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 FASENRA?
FASENRA contains the active ingredient benralizumab. FASENRA is used to treat a type
of asthma - eosinophilic asthma – in adults and children aged 12 years and over.
For more information, see Section
1. Why am I using FASENRA? in the full CMI.
2. What should I know before I use FASENRA?
Do not use if you have ever had an allergic reaction to FASENRA 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? in the full CMI.
3. What if I am taking other medicines?
4. How FASENRA 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 is 30 mg (one injection - as either FASENRA PEN or FASENRA prefilled
syringe) every 4 weeks for the first 3 doses, then one injection every 8 weeks after
that.
Continue FASENRA for as long as your doctor tells you
5. What should I know while using FASENRA?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using FASENRA.
If you have an Asthma Action Plan follow it closely at all times. If your asthma
is uncontrolled or worsening tell your doctor.
|
|
Things you should not do
|
Do not stop using FASENRA unless your doctor advises you to. It is important to keep
using FASENRA even if you feel well.
Do not stop using/reduce the dose of your other asthma medicines unless your doctor
advises you to
|
|
Looking after your medicine
|
Keep FASENRA in the refrigerator (2°C to 8°C). Do not freeze, shake or expose to
heat. Protect from light.
FASENRA may be kept at room temperature up to 25°C for no more than 14 days.
|
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.
This medicine is subject to additional monitoring in Australia. 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:
benralizumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FASENRA prefilled syringe
and FASENRA PEN prefilled pen (collectively called FASENRA in this document). 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.
Where to find information in this leaflet:
1. Why am I using FASENRA?
FASENRA contains the active ingredient benralizumab, a humanised monoclonal antibody
(a type of protein). Benralizumab works by binding to a specific receptor on eosinophils (a type of white
blood cell) called the interleukin-5 (IL-5) receptor. Eosinophils may make your asthma
worse by causing inflammation in the lungs. By binding to this receptor FASENRA reduces
the number of eosinophils in your blood and lungs.
FASENRA 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 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 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 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.
2. What should I know before I use FASENRA?
Warnings
Do not use FASENRA:
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
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), 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 can pass into breast milk. The
effects of FASENRA 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 for children under
the age of 12 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 asthma including preventer and reliever medicines.
Some medicines may interfere with FASENRA and affect how it works.
FASENRA has been used together with other commonly used asthma medicines. Do not suddenly stop taking your asthma medicines once you have started FASENRA. Some medicines (especially corticosteroids) must be stopped gradually, under the
supervision of your doctor and based on your response to FASENRA.
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.
4. How FASENRA is given?
How much is given and how long to take it
Adults and adolescents (12 years and over)
30 mg (one injection - as either FASENRA PEN or FASENRA prefilled syringe)
every 4 weeks for the first 3 doses,
then one injection every 8 weeks after that
Continue FASENRA for as long as your doctor tells you.
FASENRA helps to control your asthma but does not cure it. It is important to keep
taking your medicine even if you feel well.
How to give FASENRA
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 and FASENRA prefilled syringes carefully
before using FASENRA. Follow all directions given to you/your caregiver by your doctor or nurse carefully.
FASENRA 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 immediately throw away the used prefilled syringe or prefilled
pen (autoinjector) in a special 'sharps' disposal container as instructed by your
doctor, nurse or pharmacist.
If you forget to take FASENRA
If you have missed a dose of FASENRA 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
If FASENRA 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, 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 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?
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. If you are going to have surgery, tell the surgeon or
anaesthetist that you are using FASENRA. 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 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 unless your doctor advises you to. Interrupting or stopping
FASENRA treatment may cause your asthma symptoms and asthma attacks to come back or
become more frequent.
Do not stop using or reduce the dose of your other asthma 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.
Driving or using machines
FASENRA is not expected to affect your ability to drive a car or operate machinery.
Looking after your medicine
Keep FASENRA in the refrigerator at 2°C to 8°C. Do not freeze, shake or expose to
heat. FASENRA should be kept sealed in the original package to protect it from light.
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.
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
|
Less serious side effects
|
What to do
|
|
headache
sore throat
fever/high temperature
injection site reactions (eg pain, redness, itching, swelling near where the injection
was given).
|
Speak to your doctor, nurse of pharmacist if you have any of these less serious side
effects and they worry you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
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.
|
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.
|
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 FASENRA contains
|
Active ingredient
(main ingredient)
|
Benralizumab, 30 mg
|
|
Other ingredients
(inactive ingredients)
|
histidine
histidine hydrochloride monohydrate
trehalose
polysorbate 20
water for injections
|
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 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).
FASENRA prefilled syringe (AUST R 285718) contains 1 mL of solution in a clear glass
type I prefilled syringe. Its colour may vary from colourless to yellow, and it may
contain white particles.
The glass prefilled syringe includes a stainless-steel needle, with a FluoroTec (non-latex)
coated plunger stopper and a needle safety guard.
FASENRA prefilled syringe is available in packs containing 1 prefilled syringe (a
single dose).
Who distributes FASENRA
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:- 09 306 5650
This leaflet was prepared 9 May 2022
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 and FASENRA PEN are trade marks of the AstraZeneca group of companies.
© AstraZeneca, 2022
Doc ID-003812071 v5