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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I being given KISUNLA?
KISUNLA contains the active ingredient donanemab. KISUNLA is used to treat the early
stages of Alzheimer's disease in patients who carry one copy of a gene called apolipoprotein
E4, also known as ApoE ɛ4 heterozygotes, or in those who do not carry this gene. Prior
to initiating KISUNLA your doctor will confirm that you have a protein known as beta-amyloid
in your brain by doing a test.
2. What should I know before I am given KISUNLA?
Do not use if you have ever had an allergic reaction to KISUNLA 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?
Some medicines may interfere with KISUNLA and affect how it works.
4. How will KISUNLA be given ?
KISUNLA vial is diluted by your healthcare professional in a specialised centre and
is given through a drip in a vein in your arm (intravenous infusion) at a dose of
350 mg for the first week, 700 mg in the second week, 1050 mg in the third week and
1400 mg every 4 weeks thereafter. Your doctor will decide when to stop KISUNLA.
5. What should I know while using KISUNLA?
|
Things you should do
|
Remind any doctor, nurse, dentist or pharmacist you visit that you are using KISUNLA.
Tell your doctor if are taking any medicine that reduces blood clots.
Tell your doctor if you are feeling unwell.
|
|
Things you should not do
|
KISUNLA has been prescribed for you and should not be used by anyone else.
Do not use KISUNLA to treat any other condition, unless your doctor tells you to.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how KISUNLA
affects you.
|
6. Are there any side effects?
Temporary and sometimes serious swelling and/or bleeding in areas of the brain (ARIA),
headache, infusion-related allergic reactions, nausea and vomiting.
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 .
|
WARNINGS
Monoclonal antibodies, like KISUNLA, target clumps of beta amyloid in the brain. These
treatments can sometimes cause a side effect where swelling (ARIA-E) or bleeding (ARIA-H)
occurs in the brain. This side effect is known as amyloid-related imaging abnormalities
(ARIA). This can be serious or life-threatening. Before treatment your doctor will
discuss possible side effects, including ARIA, and what this means for you. ARIA-E
can cause specific brain problems that look like a stroke. Treatment to dissolve blood
clots should be carefully considered by your doctor.
KISUNLA is not to be used if you have two copies (called being a "homozygote") of
a gene known as ApoE ε4, as there is a higher chance of experiencing the side effect,
ARIA. Before treatment your doctor will discuss genetic testing for ApoE ε4 and what
this will mean for you.
|
Active ingredient: Donanemab
Consumer Medicine Information (CMI)
This leaflet provides important information about using KISUNLA. 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 KISUNLA.
Where to find information in this leaflet:
1. Why am I being given KISUNLA?
KISUNLA contains the active ingredient donanemab. Donanemab is a monoclonal antibody. Monoclonal antibodies are proteins that recognise
and bind specifically to certain proteins in the body.
KISUNLA is used to treat the early stages of Alzheimer's disease in patients who carry
one copy of a gene called apolipoprotein E4, also known as ApoE ɛ4 heterozygotes,
or in those who do not carry this gene.
KISUNLA belongs to a group of medicines called amyloid-targeting antibodies. This
medicine works by removing from the brain a protein called beta-amyloid that is believed
to cause Alzheimer’s disease to advance. Prior to initiating KISUNLA your doctor will
confirm that you have this protein by doing a test.
2. What should I know before I am given KISUNLA?
Warnings
Do not use KISUNLA if:
you have an allergy to donanemab, or any of the ingredients listed at the end of this
leaflet.
you previously had bleeding or swelling in the brain
you have severe white matter disease, a condition where the white matter of the brain
is changed or damaged.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
take any medicines for any other condition including medicines to reduce blood clots
from forming (antithrombotic medicines including aspirin (acetylsalicylic acid))
are on a low salt diet. Each KISUNLA dose is equivalent to 2% of the recommended maximum
daily dietary intake of sodium for an adult.
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 or intend to become pregnant. KISUNLA is
not recommended during pregnancy. The effects of KISUNLA in pregnant women are not
known
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children and adolescents
KISUNLA should not be used in children and adolescents under 18 years of age because
Alzheimer’s disease does not occur in this age group.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are:
taking any other medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
taking medicines to reduce blood clots from forming (antithrombotic medicines including
aspirin (acetylsalicylic acid)).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect KISUNLA.
4. How will KISUNLA be given?
How much and when
KISUNLA is presented as a vial containing a concentrated solution that must be diluted
by a healthcare professional.
Your doses of KISUNLA will be given to you by a healthcare professional in a specialised
centre through a drip in the vein of your arm (intravenous infusion) over approximately
30 minutes.
Your healthcare professional will monitor you for 30 minutes after your infusion for
infusion-related reactions (see
Section 5 and
Section 6).
The intravenous infusion will occur every 4 weeks starting at 350 mg for the first
dose, 700 mg for the second dose, 1050 mg for the third dose, followed by 1400 mg
every 4 weeks. This will continue up to a maximum of 18 months.
Your doctor may change your KISUNLA dose or stop treatment based on your response
to the adjusted dose.
If your KISUNLA dose is missed
If a KISUNLA dose is missed, the missed dose should be administered at the next possible
opportunity by your healthcare professional. Resume KISUNLA dosing every 4 weeks thereafter.
If too much KISUNLA is given to you
KISUNLA will be given to you by a healthcare professional. If you think you have been
accidentally given too much KISUNLA, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, 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 KISUNLA?
Things you should do
Remind any doctor, nurse, dentist or pharmacist you visit that you are using KISUNLA.
Call your doctor straight away if you have:
headache, confusion, vomiting, loss of balance, dizziness, trembling, vision changes,
speech disturbances, worsening of cognitive function (e.g. disorientation, communication
difficulties), light-headedness and loss of consciousness and fits.
These symptoms could be due to Amyloid Related Imaging Abnormalities (ARIA, see below).
Things you should not do
KISUNLA has been prescribed for you and should not be used by anyone else.
Do not use KISUNLA to treat any other condition, unless your doctor tells you to.
Amyloid Related Imaging Abnormalities (ARIA)
You should have had brain magnetic resonance imaging (MRI) within the past 6 months
before you start treatment. During treatment, you will need to have additional MRI
scans at specific times. These include before the second dose, before the third dose,
before the fourth dose, and before the seventh dose. The purpose of these scans is
to monitor for side effects that can occur with KISUNLA, particularly ARIA.
ARIA is a side effect that does not usually cause any symptoms, but serious symptoms
can occur; uncommonly ARIA can be fatal. ARIA is most commonly seen as temporary swelling
in areas of the brain, that usually resolves over time. Some people may also have
small spots of bleeding in or on the surface of the brain, and infrequently in larger
areas in the brain. Most people with this type of swelling or bleeding in the brain
do not get symptoms, however some people may have symptoms as noted under serious
side effects.
ApoE ɛ4 Genetic testing
KINSULA should not be used in patients who carry two copies of the gene ApoE ɛ4 as
this is known to increase the risk of experiencing the side effect ARIA. Your doctor
will send you for genetic testing prior to treatment.
Cerebral amyloid angiopathy
This is a condition where certain proteins damage the blood vessels in the brain and
may lead to bleeding and other serious issues. Your doctor may perform scans on your
brain to check if you suffer or have suffered from this condition.
Infusion related reactions
Your healthcare professional will monitor you for 30 minutes after your infusion for
infusion-related reactions (see
Section 6).
Driving or using machines
Be careful before you drive or use any machines or tools until you know how KISUNLA
affects you.
Looking after KISUNLA
Your healthcare professional will store KISUNLA in a refrigerator between 2°C to 8°C
until time of use.
Your healthcare professional will check the expiry date before use.
Getting rid of any unwanted medicine
Your healthcare professional will safely dispose of KISUNLA.
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
|
Less serious side effects
|
What to do
|
|
Gastrointestinal related:
Nausea
Vomiting
Allergy related:
Infusion-related reaction (mild)
Examples of symptoms may include flushing, chills, headache, chest tightness, difficulty
breathing and muscle aches.
General
Feeling weak or tired
Falls
Broken skin
Weight loss
Muscles feeling achy
Pain in the arms or legs
Dehydration
Passing out, faint
Infections
Mild cold like symptoms, including runny or stuffy nose, mild sore throat, watery
eyes, headache and feeling tired.
Nervous system related:
Headache
Dizziness
Feeling faint
Mood related
Depression
Trouble sleeping
Male
Enlarge prostate, symptoms may include increased urination
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Tell your doctor if you notice any unusual changes to your skin such as shiny lump
that is pearly or clear, pink, red or white; and may appear scaly and dry.
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 KISUNLA contains
|
Active ingredient
(main ingredient)
|
Donanemab
|
|
Other ingredients
(inactive ingredients)
|
Sodium citrate dihydrate
Citric acid
Sucrose
Polysorbate 80
Water for injections
|
If you are allergic to any of these ingredients, tell your doctor or healthcare professional.
What KISUNLA looks like
KISUNLA 350 mg/20mL is supplied in a single use glass vial with a rubber stopper and
aluminum seal. The stopper is not made with natural rubber latex (Aust R 420194).
Who distributes KISUNLA
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street, Sydney, NSW 2000
AUSTRALIA
Phone: 1800 454 559
®= Registered Trademark
If you have any questions about KISUNLA, contact Eli Lilly
at 1800 454 559 (Australia) or your healthcare professional
for assistance.
This leaflet was prepared in May 2025.