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 VERZENIO?
VERZENIO contains the active ingredient abemaciclib. VERZENIO is used to treat patients
with certain types of breast cancer which have not spread to other parts of the body
or spread beyond the original tumour and/or to other organs.
2. What should I know before I use VERZENIO?
Do not use if you have ever had an allergic reaction to VERZENIO 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 VERZENIO and affect how it works.
4. How do I use VERZENIO?
Swallow tablet whole with a full glass of water
Do not chew, crush or split the tablets before swallowing. VERZENIO may be taken with
or without food.
5. What should I know while using VERZENIO?
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Things you should do
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Remind any doctor, dentist, pharmacist or anaesthetist you visit that you are using
VERZENIO.
If you become pregnant while taking this medicine, tell your doctor immediately.
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Things you should not do
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Do not stop using this medicine or lower the dosage without checking with the doctor.
Do not take grapefruit products while on this therapy as it may increase the side
effects.
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Driving or using machines
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This medicine may cause fatigue and dizziness in some people.
If you have any of these symptoms, do not drive or operate machinery.
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Drinking alcohol
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Be careful when drinking alcohol while you are taking this medicine.
This medicine may cause fatigue and dizziness in some people.
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Looking after your medicine
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Keep your tablets in a cool dry place where the temperature stays below 30°C.
Keep your tablets in the pack until it’s time to take them.
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6. Are there any side effects?
Very common: diarrhoea, infections, nausea, feeling tired, vomiting, decreased appetite,
hair loss, alteration in taste, dizziness, dry mouth, rash, itching.
Serious side effects: fever or chills, blood clots in the veins or lung inflammation.
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:
Abemaciclib
Consumer Medicine Information (CMI)
This leaflet provides important information about using VERZENIO. 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 VERZENIO.
Where to find information in this leaflet:
1. Why am I using VERZENIO?
VERZENIO contains the active ingredient abemaciclib. VERZENIO belongs to a group of medicine called antineoplastic drugs, an anticancer
drug.
VERZENIO is used to treat patients with certain types of breast cancer (hormone receptor-positive
(HR+), human epidermal growth factor receptor 2-negative (HER2-) which have not spread
to other parts of the body (early breast cancer) or spread beyond the original tumour
and/or to other organs (metastatic breast cancer).
2. What should I know before I use VERZENIO?
Warnings
Do not use VERZENIO if:
you are allergic to abemaciclib, or any of the ingredients listed at the end of this
leaflet.
always check the ingredients to make sure you can use this medicine.
you have an intolerance to some sugars. VERZENIO contains lactose (a type of sugar
found in milk and dairy products).
Check with your doctor if you:
have any other medical conditions. Severe liver problems; blood clots in the veins
or arteries, infections, inflammation and infection of the lung
take any medicines for any other condition.
pregnant or breast feeding.
a family history of blood clots.
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
Do not take this medicine if you are pregnant. It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
It is not known if VERZENIO is excreted into breast milk and if the breast-fed infant
is at risk of harm. Talk to your doctor about breast-feeding during or after treatment
with VERZENIO.
VERZENIO may decrease fertility in men.
Child or adolescent
Do not give this medicine to a child or adolescent under the age of 18 years. Safety and effectiveness in children younger than 18 years have not been established.
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.
Some medicines may interfere with VERZENIO and affect how it works, or VERZENIO may
affect how other medicines work.
These can either increase or decrease the amount of abemaciclib in the blood.
Medicines that may
increase
the effect of VERZENIO include:
Clarithromycin (antibiotic used to treat bacterial infections).
Ketoconazole, itraconazole, voriconazole, posaconazole (used to treat fungal infections).
Diltiazem (used to treat chest pain (angina) and high blood pressure).
Verapamil (used to treat chest pain (angina), high blood pressure and heart rhythm
problems).
Lopinavir/ritonavir (used to treat HIV/AIDS).
Do not take grapefruit products while on this therapy as it may increase the side
effects of VERZENIO.
Medicines that may
reduce
the effect of VERZENIO include:
Carbamazepine, phenytoin (used to treat epilepsy to prevent convulsions, fits).
Rifampicin (used to treat tuberculosis (TB))
St. John’s wort (a herbal product used to treat mild depression and anxiety).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VERZENIO.
4. How do I use VERZENIO?
How much to take / use
Follow all directions given to you by your doctor or pharmacist carefully. They may
differ from the information contained in this leaflet.
When given together with endocrine therapy to treat your breast cancer, the recommended
dose of VERZENIO is 150 mg orally, twice daily.
Swallow the tablet whole with a full glass of water. Do not chew, crush or split the tablets before swallowing. VERZENIO may be taken
with or without food. Avoid grapefruit products.
Women treated with the combination of VERZENIO plus endocrine therapy should be in
a postmenopausal state prior to therapy.
When to take / use VERZENIO
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It ensures that there
is enough VERZENIO in your body all the time. It will also help you remember when
to take it.
For early breast cancer your doctor will advise you to take VERZENIO for adjuvant
treatment for up to 2 years unless advised otherwise.
For metastatic breast cancer treatment should be continued until disease progression
or unacceptable toxicity. Consult your doctor regarding adverse events.
If you forget to use VERZENIO
VERZENIO should be used regularly at the same time each day. If you miss (vomit) a
dose, take your next dose at its scheduled time.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you use too much VERZENIO
If you think that you have used too much VERZENIO, 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 VERZENIO?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking VERZENIO.
Call your doctor straight away if you:
become pregnant.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine. It may interfere with the results of some tests.
Remind any doctor, dentist or pharmacist you visit that you are using VERZENIO.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
have diarrhoea
At the first sign of diarrhoea, tell your doctor or pharmacist. Your healthcare provider
may tell you to temporarily stop taking VERZENIO, stop your treatment, or decrease
your dose. - Diarrhea may cause you to develop dehydration or an infection.
If you have any loose stools, right away tell your healthcare provider, start taking
an antidiarrheal medicine (such as loperamide), and drink more fluids.
Things you should not do
Do not take VERZENIO 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 taking your medicine or lower the dosage without checking with your doctor.
If necessary, your doctor will gradually reduce the amount you take each day before
stopping the medicine completely.
Do not take grapefruit products while on this therapy as it may increase the side
effects of VERZENIO.
Blood tests
Your doctor will perform a blood test before and during treatment to check whether
VERZENIO affects the number of white cells in your blood or the concentration in your
blood of enzymes that come from your liver. VERZENIO may reduce the number of white
blood cells and produce abnormalities in liver blood tests.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VERZENIO
affects you.
This medicine may cause fatigue and dizziness in some people. If you experience any
symptoms affecting your ability to concentrate and react, do not drive or use machines
until the effect goes away.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while you are taking this medicine as this medicine
may cause fatigue and dizziness in some people.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
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 sill.
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.
Your doctor may lower your dose or stop treatment temporarily to try to reduce certain
side effects while you are taking VERZENIO.
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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Stomach-related:
diarrhoea
vomiting
feeling sick (nausea)
dry mouth
inflammation of the mouth and lips (stomatitis)
Skin-related:
rash
itching
dry skin
Infection-related:
Infections
Eye-related:
watering eyes
Brain related:
alteration in sense of taste
dizziness
headache
General symptoms:
tiredness
inflammation of the lungs which causes breathlessness, cough and raised temperature
muscular weakness
hair loss
Metabolism and nutrition related
decreased appetite
abnormalities in liver blood tests
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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
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.
These side effects may not be fully attributable to VERZENIO alone but may be caused
by your condition or by other medicines that you may be taking at the same time.
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 VERZENIO contains
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Active ingredient
(main ingredient)
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abemaciclib
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Other ingredients
(inactive ingredients)
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croscarmellose sodium
lactose monohydrate
microcrystalline cellulose
silicon dioxide
sodium stearyl fumarate
polyvinyl alcohol (E1203)
titanium dioxide (E171)
macrogol 3350 (E1521)
purified talc (E553b)
iron oxide yellow (E172) [50 mg and 150 mg tablets only]
iron oxide red (E172) [50 mg tablets only]
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Do not take this medicine if you are allergic to any of these ingredients.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Contains lactose.
What VERZENIO looks like
VERZENIO is a modified oval immediate-release film coated tablet with “Lilly” debossed
on one side and tablet strength in mg debossed on the other.
50 mg tablets are beige in colour (Aust R 304765)
100 mg tablets are white in colour (Aust R 304767)
150 mg tablets are yellow in colour (Aust R 304766)
Who distributes VERZENIO
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street
Sydney NSW 2000
AUSTRALIA
™ = Trademark
If you have any questions about VERZENIO, contact Eli Lilly at 1800 454 559 (Australia)
or your healthcare professional for assistance.
This leaflet was prepared in October 2023
vA07