, a monoclonal antibody (a
type of protein). Benralizumab works by binding to a specific receptor on eosinophils called the interleukin-5
(IL-5) receptor. By binding to this receptor, FASENRA PEN reduces blood eosinophils.
Eosinophils are a type of white blood cell involved in inflammation of asthma and
eosinophilic granulomatosis with polyangiitis (EGPA).
Asthma
FASENRA PEN is used in adults and adolescents (12 years of age and older) to treat
a type of asthma – eosinophilic asthma – which is where patients have too many eosinophils
in the blood and lungs. FASENRA PEN is used together with other asthma medicines you
take regularly to treat your asthma (inhaled corticosteroids plus other asthma medicines
– for example a daily preventer puffer/inhaler).
If you are already using other asthma medicines (such as your daily preventer puffer/inhaler)
but your asthma is not well controlled by these medicines, then FASENRA PEN may help
to reduce the number of asthma attacks (exacerbations) and may also make it easier
for you to breathe normally. If you are taking medicines called oral corticosteroids
(eg prednisolone) FASENRA PEN may also help reduce the oral corticosteroid dosage
you need to take each day to control your asthma.
You must not stop taking or reduce the dose of your other asthma medicines unless
your doctor advises you to.
Eosinophilic granulomatosis with polyangiitis (EGPA)
FASENRA PEN is used to treat EGPA in adults (18 years of age and older). EGPA is a
condition where people have too many eosinophils in the blood and tissues and also
have a form of vasculitis (inflammation of the blood vessels). This condition most
commonly affects the lungs and sinuses but often affects other organs such as the
skin, heart and kidneys.
FASENRA PEN can reduce symptoms and prevent flare-ups of EGPA. It may also help reduce
the daily dose of oral corticosteroids you need to control your symptoms.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
2. What should I know before I use FASENRA PEN?
Warnings
Do not use FASENRA PEN:
If you are allergic to benralizumab, or any of the ingredients listed at the end of
this leaflet. Always check the ingredients to make sure you can use this medicine.
To treat acute asthma symptoms such as a sudden asthma attack. You will still need
your reliever puffer/inhaler.
Check with your doctor, nurse of pharmacist if you:
have, or have had, an allergic reaction to benralizumab
have, or have had, an infection caused by parasites (eg parasitic worms) or if you
live in/are travelling to an area where parasitic infections are common as this medicine
may weaken your ability to fight certain types of parasitic infections. The parasitic
infection should be treated before you are given FASENRA PEN
have any other medical conditions
take any medicines for any other condition
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?
Asthma action plan
Your doctor or nurse should give you a personal Asthma Action Plan to help manage
your asthma. This plan will include what medicines to use regularly to control your
asthma (eg preventer puffers/inhalers, as well as FASENRA PEN), as well as what reliever
medicines to use when you have sudden asthma attacks.
Ask your doctor, nurse or pharmacist if you have any questions about your personal
Asthma Action Plan.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known whether the ingredients of FASENRA PEN can pass into breast milk.
The effects of FASENRA PEN in pregnant women or their unborn babies are not known.
Your doctor can discuss with you the risks and benefits involved.
Children
There is not enough information to recommend the use of FASENRA PEN for children with
asthma under the age of 12 years.
There is not enough information to recommend the use of FASENRA PEN for children and
adolescents with EGPA under the age of 18 years.
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. This includes all the medicines that you use for
your conditions.
Some medicines may interfere with FASENRA PEN and affect how it works.
FASENRA PEN has been used together with other commonly used medicines for asthma and
EGPA. Do not suddenly stop taking your other medicines once you have started FASENRA PEN. Some medicines (especially corticosteroids) must be stopped gradually, under the
supervision of your doctor and based on your response to FASENRA PEN.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FASENRA PEN.
4. How FASENRA PEN is given?
How much is given and how long to take it
Asthma
Adults and adolescents (12 years and over)
30 mg (one injection of FASENRA PEN)
every 4 weeks for the first 3 doses,
then one injection every 8 weeks after that
EGPA
Adults (18 years and over)
30 mg (one injection of FASENRA PEN) every 4 weeks
Continue FASENRA PEN for as long as your doctor tells you.
FASENRA PEN helps to control your condition but does not cure it. It is important
to keep taking your medicine even if you feel well.
How to give FASENRA PEN
If your doctor or nurse have recommended that you/your caregiver can give your injection,
make sure you/your caregiver reads the Instructions for Use leaflet included in each pack of FASENRA PEN carefully before using FASENRA PEN.
Follow all directions given to you/your caregiver by your doctor or nurse carefully.
FASENRA PEN is given as an injection into the fat layer just under the skin (subcutaneous).
The injections are usually given in your thigh or abdomen, however when given by someone
else (for example a caregiver or your doctor, nurse or pharmacist), it may also be
given in the upper arm.
Do not try to inject yourself in the arm.
After injecting FASENRA PEN immediately throw away the used prefilled pen (autoinjector)
in a special 'sharps' disposal container as instructed by your doctor, nurse or pharmacist.
If you forget to take FASENRA PEN
If you have missed a dose of FASENRA PEN contact your doctor, nurse or pharmacist
as soon as possible. They will tell you what you need to do. You may need to reschedule your appointment
if your injection is given to you by a doctor or nurse. If you/your caregiver give the injection, do not take your missed dose unless your
doctor, nurse or pharmacist tell you to.
If you have trouble remembering your appointments or when to inject yourself, ask
your doctor, nurse or pharmacist for some hints.
If you are given too much FASENRA PEN
If FASENRA PEN is given under the close supervision of a doctor, nurse or pharmacist
it is unlikely that you will be given too much.
If you are concerned that you have been given too much FASENRA PEN, tell your doctor,
nurse or pharmacist immediately as you may need urgent medical attention.
If you think that you or anyone else may have taken too much FASENRA PEN you should
immediately:
contact your doctor, or
phone the Poisons Information Centre in Australia
(by calling
13 11 26) or the National Poisons Centre in New Zealand (by calling 0800 POISON or 0800 764 766), 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 using FASENRA PEN?
Things you should do
If you have an Asthma Action Plan follow it closely at all times. If your asthma is
uncontrolled or worsening tell your doctor.
Remind any doctor, dentist, nurse, pharmacist or other health professional you visit
that you are using FASENRA PEN. If you are going to have surgery, tell the surgeon
or anaesthetist that you are using FASENRA PEN. It may affect other medicines used
during surgery.
If you are about to have any blood tests, tell your doctor that you are having this
medicine. It may interfere with the results of some tests.
Keep all of your doctor's and/or hospital's appointments so that you don't miss any
doses and your progress can be checked.
Things you should not do
Do not have FASENRA PEN to treat any other complaints unless your doctor tells you
to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop having FASENRA PEN unless your doctor advises you to. Interrupting or
stopping FASENRA PEN treatment may cause your symptoms and flare-ups to come back
or become more frequent.
Do not stop using or reduce the dose of your other medicines unless your doctor advises
you to. Some medicines (especially corticosteroids) must be stopped gradually, under
the supervision of your doctor and on your response to FASENRA PEN.
Driving or using machines
FASENRA PEN is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep FASENRA PEN in the refrigerator at 2°C to 8°C. Do not freeze, shake or expose
to heat. FASENRA PEN should be kept sealed in the original package to protect it from
light.
FASENRA PEN may be kept at room temperature up to 25°C for no more than 14 days. This
is important whether travelling by car, bus, train, plane or any other form of transport.
FASENRA PEN must be used within 14 days or discarded.
There is a space on the carton to write the date it is removed from the refrigerator.
Follow the instructions in the carton and Instructions for Use leaflet on how to take care of your medicine properly.
Keep it where young children cannot reach it.
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.
Do not use this medicine after the expiry date.
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, nurse 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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headache
sore throat
fever/high temperature
injection site reactions (eg pain, redness, itching, swelling near where the injection
was given).
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Speak to your doctor, nurse of pharmacist 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
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 FASENRA PEN contains
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Active ingredient
(main ingredient)
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Benralizumab, 30 mg
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Other ingredients
(inactive ingredients)
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histidine
histidine hydrochloride monohydrate
trehalose
polysorbate 20
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain latex, lactose, sucrose, gluten, tartrazine or any
other azo dyes.
What FASENRA PEN looks like
FASENRA PEN (AUST R 313902) contains 1 mL of solution in a clear glass type I prefilled
syringe inside a pen (autoinjector). Its colour may vary from colourless to yellow,
and it may contain white particles.
The pen includes a stainless-steel needle, with a FluoroTec (non-latex) coated plunger
stopper and a needle safety guard inside the pen (autoinjector).
FASENRA PEN is available in packs containing 1 FASENRA PEN (a single dose).
Who distributes FASENRA PEN
Australia
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
New Zealand
AstraZeneca Limited
PO Box 87453, Meadowbank
Auckland 1742.
Telephone:- 0800 684 432
This leaflet was prepared on 12 March 2025.
The Australian Product Information document prepared for use by healthcare providers
can be found on the Therapeutic Goods Administration (TGA) website –
www.ebs.tga.gov.au/ . The New Zealand Data Sheet is available at
www.medsafe.govt.nz
FASENRA PEN is a trade mark of the AstraZeneca group of companies.
© AstraZeneca, 2025
VV-RIM-01426682 v7
Instructions for Use
FASENRA PEN™
benralizumab 30mg/1mL
For subcutaneous injection only
Single-dose pre-filled pen
You and your doctor or nurse should decide if you should inject Fasenra yourself.
You or your caregiver should receive training on the right way to prepare and inject
Fasenra. Follow all directions given to you by your doctor or nurse carefully.
Read this Instructions for Use booklet carefully all the way to the end before you
start using your Fasenra Pen and each time you get a new Fasenra Pen. There may be new information. This information does not take the place of talking
to your doctor, nurse or pharmacist about your medical condition or your treatment.
You should also read the Consumer Medicine Information (CMI; included in the pack)
for further information about this medicine such as what it is used for, possible
side effects and when to use it. More recent information may be available – the most
recent CMI is available from your pharmacist and also at www.astrazeneca.com.au/CMI
(Australia) or www.medsafe.govt.nz (New Zealand).
If you or your caregiver have any questions about Fasenra or your medical condition
talk to your doctor, nurse or pharmacist. You can also contact the Asthma Foundation
in your State who provide information about asthma treatment and management.
Important Information
Store your Fasenra Pen in a refrigerator between 2°C to 8°C. To protect it from light
it should be stored in its carton until you are ready to use it. Fasenra may be kept at room temperature up to 25°C for no more than 14 days. This
is important whether travelling by car, bus, train, plane or any other form of transport.
Fasenra must be used within 14 days or discarded (see Step 10 - Dispose of the used
Fasenra Pen safely). There is a space on the carton to write the date it is removed
from the refrigerator.
Do not use your Fasenra Pen if:
it has been frozen
if the pen itself has been dropped or damaged
the security seal on the carton has been broken or the packaging has been torn or
shows signs of tampering, or there are visible signs of deterioration of the products
the expiry date (EXP) printed on the pack has passed
Do not:
shake your Fasenra Pen
share or re-use your Fasenra Pen
If any of the above happens, throw away the Fasenra Pen in a puncture-resistant (sharps)
container (see Step 10 - Dispose of the used Fasenra Pen safely) and use a new Fasenra
Pen.
Each Fasenra Pen contains 1 dose of Fasenra that is for one-time use only.
Keep Fasenra and all medicines out of the sight and reach of children.
Your Fasenra Pen
Do not remove the cap until you have reached Step 6 of these instructions and are ready
to inject Fasenra.
Step 1 - Gather Supplies
Before your injection, gather the following and set up on a clean, flat surface:
Your Fasenra Pen, which may need to be removed from the refrigerator
The following items which are not included within your Fasenra pack:
a new alcohol wipe
a new, clean, dry cotton ball or gauze
a puncture-resistant sharps container. (See Step 10 – Dispose of the used Fasenra
Pen safely)
Step 2 - Prepare to use your Fasenra Pen
Check the expiry date (EXP) on the pack. Do not use if the expiry date has passed.
If your Fasenra Pen has been in the refrigerator, let it warm up at room temperature
for about 30 minutes before giving the injection.
Do not warm the Fasenra Pen in any other way. For example, do not warm it in a microwave
or hot water, direct sunlight or put it near other heat sources.
Use Fasenra Pen within 14 days of removing from the refrigerator.
Do not remove the cap until you have reached Step 6.
Step 3 - Check the liquid
Look at the liquid in the Fasenra Pen through the viewing window. The liquid should be clear and colourless to yellow. It may contain small white particles.
Do not inject Fasenra if the liquid is cloudy, discoloured, or contains large particles.
You may see a small air bubble in the liquid. This is normal. You do not need to do
anything about it.
Step 4 - Choose the injection site
The recommended injection site is the front of your thigh. You may also use the lower
part of your abdomen.
Do not inject:
into the 5 cm area around your belly-button
where the skin is tender, bruised, scaly or hard
into scars or damaged skin
through clothing
A caregiver may inject you in the upper-arm, thigh, or abdomen. Do not try to inject yourself in the arm.
For each injection, choose a different site that is at least 3 cm away from where
you last injected.
Step 5 - Clean the injection site
Wash your hands well with soap and water.
Clean the injection site with an alcohol wipe in a circular motion. Let it air dry.
Do not touch the cleaned area before injecting.
Do not fan or blow on the cleaned area.
Step 6 - Pull off the cap
Hold the Fasenra Pen with 1 hand. Carefully pull the cap straight off with your other
hand.
Put the cap aside to throw away later.
The green needle guard is now exposed. It is there to prevent you from touching the
needle.
Do not try to touch the needle or push on the needle guard with your finger.
Do not try to put the cap back on the Fasenra Pen. You could cause the injection to happen
too soon or damage the needle.
Complete the following steps right away after removing the cap.
Step 7 - Inject Fasenra
Follow your doctor, nurse or pharmacist’s instructions on how to inject. You can either
gently pinch at the injection site or give the injection without pinching the skin.
Inject Fasenra by following the steps in figures a, b, c and d.
Hold the Fasenra Pen in place for the entire injection.
Do not change the position of the Fasenra Pen after the injection has started.
Position the Fasenra Pen at the injection site
Place the needle guard of the Fasenra Pen flat against your skin (90-degree angle).
Make sure you can see the viewing window.
Press down firmly.
You will hear a click. A ‘click’ tells you the injection has started. The green plunger
will move down in the viewing window during the injection.
Hold down firmly for 15 seconds.
You will hear a second ‘click’. The second click tells you the injection has finished.
The green plunger will fill the viewing window.
Lift the Fasenra Pen straight up.
The needle guard will slide down and lock into place over the needle.
Step 8 - Check the viewing window
Check the viewing window to make sure all the liquid has been injected.
If the green plunger does not fill the viewing window, you may not have received the
full dose. If this happens or if you have any other concerns, call your doctor, nurse
or pharmacist.
Step 9 - Check the injection site
There may be a small amount of blood or liquid where you injected. This is normal.
Gently hold pressure over your skin with a cotton ball or gauze until the bleeding
stops.
Do not rub the injection site.
If needed, cover the injection site with a Band-Aid/plaster.
Step 10 - Dispose of the used Fasenra Pen safely
Each Fasenra Pen contains a single dose of Fasenra and cannot be re-used.
Put your used Fasenra Pen in a puncture-resistant sharps container right away after
use.
The sharps container needs to be a puncture-resistant container that is large enough
to hold the entire Fasenra Pen. Be sure that the container has a lid. You may use
a biohazard container, another hard-plastic container or a metal container.
A container is not included in the carton. Your pharmacist may have biohazard/sharps
containers for purchase or can tell you where you may be able to get them or what
else you may be able to use. Your pharmacist can also tell you how to safely throw
away the container with used syringes.
Do not throw away the Fasenra Pen in your household rubbish or recycling bin.
You can throw away the cap and other used supplies in your household rubbish.
Do not throw away your used sharps container in your household rubbish or recycling bin.
For all enquiries contact AstraZeneca on 1800 805 342 (Australia) or 09 306 5650 (New
Zealand).
This Instructions for use booklet was prepared on the 27 April 2022.
FASENRA and FASENRA PEN are trade marks of the AstraZeneca group of companies
© AstraZeneca, 2022
Doc ID-003941655 v5